Infectious Disease Practitioner

Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.

A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.

Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.

The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).

The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.

They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
 

Populations in danger

The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.

Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
 

Pollution risks

In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.

Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.

Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.

“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.

Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.

A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.

Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.

The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).

The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.

They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
 

Populations in danger

The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.

Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
 

Pollution risks

In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.

Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.

Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.

“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.

Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.

A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.

Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.

The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).

The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.

They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
 

Populations in danger

The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.

Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
 

Pollution risks

In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.

Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.

Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.

“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.

A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.

BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.

According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.

“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”

According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.

Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.

“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”

Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
 

Good news, but…

In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”

President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.

“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.

“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
 

This article first appeared on Medscape.com.

A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.

BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.

According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.

“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”

According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.

Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.

“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”

Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
 

Good news, but…

In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”

President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.

“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.

“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
 

This article first appeared on Medscape.com.

A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.

BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.

According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.

“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”

According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.

Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.

“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”

Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
 

Good news, but…

In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”

President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.

“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.

“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
 

This article first appeared on Medscape.com.

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the United States, according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.

Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.

Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.

“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”

According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.

Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.

“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.

It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.

In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.

Military health facilities are held to the same standards as private research facilities, he said.

No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.

Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.

That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.

To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.

In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.

At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.

Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.

The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.

Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.

But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.

“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.

The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.

The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.

Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.

“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”

Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the United States, according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.

Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.

Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.

“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”

According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.

Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.

“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.

It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.

In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.

Military health facilities are held to the same standards as private research facilities, he said.

No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.

Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.

That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.

To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.

In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.

At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.

Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.

The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.

Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.

But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.

“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.

The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.

The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.

Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.

“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”

Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the United States, according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.

Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.

Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.

“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”

According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.

Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.

“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.

It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.

In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.

Military health facilities are held to the same standards as private research facilities, he said.

No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.

Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.

That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.

To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.

In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.

At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.

Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.

The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.

Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.

But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.

“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.

The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.

The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.

Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.

“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”

Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Supreme Court on Tuesday will hear oral arguments in a case that, for the third time in eight years, could result in the justices striking down the Affordable Care Act.

ETIENJones/thinkstockphotos

The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.

After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.

Here are some key questions and answers about the case.
 

What are the possibilities for how the court could rule?

There is a long list of ways this could play out.

The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.

First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.

The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.

Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.

It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.

Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.

Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.

While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
 

What impact will new Justice Amy Coney Barrett have?

Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.

But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
 

Could a new president and Congress make the case go away?

Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.

Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.

“The problem is not technical,” said Bagley. “It’s political.”
 

What is the timeline for a decision? Could the court delay implementation of its ruling?

The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”

As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”

If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Supreme Court on Tuesday will hear oral arguments in a case that, for the third time in eight years, could result in the justices striking down the Affordable Care Act.

ETIENJones/thinkstockphotos

The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.

After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.

Here are some key questions and answers about the case.
 

What are the possibilities for how the court could rule?

There is a long list of ways this could play out.

The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.

First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.

The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.

Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.

It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.

Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.

Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.

While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
 

What impact will new Justice Amy Coney Barrett have?

Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.

But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
 

Could a new president and Congress make the case go away?

Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.

Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.

“The problem is not technical,” said Bagley. “It’s political.”
 

What is the timeline for a decision? Could the court delay implementation of its ruling?

The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”

As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”

If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Supreme Court on Tuesday will hear oral arguments in a case that, for the third time in eight years, could result in the justices striking down the Affordable Care Act.

ETIENJones/thinkstockphotos

The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty – a tax – that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.

After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.

Here are some key questions and answers about the case.
 

What are the possibilities for how the court could rule?

There is a long list of ways this could play out.

The justices could declare the entire law unconstitutional – which is what a federal district judge in Texas ruled in December 2018. But legal experts say that’s not the most likely outcome of this case.

First, the court may avoid deciding the case on its merits entirely by ruling that the plaintiffs do not have “standing” to sue. The central issue in the case is whether the requirement in the law to have insurance – which remains even though Congress eliminated the penalty or tax – is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.

The court could also rule that, by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers “didn’t mean to coerce anyone to do anything, and so there’s no constitutional problem,” University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund, and the University of Southern California’s Center for Health Journalism.

Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.

It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.

Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it – which happen to include the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.

Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.

While that’s not the most likely outcome, said Bagley, if it happens it could be “a hot mess” for the nation’s entire health care system. As just one example, he said, “every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?”
 

What impact will new Justice Amy Coney Barrett have?

Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That’s because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.

But with Barrett replacing Ginsburg, even if Roberts joined the court’s remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October, but she has written that she thinks Roberts was wrong to uphold the law in 2012.
 

Could a new president and Congress make the case go away?

Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department’s job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that’s not the same as dropping the case.

Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a “severability” provision saying that, if any portion of the law is struck down, the rest should remain.

“The problem is not technical,” said Bagley. “It’s political.”
 

What is the timeline for a decision? Could the court delay implementation of its ruling?

The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion “sometime in the spring.”

As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. “That practice has been more or less abandoned,” he said, but in the case of a law so large, “you could imagine the Supreme Court using its discretion to say the decision wouldn’t take effect immediately.”

If the court does invalidate the entire ACA, Congress could act to fix things, but it’s unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, “I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn’t come to a deal, and we’re back to where we were before 2010” when the ACA passed.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

People taking even low-dose methotrexate need tuberculosis screening and ongoing clinical care if they live in areas where TB is common, results of a study presented at the virtual annual meeting of the American College of Rheumatology suggest.

Coauthor Carol Hitchon, MD, MSc, a rheumatologist with the University of Manitoba in Winnipeg, who presented the findings, warned that methotrexate (MTX) users who also take corticosteroids or other immunosuppressants are at particular risk and need TB screening.

Current management guidelines for rheumatic disease address TB in relation to biologics, but not in relation to methotrexate, Dr. Hitchon said.

“We know that methotrexate is the foundational DMARD [disease-modifying antirheumatic drug] for many rheumatic diseases, especially rheumatoid arthritis,” Dr. Hitchon noted at a press conference. “It’s safe and effective when dosed properly. However, methotrexate does have the potential for significant liver toxicity as well as infection, particularly for infectious organisms that are targeted by cell-mediated immunity, and TB is one of those agents.”

Using multiple databases, researchers conducted a systematic review of the literature published from 1990 to 2018 on TB rates among people who take less than 30 mg of methotrexate a week. Of the 4,700 studies they examined, 31 fit the criteria for this analysis.

They collected data on tuberculosis incidence or new TB diagnoses vs. reactivation of latent TB infection as well as TB outcomes, such as pulmonary symptoms, dissemination, and mortality.

They found a modest increase in the risk of TB infections in the setting of low-dose methotrexate. In addition, rates of TB in people with rheumatic disease who are treated with either methotrexate or biologics are generally higher than in the general population.

They also found that methotrexate users had higher rates of the type of TB that spreads beyond a patient’s lungs, compared with the general population.

Safety of INH with methotrexate

Researchers also looked at the safety of isoniazid (INH), the antibiotic used to treat TB, and found that isoniazid-related liver toxicity and neutropenia were more common when people took the antibiotic along with methotrexate, but those effects were usually reversible.

TB is endemic in various regions around the world. Historically there hasn’t been much rheumatology capacity in many of these areas, but as that capacity increases more people who are at high risk for developing or reactivating TB will be receiving methotrexate for rheumatic diseases, Dr. Hitchon said.

“It’s prudent for people managing patients who may be at higher risk for TB either from where they live or from where they travel that we should have a high suspicion for TB and consider screening as part of our workup in the course of initiating treatment like methotrexate,” she said.

Narender Annapureddy, MD, a rheumatologist at Vanderbilt University, Nashville, Tenn., who was not involved in the research, pointed out that a limitation of the work is that only 27% of the studies are from developing countries, which are more likely to have endemic TB, and those studies had very few cases.

“This finding needs to be studied in larger populations in TB-endemic areas and in high-risk populations,” he said in an interview.

As for practice implications in the United States, Dr. Annapureddy noted that TB is rare in the United States and most of the cases occur in people born in other countries.

“This population may be at risk for TB and should probably be screened for TB before initiating methotrexate,” he said. “Since biologics are usually the next step, especially in RA after patients fail methotrexate, having information on TB status may also help guide management options after MTX failure.

“Since high-dose steroids are another important risk factor for TB activation,” Dr. Annapureddy continued, “rheumatologists should likely consider screening patients who are going to be on moderate to high doses of steroids with MTX.”

A version of this article originally appeared on Medscape.com.

People taking even low-dose methotrexate need tuberculosis screening and ongoing clinical care if they live in areas where TB is common, results of a study presented at the virtual annual meeting of the American College of Rheumatology suggest.

Coauthor Carol Hitchon, MD, MSc, a rheumatologist with the University of Manitoba in Winnipeg, who presented the findings, warned that methotrexate (MTX) users who also take corticosteroids or other immunosuppressants are at particular risk and need TB screening.

Current management guidelines for rheumatic disease address TB in relation to biologics, but not in relation to methotrexate, Dr. Hitchon said.

“We know that methotrexate is the foundational DMARD [disease-modifying antirheumatic drug] for many rheumatic diseases, especially rheumatoid arthritis,” Dr. Hitchon noted at a press conference. “It’s safe and effective when dosed properly. However, methotrexate does have the potential for significant liver toxicity as well as infection, particularly for infectious organisms that are targeted by cell-mediated immunity, and TB is one of those agents.”

Using multiple databases, researchers conducted a systematic review of the literature published from 1990 to 2018 on TB rates among people who take less than 30 mg of methotrexate a week. Of the 4,700 studies they examined, 31 fit the criteria for this analysis.

They collected data on tuberculosis incidence or new TB diagnoses vs. reactivation of latent TB infection as well as TB outcomes, such as pulmonary symptoms, dissemination, and mortality.

They found a modest increase in the risk of TB infections in the setting of low-dose methotrexate. In addition, rates of TB in people with rheumatic disease who are treated with either methotrexate or biologics are generally higher than in the general population.

They also found that methotrexate users had higher rates of the type of TB that spreads beyond a patient’s lungs, compared with the general population.

Safety of INH with methotrexate

Researchers also looked at the safety of isoniazid (INH), the antibiotic used to treat TB, and found that isoniazid-related liver toxicity and neutropenia were more common when people took the antibiotic along with methotrexate, but those effects were usually reversible.

TB is endemic in various regions around the world. Historically there hasn’t been much rheumatology capacity in many of these areas, but as that capacity increases more people who are at high risk for developing or reactivating TB will be receiving methotrexate for rheumatic diseases, Dr. Hitchon said.

“It’s prudent for people managing patients who may be at higher risk for TB either from where they live or from where they travel that we should have a high suspicion for TB and consider screening as part of our workup in the course of initiating treatment like methotrexate,” she said.

Narender Annapureddy, MD, a rheumatologist at Vanderbilt University, Nashville, Tenn., who was not involved in the research, pointed out that a limitation of the work is that only 27% of the studies are from developing countries, which are more likely to have endemic TB, and those studies had very few cases.

“This finding needs to be studied in larger populations in TB-endemic areas and in high-risk populations,” he said in an interview.

As for practice implications in the United States, Dr. Annapureddy noted that TB is rare in the United States and most of the cases occur in people born in other countries.

“This population may be at risk for TB and should probably be screened for TB before initiating methotrexate,” he said. “Since biologics are usually the next step, especially in RA after patients fail methotrexate, having information on TB status may also help guide management options after MTX failure.

“Since high-dose steroids are another important risk factor for TB activation,” Dr. Annapureddy continued, “rheumatologists should likely consider screening patients who are going to be on moderate to high doses of steroids with MTX.”

A version of this article originally appeared on Medscape.com.

People taking even low-dose methotrexate need tuberculosis screening and ongoing clinical care if they live in areas where TB is common, results of a study presented at the virtual annual meeting of the American College of Rheumatology suggest.

Coauthor Carol Hitchon, MD, MSc, a rheumatologist with the University of Manitoba in Winnipeg, who presented the findings, warned that methotrexate (MTX) users who also take corticosteroids or other immunosuppressants are at particular risk and need TB screening.

Current management guidelines for rheumatic disease address TB in relation to biologics, but not in relation to methotrexate, Dr. Hitchon said.

“We know that methotrexate is the foundational DMARD [disease-modifying antirheumatic drug] for many rheumatic diseases, especially rheumatoid arthritis,” Dr. Hitchon noted at a press conference. “It’s safe and effective when dosed properly. However, methotrexate does have the potential for significant liver toxicity as well as infection, particularly for infectious organisms that are targeted by cell-mediated immunity, and TB is one of those agents.”

Using multiple databases, researchers conducted a systematic review of the literature published from 1990 to 2018 on TB rates among people who take less than 30 mg of methotrexate a week. Of the 4,700 studies they examined, 31 fit the criteria for this analysis.

They collected data on tuberculosis incidence or new TB diagnoses vs. reactivation of latent TB infection as well as TB outcomes, such as pulmonary symptoms, dissemination, and mortality.

They found a modest increase in the risk of TB infections in the setting of low-dose methotrexate. In addition, rates of TB in people with rheumatic disease who are treated with either methotrexate or biologics are generally higher than in the general population.

They also found that methotrexate users had higher rates of the type of TB that spreads beyond a patient’s lungs, compared with the general population.

Safety of INH with methotrexate

Researchers also looked at the safety of isoniazid (INH), the antibiotic used to treat TB, and found that isoniazid-related liver toxicity and neutropenia were more common when people took the antibiotic along with methotrexate, but those effects were usually reversible.

TB is endemic in various regions around the world. Historically there hasn’t been much rheumatology capacity in many of these areas, but as that capacity increases more people who are at high risk for developing or reactivating TB will be receiving methotrexate for rheumatic diseases, Dr. Hitchon said.

“It’s prudent for people managing patients who may be at higher risk for TB either from where they live or from where they travel that we should have a high suspicion for TB and consider screening as part of our workup in the course of initiating treatment like methotrexate,” she said.

Narender Annapureddy, MD, a rheumatologist at Vanderbilt University, Nashville, Tenn., who was not involved in the research, pointed out that a limitation of the work is that only 27% of the studies are from developing countries, which are more likely to have endemic TB, and those studies had very few cases.

“This finding needs to be studied in larger populations in TB-endemic areas and in high-risk populations,” he said in an interview.

As for practice implications in the United States, Dr. Annapureddy noted that TB is rare in the United States and most of the cases occur in people born in other countries.

“This population may be at risk for TB and should probably be screened for TB before initiating methotrexate,” he said. “Since biologics are usually the next step, especially in RA after patients fail methotrexate, having information on TB status may also help guide management options after MTX failure.

“Since high-dose steroids are another important risk factor for TB activation,” Dr. Annapureddy continued, “rheumatologists should likely consider screening patients who are going to be on moderate to high doses of steroids with MTX.”

A version of this article originally appeared on Medscape.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

Joe Biden’s victory sets the stage for health care to become a high-profile priority of his presidency.

The former vice president has sketched out a big health agenda: ramping up the federal response to COVID-19, boosting the Affordable Care Act, creating a new “public option” to cover uninsured Americans, and expanding Medicare and Medicaid.

But the president-elect’s long to-do list on health is likely to face significant roadblocks in Congress and the courts, experts say.

For instance, Biden’s ambitious proposals on COVID-19 -- including his recent call for a national mask mandate -- could be waylaid by legal challenges and run into political hurdles on Capitol Hill, where he may face a divided Congress.

Joseph Antos, PhD, a health policy expert with the conservative American Enterprise Institute, predicts Biden will encounter the same type of congressional “gridlock situation” that President Barack Obama ran into during his second term.

“We have a situation that has been like this for a very, very long time -- lack of cooperation, lack of recognition that either party is capable of rising above their own electoral views to deal with problems that the country actually has.”

Antos also suggests that Biden may also face enormous political pressure to address the economic fallout from the coronavirus, including record unemployment and business closures, before anything else.

“I think it’s really going to be efforts that are intended to promote economic development and promote the economy,” he says.

In addition, Biden’s plans to expand Obamacare might face a new challenge from the Supreme Court in the year ahead. This month, the high court will take up a new case seeking to overturn the law.

Even so, experts say Biden’s plans on COVID-19 and expanding health care are likely to define his tenure in the White House as a central focus of his presidency.

“Health care will be at the very top of the list of the president’s priorities,” says Sabrina Corlette, JD, co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “I do think, however, that the administration is going to be very preoccupied with the response to COVID-19 and the economic fallout … particularly in the first year.”

Here’s a closer look at what we can expect from a Biden presidency.

COVID-19: Federalizing response efforts

Biden will move to federalize the response to COVID-19. He has said he will take back major responsibilities from the states -- such as setting national policies on mask wearing, social distancing, and the reopening of schools and businesses, based on CDC guidance. In the days leading up to the election, Biden called for a national mask mandate, after waffling on the issue throughout the summer.

He has said he will let public health science drive political policy. Biden is also planning to create his own task force to advise officials during the transition on managing the new surge in COVID-19 cases, vaccine safety and protecting at-risk populations, Politico reported this week. He received a virtual briefing on the pandemic from a panel of experts as he awaited the election’s outcome.

“I think we will no longer have this confused and contradictory public messaging,” Corlette says, “but I also think there will be humility and the recognition that the evidence is evolving -- that we don’t have all the answers, but we’re learning as we go.”

But national mandates on masks and social distancing will be challenging to enforce, experts say. They are also likely to face pushback from business interests, opposition from public officials in GOP-led states, and even legal challenges.

• Providing free COVID-19 testing for all Americans
• Hiring 100,000 contact tracers
• Eliminating out-of-pocket expenses for coronavirus treatment
• Delivering “sufficient” PPE for essential workers
• Supporting science-backed vaccines and medical treatments being developed
• Requiring the reopening of businesses, workplaces, and schools only after “sufficient” reductions in community transmission -- under evidence-based protocols put forward by the CDC
• Giving emergency paid leave for workers dislocated by the pandemic and more financial aid for workers, families, and small businesses
• Shoring up safeguards to protect at-risk Americans, including older people
• Boosting pay for health care workers on the front lines

Biden has not detailed how he would pay for many of these, beyond promising to force wealthy Americans to “pay their fair share” of taxes to help. He has proposed a tax increase on Americans making more than $400,000 a year, which would require congressional approval.

Antos says he expects Biden’s proposed COVID-19 action plan to be virtually the same as Trump’s in two areas: efforts to develop a vaccine and antiviral treatments.

The administration has spent some $225 million on COVID-19 testing efforts, with a particular focus on rural areas.

Trump launched Operation Warp Speed to fast-track a vaccine. As part of that, the federal government has contracted with six drug companies, spending nearly $11 billion. The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.

Antos would like to see “a more sophisticated approach to social distancing” from the president-elect that takes into account the different challenges facing Americans depending on their income, work situation, and other factors during the pandemic.

“There are a lot of people in this country where working from home is fine and their jobs are secure,” he notes. “It’s the person who used to work at a restaurant that closed, it’s the line worker at a factory that has severely cut back its hours. It’s basically lower-middle-class people, low-income people, middle-class people, and it’s not the elite.

“And the policies have not given enough consideration to the fact that their circumstances and their tradeoffs would differ from the tradeoffs of somebody who doesn’t have anything to worry about economically.

“So, what we need is a more supple policy [that] will give people the information they need and give them the financial support that they also need … so they can make good decisions for themselves and their families. And we basically haven’t done that.”

Obamacare on the blocks?

The Supreme Court’s decision to take up another case seeking to overturn the Affordable Care Act could hand Biden’s health agenda a major setback -- and put the medical care for millions of Americans in jeopardy.

On Nov. 10, the high court will hear oral arguments on a lawsuit that would strike down all of Obamacare. A decision is not expected until next year.

The court has previously upheld the 2010 law, which Biden helped usher through Congress as vice president. But the addition of right-leaning Supreme Court Justice Amy Coney Barrett to the bench last month gives the court a clear conservative majority that could mean the end of Obamacare, legal experts say.

Republicans have opposed the law since its passage, but they have been unable to muster the votes to repeal it, or to pass an alternative

Antos, from the American Enterprise Institute, notes conservatives believe the law has increased costs for health care and insurance over the past decade, in part because of its protections for Americans with preexisting conditions and requiring insurers to provide comprehensive “gold-plated” policies.

“It’s driven up costs, offers plans that are not very strong, put high-risk folks into the same [insurance pool], which has increased costs for everyone, the employer mandate … these are all the reasons,” he says.

The Supreme Court isn’t expected to deliver a decision on the Affordable Care Act before the middle of next year. But the uncertainty will likely push back Biden’s proposals to expand on the law.

• As many as 133 million Americans -- roughly half the U.S. population -- with preexisting conditions could find it harder, if not impossible, to find affordable health insurance. That figure does not include Americans infected with COVID-19.
• About 165 million who require expensive treatments -- for cancer and other conditions -- would no longer be protected from huge costs for care by federal caps on out-of-pocket expenditures the Affordable Care Act requires.
• An estimated 21 million who now buy insurance through the Obamacare Marketplaces could lose their coverage.
• Another 12 million on Medicaid could find themselves without insurance.
• At least 2 million young adults ages 26 and under, now on their parents’ health policies, could be kicked off.
• Millions of people who use Medicare could face higher costs.
• Federal subsidies for lower-income Americans to buy policies would disappear.

Throughout the campaign, Biden repeatedly stressed the need to preserve the law’s provision barring insurance companies from refusing coverage for Americans with preexisting conditions, such as diabetes, cancer, and heart disease. It also outlaws charging higher premiums on the basis of health status, age, or gender.

Biden has also pledged to bolster the law as president.

He has proposed a variety of add-ons to the Affordable Care Act he says will “insure more than an estimated 97% of Americans,” according to the Biden campaign site.

Biden’s proposals include offering larger federal subsidies to help low- and middle-income Americans pay for policies purchased through Obamacare insurance Marketplaces.

The boldest of Biden’s proposals is the creation of a “public option” for insurance -- a Medicare-like program that small businesses and individuals could choose if they do not have coverage, cannot afford it, or don’t like their employer-based coverage.

It would also automatically enroll millions of uninsured Americans living in the 14 states that have not expanded Medicaid, which covers low-income people.

But such a plan would require congressional approval -- including a “super majority” of 60 Senate votes to block a likely GOP filibuster. That will be a significant challenge Biden will have to overcome, with Congress so evenly divided.

The White House would also have to defeat heavy lobbying from some of the most influential industry interest groups in Washington, Corlette says.

“I’m not even confident they would get all the Democrat votes,” she says.

“So, it’s a going to be an uphill battle to get a public option passed.”

Taken together, Biden’s plans for expanding Obamacare are projected to cost $750 billion over 10 years. He has said much of that financing would come from increasing taxes on the wealthy.

That means it would likely require congressional approval, which Antos suggests is unlikely given the polarization on Capitol Hill.

Medicare, Medicaid, and drug costs

Biden has called for a host of reforms targeting Medicare, Medicaid, and rising drug costs.

On Medicare, which primarily covers seniors 65 and older, Biden has proposed lowering the eligibility age from 65 to 60. That could extend Medicare to up to 20 million more Americans.

On Medicaid, the health care safety net for low-income and disabled Americans, the president-elect supports increased federal funding to states during the current economic crisis, and potentially beyond.

Medicare is likely to become a key focus of the new administration, in light of the pressures the pandemic is placing on Medicare funding.

In April, Medicare’s trustees said that the Part A trust fund for the program, which pays for hospital and inpatient care, could start to run dry in 2026.

But those projections did not include the impact of COVID-19. Some economists have since projected that Medicare Part A could become insolvent as early as 2022.

Medicare Part B, which pays for doctor and outpatient costs, is funded by general tax funding and beneficiary insurance premiums, so it is not in danger of drying up.

Adding to those pressures is an executive order Trump signed in August temporarily deferring payroll taxes, a primary funding vehicle for Medicare and Social Security.

Under these taxes, employees pay 6.2% of their earnings (on annual income up to $137,700) toward Social Security and 1.45% for Medicare taxes each pay period. Employers pay the same rate per paycheck, adding up to a combined 12.4% Social Security tax and 2.9% Medicare tax.

Biden has said he would reverse the tax cut when he takes office.

But to get a handle on Medicare and Medicaid funding issues, he is likely to need congressional support. Corlette and other experts say that could be a challenge while the nation remains in the grip of the coronavirus pandemic.

In addition to his Medicare and Medicaid reforms, Biden has proposed several plans to lower drug prices, a subset of rising health care and insurance costs.

U.S. spending on prescription drugs has increased nearly 42% over the past decade -- from $253.1 billion in 2010 to $358.7 billion in 2020 (projected) -- according to the Centers for Medicare & Medicaid Services.

In 2020, retail prices for 460 commonly prescribed drugs have spiked an average of 5.2%, according to new analysis by 3 Axis Advisors, a health research firm.

That’s more than double the projected rate of inflation.

To control drug costs, Biden supports legislation approved by the Democratic-led House of Representatives last year that would empower Medicare to negotiate drug prices with drug companies, as private insurers do.

Federal law now bars Medicare from negotiating prices on behalf of the 67.7 million Americans who use it. Drug companies and many GOP leaders argue that the current law is necessary to allow them to spend more on research and development of new medications.

In addition, Biden supports the idea of lifting bans on importing drugs from foreign countries with lower costs.

He also backs creating an independent review board to set price caps for new medications with no competitors; making high-quality generics more available; ending tax breaks for drug company advertising; and limiting their leeway in raising prices.

All of these proposals would likely require congressional approval and could face legal challenges in the courts.

This article first appeared on WebMD.com.

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

New data document the global fallout for rheumatology patients when hydroxychloroquine (HCQ) supplies were being diverted to hospitals for COVID-19 patients.

Demand for HCQ soared on evidence-lacking claims that the drug was effective in treating and preventing SARS-CoV-2 infection. Further research has since shown HCQ to be ineffective for COVID-19 and potentially harmful to patients.

But during the height of the COVID-19-related hype, patients worldwide with autoimmune diseases, particularly lupus and rheumatoid arthritis, had trouble getting the pills at all or couldn’t get as many as they needed for their chronic conditions.

Emily Sirotich, MSc, a PhD student at McMaster University in Hamilton, Ont., presented data at the virtual annual meeting of the American College of Rheumatology demonstrating that the severity of shortages differed widely.

Whereas 26.7% of rheumatology patients in Africa and 21.4% in southeast Asia said their pharmacy ran short of HCQ – which was originally developed as an antimalarial drug but has been found effective in treating some rheumatic diseases – only 6.8% of patients in the Americas and 2.1% in European regions reported the shortages.

“There are large regional disparities in access to antimalarials whether they were caused by the COVID-19 pandemic or already existed,” she said in an interview.

Global survey polled patient experience

Ms. Sirotich’s team analyzed data from the Global Rheumatology Alliance Patient Experience Survey.

They found that from 9,393 respondents (average age 46.1 years and 90% female), 3,872 (41.2%) were taking antimalarials. Of these, 230 (6.2% globally) were unable to keep taking the drugs because their pharmacy ran out.

Researchers evaluated the effect of drug shortages on disease activity, mental health, and physical health by comparing mean values with two-sided independent t-tests to identify significant differences.

They found that patients who were unable to obtain antimalarials had significantly higher levels of rheumatic disease activity as well as poorer mental and physical health (all P < .001).

The survey was distributed online through patient support groups and on social media. Patients with rheumatic diseases or their parents anonymously entered data including their rheumatic disease diagnosis, medications, COVID-19 status, and disease outcomes.

Ms. Sirotich said they are currently gathering new data to see if the gaps in access to HCQ persist and whether the physical and mental consequences of not having the medications continue.

Hospitals stockpiled HCQ in the U.S.

Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), said in an interview that hospitals in the United States received large amounts of HCQ in late spring and early summer, donated by pharmaceutical companies for COVID-19 before the lack of evidence for efficacy became clear.

Hospitals found themselves sitting on large quantities of HCQ they couldn’t use while prescriptions for rheumatology outpatients were going unfilled.

It is only in recent months that the U.S. Department of Health and Human Services has given clear direction to hospitals on how to redistribute those supplies, Dr. Ganio said.

“There’s no good real good way to move a product from a hospital to a [drug store] down the street,” he said.

The Food and Drug Administration now lists the HCQ shortages as resolved.
 

Declined prescriptions have frustrated physicians

Brett Smith, DO, a pediatric and adult rheumatologist in Alcoa, Tenn., said he was frustrated by pharmacies declining his prescriptions for HCQ for patients with rheumatoid arthritis.

“I got notes from pharmacies that I should consider alternative agents,” he said in an interview. But the safety profiles of the alternatives were not as good, he said.

“Hydroxychloroquine has no risk of infection and no risk of malignancy, and they were proposing alternative agents that carry those risks,” he said.

“I had some people with RA who couldn’t get [HCQ] who had a substantial increase in swollen joints and pain without it,” he said.

Dr. Smith said some patients who use HCQ for off-label uses such as certain skin disorders still aren’t getting the drug, as off-label use has been discouraged to make sure those with lupus and RA have enough, he said.

Saira Sheikh, MD, director of the University of North Carolina Rheumatology Lupus Clinic in Chapel Hill, said in an interview that during the summer months pharmacists required additional documentation of the diagnosis of autoimmune disease, resulting in unnecessary delays even when patients had been on the medication for many years.

She said emerging research has found patient-reported barriers to filling prescriptions, interruptions in HCQ treatment, and reported emotional stress and anxiety related to medication access during the COVID-19 pandemic.

“This experience with HCQ during the COVID-19 pandemic teaches us that while swift action and progress to address the immediate threats of the pandemic should be commended, it is important that we move forward in a conscious manner, guided by an evidence base that comes from high-quality research, not from rushed judgments based on preliminary studies, or pressure from political leaders,” Dr. Sheikh said.

Ms. Sirotich, Dr. Smith, Dr. Sheikh, and Dr. Ganio have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

SARS-CoV-2 infection posed increased risk for pregnant women in terms of severe disease and poor pregnancy outcomes including preterm birth, based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.

The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.

Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.

Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”

Address disparities that amplify risk

The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.

“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.

Severe disease and death increased in pregnant women

In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.

After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).

“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).

The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”

“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”

More data needed for informed counseling

“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.

“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.

Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”

“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.

“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”

Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”

The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.

SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.

Further, this case suggests such infections may not be easily detectable in neonates until days after birth.
 

The data

In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.

Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.

The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.

“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.

Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”

The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
 

Some perspective

In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.

With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”

Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.

SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.

Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”

Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.

But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.

The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.

So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.

“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”

Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.

In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.

In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.

Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.

All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.

Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.

Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.

“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”

The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.

In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.

So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.

Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.

Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.

In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.

In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.

In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.

No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.

“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.