Vaccines

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Receiving a COVID-19 vaccine early in pregnancy is not associated with an increased risk for spontaneous abortion, new research suggests.

The study, published online in JAMA, evaluated the proportion of women who received the vaccine and had ongoing pregnancies in comparison with those who experienced a miscarriage or spontaneous abortion. The researchers analyzed data from 105,446 unique pregnancies over seven 4-week surveillance periods between December 2020 and June 2021. Ongoing pregnancies between 6 and 19 weeks’ gestation were identified on the last day of each 4-week surveillance period (index date). Spontaneous abortions were assigned to a 4-week surveillance period on the basis of their outcome date. There were 13,160 spontaneous abortions and 92,286 ongoing pregnancies.

Overall, a COVID-19 vaccine was received within 28 days prior to an index date among 8.0% of ongoing pregnancy surveillance periods versus 8.6% of spontaneous abortions.

“We’re hoping that this data can inform the ongoing conversations between providers and pregnant women [about the COVID-19 vaccines],” study author Elyse O. Kharbanda, MD, MPH, senior research investigator at HealthPartners Institute, told this news organization. “It should be considered in the context of all the data that’s coming out both on the risks of COVID infection and pregnancy and data on outcomes among women who are vaccinated and pregnant.”

Among the women whose pregnancies were followed, 7.8% received at least one dose of the Pfizer COVID-19 vaccine, 6% received at least one dose of the Moderna COVID-19 vaccine, and 0.5% received the Janssen vaccine.

In August, the American College of Obstetricians and Gynecologists (ACOG), the Centers for Disease Control and Prevention, and the Society for Maternal-Fetal Medicine strongly recommended that all pregnant women be vaccinated against COVID-19.

The new findings provide reassuring evidence about the safety of COVID vaccines, particularly mRNA vaccines, during pregnancy, said Denise J. Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the study.

“The study design was a carefully conducted case-control study. Although ideally the best design for studying vaccine safety and efficacy is a randomized clinical trial, data are rapidly accumulating from a variety of sources that COVID vaccines are safe in pregnancy,” said Dr. Jamieson, who serves on several ACOG committees.

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

Pediatric Vaccines and Infectious Diseases Supplement

Contents:

• We’re getting closer to a lifesaving RSV vaccine
• New tool may provide point-of-care differentiation between bacterial, viral infections
• Metapneumovirus infections clinically indistinguishable from flu, RSV
• Seeking new vaccines against whooping cough: The PERISCOPE project
• Dried blood spot tests show sensitivity as cCMV screen

With Commentary by Kristina A. Bryant, MD

Pediatric Vaccines and Infectious Diseases Supplement

Contents:

• We’re getting closer to a lifesaving RSV vaccine
• New tool may provide point-of-care differentiation between bacterial, viral infections
• Metapneumovirus infections clinically indistinguishable from flu, RSV
• Seeking new vaccines against whooping cough: The PERISCOPE project
• Dried blood spot tests show sensitivity as cCMV screen

With Commentary by Kristina A. Bryant, MD

Pediatric Vaccines and Infectious Diseases Supplement

Contents:

• We’re getting closer to a lifesaving RSV vaccine
• New tool may provide point-of-care differentiation between bacterial, viral infections
• Metapneumovirus infections clinically indistinguishable from flu, RSV
• Seeking new vaccines against whooping cough: The PERISCOPE project
• Dried blood spot tests show sensitivity as cCMV screen

With Commentary by Kristina A. Bryant, MD

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.

On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.

So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
 

White House supports boosters

In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.

“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.

“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”

He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.

“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.

Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.

Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
 

‘FDA in a very difficult position’

After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.

Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.

“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.

“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”

He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.

“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”

Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.

“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
 

Boosters already being given

But after the White House announced that boosters were on the way, many people are not waiting.

Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.

“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.

She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.

Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.

“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
 

Consequences of a third shot

But giving or getting a third dose before approval by the FDA may have legal consequences.

In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.

“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”

The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.

They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.

In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.

“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.

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

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.

On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.

So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
 

White House supports boosters

In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.

“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.

“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”

He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.

“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.

Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.

Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
 

‘FDA in a very difficult position’

After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.

Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.

“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.

“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”

He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.

“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”

Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.

“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
 

Boosters already being given

But after the White House announced that boosters were on the way, many people are not waiting.

Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.

“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.

She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.

Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.

“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
 

Consequences of a third shot

But giving or getting a third dose before approval by the FDA may have legal consequences.

In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.

“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”

The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.

They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.

In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.

“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.

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

Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections, and demand increased after the Biden administration said those shots would be offered starting on Sept. 20.

That plan, which was first announced on Aug. 18, has raised eyebrows because it comes in advance of regulatory reviews by the Food and Drug Administration and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. The move could have important legal ramifications for doctors and patients, too.

On Aug. 31, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.

So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 – hospitalization and death – even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.
 

White House supports boosters

In a recent press briefing, Jeff Zients, the White House COVID-19 response coordinator, defended the move.

“You know, the booster decision, which you referenced ... was made by and announced by the nation’s leading public health officials, including Dr. Walensky; Dr. Fauci; Surgeon General Vivek Murthy; Dr. Janet Woodcock; the FDA acting commissioner, Dr. Francis Collins; Dr. Kessler; and others,” Mr. Zients said.

“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”

He said a target date of Sept. 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Mr. Zients added that whether boosters will be administered starting on Sept. 20 depends on the FDA’s and CDC’s giving the go-ahead.

“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.

Ms. Nordlund agreed that the planned Sept. 20 start date for boosters was something to which they aspired and was not necessarily set.

Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.
 

‘FDA in a very difficult position’

After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.

Pfizer says it completed its submission for a supplemental biologics license application to the FDA on Aug. 27. To meet a Sept. 20 timeline, the entire process would have to be completed within 3 weeks.

“I don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.

“It puts FDA in a very difficult position,” Dr. Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA – at least the internal people at FDA – have been trying to do for ages.”

He said the agency took great pains with the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.

“I think all of that reflected very well on the agency,” Dr. Lurie said. “And I think it worked out well in terms of trust in the vaccines.”

Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.

“It’s critical to wait for additional data and regulatory allowance for booster doses,” Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, said in an Aug. 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.
 

Boosters already being given

But after the White House announced that boosters were on the way, many people are not waiting.

Many health care practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised – the group for which the shots are currently approved.

“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, associate professor of medicine at Vanderbilt University, Nashville, Tenn., and a member of the ACIP.

She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.

Dr. Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.

“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.
 

Consequences of a third shot

But giving or getting a third dose before approval by the FDA may have legal consequences.

In the ACIP meeting on Aug. 30, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury. Patients who get a vaccine and suffer a rare but serious side effect may lose the ability to claim compensation offered by the act.

“Many of us gasped when he said that,” Dr. Talbot said, “because that’s a big deal.”

The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.

They said that so far, the data point only to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and health care workers, who are needed now more than ever and cannot work if they’re sick.

In a White House news briefing Aug. 31, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.

“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.

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

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

People with breakthrough COVID-19 infections are two times more likely to be completely asymptomatic and are about two-thirds less likely to be hospitalized, compared with those who are unvaccinated, according to a new observational study.

Individuals infected with COVID-19 after receiving their first or second dose of either the Pfizer, Moderna, or AstraZeneca vaccine experienced a lower number of symptoms in the first week of infection, compared with those who did not receive a COVID-19 vaccine, reported the authors of the report in The Lancet Infectious Diseases. These patients also had a reduced need for hospitalization, compared with their unvaccinated peers. Those who received both doses of a vaccine were less likely to experience prolonged COVID - defined as at least 28 days of symptoms in this paper - compared with unvaccinated individuals.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the delta variant,” study co–lead author Dr. Claire Steves, said in a statement. “Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do – save lives and prevent serious illness.”

For the community-based, case-control study, Dr. Steves, who is a clinical senior lecturer at King’s College London, and her colleagues analyzed and presented self-reported data on demographics, geographical location, health risk factors, COVID-19 test results, symptoms, and vaccinations from more than 1.2 million UK-based adults through the COVID Symptom Study mobile phone app.

They found that, of the 1.2 million adults who received at least one dose of either the Pfizer, Moderna, or AstraZeneca vaccine, fewer than 0.5% tested positive for COVID-19 14 days after their first dose. Of those who received a second dose of a COVID-19 vaccine, 0.2% acquired the infection more than 7 days post vaccination.

Likelihood of severe symptoms dropped after one dose

After just one COVID-19 vaccine dose, the likelihood of experiencing severe symptoms from a COVID-19 infection dropped by a quarter. The odds of their infection being asymptomatic increased by 94% after the second dose. Researchers also found that vaccinated participants in the study were more likely to be completely asymptomatic, especially if they were 60 years or older.

Furthermore, the odds of those with breakthrough infections experiencing severe disease – which is characterized by having five or more symptoms within the first week of becoming ill – dropped by approximately one-third.

When evaluating risk factors, the researchers found that those most vulnerable to a breakthrough infection after receiving a first dose of Pfizer, Moderna, or Astrazeneca COVID-19 vaccine were older adults (ages 60 years or older) who are either frail or live with underlying conditions such as asthma, lung disease, and obesity.

The findings provide substantial evidence that there are benefits after just one dose of the vaccine, said Diego Hijano, MD, MSc, pediatric infectious disease specialist at St. Jude’s Children’s Research Hospital, Memphis. However, the report also supports caution around becoming lax on protective COVID-19 measures such as physical distancing and wearing masks, especially around vulnerable groups, he said.

Findings may have implications for health policies

“It’s also important for people who are fully vaccinated to understand that these infections are expected and are happening, especially now with the Delta variant” Dr. Hijano said. “While the outcomes are favorable, you need to still protect yourself to also protect your loved ones. You want to be very mindful that, if you are vaccinated and you get infected, you can pass it on to somebody that actually has not been vaccinated or has some of these risk factors.”

The authors of the new research paper believe their findings may have implications for health policies regarding the timing between vaccine doses, COVID-19 booster shots, and for continuing personal protective measures.

The authors of the paper and Dr. Hijano disclosed no conflicts.

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

In the wake of the Centers for Disease Control and Prevention’s recommendation for a third COVID-19 mRNA vaccine dose for immunocompromised people and the Food and Drug Administration’s authorization of the third dose, the National Institute of Allergy and Infectious Diseases has begun a phase 2 trial to assess the antibody response to a booster dose of the Pfizer-BioNTech, Moderna, or Janssen vaccine in people with autoimmune disease who did not respond to their original COVID-19 vaccine regimen, according to an announcement.

The investigators of the trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, also want to determine if pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine.

The trial will specifically look at the effects of mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and methotrexate (MTX), or receipt of B cell–depletion therapy such as rituximab within the past 12 months on immune response to a booster dose in people with systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, or pemphigus. They have to have either no serologic response to their initial COVID-19 vaccine regimen or a suboptimal response, defined as a Roche Elecsys Anti-SARS-CoV-2 S (RBD) result greater than or equal to 50 U/mL.

The results of studies conducted in solid-organ transplant recipients who take immunosuppressants showed that an extra dose of vaccine could improve the immune response to the vaccine in many of the individuals, which suggests that the same approach might work in people with autoimmune disease who need treatment with immunosuppressive drugs. Improving the immune response of people with autoimmune disease to COVID-19 vaccines is important because higher rates of severe COVID-19 and death have been reported in this group of patients than in the general population, and it is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The open-label trial, conducted by the NIAID-funded Autoimmunity Centers of Excellence, aims to enroll 600 people aged 18 years and older with those conditions at 15-20 sites in the United States.

Because medications commonly taken by people with these conditions have been associated with poorer immune responses to vaccines, the trial will randomize the following two cohorts to stop or continue taking their immunosuppressive medication(s) or stop them before and after the booster according to protocol:

• Cohort 1 includes people who are taking MMF or MPA, without additional B cell–depleting medications or MTX.
• Cohort 2 includes people who are taking MTX without additional B cell–depleting medications or MMF/MPA.

A third, nonrandomized cohort consists of people who have received B cell–depletion therapy within the past 12 months regardless of whether they are also taking MMF/MPA or MTX.

Besides the cohort-specific exclusions, other rheumatic disease medications, including biologics, are allowed in the groups.

The primary outcome of the trial is the proportion of participants who have a protective antibody response at week 4. Secondary outcomes will examine various antibody responses at intervals, changes in disease activity across autoimmune diseases, adverse events, and SARS-CoV-2 infections out to 48 weeks.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021, according to the National Institutes of Health.

The trial is being led by Judith James, MD, PhD; Meggan Mackay, MD, MS; Dinesh Khanna, MBBS, MSc; and Amit Bar-Or, MD.

[email protected]

Last summer, a team of US Department of Veterans Affairs (VA) health care professionals deployed to Alabama’s Bill Nichols State Veterans Home to help during the COVID-19 crisis. They were there as part of the “Fourth Mission”—supporting national, state, and local emergency management, public health, safety and homeland security efforts. “It was a really humbling experience,” said Mary Holloway, an RN with the Birmingham VA Health Care System. “Seeing the dedication of the staff there, some coming back to work after recovering from COVID themselves, was inspiring.”

But that turned out to be only one battle in a sadly long and drawn-out war. Since March 2020, more than 5,000 military medical personnel have deployed to 14 states and the Navajo Nation, 51 cities, 71 hospitals, all struggling to keep their heads above a cresting tsunami of new COVID patients.

Last year, the crisis spots for deployments included major metropolitan areas in coastal states: New York, California, and New Jersey. The urgency now is in the Southern states. Those tend to be reporting the highest numbers of new cases and deaths. Alabama, Arkansas, Florida, Louisiana, and Mississippi, for example, have all ranked among the highest rates of cases and hospitalizations per 100,000 people across the country in the last seven days.

This year, military teams have also deployed to support vaccination centers in 25 states and 42 cities. Nearly all—97%—of the new COVID patients in recent months are unvaccinated. And, again, they predominate in Southern states. In Alabama, for instance, only 37% of the population are fully vaccinated. In Louisiana, that number is 40%.

The at-risk states also tend to be the ones that are rapidly running out of space to put the patients in, ICU or otherwise. Where patients who might have been in the intensive care unit (ICU) are housed in the emergency department and in hallways, and where patients without COVID-19 who might have been hospitalized are being turned away. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

These states are at a breaking point. Take Alabama. On August 18, it was “negative 11.” It had 1,568 patients with COVID-19 who needed ICU beds. Only 1,557 beds were available. Patients “may even stay on the regular floor where you’re already stretched for capacity to take care of these people because so many of our staff are out with COVID,” Jeanne Marrazzo, director, Division of Infectious Diseases at the University of Alabama at Birmingham, told a CNN reporter. “It’s really just a domino effect that then clogs up our ERs, clogs up everything else. … It’s a very very tenuous situation.”

The state reported more than 4,000 new cases of COVID-19—“a new high for us,” Marrazzo said. “If you project these numbers out, you can expect that we will at some point, probably around Sept. 1, have at least 5,000 people in our hospitals. If the ratio of people who have to go to the ICU remains stable. That means that probably a third of those people are going to require ICU beds,” she continued. “That is frankly untenable, given the infrastructure, the resources, and really importantly, the staff that we have. I think it is basically apocalyptic. I do not use that word lightly.”

Thus, the US Defense Department (DoD) must once again rise to a sad and desperate occasion. At the request of Federal Emergency Management Agency and the state of Louisiana, the first of five teams of Navy doctors, nurses, and respiratory therapists were sent last week to Ochsner Lafayette General Medical Center in Lafayette, Louisiana.

The teams, consisting of approximately 20 members each, are coming from throughout the DoD’s universe, including the National Guard. US Army North, under US Northern Command’s oversight, is providing operational command of the active-duty military COVID-19 response. Lt. Gen. Laura J. Richardson, ARNORTH commander, noting that “[t]his is the second time Department of Defense medical assets have deployed to support Louisiana during the pandemic,” calls it a “whole-of-government fight against COVID-19.”

Why Louisiana and Mississippi, with so many states in dire need? “Our joint forces go where FEMA needs us,” Richardson says. “[R]ight now FEMA has determined the military’s unique surge capabilities are most needed in these two states.”

In a press briefing at the time, Pentagon Press Secretary Rear Adm. John Kirby said, “We expect that there could be additional requests from other states for other teams, so that’s why we’re being prepared to stand up five teams.” He was right: An Air Force team has now headed to Our Lady of the Lake Regional Medical Center in Baton Rouge. Mississippi also asked for assistance; an Air Force team will be supporting at University of Mississippi Medical Center in Jackson, and an Army team at North Mississippi Medical Center-Tupelo. 

The support will likely include bolstering and extending the infrastructure. From July to December 2020, the Veterans Health Administration (VHA) Emergency Management Coordination Cell delivered Fold-Out Rigid Temporary Shelters (FORTS), C-FORTS (clinics), mobile ICUs and isolation units to locations across the US, such as North Chicago, El Paso, and Oklahoma City. In 2021, they’ll be needed in more hospitals unprepared to house the spiking numbers of patients. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

The first go-round with COVID taught hard lessons that can help hone the Fourth Mission responses. One lesson, according to the VHA COVID-19 Response Report- Annex A, published this May, was the need to conduct due diligence, to be both efficient and effective. VHA, it says, now works to determine actual need before deploying resources. “For example, VHA might receive a request from a [State Veterans Home] for 50 RNs. But once VHA delved into the request and worked with the associated VISNs, it would find that 20 RNs or 10 LPNs could meet the needs of the request.”

Meeting the requests is, for the beleaguered hospitals, like answering letters to Santa. When the team of doctors, nurses, and respiratory therapists arrived at Ochsner Lafayette General Medical Center (OLGMC) last week the hospital staff greeted them with cheers and applause.

OLGMC CEO Al Patin said, "We're already in a nursing shortage, coupled with high numbers of this pandemic [which] creates a situation where we need additional support. We have patients boarding in our emergency rooms, patients in our ICU setting that can't transition out. That creates a bottleneck and does not allow us to continue to take in patients from our community."

That day, OLG posted on Twitter:

“Today, we received some much-needed assistance in the fight against COVID-19. Our team at Ochsner Lafayette General Medical Center is being expanded by four doctors, 14 nurses and two respiratory therapists – all highly trained personnel on loan from the U.S. Navy.

“These healthcare professionals are being onboarded in our facility today and are specially trained for the emergency department, ICU and Med Surg. Because of them, we’ll be able to staff an additional 16-18 beds – beds sorely needed as cases continue to rise in our area.

“We requested support from the Federal Emergency Management Agency and we were one of five U.S. cities to receive it.. We are most grateful and humbled.”

Last summer, a team of US Department of Veterans Affairs (VA) health care professionals deployed to Alabama’s Bill Nichols State Veterans Home to help during the COVID-19 crisis. They were there as part of the “Fourth Mission”—supporting national, state, and local emergency management, public health, safety and homeland security efforts. “It was a really humbling experience,” said Mary Holloway, an RN with the Birmingham VA Health Care System. “Seeing the dedication of the staff there, some coming back to work after recovering from COVID themselves, was inspiring.”

But that turned out to be only one battle in a sadly long and drawn-out war. Since March 2020, more than 5,000 military medical personnel have deployed to 14 states and the Navajo Nation, 51 cities, 71 hospitals, all struggling to keep their heads above a cresting tsunami of new COVID patients.

Last year, the crisis spots for deployments included major metropolitan areas in coastal states: New York, California, and New Jersey. The urgency now is in the Southern states. Those tend to be reporting the highest numbers of new cases and deaths. Alabama, Arkansas, Florida, Louisiana, and Mississippi, for example, have all ranked among the highest rates of cases and hospitalizations per 100,000 people across the country in the last seven days.

This year, military teams have also deployed to support vaccination centers in 25 states and 42 cities. Nearly all—97%—of the new COVID patients in recent months are unvaccinated. And, again, they predominate in Southern states. In Alabama, for instance, only 37% of the population are fully vaccinated. In Louisiana, that number is 40%.

The at-risk states also tend to be the ones that are rapidly running out of space to put the patients in, ICU or otherwise. Where patients who might have been in the intensive care unit (ICU) are housed in the emergency department and in hallways, and where patients without COVID-19 who might have been hospitalized are being turned away. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

These states are at a breaking point. Take Alabama. On August 18, it was “negative 11.” It had 1,568 patients with COVID-19 who needed ICU beds. Only 1,557 beds were available. Patients “may even stay on the regular floor where you’re already stretched for capacity to take care of these people because so many of our staff are out with COVID,” Jeanne Marrazzo, director, Division of Infectious Diseases at the University of Alabama at Birmingham, told a CNN reporter. “It’s really just a domino effect that then clogs up our ERs, clogs up everything else. … It’s a very very tenuous situation.”

The state reported more than 4,000 new cases of COVID-19—“a new high for us,” Marrazzo said. “If you project these numbers out, you can expect that we will at some point, probably around Sept. 1, have at least 5,000 people in our hospitals. If the ratio of people who have to go to the ICU remains stable. That means that probably a third of those people are going to require ICU beds,” she continued. “That is frankly untenable, given the infrastructure, the resources, and really importantly, the staff that we have. I think it is basically apocalyptic. I do not use that word lightly.”

Thus, the US Defense Department (DoD) must once again rise to a sad and desperate occasion. At the request of Federal Emergency Management Agency and the state of Louisiana, the first of five teams of Navy doctors, nurses, and respiratory therapists were sent last week to Ochsner Lafayette General Medical Center in Lafayette, Louisiana.

The teams, consisting of approximately 20 members each, are coming from throughout the DoD’s universe, including the National Guard. US Army North, under US Northern Command’s oversight, is providing operational command of the active-duty military COVID-19 response. Lt. Gen. Laura J. Richardson, ARNORTH commander, noting that “[t]his is the second time Department of Defense medical assets have deployed to support Louisiana during the pandemic,” calls it a “whole-of-government fight against COVID-19.”

Why Louisiana and Mississippi, with so many states in dire need? “Our joint forces go where FEMA needs us,” Richardson says. “[R]ight now FEMA has determined the military’s unique surge capabilities are most needed in these two states.”

In a press briefing at the time, Pentagon Press Secretary Rear Adm. John Kirby said, “We expect that there could be additional requests from other states for other teams, so that’s why we’re being prepared to stand up five teams.” He was right: An Air Force team has now headed to Our Lady of the Lake Regional Medical Center in Baton Rouge. Mississippi also asked for assistance; an Air Force team will be supporting at University of Mississippi Medical Center in Jackson, and an Army team at North Mississippi Medical Center-Tupelo. 

The support will likely include bolstering and extending the infrastructure. From July to December 2020, the Veterans Health Administration (VHA) Emergency Management Coordination Cell delivered Fold-Out Rigid Temporary Shelters (FORTS), C-FORTS (clinics), mobile ICUs and isolation units to locations across the US, such as North Chicago, El Paso, and Oklahoma City. In 2021, they’ll be needed in more hospitals unprepared to house the spiking numbers of patients. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

The first go-round with COVID taught hard lessons that can help hone the Fourth Mission responses. One lesson, according to the VHA COVID-19 Response Report- Annex A, published this May, was the need to conduct due diligence, to be both efficient and effective. VHA, it says, now works to determine actual need before deploying resources. “For example, VHA might receive a request from a [State Veterans Home] for 50 RNs. But once VHA delved into the request and worked with the associated VISNs, it would find that 20 RNs or 10 LPNs could meet the needs of the request.”

Meeting the requests is, for the beleaguered hospitals, like answering letters to Santa. When the team of doctors, nurses, and respiratory therapists arrived at Ochsner Lafayette General Medical Center (OLGMC) last week the hospital staff greeted them with cheers and applause.

OLGMC CEO Al Patin said, "We're already in a nursing shortage, coupled with high numbers of this pandemic [which] creates a situation where we need additional support. We have patients boarding in our emergency rooms, patients in our ICU setting that can't transition out. That creates a bottleneck and does not allow us to continue to take in patients from our community."

That day, OLG posted on Twitter:

“Today, we received some much-needed assistance in the fight against COVID-19. Our team at Ochsner Lafayette General Medical Center is being expanded by four doctors, 14 nurses and two respiratory therapists – all highly trained personnel on loan from the U.S. Navy.

“These healthcare professionals are being onboarded in our facility today and are specially trained for the emergency department, ICU and Med Surg. Because of them, we’ll be able to staff an additional 16-18 beds – beds sorely needed as cases continue to rise in our area.

“We requested support from the Federal Emergency Management Agency and we were one of five U.S. cities to receive it.. We are most grateful and humbled.”

Last summer, a team of US Department of Veterans Affairs (VA) health care professionals deployed to Alabama’s Bill Nichols State Veterans Home to help during the COVID-19 crisis. They were there as part of the “Fourth Mission”—supporting national, state, and local emergency management, public health, safety and homeland security efforts. “It was a really humbling experience,” said Mary Holloway, an RN with the Birmingham VA Health Care System. “Seeing the dedication of the staff there, some coming back to work after recovering from COVID themselves, was inspiring.”

But that turned out to be only one battle in a sadly long and drawn-out war. Since March 2020, more than 5,000 military medical personnel have deployed to 14 states and the Navajo Nation, 51 cities, 71 hospitals, all struggling to keep their heads above a cresting tsunami of new COVID patients.

Last year, the crisis spots for deployments included major metropolitan areas in coastal states: New York, California, and New Jersey. The urgency now is in the Southern states. Those tend to be reporting the highest numbers of new cases and deaths. Alabama, Arkansas, Florida, Louisiana, and Mississippi, for example, have all ranked among the highest rates of cases and hospitalizations per 100,000 people across the country in the last seven days.

This year, military teams have also deployed to support vaccination centers in 25 states and 42 cities. Nearly all—97%—of the new COVID patients in recent months are unvaccinated. And, again, they predominate in Southern states. In Alabama, for instance, only 37% of the population are fully vaccinated. In Louisiana, that number is 40%.

The at-risk states also tend to be the ones that are rapidly running out of space to put the patients in, ICU or otherwise. Where patients who might have been in the intensive care unit (ICU) are housed in the emergency department and in hallways, and where patients without COVID-19 who might have been hospitalized are being turned away. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

These states are at a breaking point. Take Alabama. On August 18, it was “negative 11.” It had 1,568 patients with COVID-19 who needed ICU beds. Only 1,557 beds were available. Patients “may even stay on the regular floor where you’re already stretched for capacity to take care of these people because so many of our staff are out with COVID,” Jeanne Marrazzo, director, Division of Infectious Diseases at the University of Alabama at Birmingham, told a CNN reporter. “It’s really just a domino effect that then clogs up our ERs, clogs up everything else. … It’s a very very tenuous situation.”

The state reported more than 4,000 new cases of COVID-19—“a new high for us,” Marrazzo said. “If you project these numbers out, you can expect that we will at some point, probably around Sept. 1, have at least 5,000 people in our hospitals. If the ratio of people who have to go to the ICU remains stable. That means that probably a third of those people are going to require ICU beds,” she continued. “That is frankly untenable, given the infrastructure, the resources, and really importantly, the staff that we have. I think it is basically apocalyptic. I do not use that word lightly.”

Thus, the US Defense Department (DoD) must once again rise to a sad and desperate occasion. At the request of Federal Emergency Management Agency and the state of Louisiana, the first of five teams of Navy doctors, nurses, and respiratory therapists were sent last week to Ochsner Lafayette General Medical Center in Lafayette, Louisiana.

The teams, consisting of approximately 20 members each, are coming from throughout the DoD’s universe, including the National Guard. US Army North, under US Northern Command’s oversight, is providing operational command of the active-duty military COVID-19 response. Lt. Gen. Laura J. Richardson, ARNORTH commander, noting that “[t]his is the second time Department of Defense medical assets have deployed to support Louisiana during the pandemic,” calls it a “whole-of-government fight against COVID-19.”

Why Louisiana and Mississippi, with so many states in dire need? “Our joint forces go where FEMA needs us,” Richardson says. “[R]ight now FEMA has determined the military’s unique surge capabilities are most needed in these two states.”

In a press briefing at the time, Pentagon Press Secretary Rear Adm. John Kirby said, “We expect that there could be additional requests from other states for other teams, so that’s why we’re being prepared to stand up five teams.” He was right: An Air Force team has now headed to Our Lady of the Lake Regional Medical Center in Baton Rouge. Mississippi also asked for assistance; an Air Force team will be supporting at University of Mississippi Medical Center in Jackson, and an Army team at North Mississippi Medical Center-Tupelo. 

The support will likely include bolstering and extending the infrastructure. From July to December 2020, the Veterans Health Administration (VHA) Emergency Management Coordination Cell delivered Fold-Out Rigid Temporary Shelters (FORTS), C-FORTS (clinics), mobile ICUs and isolation units to locations across the US, such as North Chicago, El Paso, and Oklahoma City. In 2021, they’ll be needed in more hospitals unprepared to house the spiking numbers of patients. Some Louisiana hospitals, for instance, have been sending patients in ambulances to Texas for care.

The first go-round with COVID taught hard lessons that can help hone the Fourth Mission responses. One lesson, according to the VHA COVID-19 Response Report- Annex A, published this May, was the need to conduct due diligence, to be both efficient and effective. VHA, it says, now works to determine actual need before deploying resources. “For example, VHA might receive a request from a [State Veterans Home] for 50 RNs. But once VHA delved into the request and worked with the associated VISNs, it would find that 20 RNs or 10 LPNs could meet the needs of the request.”

Meeting the requests is, for the beleaguered hospitals, like answering letters to Santa. When the team of doctors, nurses, and respiratory therapists arrived at Ochsner Lafayette General Medical Center (OLGMC) last week the hospital staff greeted them with cheers and applause.

OLGMC CEO Al Patin said, "We're already in a nursing shortage, coupled with high numbers of this pandemic [which] creates a situation where we need additional support. We have patients boarding in our emergency rooms, patients in our ICU setting that can't transition out. That creates a bottleneck and does not allow us to continue to take in patients from our community."

That day, OLG posted on Twitter:

“Today, we received some much-needed assistance in the fight against COVID-19. Our team at Ochsner Lafayette General Medical Center is being expanded by four doctors, 14 nurses and two respiratory therapists – all highly trained personnel on loan from the U.S. Navy.

“These healthcare professionals are being onboarded in our facility today and are specially trained for the emergency department, ICU and Med Surg. Because of them, we’ll be able to staff an additional 16-18 beds – beds sorely needed as cases continue to rise in our area.

“We requested support from the Federal Emergency Management Agency and we were one of five U.S. cities to receive it.. We are most grateful and humbled.”

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

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

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

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

Young women who received the quadrivalent human papillomavirus (HPV) vaccine had fewer and fewer infections with high-risk HPV strains covered by the vaccine year after year, but the incidence of high-risk strains that were not covered by the vaccine increased over the same 12-year period, researchers report in a study published August 23 in JAMA Open Network.

“One of the unique contributions that this study provides is the evaluation of a real-world example of the HPV infection rates following immunization in a population of adolescent girls and young adult women at a single health center in a large U.S. city, reflecting strong evidence of vaccine effectiveness,” write Nicolas F. Schlecht, PhD, a professor of oncology at Roswell Park Comprehensive Cancer Center, Buffalo, and his colleagues. “Previous surveillance studies from the U.S. have involved older women and populations with relatively low vaccine coverage.”

In addition to supporting the value of continuing to vaccinate teens against HPV, the findings underscore the importance of continuing to screen women for cervical cancer, Dr. Schlecht said in an interview.

“HPV has not and is not going away,” he said. “We need to keep on our toes with screening and other measures to continue to prevent the development of cervix cancer,” including monitoring different high-risk HPV types and keeping a close eye on cervical precancer rates, particularly CIN3 and cervix cancer, he said. “The vaccines are definitely a good thing. Just getting rid of HPV16 is an amazing accomplishment.”

Kevin Ault, MD, a professor of ob/gyn and academic specialist director of clinical and translational research at the University of Kansas, Kansas City, told this news organization that other studies have had similar findings, but this one is larger with longer follow-up.

“The take-home message is that vaccines work, and this is especially true for the HPV vaccine,” said Dr. Ault, who was not involved in the research. “The vaccine prevents HPV infections and the consequences of these infections, such as cervical cancer. The results are consistent with other studies in different settings, so they are likely generalizable.”

The researchers collected data from October 2007, shortly after the vaccine was approved, through September 2019 on sexually active adolescent and young women aged 13 to 21 years who had received the HPV vaccine and had agreed to follow-up assessments every 6 months until they turned 26. Each follow-up included the collecting of samples of cervical and anal cells for polymerase chain reaction testing for the presence of HPV types.

More than half of the 1,453 participants were Hispanic (58.8%), and half were Black (50.4%), including 15% Hispanic and Black patients. The average age of the participants was 18 years. They were tracked for a median 2.4 years. Nearly half the participants (48%) received the HPV vaccine prior to sexual debut.

For the longitudinal study, the researchers adjusted for participants’ age, the year they received the vaccine, and the years since they were vaccinated. They also tracked breakthrough infections for the four types of HPV covered by the vaccine in participants who received the vaccine before sexual debut.

“We evaluated whether infection rates for HPV have changed since the administration of the vaccine by assessing longitudinally the probability of HPV detection over time among vaccinated participants while adjusting for changes in cohort characteristics over time,” the researchers write. In their statistical analysis, they made adjustments for the number of vaccine doses participants received before their first study visit, age at sexual debut, age at first vaccine dose, number of sexual partners in the preceding 6 months, consistency of condom use during sex, history of a positive chlamydia test, and, for anal HPV analyses, whether the participants had had anal sex in the previous 6 months.

The average age at first intercourse remained steady at 15 years throughout the study, but the average age of vaccination dropped from 18 years in 2008 to 12 years in 2019 (P < .001). More than half the participants (64%) had had at least three lifetime sexual partners at baseline.

After adjustment for age, the researchers found that the incidence of the four HPV types covered by the vaccine – HPV-6, HPV-11, HPV-16, and HPV-18 – dropped more each year, shifting from 9.1% from 2008-2010 to 4.7% from 2017-2019. The effect was even greater among those vaccinated prior to sexual debut; for those patients, the incidence of the four vaccine types dropped from 8.8% to 1.7% over the course of the study. Declines over time also occurred for anal types HPV-31 (adjusted odds ratio [aOR] = 0.76) and HPV-45 (aOR = 0.77). Those vaccinated prior to any sexual intercourse had 19% lower odds of infection per year with a vaccine-covered HPV type.

“We were really excited to see that the types targeted by the vaccines were considerably lower over time in our population,” Dr. Schlecht told this news organization. “This is an important observation, since most of these types are the most worrisome for cervical cancer.”

They were surprised, however, to see overall HPV prevalence increase over time, particularly with the high-risk HPV types that were not covered by the quadrivalent vaccine.

Prevalence of cervical high-risk types not in the vaccine increased from 25.1% from 2008-2010 to 30.5% from 2017-2019. Odds of detection of high-risk HPV types not covered by the vaccine increased 8% each year, particularly for HPV-56 and HPV-68; anal HPV types increased 11% each year. Neither age nor recent number of sexual partners affected the findings.

“The underlying mechanisms for the observed increased detection of specific non-vaccine HPV types over time are not yet clear.”

“We hope this doesn’t translate into some increase in cervical neoplasia that is unanticipated,” Dr. Schlecht said. He noted that the attributable risks for cancer associated with nonvaccine high-risk HPV types remain low. “Theoretical concerns are one thing; actual data is what drives the show,” he said.

The research was funded by the National Institutes of Health and the Icahn School of Medicine at Mount Sinai, New York. Dr. Schlecht has served on advisory boards for Merck, GlaxoSmithKline (GSK), and PDS Biotechnology. One author previously served on a GSK advisory board, and another worked with Merck on an early vaccine trial. Dr. Ault has disclosed no relevant financial relationships.

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

Many families delayed much-needed health care for their children out of fears that they may be exposed to SARS-CoV-2, according to data from the Urban Institute April 2021 Health Reform Monitoring Survey.

Data from 9,067 adults aged 18 to 64 years indicate that nearly 1 in 5 parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“It’s not surprising given the timing of the survey – April 2021 – when many people couldn’t get a vaccine yet and were reporting delayed care because of concerns about exposure during the past 30 days,” study author Dulce Gonzalez, BA, a research associate in the Health Policy Center at the Urban Institute, said in an interview.

In a previous survey that the Urban Institute conducted in September 2020, 28.8% of parents reported delaying or forgoing one or more types of health care for their children because of virus concerns or health care practitioner service limits.

These concerns still affect parents’ decision making when it comes to their child’s health. Nearly 1 in 10 parents reported that they had skipped doctor’s appointments for their children in the past 30 days. More than 1 in 10 adults forwent their own health care in the past month for the same reason.

“I think it’s important for parents to understand that health care workers and health care facilities are equipped to prevent infections from spreading,” Mundeep Kainth, DO, MPH, who was not involved in the study, told this news organization. “COVID-19 is not the first infection that we’ve seen in the medical setting, and we definitely are well aware of how it can spread and have been taking many precautions.”

The most common type of delayed or forgone care was dental care (5.3%), followed by well-child visits (4.0%) and general or specialist visits (3.2%). About 3% of parents said their child had missed out on immunizations. Nearly 6% of parents said their child had missed out on multiple types of care.

One reason dental care is the most commonly skipped type of care is because people might not consider dental care to be as urgent as other types of care, Ms. Gonzalez said. However, oral health can affect a person’s overall wellness.

Dr. Kainth, an infection disease specialist at Cohen Children’s Medical Center, New Hyde Park, New York, said the lack of immunization because of COVID-19 can have adverse health effects on children and could possibly lead to outbreaks in schools and day care settings. In the Urban Institute’s 2020 survey, 18.5% of parents said putting off their child’s health care worsened their child’s health, and 15.6% said it limited their children’s ability to go to school or day care.

“We are already concerned that we will have pockets of [vaccine-preventable] infections that we normally did not see before in communities where they are not vaccinating their children at high enough numbers,” Dr. Kainth said. “It is a little concerning that there’s probably a lot of catch up to be done for particular vaccines that are specifically for those entering day care and school.”

The current survey also found that parents with incomes below 250% of the federal poverty level were more likely than those with higher incomes to have put off care for their children in the past 30 days. More than 12% of families living in poverty put off care for their children, compared with 6.5% of those with higher incomes. They were also more likely to delay or forgo multiple types of care, at 8.1% versus 3.3%. Parents with lower family incomes were also more likely to report that their children had unmet needs for dental care, checkups, or other preventive care.

“We know that lower-income parents could be more exposed to costs they might not be able to afford if they were to get sick,” Ms. Gonzalez said. “Low-income adults have been disproportionately affected by job loss during the pandemic. They are also more likely to live in communities that have faced the largest health impacts of COVID-19.”

“There’s also advantages to the pediatrician visit that are not just about providing care but also providing guidance and advice to families and parents who are maybe struggling with certain issues that are above and beyond just the medical advice,” Dr. Kainth explained.

“That is probably the most tragic part of hearing that parents and kids are not going to the well visits, because that’s where families get a lot of support. And I think at this time, we probably need that more than ever,” she continued.

The authors said the findings highlight the importance of increasing rates of COVID-19 vaccinations among eligible adolescents and encouraging vaccinations for children younger than 12 when they become eligible, not only to protect them from COVID-19 but also to help families feel comfortable obtaining care.

The study was funded by the Robert Wood Johnson Foundation. The authors and Dr. Kainth have disclosed no relevant financial relationships.

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

Many families delayed much-needed health care for their children out of fears that they may be exposed to SARS-CoV-2, according to data from the Urban Institute April 2021 Health Reform Monitoring Survey.

Data from 9,067 adults aged 18 to 64 years indicate that nearly 1 in 5 parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“It’s not surprising given the timing of the survey – April 2021 – when many people couldn’t get a vaccine yet and were reporting delayed care because of concerns about exposure during the past 30 days,” study author Dulce Gonzalez, BA, a research associate in the Health Policy Center at the Urban Institute, said in an interview.

In a previous survey that the Urban Institute conducted in September 2020, 28.8% of parents reported delaying or forgoing one or more types of health care for their children because of virus concerns or health care practitioner service limits.

These concerns still affect parents’ decision making when it comes to their child’s health. Nearly 1 in 10 parents reported that they had skipped doctor’s appointments for their children in the past 30 days. More than 1 in 10 adults forwent their own health care in the past month for the same reason.

“I think it’s important for parents to understand that health care workers and health care facilities are equipped to prevent infections from spreading,” Mundeep Kainth, DO, MPH, who was not involved in the study, told this news organization. “COVID-19 is not the first infection that we’ve seen in the medical setting, and we definitely are well aware of how it can spread and have been taking many precautions.”

The most common type of delayed or forgone care was dental care (5.3%), followed by well-child visits (4.0%) and general or specialist visits (3.2%). About 3% of parents said their child had missed out on immunizations. Nearly 6% of parents said their child had missed out on multiple types of care.

One reason dental care is the most commonly skipped type of care is because people might not consider dental care to be as urgent as other types of care, Ms. Gonzalez said. However, oral health can affect a person’s overall wellness.

Dr. Kainth, an infection disease specialist at Cohen Children’s Medical Center, New Hyde Park, New York, said the lack of immunization because of COVID-19 can have adverse health effects on children and could possibly lead to outbreaks in schools and day care settings. In the Urban Institute’s 2020 survey, 18.5% of parents said putting off their child’s health care worsened their child’s health, and 15.6% said it limited their children’s ability to go to school or day care.

“We are already concerned that we will have pockets of [vaccine-preventable] infections that we normally did not see before in communities where they are not vaccinating their children at high enough numbers,” Dr. Kainth said. “It is a little concerning that there’s probably a lot of catch up to be done for particular vaccines that are specifically for those entering day care and school.”

The current survey also found that parents with incomes below 250% of the federal poverty level were more likely than those with higher incomes to have put off care for their children in the past 30 days. More than 12% of families living in poverty put off care for their children, compared with 6.5% of those with higher incomes. They were also more likely to delay or forgo multiple types of care, at 8.1% versus 3.3%. Parents with lower family incomes were also more likely to report that their children had unmet needs for dental care, checkups, or other preventive care.

“We know that lower-income parents could be more exposed to costs they might not be able to afford if they were to get sick,” Ms. Gonzalez said. “Low-income adults have been disproportionately affected by job loss during the pandemic. They are also more likely to live in communities that have faced the largest health impacts of COVID-19.”

“There’s also advantages to the pediatrician visit that are not just about providing care but also providing guidance and advice to families and parents who are maybe struggling with certain issues that are above and beyond just the medical advice,” Dr. Kainth explained.

“That is probably the most tragic part of hearing that parents and kids are not going to the well visits, because that’s where families get a lot of support. And I think at this time, we probably need that more than ever,” she continued.

The authors said the findings highlight the importance of increasing rates of COVID-19 vaccinations among eligible adolescents and encouraging vaccinations for children younger than 12 when they become eligible, not only to protect them from COVID-19 but also to help families feel comfortable obtaining care.

The study was funded by the Robert Wood Johnson Foundation. The authors and Dr. Kainth have disclosed no relevant financial relationships.

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

Many families delayed much-needed health care for their children out of fears that they may be exposed to SARS-CoV-2, according to data from the Urban Institute April 2021 Health Reform Monitoring Survey.

Data from 9,067 adults aged 18 to 64 years indicate that nearly 1 in 5 parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“It’s not surprising given the timing of the survey – April 2021 – when many people couldn’t get a vaccine yet and were reporting delayed care because of concerns about exposure during the past 30 days,” study author Dulce Gonzalez, BA, a research associate in the Health Policy Center at the Urban Institute, said in an interview.

In a previous survey that the Urban Institute conducted in September 2020, 28.8% of parents reported delaying or forgoing one or more types of health care for their children because of virus concerns or health care practitioner service limits.

These concerns still affect parents’ decision making when it comes to their child’s health. Nearly 1 in 10 parents reported that they had skipped doctor’s appointments for their children in the past 30 days. More than 1 in 10 adults forwent their own health care in the past month for the same reason.

“I think it’s important for parents to understand that health care workers and health care facilities are equipped to prevent infections from spreading,” Mundeep Kainth, DO, MPH, who was not involved in the study, told this news organization. “COVID-19 is not the first infection that we’ve seen in the medical setting, and we definitely are well aware of how it can spread and have been taking many precautions.”

The most common type of delayed or forgone care was dental care (5.3%), followed by well-child visits (4.0%) and general or specialist visits (3.2%). About 3% of parents said their child had missed out on immunizations. Nearly 6% of parents said their child had missed out on multiple types of care.

One reason dental care is the most commonly skipped type of care is because people might not consider dental care to be as urgent as other types of care, Ms. Gonzalez said. However, oral health can affect a person’s overall wellness.

Dr. Kainth, an infection disease specialist at Cohen Children’s Medical Center, New Hyde Park, New York, said the lack of immunization because of COVID-19 can have adverse health effects on children and could possibly lead to outbreaks in schools and day care settings. In the Urban Institute’s 2020 survey, 18.5% of parents said putting off their child’s health care worsened their child’s health, and 15.6% said it limited their children’s ability to go to school or day care.

“We are already concerned that we will have pockets of [vaccine-preventable] infections that we normally did not see before in communities where they are not vaccinating their children at high enough numbers,” Dr. Kainth said. “It is a little concerning that there’s probably a lot of catch up to be done for particular vaccines that are specifically for those entering day care and school.”

The current survey also found that parents with incomes below 250% of the federal poverty level were more likely than those with higher incomes to have put off care for their children in the past 30 days. More than 12% of families living in poverty put off care for their children, compared with 6.5% of those with higher incomes. They were also more likely to delay or forgo multiple types of care, at 8.1% versus 3.3%. Parents with lower family incomes were also more likely to report that their children had unmet needs for dental care, checkups, or other preventive care.

“We know that lower-income parents could be more exposed to costs they might not be able to afford if they were to get sick,” Ms. Gonzalez said. “Low-income adults have been disproportionately affected by job loss during the pandemic. They are also more likely to live in communities that have faced the largest health impacts of COVID-19.”

“There’s also advantages to the pediatrician visit that are not just about providing care but also providing guidance and advice to families and parents who are maybe struggling with certain issues that are above and beyond just the medical advice,” Dr. Kainth explained.

“That is probably the most tragic part of hearing that parents and kids are not going to the well visits, because that’s where families get a lot of support. And I think at this time, we probably need that more than ever,” she continued.

The authors said the findings highlight the importance of increasing rates of COVID-19 vaccinations among eligible adolescents and encouraging vaccinations for children younger than 12 when they become eligible, not only to protect them from COVID-19 but also to help families feel comfortable obtaining care.

The study was funded by the Robert Wood Johnson Foundation. The authors and Dr. Kainth have disclosed no relevant financial relationships.

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

With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

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

With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

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

With first-time COVID-19 immunizations continuing and the plan to offer booster vaccines to most Americans starting next month, what are the considerations for getting COVID-19 and flu shots at the same time?

This news organization asked Andrew T. Pavia, MD, for his advice. He is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious diseases at the University of Utah, Salt Lake City, and a fellow of the Infectious Diseases Society of America.
 

Q: With COVID-19 cases surging, is it a good idea to get the flu shot early this season?

Dr. Pavia: I don’t think there is a rush to do it in August, but it is a good idea to get a flu shot this season. The consequences of getting the flu while COVID is circulating are serious.

Q: What are the implications?

There are some we know and some we don’t know. If you develop flu-like symptoms, you’re going to have to get tested. You’re going to have to stay home quite a bit longer if you get a definitive (positive COVID-19) test than you would simply with flu symptoms. Also, you’re probably going to miss work when your workplace is very stressed or your children are stressed by having COVID circulating in schools.

The part we know less about are the implications of getting the flu and COVID together. There is some reason to believe if you get them together, the illness will be more severe. We are seeing that with RSV (respiratory syncytial virus) and parainfluenza and COVID coinfections in children. They appear to be quite severe.

But for flu, we just don’t have the data yet. That’s because there really was no cocirculation of COVID and influenza with the exception of parts of China for a brief part of February and March.
 

Q: Will the planned administration of booster COVID-19 shots this fall affect the number of people who get the flu vaccine or how it’s distributed?

It creates a lot of logistical challenges, particularly for hospitals and other places that need to vaccinate a large number of their employees for flu and that will need to give COVID boosters at about the same time period. It also creates logistical challenges for doctors’ offices.

But we don’t know of any reason why you can’t give the two shots together.
 

Q: Is it possible flu season will be more severe because we isolated and wore masks, etc., last winter? Any science behind that?

The more you study flu, the less you can predict, and I’ve been studying flu for a long time. There are reasons that might suggest a severe flu season – there has been limited immunity, and some people are not wearing masks effectively and they are gathering again. Those are things we believe protected us from influenza last season.

But we have not seen flu emerge yet. Normally we look to Australia, New Zealand, and South Africa during their winter – which is our summer – to get some idea of what is over the horizon for the Northern Hemisphere. Flu activity in Australia has been very modest this year.

That might mean flu may not show up for a while, but I would be loathe to make a prediction.
 

Q: What are the chances we’ll see a flu outbreak like we’re seeing with RSV, which is normally a winter illness?

The fact that we had a summer RSV surge just gives you an idea of how the normal epidemiology of viral infections has been disrupted. It means anything could happen with influenza. It could show up late summer or fall or wait until next spring.

We really don’t understand how those interactions work. When a new flu strain emerges, it often ignores the traditional behavior and shows up in the spring or fall. It happened in the 2009 pandemic, it happened in 1918.

The one thing I would safely predict about the next flu wave is that it will surprise us.
 

Q: Are you hopeful that combination vaccines in development from a number of companies, such as Moderna, Novavax, and Vivaldi, will be effective?

It is beginning to look like COVID will be with us for the foreseeable future – maybe as a seasonal virus or maybe as an ongoing pandemic. We are going to need to protect (ourselves) simultaneously against the flu and COVID. A single shot is a great way to do that – nobody wants two needles; nobody wants two trips to get vaccinated.

An effective combination vaccine would be a really great tool.

We have to wait to see what the science shows us, because they are quite different viruses. We won’t know if a combination vaccine works well and has acceptable side effects until we do those studies.
 

Q. Do you know at this point whether the side effects from two vaccines would be additive? Is there any way to predict that?

There is no way to predict. There are so many things that go into whether someone has side effects that we don’t understand. With fairly reactogenic vaccines like the mRNA vaccines, lots of people have no side effects whatsoever and others are really uncomfortable for 24 hours.

Flu is generally a better tolerated vaccine. There are still people who get muscle aches and very sore arms. I don’t think we can predict if getting two will be additive or just the same as getting one vaccine.
 

Q: Other than convenience and the benefit for people who are needle-phobic, are there any other advantages of combining them into one shot?

The logistics alone are enough to justify having one effective product if we can make one. It should reduce the overall cost of administration and reduce time off from work.

The combination vaccines given by pediatricians have been very successful. They reduce the number of needles for kids and make it much easier for parents and the pediatricians administering them. The same principle should apply to adults, who sometimes are less brave about needles than kids are.

Historically, combined vaccines in general have worked as well as vaccines given alone, but there have been exceptions. We just have to see what the products look like.
 

Q: For now, the flu vaccine and COVID-19 vaccine are single products. If you get them separately, is it better to put some time between the two?

We don’t know. There are studies that probably won’t be out in time to decide in September. They are looking at whether you get an equivalent immune response if you give them together or apart.

For now, I would say the advantage of getting them together is if you do get side effects, you’ll only get them once – one day to suffer through them. Also, it’s one trip to the doctor.

The potential advantage of separating them is that is how we developed and tested the vaccines. If you do react to them, side effects could be milder, but it will be on two separate days.

I would recommend doing whatever works so that you get both vaccines in a timely manner.

I’m going to get my flu shot as soon as it’s available. If I’m due for a COVID booster at that time, I would probably do them together.
 

Q: Do you foresee a point in the future when the predominant strain of SARS-CoV-2 will be one of the components of a flu vaccine, like we did in the past with H1N1, etc?

It really remains to be seen, but it is very conceivable it could happen. The same companies that developed COVID-19 vaccines are working on flu vaccines.

Q: Any other advice for people concerned about getting immunized against both COVID-19 and influenza in the coming months?

There is no side effect of the vaccine that begins to approach the risk you face from either disease. It’s really one of the best things you can do to protect yourself is to get vaccinated.

In the case of flu, the vaccine is only modestly effective, but it still saves tens of thousands of lives each year. The SARS-CoV-2 vaccine is a much better vaccine and a deadlier disease.

Dr. Pavia consulted for GlaxoSmithKline on influenza testing.

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