Government and Regulations

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

Consumer advocacy group Public Citizen filed a lawsuit on Sept. 8 on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the Food and Drug Administration for the agency’s failure to act on a petition submitted by the foundation 4 years ago.

The September 2017 petition requested that the FDA take the popular hair-loss drug (1 mg finasteride, Propecia) off the market because of evidence of serious risk of patient injury, including depression and suicidal ideation. 

As an alternative, PFSF requested that the FDA require the drug’s manufacturers revise the safety information on the labeling and add boxed warnings to disclose the potential for side effects, another of which is erectile dysfunction.

Public Citizen points to a recent analysis of the VigiBase global database, which tracks adverse effects from global pharmacovigilance agencies, lists 356 reports of suicidality and 2,926 reports of psychological adverse events in finasteride users. Yet, 4 years after submitting the petition, the FDA has neither granted nor denied it.

The lawsuit claims that FDA has acted unlawfully in failing to act on PFSF’s petition, and further cites “88 cases of completed suicide associated with finasteride use” per data from the VigiBase database.

“On the same day that PFSF submitted the petition, FDA’s docket management division acknowledged receipt and assigned the petition a docket number,” Michael Kirkpatrick, the Public Citizen attorney serving as lead counsel for PFSF, told this news organization.

Yet, to date, “there has been no substantive response to the petition. The lawsuit filed today seeks to force FDA to issue a decision on PFSF’s petition,” Mr. Kirkpatrick said.

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia. The FDA’s failure to act exposes consumers to potentially life-threatening harm,” he added in a statement.

The complaint filed today by Public Citizen in the U.S. District Court for the District of Columbia is available online. 

This news organization reached out to the FDA for comment but did not receive a response by press time.
 

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

Consumer advocacy group Public Citizen filed a lawsuit on Sept. 8 on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the Food and Drug Administration for the agency’s failure to act on a petition submitted by the foundation 4 years ago.

The September 2017 petition requested that the FDA take the popular hair-loss drug (1 mg finasteride, Propecia) off the market because of evidence of serious risk of patient injury, including depression and suicidal ideation. 

As an alternative, PFSF requested that the FDA require the drug’s manufacturers revise the safety information on the labeling and add boxed warnings to disclose the potential for side effects, another of which is erectile dysfunction.

Public Citizen points to a recent analysis of the VigiBase global database, which tracks adverse effects from global pharmacovigilance agencies, lists 356 reports of suicidality and 2,926 reports of psychological adverse events in finasteride users. Yet, 4 years after submitting the petition, the FDA has neither granted nor denied it.

The lawsuit claims that FDA has acted unlawfully in failing to act on PFSF’s petition, and further cites “88 cases of completed suicide associated with finasteride use” per data from the VigiBase database.

“On the same day that PFSF submitted the petition, FDA’s docket management division acknowledged receipt and assigned the petition a docket number,” Michael Kirkpatrick, the Public Citizen attorney serving as lead counsel for PFSF, told this news organization.

Yet, to date, “there has been no substantive response to the petition. The lawsuit filed today seeks to force FDA to issue a decision on PFSF’s petition,” Mr. Kirkpatrick said.

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia. The FDA’s failure to act exposes consumers to potentially life-threatening harm,” he added in a statement.

The complaint filed today by Public Citizen in the U.S. District Court for the District of Columbia is available online. 

This news organization reached out to the FDA for comment but did not receive a response by press time.
 

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

Consumer advocacy group Public Citizen filed a lawsuit on Sept. 8 on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the Food and Drug Administration for the agency’s failure to act on a petition submitted by the foundation 4 years ago.

The September 2017 petition requested that the FDA take the popular hair-loss drug (1 mg finasteride, Propecia) off the market because of evidence of serious risk of patient injury, including depression and suicidal ideation. 

As an alternative, PFSF requested that the FDA require the drug’s manufacturers revise the safety information on the labeling and add boxed warnings to disclose the potential for side effects, another of which is erectile dysfunction.

Public Citizen points to a recent analysis of the VigiBase global database, which tracks adverse effects from global pharmacovigilance agencies, lists 356 reports of suicidality and 2,926 reports of psychological adverse events in finasteride users. Yet, 4 years after submitting the petition, the FDA has neither granted nor denied it.

The lawsuit claims that FDA has acted unlawfully in failing to act on PFSF’s petition, and further cites “88 cases of completed suicide associated with finasteride use” per data from the VigiBase database.

“On the same day that PFSF submitted the petition, FDA’s docket management division acknowledged receipt and assigned the petition a docket number,” Michael Kirkpatrick, the Public Citizen attorney serving as lead counsel for PFSF, told this news organization.

Yet, to date, “there has been no substantive response to the petition. The lawsuit filed today seeks to force FDA to issue a decision on PFSF’s petition,” Mr. Kirkpatrick said.

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia. The FDA’s failure to act exposes consumers to potentially life-threatening harm,” he added in a statement.

The complaint filed today by Public Citizen in the U.S. District Court for the District of Columbia is available online. 

This news organization reached out to the FDA for comment but did not receive a response by press time.
 

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

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.”

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.”

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

New policy hopes to be in line with full FDA approval expected in September. When the largest employer in the world makes any significant decision, everyone sits up and takes notice.

That’s what happened when Secretary of Defense Lloyd Austin III sent out a memo to all US Department of Defense (DoD) employees saying he was seeking President Biden’s approval to make COVID-19 vaccines mandatory. His decision affects not only the 3.2 million employees on the payroll, but their families, communities, and states. Florida, for instance, where approximately 40% of the population remains unvaccinated has about 55,000 active duty service members and 36,000 reservists.

Vaccination rates in the military have lagged behind other populations, especially among Black and Hispanic service members. An April study published in Medical Surveillance Monthly Report found that “non-Hispanic Blacks, as well as those who were female, younger, of lower rank, with lower education levels, and those serving in the Army were less likely to initiate COVID-19 vaccination after adjusting for other factors.”

The decision had been in the offing for some time but when cases of the Delta variant of the virus began to spike in July, President Biden asked Sec. Austin to consider how and when the COVID vaccine could be added to the list of required vaccines for service members. It’s a long list already: Depending on their location, service members can get as many as 17 vaccines. It also folllows on the heals of the decision by the US Department of Veterans Affairs to require vaccinations for frontline health care workers.

Austin promised to “not let grass grow.” He consulted with Army Gen. Mark Milley, the Joint Chiefs of Staff, service chiefs, service secretaries, and medical professionals. Based on those discussions, he decided to ask for approval to make the vaccines mandatory no later than mid-September or immediately upon FDA licensure, whichever comes first.

However, he added, “[t]o defend this Nation, we need a healthy and ready force. I strongly encourage all DoD military and civilian personnel—as well as contractor personnel—to get vaccinated now and for military Service members to not wait for the mandate.” Currently, 73% of active-duty personnel have had at least one dose of the vaccine.

Leaping upon the news—and based on the wording in the memo—some in the media were reporting that it meant all troops have to be vaccinated by mid-September. “He’ll make the request by mid-September, unless or until FDA licensure occurs before that time, at which point the Secretary has the authority he needs…to make whatever vaccine is then given that license mandatory.”  That’s not the case, said Pentagon press secretary John Kirby in a briefing. Some voices also have called on the DoD to do more to dispel vaccine hesitancy among the troops.

In the meantime, Kirby said, “[T]wo things are going to happen. One, the services are going to be tasked to come back to the Secretary with implementation plans for how they’re going to get this moving.” Noting that mid-September isn’t far away, he pointed out that the services have a “fair but limited amount of time” to arrange their implementation plans. “I have every confidence that service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin wrote in his memo.

The second thing, Kirby said, was that DoD would be developing policies that comply with the President’s direction that the unvaccinated will have to be subjected to “certain requirements and restrictions.” The Delta variant is hitting the unvaccinated hardest. Austin said the DoD will keep a close eye on infection rates “and the impact these rates might have on our readiness. I will not hesitate to act sooner or recommend a different course to the President if I feel the need to do so.”

Kirby said he didn’t have all the details for that yet, but the department is “working hard” on a policy directive that will clarify what those requirements and restrictions might be.

President Biden replied almost immediately to Austin’s message. “I strongly support Secretary Austin’s message to the force today…. Secretary Austin and I share an unshakeable commitment to making sure our troops have every tool they need to do their jobs as safely as possible. These vaccines will save lives. Period.”

“All FDA-authorized COVID-19 vaccines are safe and highly effective,” Austin said in the close to his memo. “They will protect you and your family. They will protect your unit, your ship, and your co-workers. …Get the shot. Stay healthy. Stay ready.”

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

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

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

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

The Centers for Disease Control and Prevention (CDC) once again is recommending that some Americans wear masks indoors. The agency has called for masks in K-12 school settings and in areas of the United States experiencing high or substantial SARS-CoV-2 transmission, even for the fully vaccinated.

The move reverses a controversial announcement the agency made in May 2021 that fully vaccinated Americans could skip wearing a mask in most settings.

Unlike the increasing vaccination rates and decreasing case numbers reported in May, however, some regions of the United States are now reporting large jumps in COVID-19 case numbers. And the Delta variant as well as new evidence of transmission from breakthrough cases are largely driving these changes.

“Today we have new science related to the [D]elta variant that requires us to update the guidance on what you can do when you are fully vaccinated,” CDC Director Rochelle Walensky, MD, MPH, said during a media briefing July 27.

New evidence has emerged on breakthrough-case transmission risk, for example. “Information on the [D]elta variant from several states and other countries indicates that in rare cases, some people infected with the [D]elta variant after vaccination may be contagious and spread virus to others,” Dr. Walensky said, adding that the viral loads appear to be about the same in vaccinated and unvaccinated individuals.

“This new science is worrisome,” she said.

Even though unvaccinated people represent the vast majority of cases of transmission, Dr. Walensky said, “we thought it was important for [vaccinated] people to understand they have the potential to transmit the virus to others.”

As a result, in addition to continuing to strongly encourage everyone to get vaccinated, the CDC recommends that fully vaccinated people wear masks in public indoor settings to help prevent the spread of the Delta variant in areas with substantial or high transmission, Dr. Walensky said. “This includes schools.”
 

Masks in schools

The CDC is now recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Their goal is to optimize safety and allow children to return to full-time in-person learning in the fall.

The CDC tracks substantial and high transmission rates through the agency’s COVID Data Tracker site. Substantial transmission means between 50 and 100 cases per 100,000 people reported over 7 days and high means more than 100 cases per 100,000 people.

The B.1.617.2, or Delta, variant is believed to be responsible for COVID-19 cases increasing more than 300% nationally from June 19 to July 23, 2021.
 

“A prudent move”

“I think it’s a prudent move. Given the dominance of the [D]elta variant and the caseloads that we are seeing rising in many locations across the United States, including in my backyard here in San Francisco,” Joe DeRisi, PhD, copresident of the Chan Zuckerberg Biohub and professor of biochemistry and biophysics at the University of California San Francisco, said in an interview.

Dr. DeRisi said he was not surprised that vaccinated people with breakthrough infections could be capable of transmitting the virus. He added that clinical testing done by the Biohub and UCSF produced a lot of data on viral load levels, “and they cover an enormous range.”

What was unexpected to him was the rapid rise of the dominant variant. “The rise of the [D]elta strain is astonishing. It’s happened so fast,” he said.
 

“I know it’s difficult”

Reacting to the news, Colleen Kraft, MD, said, “One of the things that we’re learning is that if we’re going to have low vaccine uptake or we have a number of people that can’t be vaccinated yet, such as children, that we really need to go back to stopping transmission, which involves mask wearing.”

“I know that it’s very difficult and people feel like we’re sliding backward,” Dr. Kraft said during a media briefing sponsored by Emory University held shortly after the CDC announcement.

She added that the CDC updated guidance seems appropriate. “I don’t think any of us really want to be in this position or want to go back to masking but…we’re finding ourselves in the same place we were a year ago, in July 2020.

“In general we just don’t want anybody to be infected even if there’s a small chance for you to be infected and there’s a small chance for you to transmit it,” said Dr. Kraft, who’s an assistant professor in the department of pathology and associate professor in the department of medicine, division of infectious diseases at Emory University School of Medicine in Atlanta.
 

Breakthrough transmissions

“The good news is you’re still unlikely to get critically ill if you’re vaccinated. But what has changed with the [D]elta variant is instead of being 90% plus protected from getting the virus at all, you’re probably more in the 70% to 80% range,” James T. McDeavitt, MD, told this news organization.

“So we’re seeing breakthrough infections,” said Dr. McDeavitt, executive vice president and dean of clinical affairs at Baylor College of Medicine in Houston. “We are starting to see [such people] are potentially infectious.” Even if a vaccinated person is individually much less likely to experience serious COVID-19 outcomes, “they can spread it to someone else who spreads it to someone else who is more vulnerable. It puts the more at-risk populations at further risk.”

It breaks down to individual and public health concerns. “I am fully vaccinated. I am very confident I am not going to end up in a hospital,” he said. “Now if I were unvaccinated, with the prevalence of the virus around the country, I’m probably in more danger than I’ve ever been in the course of the pandemic. The unvaccinated are really at risk right now.”
 

IDSA and AMA support mask change

The Infectious Diseases Society of America (IDSA) has released a statement supporting the new CDC recommendations. “To stay ahead of the spread of the highly transmissible Delta variant, IDSA also urges that in communities with moderate transmission rates, all individuals, even those who are vaccinated, wear masks in indoor public places,” stated IDSA President Barbara D. Alexander, MD, MHS.

“IDSA also supports CDC’s guidance recommending universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission.”

“Mask wearing will help reduce infections, prevent serious illnesses and death, limit strain on local hospitals and stave off the development of even more troubling variants,” she added.

The American Medical Association (AMA) also released a statement supporting the CDC’s policy changes.

“According to the CDC, emerging data indicates that vaccinated individuals infected with the Delta variant have similar viral loads as those who are unvaccinated and are capable of transmission,” AMA President Gerald E. Harmon, MD said in the statement.

“However, the science remains clear, the authorized vaccines remain safe and effective in preventing severe complications from COVID-19, including hospitalization and death,” he stated. “We strongly support the updated recommendations, which call for universal masking in areas of high or substantial COVID-19 transmission and in K-12 schools, to help reduce transmission of the virus. Wearing a mask is a small but important protective measure that can help us all stay safer.”

“The highest spread of cases and [most] severe outcomes are happening in places with low vaccination rates and among unvaccinated people,” Dr. Walensky said. “With the [D]elta variant, vaccinating more Americans now is more urgent than ever.”

“This moment, and the associated suffering, illness, and death, could have been avoided with higher vaccination coverage in this country,” she said.

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

A high-profile, Washington-based consumer advocacy group is calling for the removal of the U.S. Food and Drug Administration’s acting commissioner and two other top officials, saying that the agency’s approval of the Alzheimer’s drug aducanumab (Aduhelm, Biogen) was “reckless.”

In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.

“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.

Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.

“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.

“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”

In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
 

Advocates who backed approval decry cost

Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.

The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.

The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.

“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”

UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.  

“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.

Dr. Carome said the advocates’ complaints were hard to fathom.

“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”

“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.

“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.

“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.

Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.

Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.

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

A high-profile, Washington-based consumer advocacy group is calling for the removal of the U.S. Food and Drug Administration’s acting commissioner and two other top officials, saying that the agency’s approval of the Alzheimer’s drug aducanumab (Aduhelm, Biogen) was “reckless.”

In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.

“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.

Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.

“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.

“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”

In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
 

Advocates who backed approval decry cost

Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.

The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.

The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.

“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”

UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.  

“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.

Dr. Carome said the advocates’ complaints were hard to fathom.

“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”

“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.

“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.

“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.

Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.

Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.

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

A high-profile, Washington-based consumer advocacy group is calling for the removal of the U.S. Food and Drug Administration’s acting commissioner and two other top officials, saying that the agency’s approval of the Alzheimer’s drug aducanumab (Aduhelm, Biogen) was “reckless.”

In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.

“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.

Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.

“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.

“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”

In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
 

Advocates who backed approval decry cost

Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.

The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.

The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.

“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”

UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.  

“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.

Dr. Carome said the advocates’ complaints were hard to fathom.

“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”

“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.

“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.

“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.

Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.

Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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