CDC Chief Overrules Panel, OKs Boosters for Healthcare Workers

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults aged 18 to 64 who live or work in a place where the risk for COVID-19 is high. That would have included healthcare workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18- to 64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said in a statement after midnight Thursday. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Walensky agreed with the rest of the advisory committees decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and older and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if that person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50-64.

The Advisory Committee on Immunization Practices considered, but narrowly rejected, boosters for a fourth group — adults ages 18 to 64 who live or work in a place where the burden of COVID-19 and risk of transmission are high.

That would have included healthcare or other frontline workers and people who live in group settings like homeless shelters and prisons.

The committee left out healthcare workers, a group many expected would be first in line for third doses because of their risk.

That is a departure from the FDA’s authorization, which included boosters for those 65 and over and for those aged 18-64 who are at high risk for severe illness from the coronavirus, including essential workers — such as those in healthcare — whose jobs increase their risk for infection.

This is the group Walensky added to the eligible list on her own.

“The [panel] did not buy into the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, Tennessee. Schaffner sits on the ACIP work group that considered the evidence behind boosters. He added that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, MPH, an ACIP panel member and clinical professor at the University of Washington, Seattle. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that healthcare workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, Pennsylvania. Long voted to reject boosters for healthcare and other high-risk workers.

“We might as well just say ‘give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working and it is working,” she said.

The committee saw data that showed that all the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the Delta variant.

Those at highest risk for severe breakthrough infections — those that cause hospitalization or death — are older adults.

How Much Will the US Benefit From Boosters?

Some on the panel felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, a family practice doctor in Ithaca, New York. He said he felt like the goal of giving boosters in the US should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Loehr said that based on his calculations of the benefits of boosters for each age group, that “even if we gave boosters to all 13 million seniors previously vaccinated with Pfizer we might prevent 200 hospitalizations a day, which would be a lot. But considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University in Boca Raton, who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford University, said she had cared for children who had died of COVID-19, which influenced her decision in favor of boosters.

“I can tell you that their family members really wished they had the extra protection [to protect] their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.

Next Steps

The recommendations would have ― before Walensky stepped in ― effectively narrowed the scope of the FDA’s Emergency Use Authorization for the Pfizer vaccine, which had included people who live or work in high-risk settings.

“This was a group that wanted to use a rifle rather than a shotgun,” said Schaffner.

One of the panel members tried to propose revised wording for a fifth vote, but the meeting was concluded because of the late hour.

Lee closed the meeting by reminding the public that the recommendations were temporary and that the committee would be back to reconsider the issue of third doses again soon.

For now, people who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the US.

Still, Schaffner noted that while the ACIP’s recommendations are important, in this case, they may not have a huge practical effect. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he notes, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” Schaffner said.

https://www.medscape.com/viewarticle/959389?fbclid=IwAR0sTVCR4NkTMUo8I94iWGtrunkzHUvI-3n__084a9A1iOsqJg4DLUePkvs#vp_1