Last Friday, FDA’s advisory committee (VRBPAC) voted 16 to 2 against giving a license to a third Pfizer booster shot for everyone age 16 and up.
Although a second vote at Friday’s meeting had not been planned, another question was hastily developed. That question asked whether the vaccine could be licensed for a third booster dose for high risk people under the age of 65 and those over 65. That vote got a unanimous yes.
The panel’s decisions are not final. The FDA is obliged to take the panel’s advice into consideration, but it is not required to adopt it. So yesterday, the FDA issued an EUA, not a license, for the Pfizer vaccine for the booster dose.
But in doing so, FDA added an additional category of people for the booster dose, a category that had not been included in the Advisory Committee’s vote:
This is what I call weasel wording. This statement does not make sense. People whose occupation puts them at high risk of exposure to COVID are no more likely to be at high risk of serious complications or severe COVID-19 than anyone else. They are at higher risk of developing COVID, but not at higher risk of serious COVID.
What FDA did (and you know who did this: Peter Marks, head of CBER and Janet Woodcock, acting Commissioner, are the only people with the authority to come up with this BS) was to take the VRBPAC approval for people with underlying conditions that put them at high risk for severe COVID, and twist it into an EUA for all health care workers, staff at schools and colleges, grocery store workers, big box employees, etc.
So no broadening of the license was accomplished, though the EUA was broadened. (My first draft was wrong about this.) This is curious. It may reflect on the fact that offering a licensed product opened up liability, and/or that no licensed product is available. It may also reflect the fact that FDA does not want to be embroiled in yet more claims of “bait and switch” over its deliberate blurring of the EUA and licensed vaccine on August 23, when it issued the first Covid vaccine license.
There was a small hoop left to jump through before boosters could be offered to a larger population. While FDA determines how a drug or vaccine should be licensed or authorized for use, the CDC’s ACIP committee is the group responsible for creating the recommendations for use of the vaccine in different demographic groups.
And so ACIP did what it never does. It rejected one of 4 CDC proposals to offer the third dose to all people with potential occupational exposures. The ACIP limited their approval to only those groups the FDA advisory committee had voted for last Friday. As CNBC noted,
…Dr. Leana Wen [member of the Council on Foreign Relations and the World Economic Forum], an emergency physician and former Baltimore health commissioner, on Twitter called the CDC panel’s vote to reject boosters more widely a “mistake.”
“Really, we are not allowing healthcare workers, many of whom got vaccinated back in December, to get a booster? What about teachers in cramped classrooms where masks aren’t required?” she tweeted, adding CDC Director Dr. Rochelle Walensky should overrule the recommendation.
… In a paper published days before an FDA advisory meeting last week, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, contended in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time.
I think 2 things happened. The propaganda that the vaccines still prevent serious disease while perhaps not preventing mild disease stood in the way of approving boosters to prevent mild disease. Why give a potentially dangerous booster to prevent a cold? It doesn’t make sense.
Second, everyone on those committees knew that if the vaccine’s third dose did get approved for a huge swath of the general public, it would soon be mandated for themselves. A third dose would probably have been required for every member of both FDA’s and CDC’s advisory committees. I don’t think they were ready for that. And maybe they weren’t ready for the resistance from those who took the 2 shots thinking they were done… but soon could be fired for not having a third dose. What about the 4th, 5th, 6th etc. doses?
Or maybe the large demonstrations in Australia and Europe were influencing those advisory committee members…
Rochelle Walensky still has to sign off on the recommendations. Will she be ordered to overrule the ACIP advisors? Stay tuned.
Update September 24, 9 am: I guessed right. Rochelle was instructed to overrule her advisory committee and make the shots available to anyone aged over 18 who wanted them. From the WaPo:
In a rare move, CDC Director Rochelle Walensky late Thursday overruled her agency’s advisory panel and added a recommendation for boosters for people whose jobs put them at risk of infection.
The advisory panel had made a recommendation that largely mirrored an authorization issued a day earlier by the Food and Drug Administration, with a call for a third shot of the Pfizer-BioNTech vaccine for people 65 and older, nursing home residents and people 50 to 64 with underlying medical conditions six months after completing their second shot.
The panel also said younger people, 18 to 49 years old with underlying medical conditions, may assess their own risk and choose to get a booster if they want one.
The CDC panel parted with the FDA on a pivotal issue: It declined to recommend a booster for people at risk of illness because of their job.
While Walensky agreed with most of what the advisers recommended, she added a recommendation that hewed closely to the FDA language. Individuals ages 18 to 64 at risk of exposure and transmission because of [their] occupational or institutional setting may receive a booster shot, she said in a statement, released just before midnight.
The FDA had authorized Pfizer boosters for several populations: people 65 and older; those 18 to 64 at high risk of severe illness; and those 18 to 64 years whose “frequent institutional or occupational exposure” to the coronavirus puts them at high risk of covid-19 complications, including teachers, health-care workers and grocery store employees…
About 70 percent of vaccine doses are being given at pharmacies, and boosters will not require additional documentation, CDC officials said.
“In reality, anyone who wants a booster will get one, as has already been happening,” said one federal health official who spoke on the condition of anonymity because they were not authorized to comment publicly.
…The Biden administration had been hoping it could offer boosters beginning this week to any fully vaccinated adults eight months after their second shot, to reduce viral transmission and curb the pandemic. That broad plan ran into opposition from outside experts and some of the government’s own vaccine scientists, who argued that two doses of the vaccines still offer robust protection against serious illness and hospitalizations, even if some data indicates [sic] waning protection against less serious cases.