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Here’s the skinny on what happened yesterday and today regarding the booster dose

By Meryl Nass, MD | September 23, 2021

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. That vote got a unanimous yes.

The panels decisions are not final. The FDA is obliged to take the panels advice into consideration, but it is not required to adopt it. So yesterday, the FDA issued 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:

  • “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

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 approval for all health care workers, staff at schools and colleges, grocery store workers, big box employees, etc.

Why? Because a license is necessary to impose a mandate, that’s why.

It looked like the weasels had won again. However, there was a small hoop left to jump through before any mandates came down.

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 the CDC’s proposal to widen the license for the third dose to all with potential occupational exposures. the ACIP limited their approval to what the FDA advisory committee had voted for last Friday. As CNBC noted,

The panel struggled over a controversial proposal to give boosters to a wide swath of the U.S. population, rejecting the plan by a vote of 9-6.

… 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 in 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 be mandated for themselves in no time. A third dose would 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… and now, it seems they could get into a situation where they could be fired for not having a third dose. What about more and more doses?

Or maybe the large demonstrations in Australia and Europe were influencing those advisory committee members…

September 23, 2021 - Posted by | Aletho News | , , , ,

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