Saturday, September 18, 2021

FDA Panel Rejects COVID Boosters

Via the New York Post:

A Food and Drug Administration advisory panel voted against green-lighting COVID-19 booster shots Friday for most people — throwing up a major hurdle for President Biden’s plan to dole out a third dose to most Americans.

But the independent panel, which reviewed a 23-page FDA briefing document highlighting recent studies, recommended emergency use of a third dose for Americans over age 65 and those at high risk of severe infection.

. . . The FDA is not bound to follow the advice of the independent advisory panel but has followed its guidance so far on COVID-19 vaccinations.

Overall, the panel voted 16-2 not to recommend a third dose for people 16 years and up while unanimously green-lighting it for people 65 years and older.

This decision clearly undermines the current COVID narrative. and the mainstream media now appears to be backing off boosters, which Dr Fauci had been assiduously promoting. Via CNN,

Indeed, even the FDA's official briefing paper before the meeting expressed skepticism. "Overall," agency officials noted, "data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death." The agency also stated that it's unclear whether an additional shot might increase the risk of myocarditis, which has been reported, particularly in young men, following the second Pfizer and Moderna shots.

Part of the disagreement arose because President Joe Biden had announced that Americans could get a booster as soon as Sept. 20, a date Fauci and colleagues had suggested to him as practical and optimal in one of their frequent meetings just days before — though he cautioned that boosters would need CDC and FDA approval.

As far as I can see, this is the first case of overt disagreement on The Science from within the public health establishment. The same people have been able to finesse disagreements over the lab leak theory of COVID, pushing any serious investigation into the background. This will be much less easy with official non-endorsement of boosters. And since boosters have been part of Biden's public agenda for vaccine mandates, this will also make that agenda harder to sell.

Alex Berenson cimmented via Substack,

Make no mistake, this is a huge loss for the Biden administration and for Dr. Anthony S. Fauci, who was desperately pimping boosters as recently as two days ago, when he told Reuters that they were needed for everyone to stop a rise not just in infections but in “mildly to moderately symptomatic disease.”

Fauci is correct that the original two-dose regimen is now failing to prevent symptomatic disease.

. . . Which raises the question - if you are under 65, not at high risk for severe Covid, and have not yet been vaccinated, why on earth would you be? Putting side effects and long-term risks aside, you now know that vaccines are likely to do little more than delay your risk of infection for a few months. What’s the point?

In recent weeks, I keep remembering Stein's Law: That which cannot continue must stop.