How did it get FDA Approval?
- informedchoiceiowa
- Sep 25, 2021
- 2 min read
Normally when a vaccine (booster) gets approved for use, the President, FDA commissioner, CDC director, & the Surgeon General don't announce it will be available for everyone before going through the proper voting channels first. Why did Biden announce that last month?
The normal process for a proposal goes through the FDA & CDC committees. Based on their votes, the agencies recommend or reject the proposal.
➡️FDA committee: Vaccines and Related Biological Products Advisory Committee (VRBPAC)
➡️CDC committee: Advisory Committee on Immunization Practices (ACIP)
Talking about Pfizer's booster proposal for everyone 16 & older:
2 weeks ago, the VRBPAC committee voted 16-2 AGAINST boosters... except for those 65 & older & those with certain underlying medical conditions.
After deliberation, the committee stated that the vaccine's risks don't outweigh the benefits for the general population 16 & older to get a booster.
▶️FDA went against the panel's vote & added a recommendation to include essential workers, [health care workers, teachers and day care staff, grocery workers] which was explicitly voted down by the panel.
Last week, ACIP voted 9-6 AGAINST boosters except for those 65 & older & those with certain underlying medical conditions.
▶️CDC went against the vote & added the same recommendation to line up with the FDA's to include essential workers.
What kind of pressure was put on the FDA commissioner & CDC director to do this when the President announced boosters were going to be available and even included a timeline of "by September 20"?
⭕What data was used to determine Pfizer booster recommendation approval?
▶️200 people ages 18-55 years old given a booster & antibody response assessed after 1 month
▶️306 people ages 18-55 years old & 12 people 65 & older were assessed for safety over an "average" of 2 months
The end. That's the data used.
When it comes to mandates, at what point do the mandates end? How many boosters can be added to the mandates? For how many years? How often?
Who is asking these questions?
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