FDA panel set to vote on whether to approve Pfizer COVID booster shots

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Posted at 7:55 AM, Sep 17, 2021
and last updated 2021-09-17 11:55:14-04

A key Food and Drug Administration panel will meet Friday to discuss whether it should approve Pfizer booster shots, just days ahead of a Sept. 20 target date set by the White House to begin distributing third doses of the vaccine.

The FDA's Vaccines and Related Biological Products Advisory Committee will meet virtually for a day full of presentations and debate, which will culminate in the vote on a single question — does the evidence show that a Pfizer booster shot would be safe and effective for everyone aged 16 and up?

In data released by the FDA on Wednesday, Pfizer argued that vaccine booster shots were not only safe and effective but would be necessary for all Americans over 16 because real-world studies show the effectiveness of the first two doses wanes over time.

The data released by the FDA also showed that a third vaccine dose restored efficacy in preventing COVID-19 to up to 95%.

Following Friday's vote, the Centers for Disease Control and Prevention will meet next week to discuss who should get boosters first and when, according to The Associated Press.

In August, the Biden administration health officials recommended that those who received mRNA vaccines made by Pfizer and Moderna should seek out a booster eight months after their final shot — pending final approval from the FDA.

Earlier this month, Dr. Anthony Fauci said that it was likely that Pfizer's booster shots would likely be approved first and that Moderna's booster shot would follow a few weeks after the Sept. 20 target date.

The FDA has already approved the use of booster shots in people with compromised immune systems.