A panel of advisers to the US Food and Drug Administration voted on Friday to recommend Pfizer booster shots for people over 65 or at high risk of severe COVID-19, largely scaling back Pfizer’s proposal that would have covered anyone 16 and older.
The advisory panel also said health care workers and others at high risk for occupational exposure should be included in the emergency use authorization of the boosters, which is pending an FDA decision.
So what happens next?
Following the expert panel’s recommendations, the FDA will announce its decision on the booster shot by next week. The FDA isn’t required to follow the panel’s recommendation, but typically does.
While the FDA authorizes vaccines, the Centers for Disease Control and Prevention will set the vaccination policy. If things go as expected, the CDC’s advisory committee will meet next week to make a recommendation to the agency.
Didn’t President Biden say booster shots would be available as soon as Sept. 20?
Yes, he did say that. But he also acknowledged that the final decision was subject to approval by the FDA and CDC. Given the timeline outlined above, it is unlikely that the FDA and CDC would both announce their decisions by Monday.
Will there be Moderna or Johnson & Johnson booster doses?
If you got the Moderna or Johnson & Johnson vaccine, you’re not out of luck. Those companies were just not as far along as Pfizer was in submitting data for a booster dose to the FDA.
Moderna started the rolling submission of its application to the FDA for a booster dose on Sept. 1, whereas Pfizer started that process on Aug. 25.
Johnson & Johnson has yet to begin its booster dose application with the FDA. The company is waiting for data from its clinical trial. Early data from the trial support a booster dose for people who previously received Johnson & Johnson’s one-shot vaccine.