FDA still silent on Covid booster shots as key CDC panel concludes first day of a two-day meeting

The Food and Drug Administration still hasn’t announced whether it will authorize Pfizer-BioNTech Covid booster shots for some Americans even as a key Centers for Disease Control and Prevention vaccine advisory group concludes its first day of a two-day meeting on the topic.

Usually, the FDA announces its decision on certain vaccines or drugs before the CDC and its Advisory Committee on Immunization Practices take their turn to meet and issue their own recommendations. The CDC panel is supposed to vote on the booster shots Thursday, but officials said they will postpone that meeting if the FDA’s decision isn’t announced by the time the committee reconvenes at noon.

The FDA’s Vaccines and Related Biological Products Advisory Committee on Friday overwhelmingly rejected a plan to distribute the extra shots to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from severe illness.

It was considered a controversial recommendation because the Biden administration has said it wants to begin offering booster shots to the general public as early as this week, pending authorization from U.S. health regulators.

It’s now up to FDA regulators to decide whether they will accept that agency’s advisory committee’s recommendation – which it often does – or perhaps depart from the advice given and increase the number of people who are eligible to get the extra shots.

An FDA spokesperson declined to provide information on the timing of the agency’s decision.

The FDA still has some time. The CDC advisory group isn’t expected to vote on who should get Pfizer booster shots until Thursday afternoon, and federal health officials indicated earlier Wednesday that the vote may be pushed to another time if the FDA hasn’t made its decision by then.

During the meeting Wednesday, CDC advisers listened to several presentations on data to support the wide distribution of booster shots, including one presentation from a Pfizer executive, who displayed data that showed a third shot appears to be safe and boost antibody levels in recipients.