The Food and Drug Administration has still not announced whether it will authorize Pfizer-BioNTech Covid-Booster vaccinations for some Americans, even as a key vaccine advisory group from the Centers for Disease Control and Prevention has its first day of two-day meeting on this subject concludes.
Typically, the FDA announces its decision on specific vaccines or drugs before it is the turn of the CDC and its Advisory Committee on Immunization Practices to meet and issue their own recommendations. The CDC panel is due to vote on the booster vaccinations Thursday, but officials said they will postpone that meeting if the FDA’s decision is not announced by the committee’s re-convening at noon.
The FDA’s Advisory Committee on Vaccines and Related Biological Products on Friday overwhelmingly opposed a plan to distribute the extra vaccinations to Americans 16 and older, before unanimously adopting an alternative plan, older Americans and people at high risk to get serious illnesses, to give refresher courses.
It has been viewed as a controversial recommendation as the Biden administration has announced that it will begin offering booster shots to the public as early as this week pending approval from U.S. health officials.
It is now up to FDA regulators to decide whether to accept the recommendation of the FDA Advisory Committee – which is often the case – or perhaps deviate from the advice given and increase the number of people eligible for the additional syringes.
An FDA spokesman declined to provide information at the time of the agency’s decision.
The FDA still has some time. The CDC advisory group is not expected to vote on who should get Pfizer booster vaccinations until Thursday afternoon, and federal health officials advised on Wednesday that the vote may be postponed if the FDA does not make a decision by then has met.
During the meeting on Wednesday, CDC advisors heard several presentations of data in support of the widespread use of booster syringes, including a presentation by a Pfizer manager showing data showing that a third syringe appears to be safe and antibody levels in those Recipients increased.