A panel of the Food and Drug Administration (FDA) in the U.S. voted on Friday to recommend a third dose of Pfizer’s Covid-19 vaccine for those over age 65, health care workers and people at high risk for occupational exposure to the virus.
An FDA official said those at high risk most likely would include teachers and essential infrastructure workers.
The agency’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend that the FDA approve the booster for everyone at least 16 years old who meets that criteria.
The FDA proposed, and the panel agreed, that approval for the so-called booster shot would come initially as an emergency use authorization, subject to final approval when more safety and efficacy data is available.
Since the proposal came from the FDA, the agency is very likely to approve the recommendation, though a spokesman said that the plan might be tweaked.
The Advisory Committee for Immunization Practices will meet next week to advise the Centers for Disease Control and Prevention how to apply the FDA’s eventual approval.
The CDC scheduled a meeting of its vaccine advisers for next Thursday and Friday. The CDC must approval any booster doses given under the authorization.
On Friday, the FDA panel reviewed the latest clinical data from Pfizer about the vaccine, which has been administered to tens of millions of people so far, and heard advice from outside advisers. The CDC also provided input.
The vote is non-binding, but the FDA typically acts on the committee’s recommendations. The agency will decide afterward if it should formally change approval guidance for Pfizer’s coronavirus vaccine, which received emergency authorization in December and full approval last month.
Earlier this week, a group of FDA scientists said a third dose of Pfizer’s vaccine almost certainly increases antibodies in recipients and offers greater protection against COVID-19. However, they stopped short of saying extra doses are needed by a majority of Americans.
Though the Biden administration said it hopes to begin providing booster shots by next week, experts on Friday they’re likely not necessary yet because even with waning immunity, the two-shot regime of Pfizer still largely protects against severe cases of Covid-19.
In August, U.S. health officials said they wanted to make a third dose of the Pfizer vaccine available starting Monday, mainly as a result of the Delta coronavirus variant, which is more infectious than the original strain.