The Centers for Disease Control and Prevention and its advisers still must recommend how the extra shots will be used
The agency said the extra dose of the Pfizer-BioNTech vaccine should be administered six months after its standard two-shot regimen.
The FDA, in issuing the emergency clearance, took an approach similar to what was recommended Friday by the agency’s outside panel of vaccine experts. But the agency interpreted the advisory panel’s guidance broadly to cover a larger swath of people.
“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.”
The FDA action is not the final step before the booster is made available. The Centers for Disease Control and Prevention and its advisers still must recommend in detail who should receive the shots.