MPA | Pharmacy News

The Centers for Disease Control and Prevention and its advisers still must recommend how the extra shots will be used

The Food and Drug Administration on Wednesday authorized a Pfizer-BioNTech coronavirus booster shot for people 65 and older and adults at risk of severe illness, an effort to bolster protection for the most vulnerable Americans against the highly transmissible delta variant of the virus.

In addition to older Americans, boosters should be made available to people 18 through 64 years of age at high risk of severe illness from the coronavirus and those “whose frequent institutional or occupational exposure” to the virus puts them at high risk of serious complications from the disease caused by the virus, the agency said.

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.

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