MARYLAND (Reuters) – The U.S. Food and Drug Administration is planning a rapid review process for rapid turnaround of new COVID-19 booster shots if variants of the coronavirus emerge that the vaccines do not protect against, the agency’s top official said Thursday.
Dr. Janet Woodcock, acting commissioner for the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not need the kind of major trials required for emergency authorization or approval.
The agency plans to issue a proposal on the process for public comment within a few weeks, she said at a news conference. That process likely requires safety information and, if possible, convening an outside committee of experts to review the booster shot.
Both Pfizer Inc and its German partner BioNTech and Moderna, whose vaccines are approved for emergency use in the United States, have said they are preparing for the possibility that variants will emerge that might require a booster shot.
Current vaccines still provide adequate protection against existing variants of concern, Woodcock said. A variant in the UK has been shown to be more transmissible, while some vaccines have been found to be less effective against variants emerging in South Africa and Brazil.
Arranging a regulatory process will help the FDA act quickly if necessary, she said.
“If the virus changes, we prepare for it,” said Woodcock.
The threshold for deciding whether a new vaccine is needed has not yet been established. Countries need to take surveillance measures to find variants of concerns, and then scientists need to agree on at which point a variant has strayed too far from the unaltered virus and needs a new vaccine.
(Reporting by Caroline Humer; edited by Leslie Adler)
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