MARYLAND (Reuters) – The US Food and Drug Administration is planning a rapid review process to quickly change the new COVID-19 booster shots if variants of the coronavirus against which vaccines do not provide protection appear, the agency’s top official said on Thursday.
Dr. Janet Woodcock, FDA Acting Commissioner, said that if new variants of the coronavirus that require booster vaccines or vaccine modifications occur, the agency will not require the type of large studies that were required to authorize or approve emergency use. .
The agency plans to issue a proposal for the public comment process in a few weeks, she said during a press briefing. This process will probably require safety information as well as, if possible, the convening of an external committee of experts to review the booster fire.
Both Pfizer Inc and German partner BioNTech and Moderna, whose vaccines have been authorized for emergency use in the United States, said they are preparing for the possibility of variants that could require a booster shot.
Current vaccines continue to provide adequate protection against existing variants of concern, Woodcock said. A UK variant has been shown to be more transmissible, while some vaccines have been shown to be less effective against variants in South Africa and Brazil.
The decision on a regulatory process will help the FDA move quickly if necessary, she said.
“If the virus changes, we’re preparing for it,” Woodcock said.
The threshold for deciding whether a new vaccine is needed has not yet been set. Countries need to build surveillance measures to find ways to worry, and then scientists need to agree on when a variant has gone too far from the unaltered virus and needs a new vaccine.
(Reporting by Caroline Humer; Editing by Leslie Adler)
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