MARYLAND (Reuters) – The U.S. Food and Drug Administration is planning a rapid review process for a rapid recovery of the new COVID-19 booster vaccines if variants of the coronavirus against which the vaccines do not offer protection appear, the chief official said. from the agency on Thursday.
Dr. Janet Woodcock, interim FDA commissioner, said that if new variants of the coronavirus emerge that require booster doses or changes in vaccines, the agency will not require the type of large trials that were required for authorization or approval of emergency use.
The agency plans to issue a proposal on the process for public comment in a few weeks, she said at a news conference. This process will likely require safety information, as well as, if possible, the calling of an external committee of experts to review the booster injection.
Both Pfizer Inc and the German partner BioNTech, as well as Moderna, whose vaccines were authorized for emergency use in the United States, said they were preparing for the possibility of variants that may require a booster injection.
Current vaccines still provide adequate protection against existing variants of concern, Woodcock said. A variant in the UK was found to be more transmissible, while some vaccines were found to be less effective against variants that emerged in South Africa and Brazil.
Establishing a regulatory process will help the FDA to act quickly, if necessary, she said.
“If the virus changes, we are preparing for it,” said Woodcock.
The threshold for deciding whether a new vaccine is needed has not yet been determined. Countries must create surveillance measures to find variants of concerns, and then scientists must agree on how far a variant has strayed too far from the virus unchanged and requires a new vaccine.
(Reporting by Caroline Humer; Editing by Leslie Adler)
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