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MARYLAND (Reuters) – The United States Food and Drug Administration is planning a rapid review process for prompt handling of new COVID-19 recalls if variants of the coronavirus emerge against which vaccines fail to provide protection, said Thursday the senior official of the agency.
Acting FDA commissioner Dr Janet Woodcock said if new variants of the coronavirus emerge that require booster shots or vaccine changes, the agency won’t need the type of large-scale trials required for emergency use authorization or approval.
The agency plans to release a proposal on the public comment process in a few weeks, she said at a press briefing. This process will likely require safety briefing as well as, if possible, the convening of an external committee of experts to review the recall.
Pfizer Inc and its German partner BioNTech as well as Moderna, whose vaccines have been cleared for emergency use in the United States, said they were preparing for the possibility that variants would emerge that could require a booster.
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 shown to be less effective against variants that have appeared in South Africa and Brazil.
Having a regulatory process in place will help the FDA to act quickly if necessary, she said.
“If the virus changes, we prepare for that,” said Woodcock.
The threshold for deciding whether a new vaccine is needed has not yet been determined. Countries need to put in place surveillance measures to find variants of concerns, and then scientists need to agree on the point at which one variant has strayed too far from the unmodified virus and requires a new vaccine.
(Reporting by Caroline Humer; Editing by Leslie Adler)
© Copyright Thomson Reuters 2021
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