MARYLAND (Reuters) – The U.S. Food and Drug Administration is planning a rapid review process for quick changes to new COVID-19 booster shots if coronavirus variants come out against which vaccines offer no protection, it said Thursday the top manager of the agency.
Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus appear that require booster shots or changes in vaccines, the agency will not require the type of large trials that were required for authorization. or emergency approval.
The agency plans to issue a proposal on the process for making public comments in a few weeks, he said during a news conference. This process will likely require safety information and, if possible, the convening of an external committee of experts to review the booster shot.
Both Pfizer Inc. and German partner BioNTech, as well as Moderna, whose vaccines have been authorized for emergency use in the United States, have said they are preparing for the possibility of variants appearing that may require a booster shot. .
Current vaccines still offer adequate protection against existing variants of concern, Woodcock said. A variant in the UK has been found to be more transmissible, while some vaccines are less effective against variants that emerged in South Africa and Brazil.
Deciding, establishing a regulatory process will help the FDA move forward quickly.
“If the virus changes, we prepare for it,” Woodcock said.
The threshold for deciding whether a new vaccine is needed has not yet been determined. Countries need to build surveillance measures to find variants of concern, and then scientists need to agree on when a variant has moved too far away from the unaltered virus and requires a new vaccine.
(Report by Caroline Humer; Edited by Leslie Adler)
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