U.S. FDA gearing up for rapid review of potential COVID-19 booster shots
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[February 05, 2021]
(Reuters) - The U.S. Food and Drug
Administration is planning a rapid review process for quick turnaround
of new COVID-19 booster shots if variants of the coronavirus emerge
against which the vaccines do not provide protection, the agency's top
official said on Thursday.
Dr. Janet Woodcock, acting commissioner of the FDA, said that if new
variants of the coronavirus emerge that require booster shots or changes
to vaccines, the agency will not require the type of large trials that
were required for emergency use authorization or approval.
The agency plans to issue a proposal on the process for public comment
in a few weeks, she said during a press briefing. That process will
likely require safety information as well as, if possible, the convening
of an outside committee of experts to review the booster shot.
Both Pfizer Inc and German partner BioNTech SE as well as Moderna Inc,
whose vaccines have been authorized for emergency use in the United
States, have said they are preparing for the possibility that variants
will emerge that could require a booster shot.
The current vaccines still provide adequate protection against existing
variants of concern, Woodcock said. A variant in the U.K. has been found
to be more transmissible while some vaccines have been found to be less
effective against variants that emerged in South Africa and Brazil.
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A healthcare worker administers a shot of the Moderna COVID-19
Vaccine to a woman at a pop-up vaccination site operated by SOMOS
Community Care during the coronavirus disease (COVID-19) pandemic in
Manhattan in New York City, New York, U.S., January 29, 2021.
REUTERS/Mike Segar
Settling on a regulatory process will help the FDA move quickly if
needed, she said.
"If the virus changes, we are getting prepared for that," Woodcock
said.
The threshold for deciding on whether a new vaccine is needed has
not yet been determined. Countries must build surveillance measures
to find variants of concerns, and then scientists must agree upon at
what point a variant has strayed too far from the unaltered virus
and requires a new vaccine.
(Reporting by Caroline Humer; Editing by Leslie Adler)
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