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 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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 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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