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 come out against which the vaccines do not provide protection, said the agency’s top official on Thursday.
If new variants of the coronavirus appear 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, said Dr. Janet Woodcock, the acting commissioner of the FDA.
She said during a press briefing that the agency plans to issue a proposal on the process for public comment in a few weeks. If possible, an outside committee of experts will review the booster shot.
However, both Pfizer Inc and German partner BioNTech SE as well as Moderna Inc, whose vaccines have been given authorization approval 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.
Woodcock said, the current vaccines still provide adequate protection against existing variants of concern.
It has been found that a variant in the U.K. has been found to be more contagious and some vaccines have been found to be less effective against variants that emerged in South Africa and Brazil.
She said, settling on a regulatory process will help the FDA move quickly if needed.
“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 confirmed.
However, the countries must build observation measures to find variants of concerns, and then scientists must agree upon at what point a variant has strayed too far from the unchanged virus and requires a new vaccine.