FDA recommends shorter trials for updated coronavirus vaccines
Vaccine developers will not have to conduct lengthy clinical trials to evaluate the effectiveness of shots tailored to fight new coronavirus variants, according to new guidance from the Food and Drug Administration (FDA).
According to the guidance released Monday, developers will not need large randomized control trials comparing it to a placebo.
Instead, the FDA said it recommended companies submit data from small trials comparing a person’s immune response to a vaccine that has already been authorized.
Simply put: The new guidance recommendations would speed up the review process for booster shots or new vaccines, a welcome development as experts worry about how coronavirus mutations could impact vaccines.
Anticipating, not reacting: Janet Woodcock, the agency’s acting commissioner, said the guidance is not meant as an indication that new vaccines would be needed, but is about being prepared.
“I think we need to anticipate this and work on it, so that we have something in our back pocket before the threshold is upon us, so to speak,” Woodcock said.