FDA Recommends Shorter Clinical Trials for Coronavirus Vaccines Created for Variants
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.
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.
“We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts,” Janet Woodcock, the agency’s acting commissioner, said in a statement.
