The U.S. Food and Drug Administration issued new guidance Monday that streamlines the vetting process for COVID-19 vaccines that are modified to target new coronavirus variants. It allows modified vaccines to be authorized under an amendment to their existing emergency authorizations, officials said. AdvertisementThe FDA would like companies to submit clinical data showing that the modified version of their vaccine is more effective against new variants than their original vaccine. The agency is also asking vaccine makers to test their modified vaccines in people who have never been vaccinated and in people who were previously vaccinated. It’s possible that in the future, modified vaccines could be authorized without the need for additional clinical studies, the FDA noted.
Source: Los Angeles Times February 23, 2021 00:00 UTC