FDA looks to quickly authorize COVID-19 vaccine booster shots as new variants emerge

FDA said Monday that it will expedite efforts to gauge the efficacy of coronavirus vaccines against emerging strains. Rather than require new vaccines to undergo additional trials, which would involve thousands of participants over several months, Peter Marks—director of FDA’s center for biological products—says tests of the vaccines’ resistance to new strains will take only a couple of months and require just a few hundred volunteers. Acting FDA Commissioner Janet Woodcock said the regulator is angling for “efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants.” The agency backed the statement by releasing best practices for vaccine manufacturers and makers of diagnostic test to adapt their products in response to coronavirus mutations. FDA also indicated that currently authorized vaccines in the United States do appear to remain effective against new mutations, which also have not significantly affected the accuracy of diagnostic COVID-19 tests.