The Food and Drug Administration has updated the emergency use authorizations for Moderna and Pfizer-BioNTech‘s bivalent covid-19 vaccines, clearing the way for additional booster doses for certain vulnerable individuals. The move comes as data from the Centers for Disease control and Prevention indicates waning effectiveness of the current bivalent vaccines against emergency room visits and hospitalizations.
Previously, restrictions tied to the initial emergency use authorizations prevented the CDC from broadly recommending additional boosters, even for those most at risk. The updated terms now grant the CDC and its Advisory Committee on Immunization Practices (ACIP) greater versatility to recommend further doses of the bivalent vaccines. The ACIP is scheduled to meet Wednesday to discuss and is expected to endorse the FDA’s changes.
The FDA stated it intends to make decisions regarding future vaccinations after receiving recommendations on fall strain composition from its advisory committee in June. This change aligns the U.S. approach with that of other nations, including canada and the United Kingdom, which have already offered additional bivalent boosters to high-risk populations this spring.
