Pfizer, Moderna Seek Authorization for Additional COVID-19 Vaccine Booster
This week, both Pfizer-BioNTech and Moderna each announced they have formally requested authorization from the U.S. Food and Drug Administration (FDA) for booster doses of their COVID-19 mRNA vaccines.
On Tuesday, Pfizer-BioNTech submitted a request to the FDA for an emergency use authorization (EUA) for an additional booster dose for adults 65 and older who have gotten a booster dose of any of the authorized or approved vaccines. According to the companies, the request comes as two data sets from Israel indicate an additional mRNA booster increases immunogenicity and decreases confirmed infections and severe illness.
On Thursday, Moderna then similarly submitted a request to the FDA to amend its EUA to allow for a fourth COVID-19 vaccine dose in adults 18 years of age or older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. According to Moderna, the request to include adults ages 18 years of age and older was made to provide flexibility to the U.S. Centers for Disease Control and Prevention (CDC) and health care providers to determine the appropriate use of an additional booster dose, including for those at higher risk of COVID-19 due to age or comorbidities. Moderna’s request is based in part on recently published data generated in the U.S. and Israel following the emergence of Omicron.
The FDA is anticipated to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in April to review the requests and consider recommendations for booster doses in 2022. A specific meeting date has not yet been set.