FDA & CDC Approve Moderna and J&J Boosters

On October 20, 2021, the U.S. Food and Drug Administration (FDA) announced its amended emergency use authorizations (EUA) for COVID-19 vaccines. The new authorization permits single booster doses of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to  individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and those 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19. The FDA also amended the EUA to allow the use of a single booster dose of the Johnson and Johnson COVID-19 Vaccine, which may be administered at least 2 months after completion of the single dose primary to individuals 18 years of age or older. In addition, the FDA authorized “mix and match” boosters. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated that including the use of mix and match boosters is necessary to address the public need and that the FDA “will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”

On October 21, 2021, the Centers for Disease Control (CDC) endorsed the FDA’s authorization of Moderna and Johnson & Johnson COVID-19 Vaccine booster shots, stating that “eligible individuals may choose which vaccine they receive as a booster dose. Some people may have a preference for the vaccine type that they originally received, and others may prefer to get a different booster. CDC’s recommendations now allow for this type of mix and match dosing for booster shots.”