FDA Authorizes Second COVID-19 Booster Dose for Older and Immunocompromised Individuals

On Tuesday, the U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 mRNA vaccines for older adults and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

According to the FDA, the action will make a second booster dose of COVID-19 vaccines available to other populations at elevated risk for severe disease, hospitalization, and death. Emerging evidence suggests a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.

Specifically, the FDA amended emergency use authorizations (EUAs) as follows:

• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age or older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine
• A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
• A second booster dose of the Moderna COVID-19 Vaccine may be administered at least four months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age or older with the same certain kinds of immunocompromise.

The FDA notes its actions apply only to the Pfizer-BioNTech and Moderna COVID-19 Vaccines, and authorization of a single booster dose for other age groups with these vaccines remains unchanged.

Shortly after the FDA’s decision to authorize an additional booster for specified populations, the U.S. Centers for Disease Control and Prevention (CDC) updated its recommendations to align with the FDA’s authorization. Separately, the CDC also allowed adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least four months ago to now receive a second booster dose using an mRNA COVID-19 vaccine.

The Western States Scientific Safety Review Workgroup shortly thereafter issued a statement supporting the expanded eligibility of second booster doses of Pfizer-BioNTech and Moderna vaccines for certain individuals.

Additional information from the FDA is available here.