The amended authorizations apply to the Pfizer-BioNTech and Moderna COVID-19 vaccines.
The FDA has authorized a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccines for older adults and certain other immunocompromised individuals, according to an agency press release.1
Previously, the FDA had authorized a single booster dose for certain immunocompromised individuals after completing a 3-dose primary series of the vaccine. This approval, the agency noted, “will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization, and death.” The decision was made based on emerging evidence that a second booster dose of an mRNA COVID-19 vaccine can improve protection.
The amended emergency use authorization has been updated as follows:
“Current evidence suggests some waning protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher risk individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
The authorization of a single booster dose for other age groups remains unchanged.