Breaking: FDA Authorizes Second COVID-19 Booster Dose for Older Adults, Immunocompromised Individuals

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:

  • For adults 50 years and older, a second dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine may be administered at least 4 months after receiving a first booster dose of any authorized or approved COVID-19 vaccine
  • For individuals 12 years of age and older with certain kind of immunocompromise—including those who have undergone a solid organ transplant or those living with conditions that have an equivalent level of immunocompromise—a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine may be administered at least 4 months after receiving a first booster dose of any authorized or approved COVID-19 vaccine
  • For individuals 18 and older with the same certain kinds of immunocompromise, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine may be administered at least 4 months after receiving a first booster dose of any authorized or approved COVID-19 vaccine

“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.

Reference

  1. Coronavirus (COVID-19) update: FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals. News release. FDA. March 29, 2022. Accessed March 29, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and