FDA Authorizes 2nd Booster for Older and Immunocompromised Individuals

If you are 50 or older or employ those who are, you’ll want to take notice of the latest announcement on COVID-19 boosters. 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 vaccine for older people 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. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization, and death, according to the FDA’s announcement.

“Current evidence suggests some waning of 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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.”

The agency amended the emergency use authorizations 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 and 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. These are people who have undergone solid organ transplantation or who are living with conditions that are considered to have an equivalent level of immunocompromise.
• 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 and older with the same certain kinds of immunocompromise.

Read the FDA’s full announcement here.