FDA authorizes second booster dose for older and immunocompromised individuals

The United States Food and Drug Administration (FDA) authorized a second booster dose of either Pfizer-BioNTech or the Moderna coronavirus (COVID-19) vaccines for individuals 50 years of age and older as well as certain immunocompromised individuals.

Previously, the FDA authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. Now, a second booster dose of these vaccines is available to those at high risk for severe disease, hospitalization, and death.

The FDA 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.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.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. 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.”

According to the FDA, this action only applies to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available.