Evidence suggests a second booster improve protection against severe COVID.
The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The agency 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.
The agency amended the emergency use authorizations as follows:
“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”
The FDA action applies only 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.