FDA authorizes Pfizer and Moderna to give fourth dose of COVID-19 vaccine

Photo: Longhua Liao/Getty Images

The Food and Drug Administration today authorized both Pfizer and Moderna to give a second booster dose of their COVID-19 vaccines to individuals aged 50 and older and to those who are immunocompromised.

The additional shot follows the completion of a three-dose primary vaccination series at least four months after the first booster.

"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 FDA said.

In addition, the FDA authorized a second booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 12 and older with certain kinds of immunocompromise at least four months after the first booster. This includes people who have undergone solid organ transplantation or who are living with an equivalent level of immunocompromised conditions.

A second booster dose of the Moderna COVID-19 vaccine may be administered to individuals aged 18 and older with the same kinds of immunocompromise, also at least four months after the first booster, the FDA said.

WHY THIS MATTERS

Vaccination remains the best defense against COVID-19, its variants and future outbreaks, said Pfizer and Moderna.

The second booster authorized today for those aged 50 and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves, Pfizer said.

Moderna CEO Stéphane Bancel said, "The FDA's endorsement of a second booster dose will allow millions of Americans to build and maintain protection against SARS-CoV-2. The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant."

THE LARGER TREND

The Pfizer-BioNTech COVID-19 Vaccine was authorized previously under Emergency Use Authorization (EUA) as a single booster administered to individuals aged 12 and older who had completed the primary vaccination series, as well as to individuals 18 and older who completed primary vaccination with another authorized or approved COVID-19 vaccine. 

On January 31, the FDA approved the Biologics License Application for Moderna's COVID-19 Vaccine, mRNA, to prevent COVID-19 in individuals ages 18 and older. Previously, Moderna's COVID-19 vaccine was available under EUA in the United States.

ON THE RECORD

"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 Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. 
 

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com