FDA authorizes second COVID-19 booster shot for people ages 50 and older

The U.S. Food and Drug Administration has authorized a second booster dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines for people ages 50 and older and some immunocompromised individuals, the agency announced Tuesday, March 29.

The new authorization will make a second booster dose available to those at higher risk for severe disease, hospitalization and death, including those who have undergone solid organ transplantation or with certain immunocompromised conditions. The second booster dose of the Pfizer vaccine may be administered to people ages 12 and older with certain immunocompromised conditions at least four months after they have received a first booster dose of any COVID-19 vaccine.

The Moderna COVID-19 vaccine can be offered as a second booster dose at least four months after the first booster dose of any authorized or approved COVID-19 vaccine to people 18 years and older who are immunocompromised.

“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 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. Those who have not received their initial booster dose are strongly encouraged to do so,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

The FDA will continue to evaluate whether to authorize the potential use of a second booster dose in other age groups.

“The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations,” the agency said in the statement.

The FDA looked at safety surveillance data provided from the Ministry of Health of Israel, which found no new safety concerns after the second booster among about 700,000 people ages 18 and older who received the Pfizer vaccine. Approximately 600,000 of those people were ages 60 or older. The second booster shot of the Moderna vaccine also showed no additional safety concerns.

Increases in antibody levels against the SARS-CoV-2 virus, including delta and omicron variants, appeared two weeks after the second booster in the Israeli study.

The U.S. Centers for Disease Control and Prevention also approved the authorization on Tuesday. Santa Clara County said that with the CDC’s approval, the shots will be made available “immediately.”