FDA Authorizes Spring COVID-19 Booster for Certain Americans

TUESDAY, April 18, 2023 (HealthDay News) — Seniors and people with weakened immune systems can get another booster dose of the bivalent COVID-19 vaccine this spring, the U.S. Food and Drug Administration announced Tuesday.

Seniors aged 65 years and older can get a booster at least four months following their first dose of the bivalent vaccine, which protects against both the original and omicron strains of COVID-19, the FDA said. People with weakened immune systems can get a booster at least two months after their last vaccine dose, based on their doctor’s judgment, the agency added.

The FDA announcement was part of an overall effort to simplify the COVID-19 vaccine schedule for Americans, the agency said. In its Tuesday announcement, the FDA also rescinded its emergency use authorization for the original Moderna and Pfizer mRNA vaccines, which are credited with saving tens of millions of lives during the pandemic. Only the bivalent vaccines will be available going forward, the FDA said.

Adults and children who have only gotten the original vaccine remain eligible for a dose of bivalent vaccine manufactured by either Moderna or Pfizer. Roughly 75 percent of Americans younger than 65 years are eligible for a bivalent vaccine dose but have not gotten the booster, Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said during a Tuesday morning media briefing.

People who remain unvaccinated now only need to get one dose of the bivalent vaccine, rather than the two-shot series associated with the original vaccines, the FDA said. Unvaccinated children ages 6 months to 5 years can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer bivalent vaccine, the agency said.

The FDA announcement did leave the door open for future boosters, in case a new COVID-19 variant starts tearing through the United States. An advisory committee in June will review the COVID-19 strain composition expected for the fall and weigh whether another booster dose will be needed in the fall, the agency said.