FDA Authorizes Additional Bivalent Booster for Immunocompromised, Older Americans

The U.S. Food and Drug Administration (FDA) announced April 18 that it has amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines “to simplify the vaccination schedule for most individuals.”

With this action the agency authorized use of the current bivalent vaccines (original and omicron BA.4/BA.5 strains) for all doses administered to persons 6 months of age and older.

“Individuals 65 years of age and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose,” the FDA stated in its announcement. Data show that among older individuals, immunity from previous vaccinations can wane, and then be restored by receiving an additional dose, the agency explained.

The FDA statement further noted that people “with certain kinds of immunocompromise,” including patients receiving chemotherapy and those with solid organ transplants, who have received a single bivalent booster, may be eligible for a second dose 2 months or more later. How or if this applies to patients with autoimmune conditions who are treated with immune-suppressing medications was not specified.

Most Americans who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA said it “intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.”

The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. Those who have never been vaccinated against SARS-CoV-2 may now receive a single dose of the bivalent vaccine rather than multiple doses of the original monovalent vaccines.

—Rebecca Mashaw

Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. News release. U.S. Food and Drug Administration; April 18, 2023. Accessed April 18, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines