FDA Updates EUA for Bivalent mRNA COVID-19 Vaccines to Simplify Use

On April 18, 2023, the FDA issued an announcement, updating the emergency use authorization (EUA) for the bivalent mRNA COVID-19 vaccines. Attempting to simplify use for healthcare professionals, the new provisions authorize using bivalent vaccines for all eligible patient populations. The update overturns the EUA for monovalent vaccines, prohibiting their use in the United States.

Any eligible patient who has not received a bivalent mRNA COVID-19 vaccine but has received a monovalent vaccine is eligible for one bivalent vaccine dose. Additionally, patients between 6 months and 5 years who have been vaccinated with the monovalent vaccine can get a bivalent vaccine, with the number of doses depending on vaccination history.

Most people who have already received one dose of the bivalent vaccines should not have a second dose. However, those over 65 may get a second bivalent vaccine four months after their initial bivalent vaccine.

Immunocompromised individuals also qualify for a second bivalent booster two months after their initial bivalent dose. Generally, final eligibility for immunocompromised people is determined by their healthcare provider. For immunocompromised patients between 6 months and 4 years of age, providers are advised to use discretion while accounting for previously used vaccines.

Pediatric patients between 6 months and 5 years who are unvaccinated are eligible for a two-dose series of the bivalent Moderna vaccine or a three-dose series of the bivalent Pfizer vaccine. One caveat is that 5-year-old patients only need one Pfizer bivalent vaccine dose.

All other unvaccinated individuals should get a single dose of the bivalent vaccine to replace a multidose monovalent series.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines, and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the announcement.

“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death,” he continued.