Bivalent Boosters: FDA Updates & Who’s Eligible
FDA Authorizes Additional COVID Boosters for Seniors, Immunocompromised
The Food and Drug Management (FDA) has amended its emergency use authorizations, or EUAs, for the Moderna and Pfizer bivalent COVID vaccines. This action allows adults 65 and older, as well as certain immunocompromised individuals, to receive an additional booster dose. These updated COVID vaccine guidelines take effect ahead of the anticipated fall vaccination campaigns.
The bivalent vaccines target both the original COVID-19 strain and the Omicron variants. They have been available in the U.S. as September under EUAs, which previously restricted their use. The FDA’s recent decision broadens access to these COVID bivalent boosters for specific populations.
Specifically, adults aged 65 and older who have already received one dose of a bivalent vaccine may now receive an additional dose at least four months after their initial shot. Similarly, most immunocompromised individuals who have received an initial bivalent dose can get a second dose at least two months later. Further doses for immunocompromised individuals are at the discretion of their healthcare provider.
Dr.Peter Marks,head of the FDA’s Center for Biologics Evaluation and Research,stated in a news release that the agency encourages individuals to stay current with vaccination,including with a bivalent COVID-19 vaccine. He added that available data continues to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.
For children aged 6 months to 4 years with compromised immune systems, eligibility for extra bivalent doses depends on their prior vaccination history, according to the FDA. A notable change is that most previously unvaccinated individuals can now receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent vaccines. The FDA simplified this recommendation recognizing that most Americans now possess some immunity to COVID-19, whether through vaccination or prior infection.
The agency stressed that most individuals who have received one dose of a bivalent vaccine are not currently eligible for a second dose. They also encouraged those who have not yet received their first bivalent dose to do so,noting that only about 17% of eligible Americans have received the recommended dose.
Dr. Peter Hotez, co-director of the Center for Vaccine Growth at Texas Children’s Hospital, said the FDA’s guidance generally makes sense. However,he questioned the age cutoff of 65,suggesting it should be lowered to 60 or even 50.
“For those Americans who understand its importance, we should make second bivalent boosters available. we’ll soon need guidance about another annual fall booster. Presumably that facts comes sometime this summer,” Hotez said.
What’s next
The FDA intends to make decisions about future vaccinations after receiving recommendations on the fall strain composition from its advisory committee in June. The CDC’s Advisory Committee on Immunization Practices is expected to endorse the FDA’s changes.