FDA simplifies COVID-19 vaccination schedule

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The Food and Drug Administration (FDA) is simplifying its recommended COVID-19 vaccination regimen by authorizing single-shot bivalent vaccines for many Americans, including those who are unvaccinated or previously vaccinated with a monovalent version of the vaccine.

On April 18 the FDA announced it was amending its emergency use authorizations for Moderna’s and Pfizer-BioNTech’s current bivalent mRNA vaccines to authorize their use for people age six months and older. The action follows a unanimous recommendation in January from the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) to harmonize the strain composition of all COVID-19 vaccines used in the U.S. The committee also supported simplifying the dosing schedule.

“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Marks said that according to available evidence most Americans age five and older have some immunity to the virus that causes COVID-19, which can serve as the basis for the protection bivalent vaccines provide. Nevertheless, “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,” he said.

Those eligible for the single-dose bivalent vaccine include:

• Individuals, depending on age, who have been vaccinated with a monovalent COVID-19 vaccine and haven’t received a dose of a bivalent vaccine,
• Individuals 65 and older who have gotten a single-dose bivalent vaccine, provided they receive it at least four months after getting the previous dose,
• Individuals with certain kinds of immune compromise who’ve received a bivalent vaccine, provided it is at least two months following the previous dose. Eligibility for immunocompromised children age 6 months to 4 years will depend on the vaccine they received previously
• Most unvaccinated individuals, and
• Children age six months to five years who have received one, two, or three doses of a monovalent vaccine, with the number of bivalent doses they receive dependent on the vaccine and their vaccination history

People under 65 who’ve already received a single-dose bivalent vaccine are not currently eligible for another dose. But the FDA says it will decide about future vaccinations after getting recommendations on the fall strain composition of the COVID-19 vaccines at the June VRBPAC meeting.

Moderna’s and Pfizer-BoNTech’s monovalent COVID-19 vaccines are no longer authorized for use in the U.S., the agency says.