FDA Revamps COVID-19 Vaccination

The U.S. Food and Drug Administration has updated the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 vaccines to simplify the vaccine schedule for most individuals.

According to the FDA, the current bivalent vaccines will now be used for all doses administered to individuals aged 6 months and older, including additional doses for certain populations. "The bivalent COVID-19 vaccines include a component of the original virus strain to provide broad protection against COVID-19 and a component of the omicron variant to provide better protection against COVID-19 caused by the omicron variant," according to the FDA.

The monovalent vaccines are no longer authorized for use in the United States.

Depending on their age, most individuals who have previously received a single dose of the bivalent vaccine are not currently eligible for another one. Those 65 and older may receive on an additional dose at least four months after their initial bivalent dose. Children aged 6 months through 5 years who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine or a three-dose of the Pfizer, and children over 5 may receive two doses of Moderna and one of the Pfizer bivalent.

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

The decision to simplify the vaccination schedule was based on data that almost all of the U.S. population aged 5 and over have antibodies as a result of either vaccination or infection against SARS-CoV-2, the virus that causes COVID-19.

In June, the FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the strain composition of the COVID- vaccines for the second half of the year.

Once the specific strains are selected, the FDA expects manufacturers to make updated formulations readily available by the fall of 2023.