FDA Announces Major Changes to Covid Vaccine Schedule

Leah Barkoukis | April 20, 2023 8:30 AM

The U.S. Food and Drug Administration announced major changes to the COVID vaccine schedule on Tuesday, including that the bivalent vaccines should be used for all doses now instead of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines, whose authorizations have been revoked.

FDA claims this has been done to "simplify the vaccination schedule for most individuals."

Most unvaccinated individuals are also being advised to get a single dose of the bivalent vaccine, not multiple doses of the mRNA shots that targeted the original COVID strain.

This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
— U.S. FDA (@US_FDA) April 18, 2023

Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. We intend to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
— U.S. FDA (@US_FDA) April 18, 2023

Most individuals with certain kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine.
— U.S. FDA (@US_FDA) April 18, 2023

“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. “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. 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.”