The Food and Drug Administration has simplified the COVID-19 vaccination schedule, deauthorizing the original mRNA shots and recommending that seniors receive a second dose of a bivalent, omicron-adapted shot.
The current bivalent vaccines should now be used for all doses administered to individuals six months of age and older, the FDA stated in a release published Tuesday. In addition, adults aged 65 years and older and immunocompromised people who have received a single dose of a bivalent vaccine may now receive one additional dose at least four months after receiving their initial bivalent shot. This decision is supported by data showing that a second bivalent shot restores waning immunity in the senior population over time, the agency stated.
In addition, the FDA advised people who are unvaccinated to receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
Most healthy people are not eligible for a second bivalent shot, it noted.
Most Americans have antibodies
“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.
Most of the United States population has antibodies to SARS-CoV-2, either from vaccination or infection, according to Marks. These antibodies can serve as a “foundation for the protection provided by the bivalent vaccines,” he said. “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 said.
The changes follow January discussions with the FDA’s Vaccines and Related Biological Products Advisory Committee. At the time, these advisors recommended harmonizing the strain composition of COVID-19 vaccines, and some supported simplifying the vaccine dosing schedule.
The World Health Organization in late March also adjusted its COVID-19 vaccination guidance. It currently recommends that countries prioritize at-risk older adults and frontline healthcare workers, among other high-risk groups.
Fall vaccine update
The FDA is planning to update the bivalent vaccine this fall, much as it does with yearly flu vaccines. The composition will be based on the SARS-CoV-2 variants and lineages deemed most likely to circulate in the year ahead.
The bivalent vaccine was authorized for use in August 2022 in order to provide added protection against the latest omicron variants.
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