U.S. Proposes to Make COVID Shot Annual, Much Like Flu Shot

The U.S. Food and Drug Administration on Monday asked its vaccine advisory panel to weigh a proposal to turn COVID vaccines into an annual shot for most Americans.

Such a move would simplify future vaccination efforts, a critical point given the fact that efforts to get people to get COVID booster shots have fallen far short of expectations. While over 80% of Americans have had at least one dose of the original COVID-19 vaccine, only 16% of those over the age of 5 have gotten the updated booster shots that were approved last August, according to the U.S. Centers for Disease Control and Prevention.

The committee will consider the FDA proposal at its Jan. 26 meeting. If it recommends the concept be turned into policy and the agency follows those recommendations, COVID shots would likely become much like annual flu shots.

In documents filed with the Vaccines and Related Biological Products Advisory Committee, the FDA noted that “the totality of the available evidence on prior exposure to and vaccination against SARS-CoV-2 suggests that, moving forward, most individuals may only need to receive one dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period of time.”

Who might need more than one dose per year? For the very young, seniors and the immunocompromised, the agency noted that two doses may be needed to induce enough immunity to protect against COVID-19 infection.

In its proposal, the FDA suggested an annual vaccine approval system similar to the one used for the flu.

“The FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage [the vaccine advisory committee] in about early June of each year regarding strain selection for the fall season. Subsequently, a decision on the recommended vaccine composition would be made in time for any updated vaccine to be in production in time to be deployed for use no later than September of each calendar year,” the agency added.

Along with simplifying when a COVID-19 vaccine should be given, the FDA also wants to switch all COVID vaccines to target the same strains, because that would make the shots interchangeable and simpler to administer. The agency proposes to use the updated bivalent booster shots, which protect against both the original strain of SARS-CoV-2 and the Omicron variants that now dominate in the United States. According to the CDC, the XBB variant now accounts for just over 49% of all U.S. infections.

Some vaccine experts were surprised by the proposal, including some FDA vaccine advisory committee members.

“I’m choosing to believe that they are open to advice, and that they haven’t already made up their minds as to exactly what they’re going to do,” Dr. Paul Offit, one of the panel advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The New York Times.

“I’d like to see some data on the effect of dosing interval, at least observational data,” Dr. Eric Rubin, one of the panel advisers and editor-in-chief of the New England Journal of Medicine, told the Times. “And going forward, I’d like to see data collected to try to tell if we’re doing the right thing.”

More information

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines.

SOURCES: U.S. Food and Drug Administration, briefing documents, Vaccines and Related Biological Products Advisory Committee meeting, Jan. 23, 2023; The New York Times