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FDA Eyes Shift to Annual COVID-19 Vaccination Strategy with Shots in Fall 2023

The proposed strategy will no doubt face tough questions from the agency’s committee of vaccine experts during its Thursday meeting.

The Food and Drug Administration wants updated COVID-19 booster shots to be offered once a year for most Americans and to follow a schedule similar to the flu vaccine, according to documents the agency posted on Monday.

The agency is proposing that its committee of outside vaccine experts discuss the “consideration of periodic updates to COVID-19 vaccine composition, including to the currently authorized or approved vaccines to be available for use in the U.S. in the fall of 2023” during its meeting on Thursday.

Review of 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,” the agency said in the documents. The FDA is proposing two shots a year for certain young children as well as older and immunocompromised Americans.

As of Monday, the Vaccines and Related Biological Products Advisory Committee is only scheduled to vote on the topic of whether the original vaccines should be changed to match the updated booster shots, which target newer omicron subvariants as well as the original coronavirus strain.

The FDA does not have to follow recommendations from the committee, though it usually does.

The move by the FDA is not a surprise given that the Biden administration and President Joe Biden himself have pushed for the idea of switching to an annual COVID-19 shot.

“For most Americans, one COVID shot each year will be all they need,” Biden said at the White House in October when he got his updated COVID-19 booster shot. “And if you get it, you’ll be protected. And if you don’t, you’re putting yourself and other people at unnecessary risk.”

But the proposed strategy will no doubt face tough questions during the Thursday meeting. Among other things, experts will discuss if the FDA’s proposed fall vaccine schedule will offer the best protection for Americans – an issue complicated by the fact that the coronavirus has yet to become seasonal.

Vaccine fatigue is another complicating factor, with only 15% of the U.S. population getting the latest COVID-19 booster shot. Additionally, experts may want to examine new education and outreach strategies for the shot, considering a recent survey of vaccinated Americans found the most common reason for not getting the shot was a lack of knowledge about eligibility for it.

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