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Most people would get one Covid-19 shot annually—as they do with the flu shot—under Food and Drug Administration proposals for simplifying the nation’s Covid-19 vaccine procedures.
The drug regulator also proposed that people getting vaccinated for the first time receive vaccines that target both Omicron and the original strain of the coronavirus.
The proposals, outlined in materials the FDA released Monday, would mark the biggest changes to Covid-19 vaccinations since boosters rolled out and are a sign of the nation’s shift to a more endemic-like approach to the coronavirus.
Vaccine experts who advise the FDA are scheduled to meet Thursday to discuss the proposals. The advisers are scheduled to vote on whether to give the bivalent shot as the initial inoculation, as is already allowed in Europe.
If eventually adopted by the FDA, the changes would streamline a complicated regimen of initial vaccinations and subsequent boosters, which has different recommendations for different ages and different shots.
Some health experts blame the confusion created by the complicated scheme for deterring some people from getting the latest boosters, though experts also attribute the relatively low uptake to other factors including lack of awareness.
Under current FDA rules, people receive the initial Covid-19 vaccines, targeting the original strain of the virus, followed by the new, so-called bivalent boosters.
Recommendations for when and how people should get a booster has varied by age group. A stream of new and updated booster authorizations every few months has made the recommendations hard to follow.
The FDA’s proposals would help Covid-19 vaccine administration for doctors and nurses giving out the shots because they wouldn’t need to worry about confusing vials of dual-target and single-target shots, FDA staff said.
The changes would also make it easier for public-health officials to communicate about who needs to get shots and when, the FDA staff said.
The annual plan would make Covid-19 vaccinations more like annual flu shots. Advisers would meet every June to select the Covid-19 shot best able to match strains they expect to circulate in the fall, similar to how influenza vaccines are chosen.
The vaccines wouldn’t undergo rigorous clinical trials before being selected, just as influenza vaccines don’t. People could get the Covid-19 shots starting in September.
If a new and very dangerous Covid-19 variant appeared, the FDA could still call for an emergency, one-off vaccine—outside the annual schedule—to meet the new threat, agency staff said.
The elderly, immunocompromised and young children may still need two-dose boosters, the FDA staff said.
The World Health Organization helps coordinate influenza vaccines. FDA staff said that a similar global strategy should exist for Covid-19 vaccines but it will be challenging to set one up.
Write to Liz Essley Whyte at liz.whyte@wsj.com
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Appeared in the January 24, 2023, print edition as ‘FDA Proposes Annual Covid-19 Vaccine.’
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