FDA says most people probably only need one yearly vaccine

FDA says most people probably only need one yearly vaccine

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The Food and Drug Administration has laid out a roadmap for what Covid-19 vaccination might look like in the future.

In a briefing document released Monday, the FDA said vaccines will likely need an annual update as the virus continues to evolve. The agency would select the Covid strain for the vaccine in the spring so that updated vaccines could be rolled out each September in time for a fall vaccination campaign.



Most people would receive an injection to restore their protection against the virus in the future, according to the briefing paper. This would apply to people who have been exposed to the virus’ spike protein at least twice, either through vaccination or infection.

But older people and people with weakened immune systems may need two doses, depending on the proposed vaccination schedule. Young children who have only received one injection before would also receive two doses.

The FDA released the roadmap ahead of a meeting of the agency’s independent vaccine experts scheduled for Thursday. The panel of experts will vote on whether to manufacture all Covid vaccines in the United States by bivalent injections, which means that they protect against both the omicron BA.5 subvariant as well as the original strain of Covid discovered in Wuhan, China in late 2019.

Currently, only booster doses from Moderna and Pfizer target the omicron variant. If adopted, the primary series would also contain the omicron strain.



The proposed system for updating Covid vaccines resembles how the FDA selects flu vaccines each year. The agency said it could update and roll out Covid vaccines without clinical data, which is also the case with the annual flu vaccine switch process.

On Thursday, the Centers for Disease Control and Prevention is also expected provide more information about an investigation in what he described as a “very unlikely” risk of stroke in older people who received Pfizer’s omicron booster.

The CDC received preliminary data on safety issues from its vaccine safety data link late last year. A subsequent review of four other major databases did not identify an increased risk of stroke, but the CDC investigation is ongoing.

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