FDA says Covid vaccines will likely get an annual update, but most people will probably only need one shot


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

In a briefing paper published Monday, the FDA said the 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 the updated injections could be rolled out each September in time for a fall vaccination campaign.

According to the briefing paper, most people would receive one injection to restore their protection against the virus. This would apply to people who have been exposed to the virus’s spike protein at least twice, either through vaccination or through infection.

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But older adults and people with compromised immune systems may need two doses, according to the suggested vaccination schedule. Young children who have previously received only one injection will also receive two doses.

The FDA released the roadmap ahead of a meeting of the agency’s independent vaccine experts on Thursday. The expert panel will vote on whether all Covid vaccines in the US should be made bivalent injections, meaning they protect against both the omicron BA.5 subvariant and the original strain of Covid discovered in Wuhan, China in late 2019 .

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Currently, only Moderna and Pfizer booster doses 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 shots each year. The agency said it could update and roll out Covid vaccines without clinical data, which is also the case with the annual process to change the flu shot.

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The Centers for Disease Control and Prevention is also expected to provide more information on Thursday about a study looking at what it has described as a “highly unlikely” risk of stroke in seniors who received Pfizer’s omicron booster.

The CDC received preliminary safety data from its Vaccine Safety Datalink late last year. A subsequent review for four other major databases revealed no increased stroke risk, but the CDC investigation is ongoing.

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