FDA says most people probably only need one annual shot

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

In a briefing released on Monday, the FDA said vaccines would likely need to be updated annually as the virus continues to evolve. The agency will select the Covid strain for the vaccine in the spring so that updated shots can be released each September in time for the fall vaccination campaign.

According to the white paper, most people will receive one shot to restore their protection against the virus in the future. This applies to people who have been exposed to the spike protein of the virus at least twice, either through vaccination or infection.

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

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

Currently, only Moderna and Pfizer booster doses target the omicron variant. If accepted, the primary batch will also contain the Omicron strain.

The proposed Covid vaccine update system is reminiscent of how the FDA screens flu shots every year. The agency said it could update and introduce Covid vaccines without clinical data, which also applies to the annual flu shot replacement process.

The Centers for Disease Control and Prevention is also expected to provide more information on Thursday about an investigation into what it called a “very unlikely” risk of stroke in older people who received Pfizer’s Omicron Booster.

Late last year, the CDC received preliminary data on safety concerns from the Vaccine Safety Data Channel. A subsequent review of four other major databases found no increased risk of stroke, but the CDC investigation is ongoing.

CNBC Health & Science

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