Big changes to the coronavirus vaccine policy.

in #fda2 years ago

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https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines

The FDA has approved a second bivalent booster for adults 65 and older and immunocompromised individuals. For 65+, they can get the second booster 4 months after the first. And for immunocompromised it will be 2 months after.

Now there will be no monovalent vaccines. Only the bivalent. And unvaccinated will only need to get one bivalent dose in the primary series instead of two.

Note the CDC still needs to sign off on this. Walenksy is expected to do so tomorrow.

For other ages, the FDA will revisit the question of an additional booster after the strain update meeting in June.

Young children are the exception to the one primary dose guidance change. They will still be required to get 2 or 3 doses in the primary series depending on which vaccine manufacturer they get.

The FDA made these changes to simplify the process and in recognition of the fact that most people should have antibodies to SARS-COV-2 at this point.

They didn't mention for those that were recently infected, but previous guidance was that people can wait 3 months after their infection to get boosted. But there isn't an explicit restriction to get it earlier than that.

The immunocompromised guidance is pretty flexible. The FDA will now defer to the individual's doctor in regards to further boosters beyond the second if needed. This is because immunocompromised are a diverse population.

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