FDA authorizes additional booster for high-risk individuals, rescinds monovalent shots

The FDA has authorized additional omicron bivalent booster doses for people 65 and older and those with compromised immune systems, the agency said April 18. 

Under the amended emergency use authorizations for Moderna and Pfizer's bivalent booster vaccines, people 65 and older may receive an additional dose at least four months after their last shot. For those with weak immune systems, a second dose can be administered two months after their last bivalent vaccine and additional doses at the discretion of their physician. 

Additionally, the FDA rescinded authorization of Moderna and Pfizer's original monovalent vaccines, meaning most unvaccinated individuals can receive a single dose of the bivalent vaccine instead of multiple doses of the monovalent vaccines. 

The agency authorized the changes to "simplify the vaccine schedule for most individuals."

The CDC is expected to endorse the updated vaccine schedule, with the policy being "permissive," meaning the agency will enable those eligible to get another booster, but not definitively recommend it. 

In June, the agency will meet to determine updated COVID-19 vaccine formulations ahead of the fall respiratory virus season. 

 

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