US Food and Drug Administration Supports COVID-19 Booster Shots Tailored to Omicron BA.4, BA.5 Subvariants – National

The U.S. Food and Drug Administration recommended on Thursday that booster doses of COVID-19 vaccines, starting this fall, be modified to include components aimed at combating the currently dominant subvariants Omicron BA.4 and BA.5 des Coronavirus are tailored.

The FDA said manufacturers would not have to change the vaccine for the primary series and said the coming year will be “a transitional period when this modified booster vaccine could be introduced.”

The new boosters would be bivalent vaccines, meaning doses would target both the original virus and the Omicron subvariants.

The decision follows a recommendation from the agency’s external consultants to change the design of the recordings this fall to combat more common versions of the coronavirus.

BA.4 and BA.5 are now estimated to account for more than 50% of US infections, according to the US Centers for Disease Control and Prevention, and have become dominant elsewhere as well.

The FDA said in a statement Thursday it hopes the modified vaccines could be deployed in early to mid-fall.

Pfizer Inc. PFE.N with partner BioNTech SE 22UAy.DE and Moderna Inc. MRNA.O have tested versions of their vaccines modified to target the BA.1 omicron variant causing the massive increase in cases in the caused last winter.

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Although they said these vaccines worked against BA.1 and the newer circulating variants, they saw a lower immune response against BA.4 and BA.5.

The companies had already manufactured their BA.1 vaccines and said Tuesday moving to a BA.4/BA.5 version could slow adoption.

Pfizer/BioNTech, which on Wednesday announced a $3.2 billion deal to supply more doses of COVID vaccine to the United States, said they will deliver a significant amount of BA.4/BA.5- vaccine ready for distribution.

Moderna said it would be late October or early November for the newly modified vaccine to be ready.

US FDA advisers recommend COVID vaccine composition change for fall

– Reporting by Michael Erman in New Jersey and Leroy Leo in Bengaluru