FDA Gives Green Signal To Second Omicron-Adapted Booster Shots For People At High Risk From Covid

On Tuesday, the FDA amended the emergency use authorizations (EUAs) of Moderna Inc MRNA and Pfizer Inc PFE, and BioNTech SE's BNTX COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule.
This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations.
The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the U.S.
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Those 65 and older can get a second dose of the updated versions of Pfizer-BioNTech's and Moderna's Covid booster at least four months after their last dose, the FDA said in a statement.
According to the agency, most immunocompromised people can get an additional dose at least two months after their last dose.
Most unvaccinated individuals may receive a single dose of a bivalent vaccine rather than multiple doses of the original monovalent mRNA vaccines, FDA said.
Unvaccinated children six months through 5 years can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine.
Children five years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
The booster shots were reformulated last August to target the BA.4 and BA.5 omicron subvariants in addition to the original strain of the virus.
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