The approval is based on data from Pfizer’s Phase 3 MONeT trial, which evaluated the vaccine’s safety and efficacy in high-risk adults, according to an Oct. 22 news release from the company.
The expansion builds on the previous indication for adults 60 years and older. The vaccine is also approved for pregnant individuals to protect infants from birth up to six months.
With the decision, Abrysvo offers the broadest RSV vaccine coverage for adults and remains the only RSV immunization approved for both younger adults and pregnant individuals.
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