: FDA advisers vote in favor of Pfizer’s maternal RSV vaccine

by | May 18, 2023 | Stock Market

Advisers to the U.S. Food and Drug Administration voted Thursday in favor of Pfizer’s
respiratory syncytial virus vaccine for pregnant people, following extensive debate about its safety. FDA advisory-committee votes are not binding, but the agency often follows their recommendations. If the FDA ultimately approves the vaccine, called Abrysvo, it would be the first in the U.S. to protect babies against RSV, which is the leading cause of hospitalization for infants under a year old. 

RSV is a common respiratory virus that typically causes mild symptoms but can cause severe illness, particularly in infants and older adults. An estimated 50,000 to 80,000 children under 5 years old are hospitalized due to RSV each year in the U.S., according to the Centers for Disease Control and Prevention.  The committee’s vote “is a critical step forward in the scientific community’s long-sought-after goal to help prevent RSV disease in infants during their most vulnerable first six months of life,” Annaliesa Anderson, a senior vice president at Pfizer, said in a statement. Pfizer is among several pharmaceutical giants that have been racing to develop RSV vaccines. Earlier this month, the FDA approved GSK’s
Arexvy for prevention of RSV in people 60 and older, making it the first RSV vaccine approved for use in the U.S. Pfizer is also working on a RSV vaccine for older adults, with an FDA approval decision expected later this month.   Nirsevimab, a monoclonal antibody developed by Sanofi
and AstraZeneca
and designed to protect infants from …

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