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PUBLIC HEALTH
FDA advisers back maternal RSV shot
A vaccine aims to protect infants from respiratory syncytial virus, a leading cause of infant hospitalization.
JAMIE KELTER DAVIS/
THE NEW YORK TIMES
/REDUX
A panel advising the U.S. Food and Drug Administration (FDA) last week recommended that it approve a vaccine given to pregnant people to protect infants from respiratory syncytial virus (RSV), which can cause severe lung infections. The vote was unanimous based on the efficacy of the vaccine, called RSVpreF and branded Abrysvo. Ten members of the panel also endorsed the safety of the vaccine, which is designed to cause mothers to produce protective antibodies that their babies acquire during pregnancy. But four panel members weren’t persuaded. A large, phase 3 trial by Pfizer, maker of the shot, found an elevated rate of premature births—5.7% in the vaccinated group versus 4.7% in the placebo group—but the difference did not reach statistical significance and neonatal deaths did not increase. Lower respiratory tract infections from RSV kill an estimated 46,000 babies younger than 7 months every year, hundreds of them in the United States, where RSV is the leading cause of infant hospitalization. The Pfizer vaccine was 69.4% efficacious in protecting this age group from severe disease. FDA is expected to rule in August whether to license the vaccine.
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Source: Science of Aging Knowledge Environment - Category: Geriatrics Source Type: research
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