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FDA Panel Backs Beyfortus, RSV Vaccine for Infants, Some Toddlers

Medically reviewed by Drugs.com.

By Cara Murez HealthDay Reporter

FRIDAY, June 9, 2023 – A U.S. Food and Drug Administration advisory panel on Thursday recommended that the agency approve an RSV vaccine for infants and some toddlers.

The monoclonal antibody shot would protect against respiratory syncytial virus (RSV) in infants born during or entering their first RSV season, the New York Times reported. It could also be used for toddlers up to 24 months old who are particularly vulnerable to the virus.

The panel voted 21-0 in favor of using the vaccine, called Beyfortus, for infants and 19-2 in favor of use in toddlers, the Times said.

While RSV can be as minor as a cold for many people, it is a leading killer around the world for infants and toddlers, the Times reported.

As many as 80,000 kids younger than age 5 are hospitalized with RSV annually. Up to 300 die, according to the U.S. Centers for Disease Control and Prevention. It also can be serious in older adults, leading to about 160,000 hospitalizations and 10,000 deaths in people 65 and older.

Now, it’s up to the FDA to decide whether to approve the shot, though it typically follows the recommendations of its panels. The agency has said it would continue to monitor the treatment for safety even after approval.

Drugmakers Sanofi and AstraZeneca gave more than 3,200 infants the antibody shot during studies of the vaccine. One of those studies found that the vaccine's effectiveness against very severe RSV was 79% after six months.

A vaccine has recently been FDA-approved for older adults. Another -- which would be delivered to women in pregnancy to help shield newborns -- has been recommended by a different FDA panel, although there are concerns about a small increase in preterm births, the Times reported.

The shot for infants, if approved, could be available in the fall.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted June 2023

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