FDA Panel Backs RSV Vaccine for Infants, Some Toddlers

FRIDAY, June 9, 2023 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Thursday recommended that the agency approve a respiratory syncytial virus (RSV) vaccine for infants and some toddlers.

The monoclonal antibody shot would protect against 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. Now, it is up to the FDA to decide whether to approve the vaccine, 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 vaccine during studies of the vaccine. One of those studies showed that the vaccine's effectiveness against very severe RSV was 79 percent 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 vaccine for infants, if approved, could be available in the fall.

The New York Times Article