FDA panel endorses antibody therapy to protect against RSV in infants

(CNN) - An advisory panel for the Food and Drug Administration has voted to recommend a monoclonal antibody therapy to prevent respiratory syncytial virus, known as RSV, in infants and some young toddlers.

The therapy was developed by Sanofi and AstraZeneca and is called nirsevimab.

It is designed to be given in a single shot at birth or a baby’s first season of RSV. It can also be given as a larger dose in a second RSV season in children who are highly vulnerable.

Nearly every child before age 2 gets RSV.

Most cases are mild, but it’s the leading cause of hospitalization among infants.

In trials, the shot was found to lower the risk of RSV needing medical attention by 75% and the risk of hospitalization by 78%.

Common side effects were rash and injection-site reactions.

While the FDA isn’t required to follow the committee’s recommendations, it usually does.

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