RSV is a seasonal virus that lands tens of thousands of young children in the hospital every year. On Thursday, advisors to the FDA voted in favor of approving a long-acting antibody that protects infants from RSV.

Christoph Soeder/Picture Alliance via Getty Images


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Christoph Soeder/Picture Alliance via Getty Images


RSV is a seasonal virus that lands tens of thousands of young children in the hospital every year. On Thursday, advisors to the FDA voted in favor of approving a long-acting antibody that protects infants from RSV.

Christoph Soeder/Picture Alliance via Getty Images

A panel of advisers to the Food and Drug Administration have recommended that the agency approve a new antibody drug to protect infants from serious lung illnesses caused by respiratory syncytial virus, also known as RSV.

On Thursday, the panel voted in favor of FDA approval for the injectable antibody medication – called nirsevimab – after hours of testimony from the drugmaker AstraZeneca, FDA scientists and the public.

The question before the panel was whether the benefits of the treatment outweigh the risks. The drug, if approved, would afford babies protection from the virus in their first RSV seasons with a single shot.

There was unanimous support on the 21-person committee for approving the drug’s use in infants ahead of or during their first RSV season. And, in a separate vote, all but two members of the panel supported giving the drug to infants with medical risks through their second RSV season.

RSV is a viral infection that puts between 58,000 to 80,000 young children in the hospital each year, making it the leading cause of hospitalization among infants in the U.S.

While the FDA isn’t required to follow recommendations, it usually does. The agency is expected to decide in the third quarter of 2023.

If it’s approved in that timeframe, the companies say they’re ready to launch the preventive shot in the U.S. ahead of the 2023-2024 RSV season. The antibody was approved last fall by authorities in the EU, and is currently being considered for use in several Asian countries.

Pien Huang

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