FDA approves monoclonal antibody to protect infants from RSV

RSV monoclonal antibody

In the latest bioscience victory over viruses, the Food and Drug Administration (FDA) on July 17 gave the first approval to a monoclonal antibody to protect infants against respiratory syncytial virus (RSV).

Beyfortus (nirsevimab-alip), made by AstraZeneca and Sanofi, was approved by the FDA for use in protecting newborns during their first season of RSV, a potentially life-threatening illness.

“In healthy people, symptoms of RSV infection are usually mild and resolve within a week. However, RSV can cause serious illness or death in vulnerable individuals,” according to the National Institutes of Health (NIH). “RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) in children younger than one year old and causes approximately 58,000 hospitalizations among children under five annually.”

As there is not yet a vaccine approved to protect infants against RSV, Beyfortus is the first FDA-approved form of RSV protection for newborns. A monoclonal antibody offers a different kind of protection from a vaccine, and the two approaches can support one another, according to Sanofi.

While vaccines enable the immune system to eventually develop longer-lasting protection, monoclonal antibodies can supplement vaccination with faster direct protection, Sanofi said. Beyfortus was shown to give five months of protection.

More help on the way

Beyfortus has been proposed for inclusion in the officially recommended immunization program for children in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Prevention and Control is expected to vote on this recommendation at their Aug. 3 meeting.

Meanwhile, another candidate to protect newborns from RSV has been developed by Pfizer. Pfizer’s RSVpreF vaccine is, in essence, a maternal vaccine, administered to expectant mothers in the late second to the third trimester of their pregnancy.

The shot triggers antibodies that are passed to the fetus. It protects infants against RSV from birth through the first six months of life.

FDA approval for Pfizer’s vaccine is anticipated some time next month, which would mean it could join Beyfortus in providing protection during the upcoming RSV season this fall.

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