RSV is the leading cause of hospitalization among children less than a year old, according to scientists.
A surge in RSV infections last fall overwhelmed children's hospitals across the U.S. and led to calls for the Biden administration to declare a public health emergency in response.
Nirsevimab was up to 75% effective at preventing lower respiratory tract infections that required medical attention among infants and 78% effective at preventing hospitalization, according to a FDA review. The FDA did not identified any safety concerns in its review of nirsevimab, though other monoclonal antibodies have been associated with allergic reactions such as skin rashes.
Nirsevimab is a monoclonal antibody that has a similar function to a vaccine. Vaccines stimulate the immune system to produce protective antibodies, while shots like nirsevimab deliver those antibodies directly into the bloodstream. The fact that nirsevimab is regulated as a drug has created some uncertainty about whether the federal Vaccines for Children program will provide the shot for free to families who face financial difficulties. The CDC advisors are expected to discuss this issue at their August meeting.that protects infants by administering the shot to the mother while she is pregnant. The FDA's independent advisors recommended Pfizer's vaccine in May.
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