This injection was approved to protect against the annual leading cause of hospitalization in infants under a year old in the U.S.
Nirsevimab, which will be sold under the brand name Beyfortus, is not a vaccine. Vaccines prompt the body to make antibodies to defend against pathogens. Instead, nirsevimab is a form of passive immunity. It's a ready-made antibody that can bind to the virus and block it from infecting healthy cells. The immune system doesn't have to make anything.
After the CDC signs off, nirsevimab will become the second antibody available to protect young children against RSV. The other, called palivizumab or Synagis, has been used only to protect the most vulnerable babies -those born prematurely who are younger than 6 months. It lasts only short time in the body, so doctors give it once a month, starting just before RSV season, until the risk has passed.
That vaccine would protect babies from the moment they are born, a benefit if the infection shows up out of season. Vaccines also prompt the mom's body to make more than one kind of antibody, which would provide broader-spectrum protection. In the clinical trials that led to its approval, nirsevimab was about 70% effective at cutting the risk that a baby would need a doctor's visit for RSV, and it was about 78% effective at preventing hospitalizations due to RSV compared with a placebo, according to an FDA analysis.
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