If the Food and Drug Administration approves nirsevimab, it will be the first medical intervention available in the U.S. that can protect infants from RSV.
Nirsevimab is administered as a single injection with the dose depending on the infant's weight. Infants that weigh less than 5 kilograms would receive a 50 mg injection for their first RSV season, and those weighing 5 kilograms or greater would receive a 100 mg injection.
The FDA did not find any cases of serious allergic reactions in the nirsevimab trials and cases of skin rash and hypersensitivity reactions were low in infants who received the antibody. But Dr. Melissa Baylor, an FDA official, said cases of these side effects will likely occur if nirsevimab is approved.
Four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases sudden infant death syndrome, one died from a tumor, one died from Covid, one died from a skull fracture, and one died of pneumonia. There is very close attention to safety due to historical failures in the development of RSV vaccines. Scientists first tried to develop a vaccine in the 1960s with an inactivated virus, but that shot actually made disease from RSV worse in some children when they received their first natural infection, resulting in the death of two infants.
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