An independent advisory panel to the Food and Drug Administration (FDA) has recommended the approval of nirsevimab, a monoclonal antibody developed by AstraZeneca to protect infants from respiratory syncytial virus (RSV), which is the leading cause of hospitalization among newborns. If approved, nirsevimab would be the first medical intervention available in the U.S. that can protect all infants from RSV. The FDA is expected to make a final decision on nirsevimab in the third quarter. The advisory panel unanimously voted 21-0 in favor of its approval, as well as 19-2 to recommend its use in children up to 2 years old who remain vulnerable to the virus in their second RSV season.
According to scientists, RSV kills nearly 100 babies in the United States every year, with hospitalized infants often requiring oxygen support, intravenous fluids, and sometimes being placed on a ventilator to support their breathing. RSV is a major public health threat, and a surge in infections last year overwhelmed children’s hospitals, leading to calls for the Biden administration to declare a public health emergency in response.
Nirsevimab is up to 75% effective at preventing lower respiratory tract infections that require medical attention, and 78% effective at preventing hospitalizations, according to a review by the FDA. The antibody would be administered as a single dose, depending on the infant’s weight, and it is not considered a vaccine because it is a monoclonal antibody.
The FDA did not identify any safety concerns in its review of nirsevimab, with very few cases of serious allergic reactions, skin rashes, and hypersensitivity reactions. The FDA’s advisors endorsed Pfizer’s maternal RSV vaccine that protects infants in May, and the agency is expected to make a decision on Pfizer’s shot in August. The safety and effectiveness of nirsevimab and Pfizer’s vaccine will be closely monitored by the FDA if they are approved.
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