Sanofi's injection in partnership with AstraZeneca has been approved by the FDA to prevent RSV in infants and children.
The FDA approves the AstraZeneca and Sanofi vaccine that protects infants and children against respiratory syncytial virus (RSV), the leading cause of infant hospitalization in the United States. Nirsevimab is the first FDA-approved injection to protect all babies from RSV, regardless of their health status or medical condition.
The FDA approved nirsevimab (Beyfortus) prior to the RSV season for virus protection in infants. Experts will convene in August to provide recommendations on the administration of the injection by healthcare professionals.
Palivizumab is used in premature infants or those with lung and heart problems, while nirsevimab is a single injection given before or during the first RSV season. Vulnerable children up to two years old can also receive it during the second RSV season.
RSV is a public health threat, causing annual deaths in babies and being the leading cause of hospitalization in children under one year old. The increase in infections last fall prompted requests for a public health emergency in the US.
Nirsevimab demonstrated efficacy of up to 75% in preventing lower respiratory tract infections in infants, with no safety concerns identified by the FDA. Other monoclonal antibodies are associated with allergic reactions.
Nirsevimab is a monoclonal antibody that functions like a vaccine, delivering protective antibodies directly into the bloodstream. Its regulation as a medication raises questions about its availability for low-income families. The CDC will discuss this issue in August.
Options to protect infants: Pfizer has developed a vaccine that provides protection by administering it to the mother during pregnancy. Recommended by FDA advisors. Final approval decision in August.
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