The FDA Approves AstraZeneca and Sanofi’s Nirsevimab Shot to Protect Babies Against Respiratory Syncytial Virus (RSV)

FDA Approves AstraZeneca and Sanofi Shots to Protect Infants and Toddlers Against Respiratory Syncytial Virus


The Food and Drug Administration on Monday approved AstraZeneca and Sanofi’s shot that protects infants and toddlers against respiratory syncytial virus (RSV). RSV is the leading cause of hospitalization among babies in the U.S.

Nirsevimab: Protecting All Infants Against RSV

Nirsevimab is the first shot approved by the FDA to protect all infants against RSV regardless of whether they are healthy or have a medical condition. The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of RSV season this fall.

Prior Vaccine and Nirsevimab Comparison

Another shot called palivizumab is already on the market, but it is given mainly to infants who are preterm or who have lung and congenital heart conditions that put them at high risk of severe disease. Nirsevimab is also administered as a single injection, which is a major advantage over palivizumab, which is administered monthly throughout RSV season.

Effectiveness of Nirsevimab

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 an FDA review.

RSV as a Public Health Threat

RSV is a major public health threat that kills nearly 100 infants annually and is the leading cause of hospitalization among children less than a year old.

Comparison with Other Options

Families might have two options to protect their infants this fall. Pfizer has developed a vaccine 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, and the agency is expected to make a final decision on whether to approve the shot in August.


The FDA’s approval of AstraZeneca and Sanofi’s nirsevimab shot provides a crucial tool in protecting infants and toddlers against RSV. The shot’s high effectiveness and single injection administration make it a promising solution in combating RSV-related illnesses and hospitalizations.

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