FDA approves AstraZeneca, Sanofi RSV shot for infants, toddlers

Approved by the Food and Drug Administration on Monday AstraZeneca and SanofiVaccine protects infants and young children from respiratory syncytial virus, leading cause of hospitalization in U.S. infants

Nirsevimab is the first FDA-approved vaccine that protects all infants from RSV infection, whether they are healthy or have a medical condition.

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The FDA approved nirsevimab months ahead of this fall’s RSV season. An independent panel of experts from the U.S. Centers for Disease Control and Prevention will meet in August to make recommendations on how health care providers should administer the shots.

Another vaccine, Palivizumab, is already on the market, but it is mainly given to premature babies or babies with lung and congenital heart disease that put them at high risk of severe disease. Nirsevimab is sold under the brand name Beyfortus and is given as a single injection. This is a major advantage over palivizumab, which is given monthly throughout the RSV season.

Nirsevimab is given before or during the infant’s first RSV season. Young children under the age of two who are still vulnerable can also receive the shot during a second RSV cause.

RSV is a major public health threat, killing nearly 100 infants each year, according to a study published last year in the medical journal JAMA Open Network. The virus is the leading cause of hospitalization in children under the age of one, according to another study published in the Journal of Infectious Diseases.

Children’s hospitals across the U.S. were overwhelmed by a surge in respiratory syncytial virus infections last fall, prompting calls for the Biden administration to declare a public health emergency.

According to an FDA review, nirsevimab was up to 75 percent effective in preventing lower respiratory tract infections in infants requiring medical care and up to 78 percent effective in preventing hospitalization.

While other monoclonal antibodies have been linked to allergic reactions such as skin rashes, the FDA has not found any safety concerns in its review of nirsevimab.

This is a story of development. Please check for updates.