FDA approves AstraZeneca, Sanofi RSV shot for infants, toddlers

The Food and Drug Administration approved it on Monday AstraZeneca And SanofiThe vaccine protects infants and young children against respiratory syncytial virus, which is the leading cause of hospitalizations among children in the United States

Nercivimab is the first dose approved by the Food and Drug Administration to protect all children from RSV, regardless of whether they are otherwise healthy or have a medical condition.

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The FDA approval of nirsevimab, which is sold under the brand name Beyfortus, comes before the RSV season this fall. The Centers for Disease Control and Prevention’s panel of independent experts will meet in August to make recommendations about how doctors should administer the shot.

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

Nirsevimab is given either before or during an infant’s first RSV season. Children as young as 2 years of age who are still weak can receive the shot during RSV season two.

RSV is a major public health threat that kills nearly 100 infants annually, according to a study published in the medical journal JAMA Open Network last year. The virus is the leading cause of hospitalizations for children under one year old, according to a study published in the Journal of Infectious Diseases.

An increase in RSV cases last fall overwhelmed children’s hospitals across the US and led to calls for the Biden administration to declare a public health emergency in response.

Nirsevimab was up to 75% effective in preventing lower respiratory tract infections requiring medical attention among infants and 78% effective in preventing hospitalization, according to an FDA review.

The FDA did not identify any safety concerns in its review of nercevimab, although other monoclonal antibodies have been associated with allergic reactions such as skin rashes.

Nirsevimab is a monoclonal antibody with a function similar to the vaccine. Vaccines stimulate the immune system to produce protective antibodies, while vaccines such as nercivimab deliver those antibodies directly into the bloodstream.

The fact that nercivimab is being regulated as a drug has created some uncertainty about whether the federal pediatric vaccine program will provide the shot for free to families in financial difficulty. CDC advisors are expected to discuss the issue at their meeting in August.

Families may have two options for protecting their children this fall. Pfizer has developed a vaccine that protects babies by giving the mother an injection during pregnancy. Independent FDA advisors recommended the Pfizer vaccine in May. The agency is expected to make a final decision on whether to approve the shot in August.