The FDA Approves AstraZeneca, Sanofi’s RSV Vaccine

(CTN News) – In a news release issued on Monday, the FDA Food and Drug Administration approved AstraZeneca and Sanofi’s vaccine that protects infants and toddlers against respiratory syncytial virus, the leading cause of hospitalization among babies in the United States.

Despite the fact that it has not been approved for use in infants with medical conditions, nirsevimab is the first vaccine to be approved by the FDA to protect all infants against RSV.

In advance of the RSV season this fall, the FDA has approved nirsevimab, sold under the brand name Beyfortus. In August, a panel of independent experts from the Centers for Disease Control and Prevention will meet to make recommendations regarding how doctors should administer the vaccine.

In addition to palivizumab, another shot is available that is given to infants who are preterm or who have lung or congenital heart conditions that put them at high risk of severe disease. Nirsevimab can also be administered as a single injection.

As opposed to palivizumab, which must be administered monthly throughout the RSV season, this is a major advantage.

Nirsevimab is administered either before or during the first RSV season in an infant. During their second RSV season, toddlers who remain vulnerable can also be administered the vaccine.

According to a study published in the medical journal JAMA Open Network last year, RSV is a major public health threat that kills nearly 100 infants annually.

Based on a study published in the Journal of Infectious Diseases, the virus is the leading cause of hospitalization among children under a year of age.

Last fall, there was a surge in RSV infections in children’s hospitals across the country, leading to calls for the Biden administration to declare a public health emergency.

A recent FDA review found that nirsevimab prevented up to 75% of lower respiratory tract infections among infants that required medical attention, and 78% of hospitalizations.

During its review of nirsevimab, the FDA found no safety concerns, however, other monoclonal antibodies have been associated with allergic reactions.

The monoclonal antibody nirsevimab functions in a similar manner to a vaccine. Shots like nirsevimab deliver antibodies directly into the bloodstream instead of stimulating the immune system to produce protective antibodies.

The fact that nirsevimab is regulated as a drug has caused some uncertainty as to whether the federal Vaccines for Children program will provide the shot for free to families who are in financial hardship.

It is expected that the CDC advisors will discuss this issue during their meeting in August.

This fall, parents may have two options for protecting their infants. Pfizer has developed a vaccine that protects infants by administering it to the mother during pregnancy.

Independent advisors of the FDA recommended Pfizer’s vaccine in May. In August, the agency is expected to make a final decision on whether to approve the shot.

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