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

The Food and Drug Administration (FDA) has granted approval for AstraZeneca and Sanofi’s shot that safeguards infants and toddlers against respiratory syncytial virus (RSV). RSV is the leading cause of hospitalization among babies in the U.S. This marks the first FDA-approved shot, called nirsevimab and sold under the brand name Beyfortus, to protect all infants against RSV, regardless of their health status.

Nirsevimab approval comes ahead of the upcoming RSV season this fall. In August, independent experts from the Centers for Disease Control and Prevention (CDC) will gather to provide recommendations on the administration of the shot by healthcare professionals.

Compared to the existing shot called palivizumab, which is primarily given to high-risk infants, such as those who are preterm or have lung and congenital heart conditions, nirsevimab holds the advantage of being administered as a single injection. This is a significant improvement over the monthly administration required throughout the RSV season for palivizumab.

The administration of nirsevimab can take place either before or during an infant’s first RSV season. Additionally, toddlers up to the age of two who remain vulnerable can receive the shot during their second RSV season.

RSV poses a grave public health risk, causing the deaths of nearly 100 infants in the U.S. every year, according to a study published in the medical journal JAMA Open Network. Children under the age of one are most likely to require hospitalization due to RSV, as reported in the Journal of Infectious Diseases.

Amid a surge in RSV cases last fall, children’s hospitals across the country became overwhelmed, leading to calls for the Biden administration to declare a public health emergency.

FDA review shows that nirsevimab is up to 75% effective at preventing lower respiratory tract infections requiring medical attention in infants, and 78% effective at preventing hospitalization. The review did not identify any safety concerns, although other monoclonal antibodies have been associated with allergic reactions.

It is important to note that nirsevimab is regulated as a drug, which raises questions about whether families facing financial difficulties will receive the shot for free through the federal Vaccines for Children program. This issue will be deliberated by CDC advisors in their upcoming meeting in August.

Come fall, families may have two options to protect their infants from RSV. Pfizer has developed a vaccine that administers the shot to pregnant mothers, safeguarding infants. Pfizer’s vaccine was recommended by FDA advisors in May, and the agency is expected to make a final decision on its approval in August.

The approval of AstraZeneca and Sanofi’s nirsevimab offers hope in the fight against RSV, a virus that poses a significant threat to infants and young children. It is a major breakthrough and brings potential relief to families and healthcare providers, especially in light of the challenges faced during the previous RSV season.