Introduction

The Food and Drug Administration has granted approval for AstraZeneca and Sanofi’s shot, which safeguards infants and toddlers against respiratory syncytial virus (RSV). RSV is the leading cause of hospitalization among babies in the U.S.

Nirsevimab: The First Shot for All Infants

Nirsevimab is the first shot approved by the FDA to protect all infants against RSV, regardless of their health condition. This approval comes ahead of the upcoming RSV season in the fall. In August, the Centers for Disease Control and Prevention’s panel of experts will provide recommendations on the administration of the injection by healthcare providers.

Advantages Over Existing Shot

Compared to the existing shot called palivizumab, Nirsevimab offers a major advantage. Palivizumab is administered monthly throughout the RSV season, while Nirsevimab, sold under the brand name Beyfortus, is administered as a single injection.

Administration and Protection

Nirsevimab can be administered either before or during an infant’s first RSV season. Additionally, toddlers up to two years old who remain vulnerable can receive the shot during their second RSV season.

RSV: A Public Health Threat

RSV poses a significant public health threat, causing nearly 100 infant deaths each year. It is also the primary cause of hospitalization among children under one year old.

Efficacy and Safety

According to a FDA review, Nirsevimab was up to 75% effective in preventing lower respiratory tract infections that required medical attention among infants and 78% effective in preventing hospitalization. The FDA did not find any safety concerns during its review, although other monoclonal antibodies have been associated with allergic reactions.

Nirsevimab as a Monoclonal Antibody

Nirsevimab functions similarly to a vaccine as it delivers protective antibodies directly into the bloodstream. It is categorized as a drug, which has raised concerns about its availability and cost under the federal Vaccines for Children program. The CDC advisors will address this issue during their August meeting.

Other Options for Infant Protection

Pfizer has developed a vaccine that protects infants when administered to the mother during pregnancy. The FDA’s independent advisors have recommended Pfizer’s vaccine, and a final decision on approval is expected in August.