Key highlights:
- Recommendation for use in all infants below 8 months of age follows earlier than anticipated FDA approval and unanimous FDA Advisory Committee vote.
- Committee also voted unanimously to include Beyfortus in the Vaccines for Children program, supporting equitable access for all eligible infants.
- Beyfortus is the first RSV prevention approved to protect all infants in the U.S. through their first RSV season and will be available ahead of the 2023-2024 RSV season.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunisation Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease for newborns and infants below 8 months of age born during or entering their first RSV season.
The Committee also voted unanimously 10 to 0 to recommend routine use of Beyfortus for children aged 8 to 19 months who are at increased risk of severe RSV disease and entering their second RSV season. Additionally, the ACIP voted unanimously 11 to 0 to include Beyfortus in the Vaccines for Children (VFC) program. Beyfortus will be available in the U.S. ahead of the upcoming 2023-2024 RSV season.
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi commented: “We have turned the corner on the threat of RSV to our youngest, most vulnerable population. The ACIP’s unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease. We appreciate the FDA and CDC leadership, as well as the ACIP public health experts, for recognising and quickly acting on the threat RSV poses to all infants.”
Dr Regena Spratling, President, National Association of Pediatric Nurse Practitioners added: “As front-line providers managing the physical and emotional toll of RSV on our patients and their families, especially during the surges of the last two years, our community of pediatric-focused nurse practitioners welcomes the recent approval of nirsevimab. Today’s ACIP vote to include nirsevimab in routine immunisation schedules, along with continued efforts to educate the public about the impact of RSV prevention, will help ensure equitable access to this immunisation and help alleviate the strain RSV disease places on babies, families, and health care systems.”
The provisional ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. The official recommendations will be published in the CDC’s Morbidity and Mortality Weekly Report (MMWR). Once approved, routine use of Beyfortus would be included in the CDC’s Child and Adolescent Immunisation Schedule.