Beyfortus: A Breakthrough RSV Shot for Infants Approved by CDC

Beyfortus: A Breakthrough RSV Shot for Infants Approved by CDC

Source – Sanofi

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has given a unanimous vote of 10 to 0 to recommend the routine use of Beyfortus (nirsevimab-alip), developed by Sanofi and AstraZeneca, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants below 8 months of age during their first RSV season. The Committee also recommended the routine use of Beyfortus for children aged 8 to 19 months who are at higher risk of severe RSV disease and entering their second RSV season.

Moreover, the ACIP voted unanimously 11 to 0 to include Beyfortus in the Vaccines for Children (VFC) program, making it accessible to a broader population. Beyfortus is expected to be available in the US ahead of the upcoming 2023-2024 RSV season.

The provisional ACIP recommendations will be reviewed and approved by the CDC’s director and the US Department of Health and Human Services. Once approved, Beyfortus will be included in the CDC’s Child and Adolescent Immunization Schedule.

“Today, 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 recognizing and quickly acting on the threat RSV poses to all infants.”

– Thomas Triomphe, Executive Vice President, Vaccines, Sanofi

Beyfortus is the first RSV prevention approved to protect all infants during their first RSV season, irrespective of their health conditions. It offers rapid protection without requiring immune system activation and can be administered at the beginning of the RSV season.

Related: The CDC Vaccination Committee Has Scheduled A Date In August To Consider Using Sanofi, Arizona’s Beyfortus RSV Antibody

The approval of Beyfortus was based on a comprehensive clinical development program involving three pivotal late-stage trials. The drug received Breakthrough Therapy and Fast-Track designations and was approved by the FDA on July 17, 2023, after a positive recommendation from the FDA Antimicrobial Drugs Advisory Committee. It demonstrated high, consistent, and sustained efficacy against RSV lower respiratory tract disease, providing protection for up to five months, which covers a typical RSV season.

“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 immunization schedules, along with continued efforts to educate the public about the impact of RSV prevention, will help ensure equitable access to this immunization and help alleviate the strain RSV disease places on babies, families, and health care systems.”

– Dr Regena Spratling, PhD, RN, APRN, CPNP-PC, FAANP, FAAN, President, National Association of Pediatric Nurse Practitioners

This recommendation from ACIP is a significant step towards effectively preventing RSV infections in vulnerable populations, ensuring better protection for newborns and infants during their early stages of life. The widespread use of Beyfortus is expected to have a significant impact on reducing the burden of RSV disease in the U.S. and safeguarding the health of children.

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