BRIDGEWATER, N.J, AUGUST 24, 2023. The U.S. Centers for Disease Control and Prevention (CDC) today published the Advisory Committee on Immunization Practices (ACIP) guidance on the recommended use of Beyfortus™ (nirsevimab-alip) in the Morbidity and Mortality Weekly Report (MMWR), a journal highlighting the latest in public health news and communicating recommendations derived from science-based research.1
On August 3, the CDC’s ACIP unanimously recommended the routine use of Sanofi and AstraZeneca’s Beyfortus 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, and for children aged 8 to 19 months who are at increased risk of severe RSV disease and entering their second RSV season. The committee also unanimously voted to include Beyfortus in the Vaccines for Children (VFC) program, which helps to support equitable access for all eligible infants.
Michael Greenberg, MD, MPH
North America Medical Head of Vaccines, Sanofi
“For the first time, parents in the United States can enter a winter virus season knowing there is an antibody designed to protect their infants from RSV disease, the leading cause of hospitalization for babies under the age of 1. Sanofi is committed to continuing to work with stakeholders across the RSV care continuum to help ensure the seamless implementation and broad availability of this innovative prevention strategy. Our goal is to provide all babies with access to Beyfortus ahead of the upcoming 2023-2024 RSV season.”
The Morbidity and Mortality Weekly Report (MMWR) is a weekly digest of epidemiological insights published by the CDC. Serving as a crucial conduit, the MMWR facilitates the distribution of CDC's public health information and recommendations, sourced from state health departments. Published material within the report resides in the public domain, enabling unrestricted reprinting without necessitating permission.
RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the CDC. RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.2 Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday.2,3 In the U.S., RSV is the leading cause of hospitalization in infants under 12 months, averaging 16 times higher than the annual rate for influenza.4,5 Approximately 75% of infants hospitalized for RSV are born healthy and at term with no underlying conditions.6 Each year in the U.S., an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.7
In the U.S., Beyfortus is the first RSV prevention approved to protect all infants through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. Beyfortus is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
As a long-acting antibody provided directly to newborns and infants as a single dose, Beyfortus offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system.8 Beyfortus administration can be timed to the start of the RSV season.
Beyfortus was granted Breakthrough Therapy and Fast-Track designations and was approved by the FDA on July 17, 2023 following the positive recommendation of the U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee. The approval was based on the extensive Beyfortus clinical development program spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus delivered high, consistent and sustained efficacy against RSV lower respiratory tract disease extending through five months, a typical RSV season.
In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid development and regulatory milestones of €120m and will pay up to a further €375m upon achievement of certain regulatory and sales-related milestones. The two companies share costs and profits in all territories except in the U.S. where Sanofi consolidates 100% of the economic benefits in its Business Operating Income.
Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:
IMPORTANT SAFETY INFORMATION
Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus.
Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:
Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received Beyfortus in the same RSV season.
Serious allergic reactions have happened with other medicines like Beyfortus. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:
The most common side effects of Beyfortus include rash and pain, swelling, or hardness at the site of your child’s injection. These are not all the possible side effects of Beyfortus. Call your healthcare provider if you have questions about side effects.
Please see full Prescribing Information, including Patient Information for more details.
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