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Beyfortus is the first and only long-acting antibody indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.1
Beyfortus is also included in the Vaccines for Children (VFC) program, supporting access for all eligible infants.
FDA approved Beyfortus for a broad range of infant populations entering their first RSV season, including those born:1
Healthy or With Underlying Conditions
Full Term or Preterm
Before or During the RSV Season*
Warnings and Precautions
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Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
- Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
All infants are at risk of RSV lower respiratory tract disease
RSV is a highly contagious virus that can lead to respiratory illness in newborns’ lower respiratory tract and lung infections, such as pneumonia and bronchiolitis.2,3
It’s important for doctors to be aware of how to recognize RSV in infants, including having an understanding of incidence and hospitalization data, seasonality, pathophysiology, and isolation precautions.
How Beyfortus works as a long-acting antibody to help prevent RSV disease
Beyfortus is the only antibody for season-long RSV disease protection that extends through 5 months based on clinical data. As a long-acting monoclonal antibody (mAb) given directly to the baby, Beyfortus provides passive immunity by inhibiting RSV F protein, preventing viral entry into the cells.1 Discover more about Beyfortus as a monoclonal antibody to help prevent RSV.
The efficacy and safety of Beyfortus was evaluated in randomized, double-blind, multicenter trials for the prevention of RSV lower respiratory tract infection
Beyfortus has been studied in Phase 2 and Phase 3 RSV clinical trials in different infant populations entering their first and second RSV seasons and has shown a consistent safety profile across multiple infant cohorts.1
Help protect against RSV disease with Beyfortus administration
When?
Beyfortus is ideally administered just before or near the start of the RSV season or from birth for infants born shortly before or during the RSV season. It is administered through a single dose, which provides passive immunization that extends through 5 months, the typical length of the RSV season, regardless of birth month.1,4
For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of Beyfortus is recommended as soon as the child is stable after surgery; please consult the Prescribing Information for complete information on dosing in these circumstances. Children up to 24 months of age who remain vulnerable through their second RSV season: 1 x 200 mg dose.
How?
The recommended dose of Beyfortus in neonates or infants born during or entering their first RSV season is based on body weight.1
Beyfortus can be given concomitantly with childhood vaccines.1
There is limited experience of Beyfortus coadministration with vaccines. In clinical trials, when Beyfortus was given with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone. Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.
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Beyfortus FDA approval
The FDA approved Beyfortus to prevent lower respiratory tract disease in July 2023, for use in:1,5
- Neonates and infants born during or entering their first RSV season
- Children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season
AAP and ACIP recommended5,6
Beyfortus is the first RSV prevention approved to protect all infants in the US through their first RSV season.
ACIP
The CDC Advisory Committee on Immunization Practices (ACIP) recommends the routine use of Beyfortus to protect infants against RSV disease.
The ACIP recommends one dose of Beyfortus for use in all infants below 8 months of age born during or entering their first RSV season.
Refer to the most current CDC immunization schedule for additional immunization considerations.
AAP
The American Academy of Pediatrics (AAP) also recommends Beyfortus, consistent with the ACIP for infants below 8 months of age born during or entering their first RSV season:
- Whose pregnant parent did not receive RSV vaccine
- Whose pregnant parent’s RSV vaccination status is unknown
- Who were born less than 14 days after the pregnant parent’s RSV vaccination
- Beyfortus may be considered for infants whose mother received the RSVpreF vaccine if the potential incremental benefit of administration is warranted based on the clinical judgment of the healthcare provider
Find out more about Beyfortus dosing and ACIP regional guidelines
AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CHD, congenital heart disease; CLD, chronic lung disease; FDA, Food and Drug Administration; MAB, monoclonal antibody; RSV, respiratory syncytial virus. wGA, weeks gestational age.
*Epidemiology research will further define when local RSV seasons start.
Important Safety Information
References: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi. 2. Yamin, D. et al. Vaccination strategies against respiratory syncytial virus. 113, 13239-13244 (216) 3. CDC. Respiratory Syncytial Virus Infection (RSV) - RSV in Infants and Young Children. Centers for Disease Control and Prevention. Accessed February 7, 2024. http://www.cdc.gov/rsv/high-risk/infants-young-children.html. 4. Obanda-Pacheto P., Justicia-Grande AJ., Rivero-Calle I., et al. Respiratory Syncytial Virus Seasonality: A Global Overview. J Infect Dis. 2018;217(9):1356-1364. doi:10.1093/infdis/jiy056. 5. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925. August 25, 2023. 6. ACIP and AAP recommendations for nirsevimab. American Academy of Pediatrics. August 15, 2023. Accessed October 7, 2023. https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab
