The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is recommending that Beyfortus™ (nirsevimab-alip) be routinely used for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease for newborns and infants younger than 8 months of age born during or entering their first RSV season.
The ACIP is also recommending the 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.
Beyfortus, a long-acting anti-RSV monoclonal antibody, is administered as a single dose timed to the RSV season. The approval was based on data from the phase 3 MELODY trial (ClinicalTrials.gov Identifier: NCT03979313), the phase 2/3 MEDLEY trial (ClinicalTrials.gov Identifier: NCT03959488), and a phase 2b trial (ClinicalTrials.gov Identifier: NCT02878330).
Results showed that Beyfortus significantly reduced the incidence of RSV disease compared with placebo. The safety profile of Beyfortus was found to be similar to that of palivizumab.
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As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness.
The panel also voted unanimously that Beyfortus should be included in the Vaccines for Children (VFC) program. The federally-funded program provides vaccines at no cost to children who would otherwise not be vaccinated because of financial reasons.
“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 US with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease,” said Thomas Triomphe Executive Vice President, Vaccines, Sanofi.
Following the committee vote, the CDC’s director Mandy Cohen, MD, MPH approved the recommendations, which will be included in the CDC’s Child and Adolescent Immunization schedule.
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” said Cohen. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
Beyfortus is supplied as a 50mg/0.5mL and 100mg/mL prefilled syringe. The product is expected to be available for the upcoming 2023-2024 RSV season.
This article originally appeared on MPR
