After receiving FDA approval earlier this month, Merck’s Enflonsia was recommended by the CDC’s ACIP for the prevention of RSV lower respiratory tract disease in infants under 8 months entering their first RSV season.
RT’s Three Key Takeaways:
- ACIP Recommendation: The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Enflonsia (clesrovimab-cfor) for the prevention of RSV lower respiratory tract disease in infants under 8 months entering their first RSV season.
- Expanded Access: ACIP also voted to include Enflonsia in the Vaccines for Children Program, helping ensure equitable access to the preventive antibody for eligible infants nationwide.
- Availability Timeline: Merck plans to make Enflonsia available for ordering in July 2025, with shipments arriving ahead of the 2025–2026 RSV season, pending final CDC or HHS approval.
The US CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season, according to Merck.
Earlier this month, the FDA approved Enflonsia for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.
“Ahead of the 2025-2026 RSV season, we are proud to offer Enflonsia as a new preventive option designed to protect healthy and at-risk infants from RSV disease across a spectrum of severity, including worsening disease requiring hospitalization,” said Dr. Richard M. Haupt, vice president, head of global medical & scientific affairs, vaccines and infectious diseases, Merck Research Laboratories. “The Committee’s recommendation is an important step forward in efforts to help reduce the significant burden RSV continues to place on infants, families and health care systems.”
The ACIP also voted to include Enflonsia in the Vaccines for Children Program—an important step in ensuring broad access to this preventive option for infants, the company says.
Merck plans to make Enflonsia available for ordering by physicians and healthcare administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season.
The ACIP’s recommendation for Enflonsia is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director).
Source: Merck
Image credit: Enflonsia (clesrovimab-cfor) for Injection via https://www.merck.com/media/media-library/
