ENFLONSIA: Merck’s New RSV Preventive Gets the Green Light, Targeting 2025-2026 Season
Ordering Begins in July, Shipments Slated Before Winter RSV Surge
RAHWAY, N.J. – Merck (NYSE: MRK), on Thursday, announced a pivotal advancement in infant health, with the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommending ENFLONSIA™ (clesrovimab-cfor). This long-awaited decision positions ENFLONSIA as a key preventative measure against respiratory syncytial virus (RSV) lower respiratory tract disease in infants under eight months of age, specifically those born during or entering their first RSV season. Also, the ACIP’s inclusion of ENFLONSIA in the Vaccines for Children Program is a noteworthy step, ensuring broader accessibility for the targeted infant population.
ENFLONSIA Logo
This innovative monoclonal antibody (mAb) offers a streamlined approach to RSV prevention, delivering direct, rapid, and sustained protection for up to five months – covering a typical RSV season – with a consistent dose, irrespective of an infant’s weight. The typical RSV season runs from fall to the following spring.
Important note: ENFLONSIA is contraindicated in infants with a history of severe hypersensitivity reactions, including anaphylaxis, to any component of the drug. See additional crucial Safety Information below.
“As we gear up for the 2025-2026 RSV season, we are thrilled to introduce ENFLONSIA,” stated Dr. Richard M. Haupt, Vice President and Head of Global Medical & Scientific Affairs for Vaccines and Infectious Diseases at Merck Research Laboratories. “This new preventive option is designed to shield both healthy and at-risk infants from the varying degrees of RSV disease, including cases that require hospitalization. The committee’s positive recommendation is a significant stride toward alleviating the substantial pressure that RSV places on infants, their families, and our healthcare systems.”
The U.S. Food and Drug Administration (FDA) approved ENFLONSIA earlier this month, backed by compelling clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck is on track to make ENFLONSIA available for order by physicians and healthcare administrators in July 2025, ensuring delivery ahead of the 2025-2026 RSV season.
The ACIP’s recommendation for ENFLONSIA is provisional and is awaiting official review and finalization by the CDC Director or the Health and Human Services Secretary.
About ENFLONSIA™ (clesrovimab-cfor)
ENFLONSIA represents Merck’s extended half-life monoclonal antibody (mAb), approved for passive immunization to stave off respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering their first RSV season. A standout feature is the standardized dosage (105 mg/0.7 mL in a prefilled syringe), independent of the infant’s weight. ENFLONSIA is crafted to provide rapid and durable protection for the typical 5-month RSV season. For infants born during the RSV season, the recommended administration is within the first week of life. Infants born outside the RSV season should receive ENFLONSIA shortly before the start of the next RSV surge. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional post-surgery 105 mg dose is recommended once the infant is stable. ENFLONSIA has a shelf life of 30 months.
Selected Safety Information for ENFLONSIA™ (clesrovimab-cfor)
ENFLONSIA is not to be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any of its components.
As with other human immunoglobulin G1 (IgG1) monoclonal antibodies, severe hypersensitivity reactions, including anaphylaxis, are possible. Should signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis emerge, immediate medical intervention is required.
The most frequently reported adverse reactions include injection-site erythema (3.8%), injection-site swelling (2.7%), and rash (2.3%).
About RSV
Respiratory syncytial virus (RSV) is a contagious virus that triggers widespread seasonal infections, often leading to severe respiratory conditions such as bronchiolitis and pneumonia. According to the CDC, hospitalization rates for RSV among infants under six months stand at two to three out of every 100 annually. Given its status as the leading cause of infant hospitalization in the U.S., there remains a critical need for RSV prevention options for both healthy and vulnerable infants during their first RSV season. The RSV season typically peaks in the winter, although the timing and intensity vary each year.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are united by a shared purpose: leveraging cutting-edge science to save and improve lives globally. For over 130 years, we have dedicated ourselves to bringing hope to humanity through groundbreaking medicines and vaccines. As the premier research-intensive biopharmaceutical company, we spearhead innovative health solutions, advancing disease prevention and treatment for both humans and animals. We cultivate a diverse and inclusive global workforce and operate responsibly every day to ensure a safe, sustainable, and healthy future for all communities and individuals.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.
Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for ENFLONSIA (clesrovimab-cfor) at https://www.merck.com/product/usa/pi_circulars/e/enflonsia/enflonsia_pi.pdf and Patient Information/Medication Guide for ENFLONSIA at https://www.merck.com/product/usa/pi_circulars/e/enflonsia/enflonsia_ppi.pdf.
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