
FDA Approves Clesrovimab to Prevent RSV in Infants During First Season
The CDC’s Advisory Committee on Immunization Practices was expected to meet later in June to issue recommendations for use.
The FDA
According to Merck, this approval offers providers a second passive immunization option for infants following the 2023
The approval was based on results from the pivotal phase 2b/3 CLEVER trial (
“RSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious respiratory conditions like bronchiolitis and pneumonia,” Octavio Ramilo, MD, chair of the department of infectious diseases at St. Jude Children’s Research Hospital and investigator for both the CLEVER and SMART (
The SMART trial enrolled high-risk infants, including those born extremely preterm or with chronic lung or congenital heart disease, and compared clesrovimab against palivizumab.4 Rates of RSV-related disease and hospitalization were similar between the 2 groups, and clesrovimab’s safety profile was consistent with findings in the CLEVER trial. Merck said efficacy in the SMART trial was supported by extrapolating pharmacokinetic data from CLEVER.1
Clesrovimab-cfor is administered as a single intramuscular injection. For infants undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended postoperatively. The product is not indicated for infants with a history of serious hypersensitivity reactions to any component.
The CDC’s Advisory Committee on Immunization Practices (ACIP) was expected to meet later in June to issue recommendations for use. However, on June 9, 2025, HHS Secretary Robert F. Kennedy Jr
In an October 2024 presentation at IDWeek,
References
- U.S. FDA approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants born during or entering their first RSV season. Merck. News release. June 9, 2025. Accessed June 10, 2025. https://www.merck.com/news/u-s-fda-approves-mercks-enflonsia-clesrovimab-cfor-for-prevention-of-respiratory-syncytial-virus-rsv-lower-respiratory-tract-disease-in-infants-born-during-or-entering-their-fir/
- Bonavitacola J. FDA approves beyfortus for use in infants with RSV. AJMC®. July 17, 2023. Accessed June 10, 2025. https://www.ajmc.com/view/fda-approves-beyfortus-for-use-in-infants-with-rsv
- Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004) (CLEVER). https://clinicaltrials.gov/study/NCT04767373. Updated May 6, 2025. Accessed June 10, 2025.
- Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) (SMART). https://clinicaltrials.gov/study/NCT04938830. Updated May 21, 2025. Accessed June 10, 2025.
- Grossi G. RFK Jr sweeps clean CDC vaccine advisory panel, aiming to bolster public confidence. AJMC. June 9, 2025. Accessed June 10, 2025. https://www.ajmc.com/view/rfk-jr-sweeps-clean-cdc-vaccine-advisory-panel-aiming-to-bolster-public-confidence
- Ungar L, Seitz A. RFK Jr. ousts entire CDC vaccine advisory committee. The Associated Press. June 9, 2025. Accessed June 10, 2025. https://apnews.com/article/kennedy-cdc-acip-vaccines-3790c89f45b6314c5c7b686db0e3a8f9
- Merck’s clesrovimab (MK-1654), an investigational respiratory syncytial virus (RSV) preventative monoclonal antibody, significantly reduced incidence of RSV disease and hospitalization in healthy preterm and full-term infants. Merck. News release. October 17, 2024. Accessed June 10, 2025. https://www.merck.com/news/mercks-clesrovimab-mk-1654-an-investigational-respiratory-syncytial-virus-rsv-preventative-monoclonal-antibody-significantly-reduced-incidence-of-rsv-disease-and-hospitalization-in-heal/
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