ACIP Recommends Clesrovimab as Alternative for Infant RSV Protection

ATLANTA—JUNE 26, 2025—The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened on June 25-26, 2025, to discuss updates to immunization recommendations. The committee, comprised of leading medical and public health experts, advises the CDC on vaccine safety, effectiveness and clinical necessity.

Key Decisions from the ACIP Meeting

During the meeting, the ACIP made several key recommendations, including:

• Clesrovimab Approval: The committee approved, by a vote of five to two, one dose of clesrovimab, a monoclonal antibody, for infants whose mothers have not received RSV vaccination. Clesrovimab represents one of two available RSV monoclonal antibody products for infant protection.
• Vaccines for Children Program Update: A resolution updating the Vaccines for Children Program for RSV prevention was approved unanimously, with a vote of seven to zero.
• Influenza Vaccination Reaffirmation: The recommendation for routine annual influenza vaccination for all individuals over six months of age without contraindications was reaffirmed by a vote of six to zero.
• Thimerosal-Free Influenza Vaccines: The ACIP recommended, by a vote of five to one, that seasonal influenza vaccines for children 18 years and younger, pregnant women, and all adults be administered in single-dose formulations free of thimerosal as a preservative.

Clesrovimab: A New Option for RSV Prevention

The approval of clesrovimab provides an additional option for protecting infants against respiratory syncytial virus (RSV). Prior to 2023, RSV was the leading cause of hospitalization among U.S. Infants [1]. Clesrovimab is intended for infants under 8 months of age born during or entering their first RSV season who have not benefited from maternal RSV vaccination.

According to the CDC, after removal from the refrigerator, clesrovimab must be used within 48 hours or discarded [1]. The dosage is 0.7mL for all eligible infants [1].

ACIP’s Commitment to Public Health

The ACIP members emphasized their commitment to honesty, transparency, and compassion in public health decision-making. They underscored the importance of evidence-based medicine, rigorous evaluation, and credible scientific data in guiding immunization recommendations. The committee also highlighted the need for robust data collection to assess both short- and long-term effects of vaccines.

“Our votes are recommendations, but we know that some may perceive them as mandates, so we take this responsibility very seriously,” stated the ACIP members. “We pledge not to hold a vote if there is not sufficient information to enable evaluation of the risks and benefits.”

Next Steps

Recommendations made by the ACIP are subject to review by the CDC Director and, if adopted, will be published in the Morbidity and Mortality Weekly Report. The ACIP plans to hold its next meeting in the third quarter of 2025.