ACIP updates: Committee recommends clesrovimab for RSV, reaffirms routine influenza vaccination
The final recommendation sign off decision will go to HHS secretary Robert F. Kennedy Jr.
ACIP updates: Committee votes 5-2 to recommend clesrovimab to protect against RSV | Image Credit: © JJHVEPhoto - © JHVEPhoto - stock.adobe.com.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) met for the second time in as many days on Thursday, June 26, to vote on multiple pediatric-related recommendations. The newly-constructed committee voted in favor of recommending Merck's monoclonal antibody clesrovimab to prevent respiratory syncytial virus (RSV) in infants,1 and reaffirmed routine influenza vaccination in persons aged 6 months and older. Additionally, the ACIP voted to recommend children 18 years and younger, as well as pregnant women, receive seasonal influenza in only single-dose formulations free of thimerosal as a preservative.2
RSV
Specifically, the ACIP voted 5-2 to recommend clesrovimab (Enflonsia; Merck), which was approved by the FDA on June 9, 2025, for infants aged 8 months and younger who are not protected by a maternal vaccine, according to a national news report from ABC News.
Additionally, in a second vote, the committee voted in unanimous fashion to update the Vaccines for Children (VFC) program to include details of clesrovimab, as approximately half of children in the United States are eligible for low-cost or free vaccines, according to ABC.1
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The VFC program provides vaccines to children whose parents or guardians may not be able to afford them, and according to the CDC, serves as "one of the nation's most important contributors to health equity."3
“Ahead of the 2025-2026 RSV season, we are proud to offer [clesrovimab] 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 Richard M. Haupt, vice president, head of global medical & scientific affairs, vaccines and infectious diseases, Merck Research Laboratories in a statement. "The Committee’s recommendations are an important step forward in efforts to help reduce the significant burden RSV continues to place on infants, families and health care systems.”4
With no CDC director in place, as a Senate confirmation hearing took place Wednesday for nominee Susan Monarez5, the final decision for voting sign off will go to Health and Human Services Secretary Robert F. Kennedy Jr.1
Influenza
By a vote of 6 "yes" and 1 "abstain," the ACIP voted to reaffirm the recommendation for routine, annual influenza vaccination for all persons aged 6 months of age and older who do not have contraindications, for the 2025-2026 influenza season.2
In a separate vote, the committee decided by 5 "yes," 1 "no," and 1 "abstain" votes to recommend that children aged 18 years and younger receive seasonal influenza vaccines only, in single-dose formulations that are free of thimerosal as a preservative.
In a second vote related to thimerosal, the ACIP voted, with 5 "yes," 1 "no," and 1 "abstain," to recommend pregnant women receive seasonal influenza vaccines only in single dose formulations that are free of thimerosal as a preservative.
References:
- Kekatos M. CDC vaccine advisory panel to study child immunization schedule, recommends RSV shot for babies. ABC News. June 26, 2025. Accessed June 26, 2025. https://abcnews.go.com/Health/cdc-vaccine-advisory-panel-study-child-immunization-schedule/story?id=123191647
- Advisory Committee on Immunization Practices (ACIP) - Day 2 of 2. YouTube. Published online June 26, 2025. Accessed June 26, 2025. https://www.youtube.com/watch?v=z-16fImZoEc
- About the Vaccines for Children (VFC) Program. CDC. Updated June 26, 2024. Accessed June 26, 2025. https://www.cdc.gov/vaccines-for-children/about/index.html
- Gonzales A. ACIP Expands RSV Immunization Recommendations. Published online June 26, 2025.
- Edwards E, Lovelace B. Kennedy and vaccines loom over Senate confirmation hearing for CDC director. NBC News. June 25, 2025. Accessed June 26, 2025. https://www.nbcnews.com/health/health-news/rfk-jr-vaccines-loom-senate-confirmation-hearing-cdc-director-rcna214870
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