FDA Expands Moderna's RSV Vaccine Use To At-Risk Adults Aged 18–59 Amid CDC Panel Shake-Up

The U.S. Food and Drug Administration (FDA) expanded approval of Moderna Inc.’s (NASDAQ:MRNA) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk for disease.

What Happened: The FDA on Thursday approved broader use of Moderna’s mRESVIA vaccine for younger at-risk adults based on late-stage trial results, reported Reuters.

The mRNA-based shot showed significant immune responses in adults with underlying health conditions and maintained a favorable safety profile. The vaccine was previously limited to adults 60 and older, where it demonstrated 79% efficacy against RSV symptoms.

Health Secretary Robert F. Kennedy Jr. simultaneously appointed eight new members to the CDC’s Advisory Committee on Immunization Practices, including prominent mRNA vaccine critics Robert Malone and Retsef Levi.

The health secretary fired all 17 existing panel members, claiming the need to “re-establish public confidence in vaccine science.” The committee provides crucial guidance on vaccine recommendations that influence insurance coverage and policy.

The CDC currently recommends RSV vaccines for adults 75 and older, plus those 60-74 at increased risk. The final CDC recommendation remains pending for the expanded age group before availability.

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Why It Matters: William Blair analysts noted the approval represents “an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.’s negative public opinion on mRNA COVID-19 vaccines.” However, they cautioned that approval alone won’t massively boost COVID vaccine sales, which depend primarily on overall vaccination market sentiment.

The advisory panel restructuring creates regulatory uncertainty for vaccine manufacturers. Kennedy’s broader policy changes include removing COVID vaccines from recommended schedules for healthy children and pregnant women, plus terminating Moderna’s $600 million bird flu vaccine contract.

RSV hospitalizes 15,000-20,000 U.S. adults aged 50-59 annually. Competing vaccines from Pfizer Inc. (NYSE:PFE) and GSK plc (LSE: GSK) also target similar demographics, intensifying market competition amid shifting federal oversight.

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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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