Moderna's mRNA RSV Vaccine Gains Expanded Approval Amid CDC Advisory Committee Shakeup

Moderna's respiratory syncytial virus (RSV) vaccine, mResvia, has received expanded approval from the U.S. Food and Drug Administration (FDA), opening up inoculation to at-risk adults aged 18 through 59 years. This development comes as the pharmaceutical industry faces potential shifts in vaccine policy following recent changes to the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP).

FDA Expands mResvia Label Based on Immunogenicity Data

The FDA's decision to broaden mResvia's use was based on immunogenicity data following multiple doses of the vaccine, which was first approved in May 2024 for adults 60 and above. William Blair analysts noted that the approval was granted without a placebo control, reflecting recent regulatory updates from the Center for Biologics Evaluation and Research (CBER). This approach, which allows for biomarker-based endpoints without saline-based placebo controls in at-risk populations, could represent a new regulatory framework being applied beyond COVID-19 vaccinations.

CDC Advisory Committee Overhaul Raises Concerns

The expanded approval comes at a time of significant change within the CDC's vaccine advisory committee. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. recently replaced all 17 ACIP members in a move he claimed was "necessary to reestablish public confidence in vaccine science." The new panel includes individuals with documented vaccine skepticism, including some who have spoken out against mRNA technology specifically.

This restructuring has raised concerns among analysts and experts about the future of vaccine recommendations, particularly for mRNA-based vaccines like mResvia. The upcoming ACIP meeting, where RSV vaccination guidelines for the newly approved patient group will be discussed, is expected to be closely watched by investors and industry observers.

Moderna's Mixed Recent Performance

While the mResvia label expansion represents a positive development for Moderna, the company has faced challenges in other areas. Last month, Moderna was forced to withdraw its FDA application for a combination flu/COVID-19 vaccine and lost a $760 million contract with HHS for the development of a bird flu vaccine.

However, the company also secured FDA approval for its next-generation COVID-19 vaccine, mNEXSPIKE, for the 2025-2026 season. William Blair analysts view Moderna's vaccine franchise growth as a "show-me story," noting that significant cost-cutting measures will be required for the company to meet its break-even guidance by 2028.

As the pharmaceutical industry continues to navigate evolving regulatory landscapes and public health priorities, the expanded approval of mResvia and the upcoming ACIP meeting will likely serve as important indicators of the future direction of vaccine policy and market dynamics.