Moderna falls on fears new CDC vaccine advisory panel could cloud RSV shot prospects

Moderna's shares fell 2.5% following concerns that a newly appointed CDC advisory panel, some members of whom have expressed anti-vaccine views, may not recommend the company's RSV vaccine, mRESVIA, for expanded use in at-risk adults aged 18 to 59, despite its FDA approval for that group; the panel's decision, expected later this month, is seen as a key sentiment indicator for the vaccine sector, with GSK, Pfizer, and Novavax also experiencing premarket declines.

Analysis

Moderna's shares (MRNA.O) declined 2.5% in premarket trading, continuing a downward trend, due to investor concerns over the potential stance of a newly appointed U.S. Centers for Disease Control and Prevention (CDC) advisory panel, the Advisory Committee on Immunization Practices (ACIP), regarding Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA. The vaccine recently secured U.S. Food and Drug Administration (FDA) approval for expanded use in at-risk adults aged 18 to 59, but requires an ACIP recommendation before it can be made available to this demographic; it is already approved for adults aged 60 and older. The apprehension stems from the recent overhaul of the ACIP by Health Secretary Robert F. Kennedy Jr., who dismissed all 17 members, and the reported inclusion of new appointees with openly anti-vaccine views, including skepticism towards mRNA technology, the foundation of Moderna's shots. This restructuring, aimed by the Health Secretary at re-establishing public confidence in vaccine science, has been warned by health experts as potentially undermining public trust. The upcoming ACIP meeting for mRESVIA, scheduled for later this month, is highlighted by William Blair analyst Myles Minter as a significant event for investor sentiment within the declining vaccine sector. This sentiment is reflected in marginal premarket declines for U.S.-listed shares of GSK (GSK.L) and Pfizer (PFE.N), and a 1.7% fall for Novavax (NVAX.O) to $7.03. The CDC currently recommends Moderna's vaccine for adults 75 and older, and at-risk adults 60-74, while a separate ACIP recommendation from April for approved RSV vaccines in at-risk adults 50-59 is still awaiting CDC endorsement.

Key Decisions for Investors

• Investors should closely monitor the proceedings and outcome of the upcoming ACIP meeting concerning Moderna's mRESVIA, as this will be a critical determinant for the vaccine's market access in the 18-59 age group and a significant indicator of the new panel's impact on the broader vaccine sector.
• Given the reported anti-vaccine stance of some new ACIP members and the specific concerns around mRNA technology, a cautious outlook on Moderna (MRNA) is warranted in the near term, with potential for further stock volatility contingent on the panel's recommendations.
• The developments surrounding the ACIP may have wider implications for companies in the vaccine space, particularly those reliant on mRNA technology or with products pending regulatory review; therefore, assessing exposure and re-evaluating risk within vaccine-related portfolios is advisable.