Later this month, HHS Secretary Robert F. Kennedy Jr.'s revamped CDC vaccine advisory committee will discuss RSV vaccination guidelines for the newly approved patient group, high-risk adults 18 through 49. Analysts and other experts have warned that the new panel includes some who have documented anti-vaccine sentiments as well as those who have spoken out against mRNA technology specifically.
The FDA signed off on the broader use of Moderna’s mRNA vaccine for respiratory syncytial virus in a ruling announced Thursday, opening up inoculation in at-risk adults aged 18 through 59 years.
William Blair analysts noted that the approval was based on immunogenicity data following multiple doses of mResvia, first approved in May 2024 for all adults 60 and above, without a placebo control.
“We see today’s approval from the FDA as internally consistent with recent regulatory updates from the Center for Biologics Evaluation and Research (CBER), which, in part, state that pivotal trials with biomarker-based endpoints without saline-based placebo controls are sufficient to warrant approval in at-risk populations,” the firm wrote to investors Friday morning. “We note that CBER’s updated regulatory guidance was published in the context of the COVID-19 vaccination, but a similar decision here by the FDA could represent this regulatory framework being applied to other viruses.”
The CDC’s guidelines currently suggest a narrower use of RSV shots, where blanket vaccination is only recommended in adults 75 and older, while in those 60 through 74 years of age, the CDC endorses immunization for those who are at risk of severe RSV. In April, the CDC’s Advisory Committee for Immunization Practices (ACIP) recommended that the CDC include high-risk adults 50 to 59 years in its RSV vaccination guidelines. At the time, ACIP announced that it would be meeting in June to discuss vaccination in adults at increased risk of severe RSV disease aged 18 through 49 years.
Since then, however HHS Secretary Robert F. Kennedy purged the ACIP of all 17 members in a move that he claimed was “necessary to reestablish public confidence in vaccine science.” The next day, he named eight new ACIP panelists, many of whom have documented histories of vaccine skepticism and two who have previously spoken out specifically against the mRNA technology that underpins Moderna’s mResvia. Whether the new panelists will expand mResvia’s use to younger patients remains to be seen.
“In our view, investor focus will likely shift to the CDC’s Advisory Committee on Immunization Practices (ACIP)’s next meeting,” the William Blair team wrote. “This will be the first time for investors to see the refreshed ACIP in action and will be important for sentiment in the vaccine sector, which continues to decline in our view. Ultimately, we see the biggest headwind to the RSV vaccination market as restrictive ACIP recommendations that do not include re-dosing potential.”
It’s been a mixed bag of late for Moderna. Lat month, for instance, it was forced to pull its FDA application for its combination flu/COVID-19 vaccine after talks with the regulator. The company plans to resubmit its application later this year with additional Phase III data. A few days later, Moderna lost a $760 million contract with the HHS, which was supporting the development of its bird flu vaccine.
Earlier this month, however, Moderna won the FDA’s approval for its next-generation COVID-19 vaccine mNEXSPIKE, in time for the 2025-2026 season. Jefferies analysts at the time called an “incremental positive” for the company.
After this week’s mResvia label expansion, William Blair wrote, “We continue to view Moderna’s vaccine franchise growth angle as a show-me story, with significant company cost-cutting required to meet break-even guidance by 2028, in our view.”
