The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the company developed for flu and COVID-19, the latest sign vaccines may face additional regulatory scrutiny under new agency leadership.
Alongside first quarter earnings Thursday, the biotechnology company said a U.S. approval decision previously expected this year may now occur in 2026. Moderna filed for approval in 2024 based on a late-stage study showing the shot sparked immune responses against both viruses in adults 50 years of age or older. But the FDA has communicated that it will require Phase 3 flu efficacy data before issuing a clearance, Moderna said.
It’s unclear whether Moderna will be able to submit the data as a “major amendment” to its current submission, or whether the company will have to refile the application, executives said on a conference call with analysts.
Moderna is also deprioritizing development of the vaccine in younger adults as part of a push by the company — already hurt by slowing product sales and a declining stock price — to cut $1.5 billion in annual spending by 2027.
On the conference call, Moderna president Stephen Hoge stressed that so far the company’s recent interactions with the FDA following the appointments of vaccine skeptic Robert F. Kennedy Jr. as Health and Human Services Secretary and new commissioner Martin Makary have been “business as usual.” The company isn’t expecting significant changes to the approval process or review timelines, he added, while noting that the agency’s request for additional flu shot data “makes good scientific sense.”
“We continue to have productive exchanges across all of our ongoing reviews,” Hoge said.
Some Wall Street analysts aren’t as optimistic. Moderna’s announcement comes amid an unusual regulatory delay for fellow COVID-19 vaccine developer Novavax and as HHS indicates new shots will need to be tested in placebo-controlled trials prior to regulatory approval. (The HHS policy, which spokesperson Andrew Nixon confirmed to BioPharma Dive, was first reported Wednesday by The Washington Post.)
The news “highlights increased scrutiny and (potentially) a higher bar for success in vaccine development – especially novel vaccines,” wrote Leerink Partners analyst Mani Foroohar. That higher bar could “negatively impact” the regulatory path for Moderna’s combination shot, he added.
Cory Kasimov, of Evercore ISI, wrote in a separate note that the upcoming decisions on Moderna’s new COVID shot, and expanded use of its respiratory syncytial virus vaccine in younger adults are near-term ”litmus tests” for vaccine regulation. Both are expected by the middle of June.
When asked about the apparent shift in approval requirements, Hoge said he could not “comment on a policy change that either hasn’t happened or that hasn’t been communicated directly” to Moderna. He also noted that many of its experimental shots have been tested in placebo-controlled studies.
“It will really depend on what the FDA and the HHS find appropriate and their guidance on a program by program level on what that will require,” he said. “Our responsibility as a manufacturer and drug developer is to make sure that we provide the data that regulators and public health officials feel like they need so that they can stand behind our products.”
Moderna recorded $108 million in revenue in the first three months of the year, down from $167 million in the same period in 2024. Shares fell by about 5% Thursday and, at roughly $27 apiece, have lost half of their value over the last six months.
