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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.