About 50 percent of revenue in 2026 is expected to come from outside the United States, compared to 38 percent in 2025, Moderna executives said in an earnings call.
FDA official Dr. Vinay Prasad, in a letter made public recently by Moderna, told the company that regulators would not review Moderna’s flu vaccine for possible approval because the control arm in a trial did not “reflect the best-available standard of care in the United States at the time of the study.”
Moderna officials disagreed, noting the control arm received a different flu shot that is already approved in the United States.
Moderna CEO Stephane Bancel said during the call that “the current uncertainty in the U.S. regulatory environment creates real challenges for business, patients, and the broader innovation ecosystem. When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines.”
He also said that “sustained regulatory uncertainty threatens U.S. leadership in innovative medicines.”
Executives said they are seeking answers from the FDA as to how Moderna can get the flu vaccine approved in the United States. They want a type A meeting, or an urgent meeting, to resolve the dispute.
The FDA and its parent agency, the Department of Health and Human Services, did not respond to requests for comment.
Prasad wrote in the letter that Moderna could request a type A meeting about the rejection. “If, after the meeting, you still do not agree with our conclusions, you may request that the application be filed over protest,” he said.
Older adults in the control arm in a Moderna immunogenicity trial for the flu vaccine received a high-dose shot, but older people used as comparison in a separate trial that covered immunogenicity and efficacy only received a standard dose.
FDA officials had told Moderna in prior years that the company could use a standard, approved flu vaccine as a control, but recommended using a high-dose shot for elderly participants, according to Moderna. High dose vaccines are recommended for older people by advisers for the Centers for Disease Control and Prevention.
“The most protective flu shots for seniors are a subset of high dose flu shots recommended by the CDC Advisory Committee on Immunization Practices, which would have served as the proper control in this study,” Andrew Nixon, a department of health spokesman, told The Epoch Times in an email on Feb. 11.
Regulators in Europe, Canada, and Australia have accepted filings from Moderna for the flu vaccine and are reviewing them.
Separately, regulators in Europe and Canada are reviewing Moderna’s combination shot against the flu and COVID-19.
“We were holding back on refiling the combo vaccine until we completed some portion of the review of the flu vaccine,” Dr. Stephen Hoge, Moderna’s president, said on the call on Friday. “With the refusal to start the review of the flu vaccine, I think that is now gated on the feedback from the type A meeting.”
Moderna’s multi-year growth outlook still features both vaccines, which could be approved outside the United States as early as this year, as well as an experimental vaccine against norovirus that is being tested in a phase 3 trial.
“If we’re able to demonstrate efficacy over placebo, it’s hard to argue that there’s a problem with the comparator,” Hoge said.
