Vaccine manufacturer Moderna said the Food and Drug Administration (FDA) declined to review its application for an “investigational influenza vaccine.”
“Moderna, Inc. today announced the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has notified the Company that it will not initiate a review of the biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and has issued a Refusal-to-File (RTF) letter. Moderna had exercised a Priority Review Voucher to facilitate a timely review of the application,” the company stated in a release.
“CBER’s RTF letter, signed by Center Director Vinayak Prasad, MD, MPH, identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna’s application. Specifically, the letter cited the lack of an ‘adequate and well-controlled’ study with a comparator arm that ‘does not reflect the best-available standard of care.’ Neither the relevant regulation, 21 C.F.R. § 314.126 (Adequate and well-controlled studies), nor the FDA’s guidance for industry on seasonal influenza vaccines contain any reference to the use of a comparator reflecting the ‘best-available standard of care.’ The letter did not identify any specific safety or efficacy concerns regarding mRNA-1010,” it continued.
“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stéphane Bancel said.
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting. We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” he added.
Today we announced that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has notified Moderna that it will not initiate a review of the biologics license application (BLA) for our investigational influenza vaccine, mRNA-1010, and… pic.twitter.com/bzetK4DlZ2
— Moderna (@moderna_tx) February 10, 2026
More from The New York Times:
Moderna had spent years and hundreds of millions of dollars testing its flu vaccine, enrolling 41,000 people and aimed at a market of adults ages 50 and older. The company concluded that its shot was superior to GSK’s product.
Dr. Stephen Hoge, the company’s president, said in an interview on Tuesday that the new flu vaccine was designed to be better tailored for a single nation than the ones that tended to be used by an entire hemisphere. He also said the F.D.A. had earlier indicated support for the company’s study plan.
“This refusal to start a review is all confusing, to say the least,” Dr. Hoge said, adding: “It is surprising, and we’re trying to understand what has changed.”
A spokesman for the Department of Health and Human Services, which oversees the F.D.A., said the agency did not comment on communications with individual applicants for drug approval.
“mRNA-1010 has been accepted for review in the EU, Canada and Australia. Submissions in additional countries are planned for 2026. Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to those ongoing regulatory reviews,” Moderna stated.
Moderna shares tumbled after news of the FDA declining to review the experimental vaccine.
Check it out:
FDA just refused to file Moderna's mRNA seasonal flu vaccine application—and it's being seen as a major win for those skeptical of mRNA tech.
The agency said the trial's control arm (standard-dose Fluarix comparator) didn't reflect the “best-available standard of care” in the… pic.twitter.com/SAi0YexA1i
— Camus (@newstart_2024) February 11, 2026
NBC News shared further:
Last year, Kennedy ordered that all new vaccines go through placebo-controlled clinical trials.
When vaccines are already available for a disease, it’s considered unethical to give clinical trial participants a placebo, rather than compare the new vaccine to the existing one. Giving a placebo would leave people who would be otherwise protected vulnerable to infection.
ADVERTISEMENTLast May, Moderna withdrew its application seeking approval for its combination flu and Covid mRNA shot after the FDA asked for more data.
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