The U.S. Food and Drug Administration has refused to review Moderna’s application for approval of its influenza vaccine, raising concerns amid recent reversals of long-standing vaccine guidelines.
In a letter to Moderna, the FDA refuted the Massachusetts-based biotech company’s rationale for comparing its already commercially available product, mRNA-1010, to a standard dose for seasonal influenza, the company said Tuesday night.
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Federal authorities cited a lack of “adequate and well-controlled” data as the reason for refusing to review the application. Moderna said in its letter that the FDA believes the biotech giant’s influenza vaccine “does not reflect the best available standard of care.”
The company rejected the allegations, and CEO Stéphane Bancel said in a letter that “we have not identified any concerns regarding the safety or efficacy of our products.”
Experts say the lack of guidance is unhelpful.
“If there are things that need scrutiny, we can address them in the review process. At the end of the review, we can identify issues that need to be fixed. This gives companies the opportunity to make changes and adapt. Without that guidance, it becomes very difficult for people submitting materials to know how to proceed,” Bruce Y. Lee, professor of health policy and management at the State University of New York School of Public Health and Health Policy, told Al Jazeera.
Moderna announced last year that its mRNA-1010 vaccine was 26.6 percent more effective than GlaxoSmithKline’s annual approved influenza vaccine.
“Conducting a comprehensive review of influenza vaccine applications using FDA-approved vaccines as comparators in studies that were discussed and agreed upon with CBER (Center for Biologics Evaluation and Research) prior to initiation should not be controversial,” Bancel said.
As for Moderna’s next steps, William Soliman, CEO of the Healthcare Industry Association, said cases like the one facing Moderna typically require companies to go back and continue their research.
“They (Moderna) will have to provide additional analysis or change the study protocol and resubmit for review. That’s how it normally works. They go back and respond to whatever the FDA is asking for and then resubmit,” Soliman told Al Jazeera.
In 2025, Moderna withdrew its application for approval of a combined influenza and coronavirus vaccine as it awaited efficacy data from late-stage trials of its influenza vaccine.
The vaccine is currently under review in the European Union, Canada and Australia, and the company expects it could be approved in late 2026 or early 2027.
political atmosphere
The FDA’s move comes amid concerns about transparency within the agency, raising questions among experts about whether its decision-making process to deny applications is merit-based or politically motivated.
“The big question is, is this part of some kind of political agenda? Many of the policies and decisions we’ve seen have rolled back vaccine policies that have long been supported by science, but again for reasons that aren’t clearly explained, so the concern is that this is part of a larger trend,” Lee said.
According to health care trade publication Stat News, career scientists, including the U.S. agency’s vaccine director, David Kaslow, were prepared to review the application, but it was rejected by FDA Commissioner Vinay Prasad, which FDA officials are contesting.
Al Jazeera was unable to independently verify this claim. The Department of Health and Human Services (HHS) did not respond to Al Jazeera’s request for comment.
HHS, a federal agency under the FDA, announced in August that it would scale back mRNA vaccine development.
Robert F. Kennedy Jr., who heads HHS, is known as a vaccine skeptic. Since his appointment as health secretary, vaccine guidance has been rolled back, including recommendations for routine vaccination against six infectious diseases, including influenza, and new guidance on childhood immunizations.
The incidence of vaccine-preventable diseases is rapidly increasing. In the United States, the number of measles cases is expected to exceed 2,200 in 2025, the highest in nearly 30 years, and more than 730 cases have been reported so far this year.
Wall Street tensions
Moderna, which rose to fame with its COVID-19 vaccine, has fallen sharply on Wall Street over the past year as the number of infections fell and sales of the vaccine also fell. In its most recent earnings report, released in November, the company reported a loss of $200 million for the quarter, with profits down $13 million from a year earlier.
The company is struggling to regain its footing amid sluggish sales.
Jeff Meacham, an analyst at Citi Research, told Reuters the FDA’s decision is a “major blow to the company’s reliance on seasonal vaccines to meet its 2028 breakeven goal.”
Moderna’s stock price fell 29% in 2025 alone and is down more than 90% from its 2021 high.
Moderna shares fell in early trading but are starting to rebound. Still well below the market’s opening price, the stock was down 4.7% in midday trading on Wednesday following news that the FDA had refused to review the application.
