Moderna, the vaccine maker, announced on Tuesday that the Food and Drug Administration (FDA) has refused to review its latest concoction, an mRNA-based flu vaccine.
“[T]he [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,” the company said in a press release.
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
The FDA’s chief vaccine regulator, Dr. Vinay Prasad, rejected the BLA because Moderna’s clinical trial involved comparing its product’s performance with that of “a product the agency did not consider the best on the market,” according to the New York Times.
Moderna fired back by alleging that the rejection was inconsistent with the FDA’s previous feedback.
“The complete stunner here is that at no point in any of this did anybody say that it was not adequate,” Moderna president Dr. Stephen Hoge told CNN on Tuesday. “This refusal to start a review is all confusing, to say the least. It is surprising, and we’re trying to understand what has changed.”
Modern CEO Stéphane Bancel added in a statement that the FDA’s decision didn’t “identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
“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,” he said.
“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 continued.
Moderna’s critics say the FDA made the right decision:
Do you really want a product where Moderna did not compare its new mRNA flu vaccine to one of the best available existing flu shots in their Phase 3 trial? That’s why it was rejected.
— Kristina Bruce (@bruce_kris56597) February 11, 2026
But in fairness to Moderna, such rejections by the FDA are extremely rare.
“[A] 2021 study of almost 2,500 applications submitted to the agency found that only 4% received such letters,” CNN notes.
On the other hand, when Prasad took over at the FDA, he reportedly laid out a stricter approach for approvals. In doing so, he sparked criticism from several former FDA commissioners, including some from President Donald Trump’s first administration.
“[These] are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety,” the former officials said in a joint statement.
The former officials included Scott Gottlieb, Norman “Ned” Sharpless, and Brett Giroir. All three served in Trump’s first administration.
However, according to the Washington Post, Prasad defended his decision by noting that the coronavirus vaccine, which was based on the same technology, led to the deaths of at least 10 children.
“These deaths are related to vaccination (likely/probable/possible attribution made by staff),” he wrote in a letter to CBER staff members.
“That number is certainly an underestimate due to underreporting and inherent bias in attribution. This safety signal has far-reaching implications for Americans, the US pandemic response, and the agency itself,” he added.
An overwhelming majority of emergency medics prefer a traditional vaccine over an mRNA vaccine.
Vinay did Moderna’s CEO a favor, that vaccine had no chance against a traditional flu shot on the open market. pic.twitter.com/YMXFwRVPEJ
— Mazda Sabouri (@msabouri) February 11, 2026
Moderna is, for its part, hoping to eventually earn a vaccine review.
“We’re trying right now to reach out to the FDA and understand what would be necessary for them to start reviewing the submission,” Hoge said.
Writers and editors can be contacted at [email protected] with feedback, tips, or corrections.
V. Saxena is a staff writer with a decade of experience as a professional writer, and a lifetime of experience as an avid news junkie. He holds a degree in computer technology from Purdue University. Saxena also contributes to BizPac Review.
Comment
We have no tolerance for comments containing violence, racism, profanity, vulgarity, doxing, or discourteous behavior. If a comment is spam, instead of replying to it please click the ∨ icon below and to the right of that comment. Thank you for partnering with us to maintain fruitful conversation.