The U.S. Food and Drug Administration (FDA) reversed course and will review Moderna’s flu vaccine.
Vinay Prasad, the head of the FDA’s vaccine and biologics division, initially refused to review the vaccine because of an inadequate clinical trial.
On Wednesday morning, Moderna announced the FDA’s change of heart:
Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
Last week, Moderna disclosed the refusal, pointing out that Prasad took issue with the company’s “choice of a licensed standard-dose seasonal influenza vaccine comparator.”
Pasad told Moderna that “the lack of an ‘adequate and well-controlled’ study with a comparator arm that ‘does not reflect the best-available standard of care.'”
A comparator in clinical trials is also called a control. Those who receive the comparator are known as the control group.
A company can use an investigational or approved medicine, a placebo, a different procedure, or an intervention as a comparator.
Moderna countered that the FDA’s guidance and regulations for an annual flu vaccine do not state that using a comparator reflects the “best-available standard of care.”
Moderna cited 21 C.F.R. § 314.126 (Adequate and well-controlled studies).
A quick search for the word “comparator” did not yield results.
Prasad’s letter also “did not identify any specific safety or efficacy concerns regarding” the vaccine.
[Featured image via YouTube]
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