FDA refuses to review Moderna’s application for mRNA flu vaccine, company says
By Meg Tirrell, CNN
(CNN) — The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology that’s been a target of some Trump administration health officials.
The agency told Moderna that its application didn’t contain an “adequate and well-controlled” trial because the control arm didn’t reflect the “best-available standard of care in the United States at the time of the study,” according to a letter dated February 3 that Moderna posted online.
The company said that the refusal was inconsistent with previous feedback from the agency and that it had requested a meeting with FDA officials to understand how to proceed.
“The complete stunner here is at no point in any of this did anybody say that it was not adequate” to run its clinical trial the way it had discussed with the agency, Moderna’s president, Dr. Stephen Hoge, told CNN on Tuesday.
CNN has asked the FDA for comment.
The company used a standard-dose seasonal flu vaccine called Fluarix as a comparator in a 40,700-person clinical trial to demonstrate the experimental mRNA vaccine’s safety and efficacy. Moderna said the FDA had agreed with that plan in April 2024 but suggested the company also include data comparing its vaccine with an approved high-dose flu vaccine for people over 65, which the company said it did.
Moderna added that as recently as August, in a meeting before it submitted its application for approval of the vaccine, the FDA suggested that it would review the filing and assess issues with the comparator during that process.
But last week, the agency refused to do the review at all, according to the letter. It was signed by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine regulation.
Prasad was an outspoken critic of the government’s response to Covid-19 before he was appointed to the FDA under US Department of Health and Human Services Secretary Robert F. Kennedy Jr. He claimed late last year without providing details that Covid-19 vaccines resulted in deaths of 10 children and has said the agency will change its vaccine approval process.
The administration also has withdrawn support for mRNA technology in infectious diseases; HHS canceled 22 projects worth about $500 million focused on mRNA vaccine development in August, claiming against evidence that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
The-CNN-Wire
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