The US FDA has refused to review Moderna’s mRNA flu shot, citing trial design issues and sparking a dispute over regulatory standards.
NEW YORK: Moderna said the US Food and Drug Administration is refusing to review an application for its first mRNA-based flu shot.
The company received a Refusal-to-File letter from the agency’s top vaccine regulator, Vinay Prasad.
In the letter, Prasad stated Moderna’s clinical trial was not “adequate and well-controlled” and had not tested its experimental shot against the best product on the market.
Moderna’s large trial compared its new vaccine with Fluarix, an approved flu shot from GSK.
The company said the rejection was “inconsistent with previous written communications” with the FDA’s Center for Biologics Evaluation and Research.
Moderna CEO Stephane Bancel said the decision “did not identify any safety or efficacy concerns with our product”.
“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,” Bancel added.
The company said it has requested a meeting to discuss the decision.
Moderna noted the shot was accepted for review in the European Union, Canada and Australia.
The move comes as the FDA has called for a reconsideration of approval procedures for certain vaccines under proposed federal policy changes.
President Donald Trump, who once called mRNA technology a “modern-day miracle”, appointed Robert F. Kennedy Jr as his health chief.
The long-time vocal vaccine skeptic has spent the past year reshaping federal health agencies.
Kennedy has cut off federal research grants that funded mRNA development.
