FDA declines to review Moderna's mRNA flu shot application

The Food and Drug Administration has declined to review Moderna's mRNA flu shot application, which the company claims contradicts what the agency previously told the drugmaker.

Moderna said Tuesday that the FDA’s Center for Biologics Evaluation and Research told the company that it would not initiate a review of the investigational mRNA vaccine. The company has requested a Type A meeting with the FDA, which is a high-priority discussion, to “understand” a path forward.

CBER Director Vinayak Prasad said in a letter that the refusal was because Moderna chose a standard-dose seasonal flu vaccine that has already been licensed as a comparison, according to the company. He cited the lack of an "adequate and well-controlled" study with a comparison that "does not reflect the best-available standard of care."

“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stéphane Bancel said in a statement.

“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 added. “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.”

The Department of Health and Human Services last year canceled millions of dollars in funding grants for mRNA vaccines, with HHS Secretary Robert F. Kennedy, Jr., claiming at the time that the decision was due to data showing those types of vaccines are ineffective, The Hill news outlet reported.

HHS didn't immediately respond to the news outlet's request for comment.