The FDA has now agreed to review an application from Moderna concerning its mRNA influenza vaccine after previously denying the company’s effort. Moderna held a Type A meeting with the FDA and proposed a “revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010,” a press release explains. Under the company’s revised proposal, it now seeks full approval for adults ages 50-64 and an accelerated approval for those aged 65 and older.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Moderna CEO Stéphane Bancel. “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.”
Initially, the FDA’s letter of refusal, signed by the agency’s Center for Biologics Evaluation and Research (CBER) Director Vinayak Prasad, “identified the choice of a licensed standard-dose seasonal influenza vaccine comparator as the sole reason for the refusal to initiate the review of Moderna’s application,” Moderna explained in a press release. The company argued that the letter is inconsistent with previous communications.
The FDA said upon refusing the proposal that Moderna’s study design was inadequate. “CBER does not consider the application to contain a trial ‘adequate and well-controlled,’ and the application is therefore, on its face, inadequate for review,” the letter read. “This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study.”
