Moderna claimed that the FDA is refusing to review an application for its first mRNA-based flu vaccine.
The letter of refusal, signed by the FDA’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 explained that the letter is inconsistent with previous communications.
“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,” said Moderna CEO Stéphane Bancel. “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. 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 development follows the company receiving millions of dollars in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate the development of its pharmaceutical company’s mRNA-based pandemic flu vaccine.
“We are proud to have the support of CEPI to advance our pandemic influenza vaccine candidate, research that is critical to our commitment to pandemic preparedness,” Bancel said in a statement. “mRNA technology can play a vital role in addressing emerging health threats quickly and effectively, and we look forward to continuing our partnership with CEPI as we advance our health security portfolio, and in parallel, further the 100 Days Mission.”
