FDA refuses to review Moderna’s mRNA flu vaccine application
Fox News
FDA refuses Moderna mRNA flu vaccine application, citing inadequate study design that could delay stronger protection shot, as Stéphane Bancel says decision contradicts prior FDA guidance.
Michael Sinkewicz is a writer for Fox News Digital. Story tips can be sent to michael.sinkewicz@fox.com
Stéphane Bancel, chief executive officer of Moderna, said the FDA's decision did not "identify any safety or efficacy concerns with our product" and "does not further our shared goal of enhancing America’s leadership in developing innovative medicines."
"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 said in a statement. "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."
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