Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration is refusing to even review the application seeking regulatory approval, telling the company that the comparator in the studies — an FDA-approved vaccine — is insufficient.The FDA’s refuse-to-file letter did not identify any safety or efficacy concerns for the vaccine, mRNA-1010, Moderna said after Tuesday’s market close. The agency told the company that the vaccine lacked an a...
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