"adequate and well-controlled trial"
"the best-available standard of care in the United States at the time of the study."
"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,"
The FDA issued a refusal-to-file for Moderna's application for an mRNA flu vaccine, objecting that the 40,000-person clinical trial did not compare the new shot to the best-available U.S. standard of care. The trial showed the vaccine was somewhat more effective in adults 50 and older compared with a standard-dose shot. FDA vaccine director Dr. Vinay Prasad cited prior 2024 guidance recommending a different comparator for seniors that Moderna did not follow. Moderna said it provided additional data versus a licensed high-dose senior shot and noted the agency raised no safety or efficacy concerns.
Read at Fast Company
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