But in a letter dated February 3, Vinay Prasad, the FDA’s top vaccine regulator under the Trump administration, informed Moderna that the agency does not consider the trial “adequate and well-controlled” because the comparator vaccine “does not reflect the best-available standard of care.”
In its news release, Moderna noted that neither the FDA’s regulation nor its guidance to industry makes any reference to a requirement of the “best-available standard of care” in comparators.
“This decision by [the FDA’s Center for Biologics Evaluation and Research], 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
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