But in a letter dated Feb. 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 comparison vaccine “does not reflect the best-available standard of care.”
In its news release, Moderna said that neither the FDA’s regulation nor its guidance for industry makes any reference to the requirement of “best-available standard of care” in comparators.
“this decision [the FDA’s Center for Biologics Evaluation and Research]”which has not identified any safety or efficacy concerns with our product, does not advance our shared goal of enhancing America’s leadership in the development of innovative medicines,” Moderna CEO Stéphane Bancel said in the release. “It should not be controversial to conduct a comprehensive review of flu vaccine submissions that use an FDA-approved vaccine as a comparator in a study that was discussed with CBER in advance of and. Consent was expressed.”
Moderna said it has requested a meeting with the FDA to understand the basis for the denial. “We look forward to engaging with CBER to quickly understand the path forward so that America’s seniors and those with underlying conditions continue to have access to American-made innovations.”
The company reported that mRNA-1010 has already been accepted for review in the European Union, Canada and Australia.
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