“They are refusing to review a new vaccine with a more flexible technology, while creating a real risk we will not have traditional vaccines for next year.”
The FDA issued a refusal-to-file letter, which means it will not consider the licensing application until Moderna provides more information. The letter did not specify which information it would require. It’s unusual for a refusal-to-file letter to be signed by the CBER director, as these are usually decisions made by the review team.
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