Moderna’s president weighs in on FDA’s decision not to review its flu vaccine
statnews.com • • business
Key Points:
- In August, FDA officials told Moderna they would review its new influenza vaccine application and requested additional supporting analyses, which Moderna included in its submission.
- Despite this initial indication, Moderna received a refusal-to-file letter this month from FDA vaccine regulator Vinay Prasad, surprising the company and halting the review process.
- Prasad objected to Moderna's choice of the standard flu vaccine as the comparator in its trial, preferring a high-dose vaccine for older adults, a stance that overruled the vaccine office staff who were ready to review the application.
- Moderna’s president, Stephen Hoge, expressed that the refusal-to-file letter was unexpected and discussed the implications for Moderna and the broader biopharma industry.
- The FDA
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