US Edition
Published • loading... • Updated
Moderna says FDA refuses its application for new mRNA flu vaccine
The FDA rejected Moderna's flu vaccine application due to trial comparator issues despite data showing it was more effective in adults 50+, with over 40,000 participants involved.
- The FDA refused to file Moderna's application on Tuesday, citing issues with trial design, as the letter was signed by CBER director Vinay Prasad.
- CBER officials contend the trial lacked a comparator reflecting the best-available U.S. standard of care, with Prasad's letter saying Moderna did not compare its shot to this standard.
- Phase 3 data showed mRNA-1010 met primary endpoints and demonstrated superiority in two studies with more than 43,800 participants, including somewhat more effectiveness in adults 50 and older and no safety concerns.
- Moderna said it will seek CBER engagement while pursuing reviews in the EU, Canada and Australia, as shares fell nearly nine percent.
- The move reflects heightened scrutiny under Health Secretary Robert F. Kennedy Jr., with HHS pulling nearly $500 million in funding and anonymous FDA officials reporting Prasad overrode staff in the rare Refusal-to-File.
Insights by Ground AI
234 Articles
234 Articles
Coverage Details
Total News Sources234
Leaning Left31Leaning Right27Center124Last UpdatedBias Distribution68% Center
Bias Distribution
- 68% of the sources are Center
68% Center
L 17%
C 68%
15%
Factuality
To view factuality data please Upgrade to Premium
