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00:02The Food and Drug Administration refused to review Moderna's application for its mRNA flu vaccine,
00:07mRNA, 1010, citing concerns about the design of the company's Phase 3 trial
00:12and its choice of comparator vaccine, according to Ars Technica.
00:16Moderna said it was blindsided by the decision, which comes as Robert F.
00:20Kennedy Jr., who oversees the agency, has reduced childhood vaccine recommendations
00:25and canceled $500 million in mRNA vaccine research funding.
00:30The trial enrolled nearly 41,000 participants and found mRNA.
00:351010 was superior to the comparator vaccines.
00:38In a February 3rd letter, FDA vaccine regulator Vinay Prasad wrote the trial was not adequate
00:43and well-controlled because the comparator did not reflect the best available standard of care.
00:49CEO Stephen Bansill said the FDA identified no safety or efficacy concerns
00:54and argued it should not be controversial to review a flu vaccine submission
00:58that used an FDA-approved comparator previously agreed upon with CBR.
01:03Moderna has requested a meeting with the agency.
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