(Ars Technica) – In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA-1010. Specifically, the FDA’s rejection was over the comparator vaccine Moderna used.

In the trial, which enrolled nearly 41,000 participants and cost hundreds of millions of dollars, Moderna compared the safety and efficacy of mRNA-1010 to licensed standard-dose influenza vaccines, including Fluarix, made by GlaxoSmithKline. The trial found that mRNA-1010 was superior to the comparators. (Read More)