In this week’s edition of InnovationRx, we look at the FDA’s refusal to review Moderna’s flu vaccine, the healthcare giants on Forbes new Greatest Innovators list, why Garner Health is worth $1.35 billion, and more. To get it in your inbox, subscribe here.

The FDA refused to review Moderna’s application for its seasonal flu vaccine, the company said on Tuesday. The decision was a surprise and raises questions about the Trump Administration’s vaccine policies. Moderna released the Refusal-to-File letter it received from Vinay Prasad, who heads Center for Biologics Evaluation and Research (CBER).

On its face, the dispute is what controls Moderna should have used in testing its new shot’s efficacy. Prasad claimed in the letter that Moderna’s application lacked data from an “adequate and well-controlled” study. The company called that “inconsistent” with previous guidance it had received from the agency, and said that it had requested an urgent meeting with CBER. Prasad reportedly overruled his own staff in making the determination.

Moderna’s seasonal flu vaccine delivers messenger RNA to the body that encodes for proteins that can be found on the surface of different flu strains. This teaches the cells of the body to produce those proteins–which are not harmful in and of themselves–in order to train the body’s immune system to detect and fight flu viruses. In clinical trials, Moderna’s shot–which was expected to be the first mRNA flu vaccine to reach market–was shown to be about 27% more effective than a seasonal flu vaccine from GSK, and showed no safety concerns.

"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative........

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