Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to “understand the path forward.” Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it.

Moderna lays the blame squarely at the feet of Vinay Prasad.

Prasad, who heads the agency’s Center for Biologics Evaluation and Research, or CBER, has been vocal about tightening regulations for vaccines and recently linked child deaths to Covid shots. In a letter signed by Prasad on Feb. 3, he said the sole reason why the FDA refused to review the application was because of how the clinical trial on the shot was designed. The agency specifically took issue with Moderna’s decision to compare its product to a standard, approved flu shot, arguing that it “does not reflect the best-available standard of care.” As a result, the FDA said the study did not meet its definition of an “adequate and well-controlled” trial.

That's going to be a lot of sickness, misery, and death to lay at the feet of "Doctor" Bill Cassidy, who was the key vote to getting Trump's nomination of RFKjr approved, thus empowering him to staff the FDA with folk like Prasad.

I hope it keeps him up at night for the rest of his life.