Vinay Prasad on Substandard Trial Comparators: warns against

What Prasad says

Dr. Vinay Prasad warns that pivotal trials must use the “best-available standard of care” as the control arm — the centerpiece rationale of his February 3, 2026 refusal-to-file letter on Moderna’s mRNA-1010 flu vaccine application. He told the company the application would not be reviewed because its comparator, GSK’s standard-dose Fluarix, was not the best available standard of care for adults 65 and older.

His stated reasoning

Prasad’s stated reasoning is that comparing a new product against a substandard control can make it look effective when it is merely better than a weak comparator. Requiring best-available-care controls, he says, is how trials earn the “adequate and well-controlled” label that justifies approval.

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