Dr. Jesse Goodman, former FDA chief scientist, called the approach the agency finally settled on very sensible, but said it was a “really badly done process” to get there.

If the FDA had strong ethical concerns about the design of the trial, it should have intervened before Moderna ran the study, Goodman said.

Pending approval, Moderna said it expects to make its flu shot available for the 2026/2027 flu season. {read}