Except this is not how medical regulation has worked in the US. This particularly is a new and stricter standard required for this particular vaccine. Even the new Trump policies for COVID vaccines now specifically requires a placebo -- comparison against standard-of-care would not be accepted.
Huh? The FDA's main guidance document on this topic, issued in 2007 with no major overhaul since [0], states that comparative efficacy or effectiveness data is valuable when:
- The comparator vaccine is indicated for the same population.
- The comparator has existing clinical effectiveness data.
In other words, the trial design should use a benchmark that makes sense given what doctors and guidelines actually recommend today. For older adults, evidence over the past 15+ years has shown that enhanced flu vaccines often provide better protection than standard-dose ones. The study used standard-dose vaccines as far as we can see.
The only oddity here is that the FDA apparently approved the study previously
The document describes proof of effectiveness as supported by demonstrating "non inferiority to... a US licensed product". So yes, a (licensed) benchmark, but I see no references to a requirement for only testing against the best standard of care. It's a separate question about whether it should be though, and the cfr is quite vague throughout, so I would probably expect this isn't an illegal move (assuming arbitrary and capricious isn't held by a court), but I don't see it supported by precedent.
