Moderna noted that neither the FDA’s regulation nor its guidance to industry makes any reference to a requirement of the “best-available standard of care” in comparators.
But shouldn’t they at least pretend that the new drug is better than the currently available options? Otherwise what’s the point of making it?
edit: It’s like Intel comparing their new CPUs with their last generation instead of what their competitors offer today.
It’s about knowing your audience and phrasing things in a way to increase the likelihood of acceptance. So despite the FDA reviewing and accepting the trial design in April '24 and August '25, plus the trial demonstrating the vaccine to be more effective than the currently available vaccines, I’d bet my last dollar they phrased it like this just for RFK and friends…
They phrased it that way because the FDA did. Without any legal basis as it seems.
Moderna said the FDA reviewed and accepted its trial design on at least two occasions (in April 2024 and again in August 2025) before it applied for approval of mRNA-1010. It also noted that Fluarix has been used as a comparator vaccine in previous flu vaccine trials, which tested vaccines that went on to earn approval.
But in a letter dated February 3, Vinay Prasad, the FDA’s top vaccine regulator under the Trump administration, informed Moderna that the agency does not consider the trial “adequate and well-controlled” because the comparator vaccine “does not reflect the best-available standard of care.”
But shouldn’t they at least pretend that the new drug is better than the currently available options? Otherwise what’s the point of making it?
edit: It’s like Intel comparing their new CPUs with their last generation instead of what their competitors offer today.
It’s about knowing your audience and phrasing things in a way to increase the likelihood of acceptance. So despite the FDA reviewing and accepting the trial design in April '24 and August '25, plus the trial demonstrating the vaccine to be more effective than the currently available vaccines, I’d bet my last dollar they phrased it like this just for RFK and friends…
They phrased it that way because the FDA did. Without any legal basis as it seems.