Hacker News Reader

Comment by CGMthrowaway | Hacker News Reader

If you would like to read the Refusal to File letter: https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fb...

More information was shared from HHS spokespeople after Moderna posted the letter, which companies usually keep secret because they are embarrassing.

The FDA's main objection is that Moderna refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy. Specifically, FDA said it was "pretty clear" that it recommended using a high-dose comparator in seniors. By comparison, Moderna used a standard-dose comparator in seniors. The implication is that this choice juiced Moderna's efficacy stats.

This has nothing directly to do with safety.

Source: I work in pharma

View on HN

Derek Lowe's take on this, probably written before those HHS comments, was that "the agency appears to have signed off on the trial design as proposed, and I can’t see Moderna going ahead with it if the agency had done otherwise". Does it appear that the design was actually approved?

https://www.science.org/content/blog-post/mrna-refusal-file

Those communications are not public. So we don't know, we only know what each side is saying: FDA says they gave clear guidance, while Moderna claims they were not told a high-dose comparator was required for 65+, which is perhaps another way of saying "you gave guidance that left room for interpretation," which frankly is not an argument that flies with any regulator anywhere, although it can be very frustrating for companies. At any rate there is active dialogue between FDA and Moderna, and if they refile anything could happen

This could just as easily be someone at the top saying "find a legitimate sounding reason to refuse this because we want to refuse it anyways". They will always give such a reason, that doesn't mean it's the real reason.

Could be. I limited my comment to facts, eschewing speculation

It's best to take the official statement at face value rather than assuming what's not said. If you take it to mean something that was not said, that's on you.

And if two official statements from two different organization differ, what do you do? And if, of the two, the government is known to be a bad faith actor, how does that affect your answer? Organizations lie, that is a simple fact of life. You can either deal with it or bury your head in the sand.

What are the two differing statements? The primary statement to the applicant by the FDA is what matters. Everything else is irrelevant political commentary.

I already preempted your response. You're behind.

No, you are distracted. Focus on the official FDA response statement and remove all else from view. Your distractions are an excuse for inaction.

Reply on news.ycombinator.com