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.
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?
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.
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.
Last year a friend of mine told me that one of the principal dividing lines in American politics is whether one can correctly answer who the president was in 2020 and 2008. They weren't wrong.
It's a really weird thing. I think the very strong negative emotions about COVID were simply naturally transferred over to Biden because he was a political enemy.
I think this is a dangerous reactionary mindset. When someone starts viewing their political enemies as the source of all evils it's very hard to have any sort of civil discourse.
So, the 'administration' specifically demands pharmaceutical companies move production to the US.
Then, when they do, and invest "hundreds of millions of dollars running Phase 3 trials enrolling over 43,000 participants based on FDA guidance..." to ge a new product approved, they get zero consideration.
Why would the executives not look at this and say "why should we remain based in the US at all?", and just move headquarters to a more business-friendly country?
Sure, the US is a big market, but if one cannot get anything close to a fair treatment of your products, you have no ability to work in that market anyway.
We have a true kakistocracy, a government by the worst, most corrupt, and least qualified.
I have no stake in this FDA thing, but it's very amusing to read economic arguments of why FDA should approve something because a US company spent $x and should be entitled to get such thing approved...
Very interesting when people complain about "corruption" when money suddenly cannot buy favors.
It is a bit funny given the origins of the FDA. That said, there does need to be some legitimacy. The value of the FDA is that the rules are being applied in a fair and logical manner. This sort of unfairness because of clear bias against mRNA tech is what is gross.
By all means, if there's a good test that's lacking or clear problems that can be demonstrated I absolutely want the FDA to use it's power to stop a drug from coming to market or even pull and existing drug from the market.
The problem I have is that when the FDA acts in an illegitimate manner, it opens the doors to questions like "do we even need this institution" or "should the power of the FDA be reduced." Both of which are things that are both bad and dangerous.
The FDA doesn't need it's powers curbed, it needs competent leadership that will follow the data.
I am absolutely NOT making any economic argument for approval or that an investment beyond $x should somehow guarantee approval! They are all professionals and know the risks and how to manage them.
And NO this is not about "money suddenly cannot buy favors". This is about illegitimate denial of even a hearing because the person occupying the agency's chair promotes idiotic conspiracy theories in order to cultivate a particularly stupid slice of the voting base. The corruption here is political.
The ONLY argument I am making is:
1) The govt agency should AT LEAST give a fair review of all applications, especially when the same agency previously gave guidance, which the applicants followed, on how the studies should be run.
2) The govt agency should NOT be issuing rare "Refusal To File" denials based on an obvious and unsubstantiated bias against a particular technology (in this case mRNA) because the leader of the agency is a conspiracy theorist.
If you aren't going to read the article before commenting, at least read the comment before replying.
> "You cannot make a return on investment if you don’t have access to the U.S. market."
That tells a lot about who pays for healthcare in the US.
As a non US person I'm grateful to Americans for paying so much towards drug development.
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
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.
Previously: https://news.ycombinator.com/item?id=46968424
RFKs quackery has the potential to kill more people than Idi Amin. Vaccines save about 4 Million lives per year according to the CDC. https://www.cdc.gov/global-immunization/fast-facts/
I'm sure it won't be long until that page is scrubbed and replaced with Newspeak.
You call out idiocy, using actual data, and get downvoted. On HN, without so much as a comment describing why you might be in error.
HN is indeed sliding.
[flagged]
Weren't the COVID lockdown all in 2020? As well as most of the mask mandate? Was 2020 during the 'last administration'?
Last year a friend of mine told me that one of the principal dividing lines in American politics is whether one can correctly answer who the president was in 2020 and 2008. They weren't wrong.
It's a really weird thing. I think the very strong negative emotions about COVID were simply naturally transferred over to Biden because he was a political enemy.
I think this is a dangerous reactionary mindset. When someone starts viewing their political enemies as the source of all evils it's very hard to have any sort of civil discourse.
[flagged]
So, the 'administration' specifically demands pharmaceutical companies move production to the US.
Then, when they do, and invest "hundreds of millions of dollars running Phase 3 trials enrolling over 43,000 participants based on FDA guidance..." to ge a new product approved, they get zero consideration.
Why would the executives not look at this and say "why should we remain based in the US at all?", and just move headquarters to a more business-friendly country?
Sure, the US is a big market, but if one cannot get anything close to a fair treatment of your products, you have no ability to work in that market anyway.
We have a true kakistocracy, a government by the worst, most corrupt, and least qualified.
I have no stake in this FDA thing, but it's very amusing to read economic arguments of why FDA should approve something because a US company spent $x and should be entitled to get such thing approved...
Very interesting when people complain about "corruption" when money suddenly cannot buy favors.
It is a bit funny given the origins of the FDA. That said, there does need to be some legitimacy. The value of the FDA is that the rules are being applied in a fair and logical manner. This sort of unfairness because of clear bias against mRNA tech is what is gross.
By all means, if there's a good test that's lacking or clear problems that can be demonstrated I absolutely want the FDA to use it's power to stop a drug from coming to market or even pull and existing drug from the market.
The problem I have is that when the FDA acts in an illegitimate manner, it opens the doors to questions like "do we even need this institution" or "should the power of the FDA be reduced." Both of which are things that are both bad and dangerous.
The FDA doesn't need it's powers curbed, it needs competent leadership that will follow the data.
> US company spent $x and should be entitled to get such thing approved...
It's not entitled for approval. It's entitled to have an unbiased approval process.
I am absolutely NOT making any economic argument for approval or that an investment beyond $x should somehow guarantee approval! They are all professionals and know the risks and how to manage them.
And NO this is not about "money suddenly cannot buy favors". This is about illegitimate denial of even a hearing because the person occupying the agency's chair promotes idiotic conspiracy theories in order to cultivate a particularly stupid slice of the voting base. The corruption here is political.
The ONLY argument I am making is:
1) The govt agency should AT LEAST give a fair review of all applications, especially when the same agency previously gave guidance, which the applicants followed, on how the studies should be run.
2) The govt agency should NOT be issuing rare "Refusal To File" denials based on an obvious and unsubstantiated bias against a particular technology (in this case mRNA) because the leader of the agency is a conspiracy theorist.
If you aren't going to read the article before commenting, at least read the comment before replying.