The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
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»In August of 2025, following the successful completion of the Phase 3 efficacy trial in which mRNA-1010 met all pre-specified primary endpoints, Moderna held a pre-submission meeting with CBER [Center for Biologics Evaluation and Research]. CBER requested that supportive analyses be included … Moderna provided the additional analyses … At no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.«
https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA
@stekopf @jeneralist Can confirm. This was a curve ball.
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@jeneralist So frustratingly corrupt that they halt studies rather than going to court or abroad.
@dalias @jeneralist Yes.
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@jeneralist
An opportunity for Moderna's German competitor, BioNTech (which also develops mRNA vaccines), perhaps@ancientsounds @jeneralist They're probably relocating assets for this. I don't know for sure, I got laid off last October and bounced from the industry.
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They 100% could apply for approval in Europe or Canada but they won't because without access to the US market their isn't enough profit for them... and companies like Moderna don't care about people, they only care about profit.
Europe, Canada, et al need to force the issue by changing patent law (at least for medical patents but honestly it would be best to cover all patents) to include a 'use it or lose it' clause. If companies don't pursue approval Government's should have the right to step in and use the companies patents to develop the drugs themselves.
@RantingCanuck @Mikal @jeneralist
Compulsory licensing* can work for drugs ("chemicals") but manufacture of vaccines and other "biologicals" typically involves too much know-how for anyone other than original patent holder to take on.
*This is the technical term for what you describe, except that no government would develop the product itself - instead they'd license a generic manufacturer to do so.
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@mirth @ujay68 @jeneralist That figure is pretty far off. The costs of trials in the US total up to around $550mus on the low end. $100mus would be very affordable across the whole process.
@drwho @ujay68 @jeneralist Yes more just trying to put in context why the cost to develop and approve one drug is not the only underlying cost the company has to cover to stay solvent.
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@mirth @ujay68 @jeneralist Executive bonuses, starting at the director level.
@drwho @ujay68 @jeneralist Generally agreed that bonuses don't really achieve what they are advertised to, though how much difference to the finances would that make in the case of a company like Moderna?
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@jeneralist Since Moderna is a multinational company, they should just wind down all operations in the US, and refocus their research in Canada and/or Europe.
And maybe that is what they are quietly doing already.
Moderna has its new influenza vaccine under review in the EU, Canada, and Australia: https://www.nbcnews.com/health/health-news/fda-declines-review-modernas-mrna-flu-shot-rcna258436
But that does not make what Trump and those with him are doing any less deadly.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist on one hand - f tRump. On the other hand kinda f moderna for giving up because they can't make enough money back to satisy the "numbers". (There's profitable enough at some point - for the average Joe thats been capped at 'breaking even' should that ever happen...)
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist It's been clear that stealth eugenics have been at the heart of the Republican policy since the beginning of the pandemic. Why else would they be so adamant to keep a pseudoscientist with literal brain damage as their head of health policy? -
@drwho @ujay68 @jeneralist Yes more just trying to put in context why the cost to develop and approve one drug is not the only underlying cost the company has to cover to stay solvent.
@mirth @ujay68 @jeneralist Gotcha - understood now.
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@drwho @ujay68 @jeneralist Generally agreed that bonuses don't really achieve what they are advertised to, though how much difference to the finances would that make in the case of a company like Moderna?
@mirth @ujay68 @jeneralist I don't know. I don't have access to their internal accounting system.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist Eugenics
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@jeneralist @EndicottAuthor Yup. With a side of shakedown as a distraction.
@Heartofcoyote @jeneralist @EndicottAuthor
You're always in a better position to negotiate if you are willing to walk away. So Trump teamed up with people who do not care for the systems they are put in charge of -- their goal is to walk away. Now it's just a matter of how much Trump can extract from everyone else while they do that -
The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
@jeneralist MS-haver here. Beyond furious.
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@crazyeddie
Yeah. There are shades of both. We have the obviously inept senate PLUS the obviously unhinged Caligula destroying a world leading economy for no gain (or negative gains due to petty grievances).@jcutting @crazyeddie why does everyone keep bringing up Caligula? Isn't he more like Nero?
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The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.
Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.
A lot of people with herpes would be angry if they found out.
A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.
Can Moderna sue the FDA ? If they conducted their studies the way FDA wanted them done, then it's a breach of contract by the FDA, isn't it?
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@mirth @ujay68 @jeneralist I don't know. I don't have access to their internal accounting system.
@drwho @ujay68 @jeneralist Eyeballing some news articles they pay maybe something like $100M/year in bonuses? Not insignificant, but proportionally also probably doesn't change the overall financial picture by a whole lot.
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Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?
@Mikal @jeneralist
I think they were targeting a market that they could make a lot of money out of. US regs tend to favor price engineering - or at least it's permissible to it. -
Moderna has its new influenza vaccine under review in the EU, Canada, and Australia: https://www.nbcnews.com/health/health-news/fda-declines-review-modernas-mrna-flu-shot-rcna258436
But that does not make what Trump and those with him are doing any less deadly.
@michael_w_busch @jeneralist Very true. My comments were a bit insensitive and callous, especially to all of us whom are affected by our current admin.
