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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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 This is where the EU should step in to fund it. Then charge the US premium prices to recoup the investment.
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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 yes
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@ujay68 @jeneralist I agree it's dysfunctional but I think it's about as simple as the CEO says. In pharma development and trials are very expensive, and most candidates don't pass for one reason or another (don't work well enough, bad side effects, etc). If it costs an average US$100M (rough guess) to develop and bring a drug through trials, and 9/10 fail, what do they need to make from the one that works? It itself may only cost $100M but the other $900M needs to come from somewhere.
@ujay68 @jeneralist The consequence of that is the direct cost of manufacturing and delivering a drug could be $1 but that $900M plus some interest on debt or return to investors needs to get spread across whatever it is that they can sell (about $0.10 per dose if you could give it to every person in the world). One way to reduce the overhead of this whole system is to shift more fundamental research to government-funded labs, but of course the US in the process of gutting those as well.
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@ujay68 @jeneralist The consequence of that is the direct cost of manufacturing and delivering a drug could be $1 but that $900M plus some interest on debt or return to investors needs to get spread across whatever it is that they can sell (about $0.10 per dose if you could give it to every person in the world). One way to reduce the overhead of this whole system is to shift more fundamental research to government-funded labs, but of course the US in the process of gutting those as well.
@ujay68 @jeneralist In any case, if the US stops vaccinating people (sigh) that doesn't make development any cheaper, it just means everyone else has to figure out how to make the math work or go without.
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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
An opportunity for Moderna's German competitor, BioNTech (which also develops mRNA vaccines), perhaps -
I mean... rich people will still get them.
Only by leaving the USA.
This isn't about whether RNA vaccines get recommended for use in the USA (meaning insurers might have to fund them), it's about whether they get LICENSED for use in the USA.
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@jeneralist This is where the EU should step in to fund it. Then charge the US premium prices to recoup the investment.
The US won't buy if the FDA won't license, regardless of where the product is developed and made
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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
Siri, what is the opposite of capitalism? -
@ujay68 @jeneralist In any case, if the US stops vaccinating people (sigh) that doesn't make development any cheaper, it just means everyone else has to figure out how to make the math work or go without.
@ujay68 @jeneralist As an addendum to address the "but there must be another way", yes, probably, with bigger systemic fixes. Lots of people who work on stuff like this don't care to make as much money as possible, but still have children and need schooling, medical care, a place to live, and so forth, and wow that is expensive in most places. Improving any of these improves all of them.
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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 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.
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@jeneralist @Mikal the US overpays for meds, so that 40% probably accounts for a majority of their profit. I’d be surprised if they truly wouldn’t make a profit, but I can’t rule it out with certainty.
@c0dec0dec0de @jeneralist @Mikal Former pharma here - that sounds about right.
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@jeneralist "You cannot make a return on investment if you don't have access to the U.S. market" is a scary phrase.
@AzureArmageddon @jeneralist that really does make me wonder that if the United States ever fixed its medical system to be in line with the rest of the civilized world. Would that take away the actual impetus for medical research that has been improving the lives of people worldwide?
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@jeneralist @Mikal the US overpays for meds, so that 40% probably accounts for a majority of their profit. I’d be surprised if they truly wouldn’t make a profit, but I can’t rule it out with certainty.
@c0dec0dec0de @jeneralist @Mikal
Vaccines are generally NOT hugely profitable. This is because:
They are given to healthy people, meaning that they have to be much more safe than drugs given to sick people who will tolerate more risk of side effects. This requires very large and costly trials.
Few doses are needed (up to 3 for most vaccines) and there is no long-term repeat prescribing.
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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 Just for clarity. Moderna announced stopping work on the latter vaccines mentioned back in November; while some mRNA work continues. This gives details for their reasoning. They've been doing a lot of cost-cutting.
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@ujay68 @jeneralist I agree it's dysfunctional but I think it's about as simple as the CEO says. In pharma development and trials are very expensive, and most candidates don't pass for one reason or another (don't work well enough, bad side effects, etc). If it costs an average US$100M (rough guess) to develop and bring a drug through trials, and 9/10 fail, what do they need to make from the one that works? It itself may only cost $100M but the other $900M needs to come from somewhere.
@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.
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@ujay68 @jeneralist The consequence of that is the direct cost of manufacturing and delivering a drug could be $1 but that $900M plus some interest on debt or return to investors needs to get spread across whatever it is that they can sell (about $0.10 per dose if you could give it to every person in the world). One way to reduce the overhead of this whole system is to shift more fundamental research to government-funded labs, but of course the US in the process of gutting those as well.
@mirth @ujay68 @jeneralist Executive bonuses, starting at the director level.
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$&#&@% death cult enagelical Christians and their crazed belief that god micromanages who gets infected
@alienghic @jeneralist 3/5 times, scratch an evangelical and find a social darwinist (ironically).
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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.
