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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@jeneralist
Squandering what is probably the most important medical breakthrough of my lifetime because the most unqualified, narcissistic sociopaths somehow got elected because they were the right sort of bigots.
It's so tragic. It's like reading about the collapse of the Roman or Mongol empires due to easily avoidable systematic issues except we're living it.@jcutting @jeneralist Feels to me more like the crisis of the roman republic than the fall of the empire that replaced it.
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If there's one thing that can be said about the current US administration is that it's airing out all the dirty laundry of the world.
The fact that a pharmaceutical company puts profit over human lives is an abomination. The fact that one single country can hold the rest of us hostages because they allowed themselves to be scammed rather than have universal healthcare is an abomination.
If they ever get out of this, I hope Americans fix their stuff.
@fruitcakesareyum @jeneralist We won't. We're being held hostage by Texas.
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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 So frustratingly corrupt that they halt studies rather than going to court or abroad.
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I'm not the right person to be explaining the perverse intersection of healthcare and capitalism. The short answer is, most large companies won't do anything that loses money. In fact, in US law they are specifically prohibited from doing things that are expected to lose money.
@jeneralist Understandable. However, it doesn’t seem impossible to me to produce, at a profit, vaccines for the world’s population minus the US population. Not a really negligible target group. I’m no industry specialist, but there might also be … let’s say … other factors behind such a decision?
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@jcutting @jeneralist Feels to me more like the crisis of the roman republic than the fall of the empire that replaced it.
@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). -
A vaccine manufacturer would normally apply for approval in many jurisdictions.
But for some back-of-the-envelope calculations: new vaccines are generally introduced to more affluent countries first, especially for diseases that aren't immediately fatal. The market for vaccines against EBV, HSV, and VZV would be in this category.
EU: 450M people
Canada: 40M
US: 350MWithout US, the market is AT LEAST 40% smaller. Is it still worth it do to the studies?
@jeneralist but how many US citizens would even be able to afford it?
@Mikal -
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.
Eugenics is the plan.
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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
We shall need a different model then.
Which might include States (eg those of Europe) not buying vaccines, but developing them and owning the result.
Perhaps some clever Americans might like to come and help. -
Moderna has shareholders. It's on the NASDAQ, stock symbol MRNA.
@jeneralist @ujay68 So basically it's confirming that people in the USA are paying far too much for their medication. And the Pharmaceutical companies don't care too much, because if the people survive to old age they will make bank on them.
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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 generally speaking, vaccines are not profitable. Losing a huge market makes them even less so.
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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 at this point I hope everyone in the #USA is doing a #ClassAction against the #FDA and that people in the #EU will do the same since #Modena refusing to do R&D despite the EU having an entirely different approval process than the #FDA.
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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.
Some of us WITHOUT herpes are pretty mad too. I got vaxxed absolutely as soon as I was able. Watched my father in law suffer greatly for years from this disease.
I'm not sure I'd wish it on RFK junior. It's that bad.
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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 I read a significant body of evidence related to brain decay and herpes, somethin easily escalated within the body, something easily contracted. Good work MAGA for population decline, pain and suffering.
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@jeneralist Understandable. However, it doesn’t seem impossible to me to produce, at a profit, vaccines for the world’s population minus the US population. Not a really negligible target group. I’m no industry specialist, but there might also be … let’s say … other factors behind such a decision?
@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.
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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.
