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 The only reason would be that competing companies have bought their way into favor with the DJT administration, and Moderna is on the outside looking in.
@EndicottAuthor Sadly, that's a more hopeful interpretation than mine: the administration is pursuing an anti-vaccine agenda, and is doing what it can to make EVERY vaccine manufacturer pack up and leave. Moderna is just the first.
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@jeneralist The only reason would be that competing companies have bought their way into favor with the DJT administration, and Moderna is on the outside looking in.
@EndicottAuthor @jeneralist NOpe. They are anti-vaccine.
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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.
Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?
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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 This!
Like so many other science or tech stuff going on in usa... Let's profit of it's stupidity to expand European knowledge/market! -
Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?
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?
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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?
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.
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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 They could still develop vaccines for the other 8 billion people on this planet, couldn’t they? If they wanted to? No?
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@EndicottAuthor Sadly, that's a more hopeful interpretation than mine: the administration is pursuing an anti-vaccine agenda, and is doing what it can to make EVERY vaccine manufacturer pack up and leave. Moderna is just the first.
@jeneralist @EndicottAuthor Yup. With a side of shakedown as a distraction.
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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 am as furious at the CEO of Moderna as I am at the brainworm and his boss.
The CEO is taking the rest of the world hostage so they please bribe Trump for him.
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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 EBV is also a common trigger for the lifelong illness known as ME/CFS.
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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 "You cannot make a return on investment if you don't have access to the U.S. market" is a scary phrase.
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@jeneralist They could still develop vaccines for the other 8 billion people on this planet, couldn’t they? If they wanted to? No?
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.
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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 @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.
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@jeneralist EBV is also a common trigger for the lifelong illness known as ME/CFS.
@brianvastag Yep! And I really want any potential vaccine to evaluate the effect on ME/CFS. Is it the pathogen that causes problems, or the immune system's response to the pathogen? Could a poorly-designed vaccine make things worse?
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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.
$&#&@% death cult enagelical Christians and their crazed belief that god micromanages who gets infected
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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.
»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
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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.
Oligarchy = Devolution, regression, deregulation, subversion = revolution
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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 live in a first world shithole
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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 @ujay68 If they have shareholders anyway. I think non-profits and closely held (I think that's the term) don't have that restriction. But I don't think that applies to any pharmaceutical company.
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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.
I mean... rich people will still get them.
