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.

@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!

@jeneralist

@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.

@jeneralist

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.

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.

@ujay68

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.

@jcutting @jeneralist Feels to me more like the crisis of the roman republic than the fall of the empire that replaced it.

@Mikal

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: 350M

Without US, the market is AT LEAST 40% smaller. Is it still worth it do to the studies?

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.

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.

@ariaflame @ujay68

Moderna has shareholders. It's on the NASDAQ, stock symbol MRNA.

@jeneralist

Is there any reason they couldn't apply for approval in Europe or Canada or some other place that hasn't lost his mind?

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.

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.

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 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?

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.

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.

@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.

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.