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.
Lorraine Lee likes this.
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Cassandrich
in reply to Jennifer Hamilton, MD PhD • • •The Doctor
in reply to Cassandrich • • •Kim Possible
in reply to Jennifer Hamilton, MD PhD • • •EndicottRoad59
in reply to Jennifer Hamilton, MD PhD • • •Jennifer Hamilton, MD PhD
in reply to EndicottRoad59 • • •Aaron reshared this.
CrazyDogLadySezPEACE
in reply to Jennifer Hamilton, MD PhD • • •2xfo
in reply to CrazyDogLadySezPEACE • • •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
cognitively accessible math
in reply to EndicottRoad59 • • •James Wells
in reply to cognitively accessible math • • •@geonz
No, there is a bit more to it. Moderna was the first to announce the possibility of using mRNA to build the vaccine, they announced it either just after Chump lost in 2020 or just after Chump left the white house in 2021. And then they had the audacity to lose to Pfizer to market launch, so to Chump it is very personal, which means to RFKjr it is personal.
@EndicottAuthor @jeneralist
My camera shoots fascists
in reply to Jennifer Hamilton, MD PhD • • •Jennifer Hamilton, MD PhD
in reply to My camera shoots fascists • • •@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?
Frieke
in reply to My camera shoots fascists • • •@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
RantingCanuck
in reply to My camera shoots fascists • • •@Mikal
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.
Aaron reshared this.
Aaron
in reply to RantingCanuck • • •We would do even better if these companies were cooperatives driven by community benefit instead of publicly traded corporations driven by profit. Profit (as opposed to wages) is intrinsically extractive -- the antithesis of healthcare or anything else related to customer well-being.
Stacky
in reply to My camera shoots fascists • • •John Ulrik
in reply to Jennifer Hamilton, MD PhD • • •Aaron reshared this.
Jennifer Hamilton, MD PhD
in reply to John Ulrik • • •@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.
Aaron reshared this.
Ariaflame
in reply to Jennifer Hamilton, MD PhD • • •Jennifer Hamilton, MD PhD
in reply to Ariaflame • • •@ariaflame @ujay68
Moderna has shareholders. It's on the NASDAQ, stock symbol MRNA.
Ariaflame
in reply to Jennifer Hamilton, MD PhD • • •Aaron
in reply to Ariaflame • • •James Wells
in reply to Aaron • • •@hosford42
Yes, but it has to be targeted cooperatives. A coop is not going to be able to afford research into novel uses of mRNA vaccines. Coops cannot afford the protein synthesizers needed to make those novel mRNA vaccines into enough doses.
Now, if we instead taxed corporations / share holders profits the right way, they would be incentivized to spend the money that coops couldn't afford to spend.
@ariaflame @jeneralist @ujay68
Aaron
in reply to James Wells • • •Lorraine Lee reshared this.
Brian Vastag
in reply to Jennifer Hamilton, MD PhD • • •EBV is also a common trigger for the lifelong illness known as ME/CFS.
mdpi.com/2076-2607/13/4/702
Jennifer Hamilton, MD PhD
in reply to Brian Vastag • • •Martin Seeger
in reply to Jennifer Hamilton, MD PhD • • •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.
AzureArmageddon
in reply to Jennifer Hamilton, MD PhD • • •Eugene Glover
in reply to AzureArmageddon • • •Aaron
in reply to Eugene Glover • • •@LoneLocust @AzureArmageddon
In our current economic system, it probably would. (And we are about to find out, because the US is on a terrible trajectory right now and on course to cease being a major player.)
That's why profit shouldn't be the driver for medical research. If these companies were consumer cooperatives, their purpose and focus would be to benefit their customers, not to extract money from their customers' pockets and put it into shareholders' hands. Then it wouldn't matter if the drug was profitable. It would matter if it was affordable and worthwhile to develop, manufacture, and deliver it.
Diane
in reply to Jennifer Hamilton, MD PhD • • •The Doctor
in reply to Diane • • •Sepia Fan
in reply to Jennifer Hamilton, MD PhD • • •»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.«
feeds.issuerdirect.com/news-re…
News Release
feeds.issuerdirect.comThe Doctor
in reply to Sepia Fan • • •Sepia Fan
in reply to Sepia Fan • • •Scale Theory
in reply to Jennifer Hamilton, MD PhD • • •Miakoda
in reply to Jennifer Hamilton, MD PhD • • •Sassinake! - ⊃∪∩⪽
in reply to Jennifer Hamilton, MD PhD • • •Hilary
in reply to Sassinake! - ⊃∪∩⪽ • • •@Sassinake
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.
Ryan @ Ansible Games
in reply to Jennifer Hamilton, MD PhD • • •Fruits! 🧔🏻♂️🏳️⚧️🏳️🌈
in reply to Jennifer Hamilton, MD PhD • • •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.
crazyeddie
in reply to Fruits! 🧔🏻♂️🏳️⚧️🏳️🌈 • • •Guillaume Racicot
in reply to Jennifer Hamilton, MD PhD • • •John Cutting
in reply to Jennifer Hamilton, MD PhD • • •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.
crazyeddie
in reply to John Cutting • • •Human after all
in reply to Jennifer Hamilton, MD PhD • • •Spirit
in reply to Jennifer Hamilton, MD PhD • • •cognitively accessible math
in reply to Jennifer Hamilton, MD PhD • • •Helle, Queen of Dissociation
in reply to Jennifer Hamilton, MD PhD • • •even without MS, EBV is itself such a mess, had it as an adult and I have had my long term health so significantly affected by it
it is such a mess that the USA is handling this badly as a country and that commercial interests are also involved instead of just the good of everyone on the planet :\
MidgePhoto
in reply to Jennifer Hamilton, MD PhD • • •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.
#vaccines #Europe #braindrain
Angie
in reply to Jennifer Hamilton, MD PhD • • •Kevin Karhan
in reply to Jennifer Hamilton, MD PhD • • •lemgandi
in reply to Jennifer Hamilton, MD PhD • • •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.
Cress
in reply to Jennifer Hamilton, MD PhD • • •Graeme 🏴
in reply to Jennifer Hamilton, MD PhD • • •Hilary
in reply to Graeme 🏴 • • •The US won't buy if the FDA won't license, regardless of where the product is developed and made
Starla
in reply to Jennifer Hamilton, MD PhD • • •𝔸𝕟𝕔𝕚𝕖𝕟𝕥 𝕊𝕠𝕦𝕟𝕕𝕤 🔉
in reply to Jennifer Hamilton, MD PhD • • •The Doctor
in reply to 𝔸𝕟𝕔𝕚𝕖𝕟𝕥 𝕊𝕠𝕦𝕟𝕕𝕤 🔉 • • •bk
in reply to Jennifer Hamilton, MD PhD • • •AdventureTense
in reply to Jennifer Hamilton, MD PhD • • •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.
Michael Busch
in reply to AdventureTense • • •@adventure_tense
Moderna has its new influenza vaccine under review in the EU, Canada, and Australia: nbcnews.com/health/health-news…
But that does not make what Trump and those with him are doing any less deadly.
FDA refuses to review Moderna's mRNA flu shot
Berkeley Lovelace Jr. (NBC News)AskPippa🇨🇦
in reply to Jennifer Hamilton, MD PhD • • •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.
1. biospace.com/business/moderna-…
2. biospace.com/business/moderna-…
Moderna Won’t Run Phase III Vaccine Trials as Skepticism Grows in US: Bloomberg
Tristan Manalac (BioSpace)decapitae
in reply to Jennifer Hamilton, MD PhD • • •Pip
in reply to Jennifer Hamilton, MD PhD • • •Social murder - Wikipedia
Contributors to Wikimedia projects (Wikimedia Foundation, Inc.)Netraven
in reply to Jennifer Hamilton, MD PhD • • •Carlos Solís
in reply to Jennifer Hamilton, MD PhD • • •shadower
in reply to Jennifer Hamilton, MD PhD • • •Shamrock4EU
in reply to Jennifer Hamilton, MD PhD • • •James Wells
in reply to Jennifer Hamilton, MD PhD • • •Pete Alex Harris🦡🕸️🌲/∞🪐∫
in reply to James Wells • • •@nikatjef
They wouldn't be embarrassed, it's not an unintended or unwelcome outcome for them.
At this point, if someone leaked a memo that Peter Thiel has been trying all this time to bring about the end times by raising an antichrist to the presidency and instantiating the 4 horsemen of the apocalypse as US government policy, I'd barely raise an eyebrow.
The only surprising thing would be Trump hadn't boasted about it yet.
Doug 🌈🇨🇦
in reply to Jennifer Hamilton, MD PhD • • •xs4me2
in reply to Jennifer Hamilton, MD PhD • • •Tuchowski
in reply to Jennifer Hamilton, MD PhD • • •Why is the US market more "important" than Asian, European etc. markets?
#DiD
Jennifer Hamilton, MD PhD
in reply to Tuchowski • • •@adipoeserPursch
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
Australia & NZ: 30M
Without US, the market is about 40% smaller.
Daniel Brotherston
in reply to Jennifer Hamilton, MD PhD • • •Frank’s Ting
in reply to Jennifer Hamilton, MD PhD • • •Mu
in reply to Frank’s Ting • • •Bond. James Bond.
in reply to Jennifer Hamilton, MD PhD • • •Momo
in reply to Jennifer Hamilton, MD PhD • • •Just to point it out: This is shelved WORLDWIDE because if it can't be sold in the US, it won't hit ROI even if sold in the rest of the world.
And THIS is outright wrong!
RRB
in reply to Jennifer Hamilton, MD PhD • • •files.mastodon.social/media_at…