WHO Asks South African Startup To Replicate Moderna's mRNA Vaccine 63
An anonymous reader quotes a report from NPR: The World Health Organization has hired the company, called Afrigen Biologics and Vaccines, as part of a $100 million plan to figure out how to make an mRNA vaccine against COVID that is as close as possible to the version produced by Moderna. Until recently, Afrigen specialized in developing veterinary vaccines using fairly traditional methods. Now, says Afrigen's managing director, Petro Treblanche, the company's labs are a hive of research into the cutting-edge technology behind mRNA vaccines. Once Afrigen has sorted out all the complicated steps to make Moderna's shot on an industrial scale, WHO and other partners plan to pay Afrigen to become a teaching center.
"We call it a 'technology transfer hub,' " says Martin Friede, the WHO official in charge of this effort. "Manufacturers from around the world will be invited to come and learn the entire process. So this will accelerate the availability of the technology, not to one manufacturer but to many manufacturers." Friede says it makes sense to set up more manufacturers of mRNA vaccines in particular because the technology appears so effective against COVID -- and because it shows promise against other diseases including malaria and tuberculosis. As to why WHO has chosen to try to copy Moderna rather than the other mRNA COVID vaccine, which is made by Pfizer BioNTech, Friede says the choice was practical. "Moderna has reiterated on several occasions that they will not enforce their intellectual property during the pandemic," says Friede. In other words, a manufacturer probably won't face a lawsuit for producing a vaccine that's virtually identical to Moderna's. Also, says Friede, compared to Pfizer's vaccine, there just happens to be a lot more information in the public domain about how Moderna's vaccine is made.
But Afrigen's Petro Treblanche says there are still a lot of unknowns. Take Moderna's patent. "It's written very carefully and cleverly to not disclose absolutely everything," says Treblanche. So while Afrigen has been able to determine most of the equipment and specialized ingredients that are needed, "what we don't know is the exact concentrations," says Treblanche. "And we don't know some of the mixing times -- some of the conditions of mixing and formulating." A particularly vexing question is how to replicate Moderna's "lipid nano-particle" -- a special casing around the mRNA strand at the heart of the vaccine that keeps it stable as it travels through the body to, as Treblanche puts it, "essential places like the spleen and lymph nodes." "We understand other encapsulations," says Treblanche. But for all the expertise at Afrigen, "my team has never formulated a liquid nanoparticle."
"We call it a 'technology transfer hub,' " says Martin Friede, the WHO official in charge of this effort. "Manufacturers from around the world will be invited to come and learn the entire process. So this will accelerate the availability of the technology, not to one manufacturer but to many manufacturers." Friede says it makes sense to set up more manufacturers of mRNA vaccines in particular because the technology appears so effective against COVID -- and because it shows promise against other diseases including malaria and tuberculosis. As to why WHO has chosen to try to copy Moderna rather than the other mRNA COVID vaccine, which is made by Pfizer BioNTech, Friede says the choice was practical. "Moderna has reiterated on several occasions that they will not enforce their intellectual property during the pandemic," says Friede. In other words, a manufacturer probably won't face a lawsuit for producing a vaccine that's virtually identical to Moderna's. Also, says Friede, compared to Pfizer's vaccine, there just happens to be a lot more information in the public domain about how Moderna's vaccine is made.
But Afrigen's Petro Treblanche says there are still a lot of unknowns. Take Moderna's patent. "It's written very carefully and cleverly to not disclose absolutely everything," says Treblanche. So while Afrigen has been able to determine most of the equipment and specialized ingredients that are needed, "what we don't know is the exact concentrations," says Treblanche. "And we don't know some of the mixing times -- some of the conditions of mixing and formulating." A particularly vexing question is how to replicate Moderna's "lipid nano-particle" -- a special casing around the mRNA strand at the heart of the vaccine that keeps it stable as it travels through the body to, as Treblanche puts it, "essential places like the spleen and lymph nodes." "We understand other encapsulations," says Treblanche. But for all the expertise at Afrigen, "my team has never formulated a liquid nanoparticle."
Re:I don't like where this is going (Score:4, Informative)
Changing the DNA of an already-grown organism (such as yourself) isn't happening anytime soon.
1. This isn't relevant to Moderna's COVID vaccine.
2. And changing the DNA of already grown organisms has been commonplace for years. Gene therapy for humans via viral vectors has had a rocky road in clinical trials (i.e., it kills people kinda often), but CRISPR based therapies delivered by - you guessed it: lipid nanoparticles - looks promising to me.
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getting way to easy to make stuff that changes your DNA, or is super infectious
The vaccine does neither.
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getting way to easy to make stuff that changes your DNA, or is super infectious
The vaccine does neither.
Yea, no kidding. Where are people getting seeded with this ridiculous idea that mRNA vaccines have any effect at all on DNA, let alone a permanent one.
Really, do us all a favor and go read a high school biology book. Idiocracy wasn't supposed to play itself out for at least another few hundred years...
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Re: I don't like where this is going (Score:5, Interesting)
High School is meant to teach you very simplified, technically incorrect stuff essential to get you some background to get started with actual correct science, still a little simplified and partially incorrect, in graduate level.
Once you cross PG you reach the level of understanding required to know that while 100s of previous generations' knowledge has been imparted to you there is a 1000x more needed to actually understand things completely. Till then some thumbrules and just theories on how some stuff seems to work can be used for practical benefits subject to a lot of care being taken not to start assuming you know everything.
Dont believe that ? What were you taught about Gravity ? The reality is that its NOT a force in any way, just a curvature of space-time that makes it look to 3D space beings that objects in 4D space are converging. That is essentially Einstein's explanation and it's quite difficult to comprehend so just a small % of people understand with while rest of us can't visualize 4D so either we are just taught some practical stuff treating gravity as a force or we use advanced math to work with it without needing to visualize it.
Next up, atom, electrons, protons, neutrons are not the indivisible things or even spherical things we are taught bor are they orbiting each other the way we are taught. Difficult to visualize probability based orbital stuff so its simplified to shit. When you go to current leading scientists you find there are like 40 sub atomic particles proposed with the weirdest properties like flavors and tone and they dont spin but have spin ! Obviously because diffi5to visualize so people come up with stuff that might help in understanding. Most of the sub atomic particles aren't physically 'found', they are sort of placeholders for imaginary stuff that could be there to explain why our equations dont match reality.
Just like dark matter is not actually dark matter, it's like they assumed 'ether' earlier to explain some things so dark matter is the hypothetical stuff which balances out the error in our equations.
It's like suspense account or adjustments in accounting. Practically it makes sense that the $100 error in your financials be set aside as suspense /adjustment/ write off etc and get in with life because for most things it doesnt matter so much. Most. Not All.
Coming to biology /medicine, we are even worse off. It's way more complicated than fundamental physics. We still keep discovering new organs ! Leave aprt actual purpose of organs we assumed vestigial. We have 75,000 chemical reactions going on inside your body and almost all need such arcane catalysts that just figuring out what reaction is happening is a noble prize worthy thing. Current nobel prize was for the process of our body sensing heat !
Coming to vaccines, you are forgetting that the tools like CRISPR are NOT made by scientists or even understood fully - they use certain viruses which have that capability to edit a tiny part of your dna/RNA or associated amino acids and get us the desired result.
It's a crude hack. Very useful but only idiots with no clue think they know how it works to fool your cells into creating a spike protein of corona virus. We just have some currently reasonable looking possible explanations. These get overturned or modified every few months drastically.
Most medicine is still 99% using your own body and other natural organisms/chemicals to help you get well.
It's all most of the slashdot crowd might well windows n linux a few thousand times or recompiled kernels 200 times or fixed 200 laptops of their friends & family with arcane errors, and that has practical value but that doesnt mean we understand the whole OS or Hardware. Just that we understand it abstracted into imaginary modules and know what to check or ditch or replace. Like any roadside mechanic fixing your car. It's fine when there's no alternative and if it's not too complicated a problem but dont assume that guy knows all
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Dont believe that ? What were you taught about Gravity ? The reality is that its NOT a force in any way, just a curvature of space-time that makes it look to 3D space beings that objects in 4D space are converging. That is essentially Einstein's explanation and it's quite difficult to comprehend so just a small % of people understand with while rest of us can't visualize 4D so either we are just taught some practical stuff treating gravity as a force or we use advanced math to work with it without needing to visualize it.
That's not true. 4D space is just how it happens to be convenient to model it mathematically, not some deep insight into the structure of the universe. For all we know it could be a force that mimics the effects of space-time curvature, or even space-time might not exist, and we could be living in some giant simulation, and Einstein's theory describes not some intrinsic property of space-time, but how a subroutine in the simulation program works.
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The reality is that its NOT a force in any way
Dude, no. It is both a force and an effect of the curvature of space (or rather spacetime) around massive objects. It's like saying that light is not a wave because it is also a particle.
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The misinformation online is strong. I had a whole semester on biotechnology at the university and when these vaccines came out and first read about them online I also got the wrong impression. It took a little bit of digging into my rusty memory of that semester's teachings to say to myself "Duh! What have I been thinking?!". If someone relies only on information online without any background whatsoever, it's easy for them to fall into some demagogue's trap or at least get very sceptical and start believin
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People that haven't read up on what messenger RNA actually is hear mRNA and instantly translate it into DNA because, well, let's be honest, most people are kinda idiots when it comes to things outside their own wheelhouse. Meanwhile, those of us that have had our heads stuck in books about the early days of life on earth and thus have a basic understanding of what mRNA actually is are stuck with a raised eyebrow and a sneakin' suspicion that most folks around them aren't qualified to make their own life de
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It's ridiculous that in Africa health workers are being attacked because some negro has spread the rumor that vaccines are a Western plot to make them infertile.
As far as I'm concerned I wish they'd all starve.
Last but not least: we should've expelled all the freed slaves back to Africa after the Civil War. They weren't U.S. citizens and therefore had no right to stay, even if they were born there.
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Just because your mother serviced hundreds of black men in the alley behind the ditch where she gave birth to you is no reason to be angry and bitter. Or is the problem that all the women in your life are still looking after the sexual needs of the male African American community? Is that what makes you say such ugly things?
Patent rights (Score:4, Interesting)
Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.
So anyone that makes it would be a shoe in to keep doing it at a profit after the pandemic is ‘over’. Good luck to them because mass manufacturing a mRNA vaccine is not something easily done and requires not only specialized equipment but knowledge.
They're legally required to license their IP (Score:4, Informative)
Congresswoman Katie Porter has a good video you can find of her going over where the money pharmaceutical companies get actually goes around 80% of it goes to stock BuyBacks and CEO pay. Of the remaining 20% a large portion of that goes not to developing new drugs but the finding ways to extend patents on Old drugs.
Big pharma is a scam but they've got so much money that good luck getting that message out when they can just buy the airwaves. It's like when the private insurance companies faced real competition in the form of public option and just spent half a trillion dollars scaring the public off from it
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"required to license IP" means you have to buy or otherwise make some sort of deal to use it, until the patent expires. So the WHO normally would have needed to buy it. But they've apparently decided to steal it instead, which on the surface is really strange because, as burtosis quotes, the price is $0. (No doubt they wanted to be able to produce it free forever, or wanted free access to the technology to make other stuff the same way, or some other some future advantage, which is why they're stealing some
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I don't want to outlaw them (Score:3)
But I don't have the political power to do that beca
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So the WHO normally would have needed to buy it. But they've apparently decided to steal it instead, which on the surface is really strange because, as burtosis quotes, the price is $0.
What makes you believe that the WHO is not simply taking up the offer of $0? Getting the patents for free does not magically make it possible to produce the vaccine. You still need the know-how -- which is what the WHO is setting up.
That's Luckyo level foolishness. (Score:1)
Plus the majority of the funding that paid for moderna's vaccine came from the government, the rest of it coming from a private donor.
That's Luckyo level foolishness.
mRNA vacines were being worked on for years before Covid. All they had to do for Covid was pick which proteins to target. Nobody needed government money to do that.
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That's Luckyo level foolishness. mRNA vacines were being worked on for years before Covid. All they had to do for Covid was pick which proteins to target. Nobody needed government money to do that.
It literally took three days to just change the payload.
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It's part of getting a patent.
No, they are not required to license their IP as part of getting a patent. They are required to disclose it - the disclosed parts are what they are getting a patent on, in contrast to trade secrets which are not protected against reverse engineering or reinvention.
Maybe you mixed it up with the normal requirements of licensing if someone wants their patent to be part of a standard?
teg - posting anon to avoid undoing mods
Re: They're legally required to license their IP (Score:2)
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It's part of getting a patent.
It's part of getting a patent.
False [fda.gov]
, it’s not at all true, as explained by the FDA. Further, there is no US government requirement for mandatory licensing during covid. [ipwatchdog.com]
The cynical side of me thinks Moderna said it for PR value because it’s not possible for third world countries or even some of the first world ones to simply start making the vaccine even with funding, it’s a very difficult and specialized type of manufacturing. But the reality is authoritarian greed can extract free
Moderna has a ten year head start on Afrigen (Score:3)
Patent invalidation/unauthorized production (Score:3, Insightful)
I hope this works better than the last great example of patent invalidation/unauthorized production. In 2004, bleeding hearts wanted the patents on AIDS drugs to be invalidated so they could be cheaply produced in India's factories for the poor disadvantaged people of Africa. The heartless President Bush ignored that option and instead made the program PEPFAR where low cost production methods were used to make fully authorized and fully effective AIDS drugs at low cost guaranteed sales. Good thing he did because it turned out that unauthorized 'generics' being produced in India were later found to be "subpotent and adulterated" to quote Scott Gottlieb, who at that time was working for the FDA.
So, the kind hearted people who thought corporate profits shouldn't stand in the way of poor people's health would have caused a explosive health care disaster giving Africans second- or last-class-quality fake medicines and at the same time undercutting the very people who invented them, possibly sabotaging future developments. And the mean and greedy corporate puppets who put profits before people are the ones who actually brought fully effective medicines to the disadvantaged people of Africa without shortcutting around the patent holders.
I think this is a good example of how when you decide to take emotional shortcuts you can really do damage to the very cause you're trying to help. I hope 3-5 years from now when the WHO wonders why pharmaceutical companies are not all buddy-buddy with them, or worse, that the unauthorized vaccines do actual harm, they will have the honesty to look back and realize what a mistake this course of action almost certainly will turn out to be.
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Good thing he did because it turned out that unauthorized 'generics' being produced in India were later found to be "subpotent and adulterated" to quote Scott Gottlieb, who at that time was working for the FDA.
No reason not to try again. If anyone tried to pull that shit in China today they'd have a bullet in the back of their head faster than you can say reverse transcriptase.
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Yup definitely no substandard knockoffs and fakes coming out of China these days. Top quality, that's what China is known for.
Not for pharmaceuticals. What you said is true for cheap, low-value added knock-offs (and the occasional food tampering scandal), but if you claim this is also happening with pharmaceuticals, I think we need to see some citations.
I'm not a fan of many industrial practices in China, but there's no need to make up stuff just because. We can (and should) criticize while being factual.
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Re:Patent invalidation/unauthorized production (Score:4, Informative)
"PEPFAR" is short for (US) President's Emergency Plan for AIDS Relief. In other words, not from WHO, not from CDC, not from congress, it's President Bush's program. (Not to say there weren't a lot of people involved, I'm just talking about the origin is pretty clear from the name alone.)
First paragraph of the wikipedia story on it says that it's provided about $90 billion in funding for HIV/AIDS treatment, saving about 19 million lives.
So are you saying pepfar didn't really help those people, or are you saying that pepfar did it by breaking patents? Any other objection you have is just details, not relevant here for a story about WHO deciding they'd rather break patents and try to make a rogue generic of the Moderna vaccine. And I'm giving it as a great example of of how that approach was almost disastrous. fairly recently.
See https://www.wsj.com/articles/c... [wsj.com] for a story on this exact issue. In fact, there's a great line about why WHO will probably fail: "But this time it isn’t a matter of punching out a bunch of pills, a relatively simple process that still went awry in 2004. Covid vaccines require a complex manufacturing process. Some use difficult-to-secure ingredients and equipment, such as the scarce lipid particle and mixers to make mRNA vaccines such as the one produced by Pfizer."
ps Dr Gottleib was commissioner of the FDA 2017-2019. Might know a little bit more about PEPFAR than netflix.
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Only fly-by-night manufacturers were willing to copy a patent-protected vaccine. If the patent holder had been forced to license at close to zero cost, reputable manufacturers would have stepped up and the copies would not be subpotent or adulterated.
Supposed to trade "monopoly" for "secrets"... (Score:2)
"It's written very carefully and cleverly to not disclose absolutely everything,"
Doesn't that defeat the whole point of granting a patent in the first place, where the whole reason to grant the temporary monopoly is to get people to publicly reveal the trade secrets rather than keep them secret? Sounds like they didn't hold up their part of the deal, and maybe the patent should be invalidated.
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They're patenting the idea they want to patent, without disclosing things they probably consider trade secrets.
Sorta like if Tesla patents their new Lithium-whatever battery, but doesn't describe the secret process they use to maintain quality control, or put the materials together, or the sequence they do the assembly, in order to build the patented battery or whatever it might be about.
In fact, you can't patent a 'recipe' / 'business process' to do something. (actually that's what was so bad about the 200
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In fact, you can [ipwatchdog.com] / can. [uspto.gov]
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"It's written very carefully and cleverly to not disclose absolutely everything,"
Doesn't that defeat the whole point of granting a patent in the first place, where the whole reason to grant the temporary monopoly is to get people to publicly reveal the trade secrets rather than keep them secret? Sounds like they didn't hold up their part of the deal, and maybe the patent should be invalidated.
It's not "cleverly written to not disclose everything". It's simply that this stuff is HARD, and it's impossible to perfectly document everything. When other pharma companies produce the vaccine for example for Astra Zeneca under a licence (what? you thought only AZ produces the vaccine they developed?), they don't get shipped a crate of paper describing the process, and get told to get cracking, people from AZ actually come there and set everything up. That includes bringing in custom hardware which will h
Patents that are hard to reproduce are evil (Score:4, Insightful)
The deal used to be you describe exactly how it is done and in exchange you get protection for a while. A patent that does not match this should be automatically invalid and the ideas described should become impossible to protect again. People that write and endorse patents that try to hide things are stealing from society.
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And why do you think I am talking about current US legislation when I say "originally"?
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No, that was never 'the deal'. Show me a single patent (from any point in time) that does that. There are zero patents that describe not only the invention, but exactly what tooling, manufacturing processes, etc are required to make it. None.
The actual requirement is that the patent provide enough detail that someone 'skilled in the art' can create the thing, not that any old schmo can create the thing. Look at any old patent for a machine. A lot of them used cams,etc. Do any of those patents show how t
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You are mistaken about what "skilled in the art" means. It actually means an average expert, not somebody that could have done the research themselves.
The cutting-edge technology behind mRNA vaccines (Score:1)
Look it's a Luckyo link (Score:1)
Why would they need to hire a company to figure out how to make an mRNA vaccine. Since the basic research was 100% [modernatx.com] funded by the Federal government.
The basic research was done in the years prior to covid even existing you moron.
The money given was for speeding up testing and building manufacturing capacity. Not the basic research...
Yet more proof the patent system is broken (Score:3)
A patent is supposed to disclose all that's needed for someone "skilled in the art" to reproduce the invention.
skilled in the art of mRNA vaccines is common? (Score:1)
Heh yeah but apparently only pfizer is also 'skilled in the art'. Random clown company in South Africa, not so much. Hence the reason the contract seems to be for a lot of investigation, not just straight up production.
Re: Yet more proof the patent system is broken (Score:2)
I give up, who? (Score:1)
And you left out the question mark at the end of the title.
That makes the patent invalid (Score:2)
If a person of the industry cannot reproduce the item following the step in the patent then it is invalid and should be rejected. Patent protect you if you DISCLOSE fully how to repro
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They will have their vaccines in 2.5 years... (Score:4, Interesting)
Instead of what they may be thinking this course of action will not lead to an increase in the number of vaccines but a decrease. I was recently informed by a Pfizer employee on how their vaccines are assembled (roughly of course, not in detail). Pfizer needs at least 3 highly specialized factories for that, one creating the mRNA, one creating the lipid particles and a third handling the assembly. Even for Pfizer, this is a difficult product to make and it is very unlikely that it can be replicated without Pfizer's help on a short term. The estimated time to start something like that up from scratch is around 2.5 years.If you have the right people. I think the same will be true for the Moderna vaccine.
As moves are being made towards suspending the underlying patents, at least at Pfizer, the willingness to help out seems to decrease. And who can blame them. We are talking about 20 bucks for a shot. That is not overly expensive, even for so called 'poor' countries. Deduct production costs and research costs (that have been huge since the mRNA development underlying this vaccine has been ongoing for many years) and I think to complain about that prices is ludricous. Even Pfizer and Moderna need to make money.
I guess if they push it too far, these companies may say: "Ok, then do it yourselves and see where how far you can come", and turn away. Good luck with that!
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As moves are being made towards suspending the underlying patents, at least at Pfizer, the willingness to help out seems to decrease.
That does not really matter, as willingness is close to 0% already.
Pfizer and Moderna have contributed practically nothing to vaccinations outside the Western world, and there is no sign that they will ever be able to supply the billions of vaccine doses needed.
If it takes 3 years to develop a Moderna clone that is allowed to be mass produced, it will still be worth it, because Moderna and Pfizer cannot deliver the required quantity in 3 years.