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Medicine

WHO Asks South African Startup To Replicate Moderna's mRNA Vaccine 63

Posted by BeauHD from the cracking-the-code dept.
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."
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WHO Asks South African Startup To Replicate Moderna's mRNA Vaccine More

WHO Asks South African Startup To Replicate Moderna's mRNA Vaccine

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  • Patent rights (Score:4, Interesting)

    by burtosis ( 1124179 ) on Wednesday October 20, 2021 @07:36PM (#61912023)
    Moderna said a year ago that it would waive any licensing [modernatx.com] during the pandemic.

    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)

      by rsilvergun ( 571051 ) on Wednesday October 20, 2021 @08:27PM (#61912133)
      It's part of getting a patent. 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.

      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

      • "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

        • It does seem pretty weird, they're paying a company to copy/reverse-engineer a patented technology, which they could get for free and even if Moderna wouldn't give it to them could quite reasonalby get under the Doha Declaration. There must be more to it than this because what's there now doesn't make any sense.
          • If they just seize the technology United States will come down on them like a ton of bricks. We don't talk about it much but we very much hide the iron fist behind the velvet glove and we are very much a military empire.
        • Because criminalization generally solves nothing (outside of petty crime and violence, and even then with the host of asterises). I would happily put them out of business by shifting the funding that they get from the government to direct payments to the university system of research with a stipulation that the researchers don't get to take their work with them if they leave (have they often do forming companies using the work my tax dollars paid for).

          But I don't have the political power to do that beca

        • Re: (Score:2)

          by amorsen ( 7485 )

          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)

        by Anonymous Coward

        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.

        • 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.

      • Re: (Score:1)

        by Anonymous Coward

        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

      • 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)

    by tekram ( 8023518 ) on Wednesday October 20, 2021 @08:48PM (#61912165)
    Well, it won't be easy, but it is doable. Moderna had already by 2010 founded a company ready to do clinical trials on liposome packaged mRNA vaccine. But the idea of packaging mRNA goes back at least 20 year before that and thousands of researchers, if not tens of thousands have worked in this area. Afrigen should reach out to those researchers and ask for their help. I won't be surprised if some of them are very willing to volunteer their time.

  • Patent invalidation/unauthorized production (Score:3, Insightful)

    by bookwormT3 ( 8067412 ) on Wednesday October 20, 2021 @08:52PM (#61912169)

    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.

    • Re: (Score:1)

      by Anonymous Coward

      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.

      • Yup definitely no substandard knockoffs and fakes coming out of China these days. Top quality, that's what China is known for.

        • 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.

    • Re: (Score:3, Interesting)

      by senileoldfart ( 1146807 )
      You folks certainly know how to spin this story. "Fire in the Blood" free on NETFLIX https://www.netflix.com/title/... [netflix.com]

      • Re:Patent invalidation/unauthorized production (Score:4, Informative)

        by bookwormT3 ( 8067412 ) on Thursday October 21, 2021 @03:06AM (#61912781)

        "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.

    • Re: (Score:2)

      by amorsen ( 7485 )

      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.

  • "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.

    • 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

      • Re: (Score:2)

        by jbengt ( 874751 )

        In fact, you can't patent a 'recipe' / 'business process' to do something.

        In fact, you can [ipwatchdog.com] / can. [uspto.gov]

    • "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)

    by gweihir ( 88907 ) on Wednesday October 20, 2021 @09:49PM (#61912315)

    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.

    • Re: (Score:2)

      by bws111 ( 1216812 )

      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

      • Re: (Score:2)

        by gweihir ( 88907 )

        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.

  • 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.

    • Look it's a Luckyo link (Score:1)

      by Anonymous Coward
      Look it's a Luckyo link. It doesn't say what you're claiming it says.

      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...

  • A patent is supposed to disclose all that's needed for someone "skilled in the art" to reproduce the invention.

  • And you left out the question mark at the end of the title.

  • "It's written very carefully and cleverly to not disclose absolutely everything""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"

    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

    • A person of *what* industry? Just how generic should we consider 'skilled in the art'... I guess you're arguing someone skilled in making completely different vaccines is skilled in the art of mRNA vaccines... what about drugs in general. I know enough chemistry to synthesize simple drugs, should their patent be complete enough I could make it?

  • They will have their vaccines in 2.5 years... (Score:4, Interesting)

    by Delgul ( 515042 ) <gerard@onlinespam f i lter.nl> on Thursday October 21, 2021 @06:22AM (#61913059) Homepage

    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!

    • Re: (Score:3)

      by amorsen ( 7485 )

      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.

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