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This is an antibody, not a vaccine. It's for treating a single infection, not for conferring immunity.

how likely is it that this leads to some type of universal vaccine?

Not saying it's impossible, but I've never heard of it happening in that direction[0]. The immune system uses natural selection to randomly generate and amplify successful antibodies. It seems that the likelihood of generating exactly that antibody in the immunization process is astronomically low.

[0] unless the lab-gnerated antibody is "seeing" a different part of the virus that the current vaccine doesn't see, in which case targeting the new spot in the virus is an obvious "next move".

I admittedly have no idea how it works, what the differences are but the article infers that the tech developed here can be used for vaccines. From the article:

“If it does,” he added, “it might provide a new therapeutic and also contribute to new vaccine strategies.”

Maybe you know, is this just for therapeutics and not vaccines?

Edit: looks like someone else answered this below....

Feel free to correct me if I'm wrong here but what I took away from all of the papers on the MRNA vaccines is that they were designed to tell cells to build a protein (spike protein) that would stimulate the immune system to create an antibody that recognized said protein and it was those antibodies that made it harder to become infected with SARS-COVID-2.

One of the papers I read compared and contrasted the antibody that Pfizer used in their development vs the one that Moderna used in their development, with the conclusion that the Moderna "provoked" antibody was slightly more effective at preventing an infection from taking hold.

And based on that understanding (which may be flawed, please let me know if it is) then having a better 'target' antibody that you are trying to provoke the immune system to create, would make an MRNA vaccine more effective.

> a lifetime perpetual non-exclusive right to use and re-license said patent on what ever terms they deem acceptable.

Probably the biggest immediate positive impact would be automatically securing the rights to produce and distribute the patented good in developing nations. BigCo isn’t making much money there anyway.

Economy of scale. You make little from a large population. Or you can go Nestle level evil and straight out exploit the most in need [1]. Plenty of ways for BigCo to make money of developing nations.

[1] https://en.wikibooks.org/wiki/Professionalism/The_Nestlé_Inf...

Agree. See also: Suez Environnement

> Plenty of ways for BigCo to make money of developing nations.

Making some money sure, but developing nations are not great consumer markets and BigCo isn’t making a big chunk of its profit there. It ought to be possible for BigCo to be made to accept the loss of a market they probably would neglect anyway (especially pharma) in exchange for R&D funding to give legal clearance for other organizations to serve those populations.

You wrote: <<automatically securing the rights to produce and distribute the patented good in developing nations>>.

Real question for you and others: Where do we draw the line? That is an enormously complex question!

I have an equivalent to discuss: During the COVID-19 crisis, I was bothered that the South Africa gov't was pushing so hard to get access to produce vaccines locally without paying patent licensing costs. (Without very advanced pharma manuf facils, it would be useless. Many people under estimate the complexity of producing these new mRNA vaccines, let alone distributing them safely and correctly.) South Africa is, by many measures, a middle income economy. They could absolutely affort 10-20 USD per citizen to vaccinate their population -- not so different than what EU paid for vaccines. Please do not interpret this post as "dumping on SA"!. I just want to discuss a very specific example.

Related: The Serum Institute of India (which I think is the world's largest producer by vaccine doses) eventually secured a licenses to produce and sell vaccines. (Wiki tells me three were licensed [very impressive!]: AstraZeneca/Oxford, Novavax, and Russia's Gamaleya Sputnik V.) Does anyone know the details of SI's licensing agreements?

Alternatively, why don't researchers just take investment in place of grants?

Why not get both, I suppose..

Because that is a sign of bias in research

That hasnt bothered modern researchers

If their research is of something that is attractive to investors, no doubt they will. Grants are often used to fund research that does not attract investment for whatever reason.

Why would Pfizer drop a few billion on getting the vaccine to market if the funders would then relicense it?

Because they could make more than $XB by selling it afterwards?

Also, who's to say that Pfizer can't make an additional deal, or funding, for this effort?

How? What’s the incentive for Pfizer to fund development if they don’t get exclusivity?

Governments should not just fund drug and vaccine research. They should employ most of the researchers and own most of the labs. Problem solved. Give a hundred billion to vaccine research and then release it to the public with a mandated price - job complete.

What about development?

Basically I’m saying they should make a finished solution but leave distribution and full scale manufacturing to private industry. Not because private will do that part better, but because at that point there’s not much need to use taxes to finish the job. What drug manufacturer wouldn’t want the contract to exclusively sell an already developed product? All they need to do is follow FDA regulations and pricing.

“Making a finished solution” is the really, really expensive part. How does the government allocate limited resources in your model?

Either development is the tricky part, in which case it would be irrelevant if the formula is public, since another company won't be able to compete just by knowing the formula, they also have to fund development of their own; or the basic research is the problem, in which case development is a minor expense and should be covered by the sales.

Either way, making the results of research that has already been funded by charities, the state etc public should be mandatory, and would still leave these companies with plenty of profits.

Development is everything that goes into putting an application together for the FDA, as well as getting facilities together for their inspectors. It is indeed irrelevant if the “formula” is public. Every company needs to put together an application of some kind to make marketing claims. There are many kinds of applications.

> would still leave these companies with plenty of profits.

Development is undertaken with risk capital. “Plenty of profits” is not the bar; the returns must exceed those found elsewhere for the same level of risk. Otherwise new drugs are simply not developed.

Again, we are talking in circles.

The thread was about "why would Pfizer pay for R&D if the vaccine/antibody could then simply be relincesed".

And the answer is: because they can sell the vaccine for more money than it costs to research a new one.

If they have to pay extra to develop, then they still have a huge moat. Even if Moderna or J&J is also licensed to produce the same vaccine, Moderna will also have to pay the same cost before they can have a product, so no change in incentives compared to today.

This whole "but then who pays for development" is a red herring you've thrown in.

And in general, the bottom line is this: if a piece of research, be it basic research or clinical trials or anything else is mainly funded from public money, then it should belong to the public, not to the corporation that was payed to execute the study. The corporation has already gotten paid for the R&D in this scenario, so it's fair for the public to license that R&D to other corps as well, and allow all corps to compete on price of the finished good. If this research stops at the molecule, then let various corps compete on turning the same molecule into a finished product, and let them patent the finished drug, but not the molecule itself.

In small molecule the second player can just copy. With vaccines this is harder but a lot of the risk is already gone. Development encompases everything from tox, to dosing, and there is much risk at every step of the procees. For small molecule the lead is going to get massive amounts of small variations made and tested to try to find the one that works: that's not coming from the research that lead to a paper with a hit.

What's a good reference for this? I see it said a lot but are there a few good case studies around to explain it out?

The point here is precisely that development has been funded by those charitable institutions and public entities listed.

> Governments should not just fund drug and vaccine research. They should employ most of the researchers and own most of the labs. Problem solved. Give a hundred billion to vaccine research and then release it to the public with a mandated price - job complete.

That seems... a spectacularly naïve idea.

Governments could have done this for fifty years, but by and large they don't, because governments are generally capricious and short termist, and don't value R&D.

Heck, the UK government just sold off it's vaccine development centre even after Covid happened. https://researchprofessionalnews.com/rr-news-uk-innovation-2...

Actually governments used to do this. Universities being free and all. Yes companies can sell and distribute the products, but the government/universities retain the IP/patents.

One of the most interesting ideas I saw during the COVID-19 crisis about the balance of pharam research and distribution of new vaccines: What if the gov't guaranteed a price-per-vaccine and number of vaccines to be purchased if a new vaccine could be created? This is basically the scheme of Operation Warp Speed. The US gov't dumped tons of money into a few great ideas, then guaranteed to buy if they were approved by FDA. It stimulated massive parallel investment and created a few new vaccines in the shortest time in human history.

They acquire the rights i don't think they fund much.

Why these diseases are serious enough to lock us all in our fucking homes but yet rampant profiteering is allowed is a travesty. The entire state and industry hand in hand, defacto fascism.

Here’s their pipeline snapshot [1]. Pfizer’s 12-month R&D spend was $14.712 billion at last reporting.

[1]: https://www.pfizer.com/science/drug-product-pipeline

You can't sell something without exclusivity now?

Who funds development? You can’t sell a product that does not exist.

You're going in circles. We were discussing a vaccine that was discovered with most funding coming from charities (B&M Gates foundation) or the state (NIH), and some by Pfizer. But, Pfizer gets to keep 100% of the results of this research.

Now, if by "development" you mean the cost of mass manufacturing and marketing the substance, then every company that wants to manufacture it can find their own, which will be payed for by, you know, sales.

Development means clinical testing, preparation and submission of applications for FDA approval, as well as design of production processes for new drugs.

Here’s an accessible overview from the CBO: https://www.cbo.gov/publication/57126

How is this relevant to the topic at hand, of licensing the base molecule (not the finished drug) to multiple companies?

You can't come close to recouping development costs if Joe Blow down the street can copy it and charge cost-of-goods plus 10%.

Why would RedHat develop Linux when Debian gives it away for free?

Debian doesn't have to spend a billion bucks to convince Uncle Sam to let you download it.

It's funny about that. I listened to an interview with Bourla where he said both that they need the patents for a return on investment/protect their IP and that it would take over a year for a competitor to scale up and release the product after they have released it so it's tricky.

Cake and eat it.

I've always been confused about the arbitrary lengths of patents. Surely for something like this, six months or a year is fine? Enough time to get to market and make a considerable size of buck, but brief enough that a much needed thing that is subsidised by public money can be used as widely as possible. (Remember, philanthropic funds are often treated favourably for tax, so are, in a way, also public-ish money)

On the other hand, you may have invented a novel type of hammock which is neat but has no social function, so, by all means have a quarter of a century of monopoly on that.

Actually patents themselves don't have arbitrary length. They are 20 years and then done[1]. That said, there are patents on refinements or add-ons that come later, and so sometimes the patent expires but it has been replaced by a new way that is even better.

There is a scheme in the pharmacy market for shifting patents to prevent generics from being produced, that scheme would be outlawed if we had the right mix of legislators in Congress (basically fewer people who are dependent on these pharmaceutical companies for campaign funds and PAC support). But the original patents do expire, the trick is convince folks that they don't do what they do as well as the new thing does what it does.See here[2] if you want the boring details.

[1] I've got a bit over a dozen patents that arose out of work I've done for others and ended up becoming very familiar with them, even get the occasional expert witness work when trolls need to be disabused.

[2] https://www.upcounsel.com/patents-in-pharmaceuticals

The problem starts with the time between patent award and regulatory approval limiting the commercial exclusivity. This has driven big pharma to patent manufacturing processes instead of the compounds. If I understand it correctly from memory the Ritalin availability crisis was a example of process patent reengineering.

Edit: was not is.

There is a system called supplementary protection certificates (SPCs) that gives an extension you the monopoly period to account for regulatory approval periods.

https://en.wikipedia.org/wiki/Supplementary_protection_certi... (I haven't checked this link).

Drug patents have 20 years from the time of invention, but getting FDA approval takes 10 years after invention so that really only leaves you with a 10 year monopoly.

I think people are under the impression that the government is giving like 75% of the funding for drug development. It’s more like 1%. Getting FDA approval is a very arduous and expensive process. If you want to build an insulin factory, you’re looking at 8-10 years and $100 million to prove to the government that your insulin is safe to use. [1] That’s just for making generic insulin. Developing a new drug from scratch and getting it approved is orders of magnitude harder. A 6 month monopoly wouldn’t be close enough to recoup your costs.

[1]: https://www.healthaffairs.org/do/10.1377/forefront.20190405....

I think it would make a lot of sense if "any patents arising from research done with monies given by <x> will confer on <x> a lifetime perpetual non-exclusive right to use and re-license said patent on what ever terms they deem acceptable."

If this were implemented, wouldn't it just be the case that no one would take your money?

Perhaps, I haven't been personally involved in a university lab looking for grant money so I don't know if they would turn down a grant if it required that any patentable work be also licensed to the grantor organization.

And to be clear, I don't expect this situation to change any time soon. Just annoyed by it.

Perhaps it would be worthwhile to understand the system you're criticizing a bit better before moving ahead and criticizing it

Perhaps.

If you feel you have an understanding of the system I'm criticizing, why not help me understand why it has to be this way? I get it if you don't have the time or inclination to do so, but surprisingly I'm actually really open to learning new things and it would be appreciated not only by me but by other people reading your comments if you could explain the current system, perhaps other systems that have been tried and failed, and perhaps compare it with other systems (if they exist) that don't do it this way (giving the IP to the university even though it might be considered, by some less knowledgeable people, to be a 'work for hire.' Where it would seem that the agencies providing grants are doing the hiring.

Always ready to listen an learn new things.

well I don't really understand the system either, but there were multiple organizations making grants, so if you granted rights to all of them what rights would be left for you - that seems problematic. Also I suppose it was an expensive thing to do so they needed to get grants from multiple places, it seems like any recommendation to change this would be liable to have all sorts of side effects and, in the short term at least (5-10 years) likely to make the system function worse than it is now.

Perhaps there is some negotiation already going on for grant moneys, I would expect so if any grants were sizable, I mean if I am giving you a million dollars to study something I might say before hand these are my requirements and you would probably say yes or no, but maybe some grants were much less in size and involved things like use of facilities. In those cases it would be much more likely to change your value estimation of the grant and maybe refuse because not worth it, but if not worth it less stuff gets made and at some point we are the things working worse than before because some researchers would be like screw this academic career I can just go be a quant somewhere.

I mean as I understand it being a scientist is not exactly really rewarding https://www.zippia.com/scientist-jobs/salary/ so I would probably not want to do anything that made it potentially less (financially) rewarding because while people also do things for the good of humanity and so forth at some point when you're eating your Top Ramen with your disgusting room-mates maybe you might be tempted to change your life course for something with increased comfort.

I took an undergraduate course on the economics of science and technology. A large portion of it was devoted to patents.

The problem is generally that public funding accounts for extremely small amounts of the funding that it requires to take a drug to market. I didn't lookup any numbers for this, but I would guess it's very rarely above 1%.

The government could try to claim some share of the profits from drugs derived from research that was partially grant funded, but that seems logistically very difficult and not worth it. The government already gets a share through various taxes anyways.

The purpose of public research is to encourage innovation, which in turn benefits everyone. Private companies usually have no incentive to make any of their research public which can lead to many places repeating the same things.

Yeah. This is the only system ever found that reliably turns out 30–40 new drugs a year. Others like USSR’s and Japan’s didn’t.

How many of those are any good and not snake-oil crap?

The FDA publishes withdrawal notices in the Federal Register [1]. The withdrawal rate for reasons of effectiveness is something like ~1/yr.

[1]: https://www.federalregister.gov/agencies/food-and-drug-admin...

Withdrawal notices are only related to active harm and not efficacy AFAIK

We could have many compounds out there that don't do anything for their intended target but aren't actively harmful

I apologize if my statement was unclear. I'm not claiming to understand the system any better than you.

The type of comment that you left is a pattern I have been noticing where someone will state that they don't understand something and then proceed to criticize it.

This does not make sense to me, as I don't understand how someone can assume they have legitimate criticisms of a system without first asking clarifying questions to improve their understanding.

That's fair and I appreciate the feedback. FWIW, I suspect we think about the phrase 'legitimate criticism' a bit differently, I was trying to be pretty clear that my criticism, such as it was, was based on the existing system annoying me. For me, anyone who tells me about a system that annoys them I consider it a legitimate criticism in part because I think it is legitimate for anyone to criticize any system that annoys them for any reason. I may not agree with it, and the system may not annoy me, or I may sympathize but realize it is unavoidable, but it is still okay for them to criticize it.

That actually is a requirement with many DoD grants, in my experience. In general, such a clause would have to get additional approval from lawyers/grant admins at the university.

You realize it take tens, if not hundreds, of millions of dollars to get from this stage to an actual product and the chances of failure are 90%+?

And you're mad because when the government funded 0.01% of the total cost of development you can't get it for free?

The government (or other non-profit entities) funded significantly more than 0.01% in this case. You’re not wrong that there’s still a ton of money required to get from “this works in a lab” to “this is something available at your local pharmacy”, but it’s not 4 orders of magnitude more…

That’s also discounting the fact that they aren’t paying for all the projects that don’t make it to the “works in a lab” stage. That a significant chunk of risk that they aren’t exposed to.

It most certainly is several orders of magnitude.

You can just look at the budget of the NIH versus private and corporate investment in drug development. What the government spends is a fraction of what private companies invest.

To get a drug approved you're looking at $5k-$15k/person/year in a Phase 3 trial (depending on the monitoring needed). You can call up an CRO and ask for a quote. I did this several jobs ago.

Just to give you a sense, the Pfizer Covid-19 vaccine was 47,000 patients [1]. These patients were followed for 2 years. For a rough estimate, that's $5,000 x 47,000 x 2 years = $470M.

Half a billion dollars, just for one clinical trial.

That's already 3 orders of magnitude larger than a typical $500,000 grant for basic lab research like this paper.

And that's just the clinical trials. It doesn't include the trials leading up to the pivotal trial, the manufacturing development costs, the health authority submissions costs across 130 countries, etc. Then add on top the cost to make the actual drug and put it in a vial and ship it around the world.

And sure, "they aren’t paying for all the projects that don’t make it to the “works in a lab” stage". But conversely, the government never bears the risk for later development that fails. I remember Pfizer a couple decades ago spent $1B on a new manufacturing plant for a drug that never got approved.

[1]https://www.pfizer.com/science/coronavirus/vaccine/about-our...

More even, billions+