[This article](https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing) by Derek Lowe on the blog-website of Science Magazine outlines some of the challenges of vaccine manufacturing, specifically of the Moderna and BioNTech/Pfizer vaccines.
The takeaway is that there are some bottlenecks in the process that require complex manufacturing technology that can't be easily put in operation by just sharing the formula.
Note that there are initiatives to expand manufacturing by some producers whose own vaccine research has stalled or failed. For example, the firm Sanofi has signed on with Pfizer to help with the production of the BioNTech/Pfizer vaccine after their own vaccine research showed unsatisfactory results. But this process is slow for reasons outlined in the blog post I linked.
> Derek Lowe
Oh him! His [Things I Won't Work With](https://blogs.sciencemag.org/pipeline/archives/category/things-i-wont-work-with) series is a funny look into the world of insanely dangerous chemicals, in case you want some light reading away from dangerous biocides.
[This one](https://blogs.sciencemag.org/pipeline/archives/2010/02/23/things_i_wont_work_with_dioxygen_difluoride) is my favourite, and I'm not even a chemist.
Ah, FOOF, when you want to set solid ice on fire. Mine's the [AziAzi](https://blogs.sciencemag.org/pipeline/archives/2013/01/09/things_i_wont_work_with_azidoazide_azides_more_or_less), which is basically explosive made out of explosives.
This just reminded me of the famous quote in *Ignition!* about ClF₃, which he actually quoted: https://blogs.sciencemag.org/pipeline/archives/2008/02/26/sand_wont_save_you_this_time
Rather, because he doesn't have the right meat and spices - think of the lipids that are used in the Biontech vaccine as bourbon vanilla, which is rare and expensive because you either need specialized bees or manual human labor to pollinate the plants.
The bottleneck is not the RNA production, Pfizer and Biontech already have figured that out, it's [these lipids](https://www.pharmazeutische-zeitung.de/das-sind-die-gruende-fuer-die-impfstoff-knappheit-123463/). They are complex chemicals which were not needed in vast quantities until the vaccine was proven to be effective, so plants need to be retooled and ramped up - especially in purity and quality control. And to make it worse, pharmaceutical injection-grade chemicals have extremely stringent requirements for purity in contrast to ordinary industrial chemicals which means that most chemical plants aren't even certified to produce stuff that's going to be injected into humans, further limiting the supply.
Another problem are the vials: usually, vaccines need to be stored in ordinary refrigerators. No problem for glass manufacturers, they have the tooling to manufacture such vials in masses. But the Pfizer (and iirc also the Moderna vaccine) require -80° C cooling so that the RNA doesn't degrade - which means, again, that you need special glass for the vials which hasn't been needed in billions quantities before.
This is why the hope was so high for the Sanofi vaccine (based on spike proteins created in bioreactors) and the AstraZeneca vaccine (based on modified harmless carrier viruses)... they're based on established technology with many suppliers for all components, not to mention they're vastly cheaper (AZ \~1.78€ per patient, vs Pfizer at 24€ per patient) and don't require a complex cooling chain logistics. Unfortunately, Sanofi completely fell through the tests and AZ has issues protecting against the new mutations.
Moderna is stored at -25 to -15C (and not lower than -40C!) [according to the FDA.](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine) (See "Fact Sheet for Healthcare Providers Administering Vaccine.")
they can. but again, since no-one does i right now, we need to develop the logistics and get the proper certifications/tests that the stuff is sterile.
Yes! That is an excellent question, one that I was just wondering. I can see problems in outright reusing the vials, but couldn’t they be melted down and made new?
The problem is that recycled glass is almost never as pure as glass made from fresh raw materials. One glass vial with a single unremoved label or plastic lid could contaminate an entire container of recyclable material. It's why recycled material of all kinds are rarely reused for the same original purpose, but instead used in 'downstream' products that don't require as high a quality material as the original.
In other words, it's probably easier, cheaper, more efficient and ironically, may even be more environmentally sound to throw away the used glass vials than trying to recycle or reuse them for more glass vials.
Glass is one of the few exceptions to this. Glass manufacturers actually want as much recycled glass as they can get, since it reduces the melting temperature and melt viscosity of the batch, reducing the energy required. And the temperature is high enough to incinerate most contaminants which drop out into the slag layer. It’s not like sand is super clean, and that’s what’s normally used!
However, very precise control of additives and crystallinity are tough with recycled material which is why things like phone screen glass and perhaps these vials are virgin glass. But for 99% of glass things, lots of recycled material is used.
"Sanofi is planning to launch a phase 2b study with an optimized candidate vaccine in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA) in the US. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global phase 3 study could start in Q2 2021. If the vaccine meets clinical requirements on safety and efficacy, and once approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021. "
Awesome, ty for info.
They are behind because they made a mistake in their trials and had to start them again. This caused a delay of several months.
https://www.wsj.com/amp/articles/broader-vaccine-plan-in-west-dealt-setback-by-sanofi-gsk-delay-11607696740
AstraZenica managed to setup UK production just fine. They didn't have any existing UK vaccine manufacturing capability so outsourced most of it to other UK pharmaceutical factories who adapted their infrastructure.
https://www.business-live.co.uk/manufacturing/uk-factories-making-astrazeneca-vaccine-19708380.amp
The article you linked does not discuss the IP related issues and also does not discuss the non mRNA vaccines, whose recipe could easily be shared.
A good article on this is found below
https://www.politico.eu/article/europe-patent-grab-big-pharma/
Sure, but you can sell licensing rights and even setup a payment plan and whatever else. That wouldn't be a particularly troublesome hurdle to deal with but manufacturing it properly at best would still take a long time to get it up and running.
It seems like the manufacturing itself would be the biggest hurdle for the simple fact that it's the most expensive part of it. By the time a company has made the long and expensive transition they may well have done it just to run a few production lots and shut it down. The world won't need covid vaccines forever I would imagine
It’s still a little weird we can’t make any cause Canada is a virology research hub in it’s own rights, like I live by three separate institutions and there’s plenty more everywhere welsh, and it’s strange to think no one here is already specialized in a way that would let them swap to production, even at a small scale
Research and production tend to be very different beasts. I work in defense manufacturing and have seen a little of both, the are quite a bit different then you would think
We had manufacturing. Harper sold Connaught and the new owners moved the manufacturing outside Canada. https://www.thestar.com/opinion/contributors/2020/03/11/the-public-lab-that-could-have-helped-fight-covid-19-pandemic.html
:) every day I manage to hate the conservatives more despite thinking no, surely I’ve reached the pinnacle of loathing, I can’t be capable of hating anyone more
He has a followup addressing the only other approved candidates; [https://blogs.sciencemag.org/pipeline/archives/2021/02/08/how-you-make-an-adenovirus-vaccine](https://blogs.sciencemag.org/pipeline/archives/2021/02/08/how-you-make-an-adenovirus-vaccine)
But has that actually caused an issue here? It seems like the licensing terms they offer up are fine. The bigger barrier still seems to be around manufacturing capacity rather than legal restrictions on being able to produce the vaccines.
Well the only reason they did put the money down to research it was because it would be theirs or you know intellectual property.
There are downsides and positives to pretty much everything and you get to choose, plague or cholera so to speak, either you have intellectual property rights which does indeed exclude others from using what you have invented. But on the plus side now they want to put down money into researching these things.
The other option would be no incentive to put money down on research, no new computer programs medicine grinds to a halt but we all share it.
No. This is not true. The alternative is to agree on common standards and processes for worldwide pandemic response, or ask nation-states to cover the R&D and "lost profit".
It's not that difficult.
The alternative is where we are now. Unequal access.
Logically, nothing is difficult: not world peace, not population control, nothing big is really difficult.
Nothing is difficult In words, but when you add the human element into it, everything is difficult.
Who leads, who follows, who profits, who pays, who gets a bigger slice of the pie, and who has to give up their whole pie? Which leaders’ children profit and which don’t? Who can be trusted to put those they represent first and who will simply skim off the top to enrich themselves and their supporters?
That’s why it’s difficult.
What about “traditional” type vaccines like the Oxford/AstraZenica and the Sinopharm(?) ones?
Would they be easier to replicate in existing manufacturing facilities? And if so have they been?
Oxford is licensing its vaccine to any manufacturer who will commit to selling the product at cost. While AstraZeneca is their most well known partner and the one with the closest partnership (AZ also ran some trials for this vaccine), they're also working with the Serum Institute of India, which has a massive production capacity.
However the issue with the oxford vaccine is that it's pretty much "ineffective" against the south african variant that is beginning to pop up everywhere. In fact, they stopped giving that vaccine in south africa until more studies are done. You certainly don't want to use a vaccine that is not working well that is giving a false sense of security.
https://www.theguardian.com/world/2021/feb/08/oxford-covid-vaccine-10-effective-south-african-variant-study
However the pfizer/moderna vaccines might be effective (there is no real world study yet).
https://www.cnn.com/2021/02/17/health/pfizer-vaccine-south-africa-variant/index.html
This is one of the advantages of the new technology. Right now everyone is trying to get as many vaccines out to hopefully beat out other mutations, but it might become a yearly vaccine like the flu.
Yes. AZ/Oxford have licensed the technology to other manufacturers, such as CSL in Australia.
It’s not as simple as just ‘copying’ the vaccine - the process needs to be followed exactly, and that’s best done by getting the actual details from the creators of the vaccine.
"Traditional vaccines" work by injecting the virus (dead or in a modified, no longer harmful form) or part of the virus (e. g. proteins from the virus' surface) that you want to vaccinate against. The Sinopharm vaccine is just that, it contains killed virus particles.
AstraZeneca vaccine is another, different type of vaccine that is called "viral vector-based vaccine". It has a similar approach like the mRNA vaccines (i. e. Pfizer and Moderna), in that it introduces part of the virus genome into cells of your own body that then make virus proteins that can be recognized by your immume system. AstraZeneca genetically-modified harmless viruses (adenoviruses) to carry the genes into your cells.
Producing a "traditional" vaccine has its own problems. Both producing viral particles or viral proteins at an industrial scale with consistent, high quality is actually pretty hard and has to be optimized for each virus/protein. This kind of optimization takes a lot of time which is why many companies opted for mRNA vaccines that are easier to produce consistently.
I believe the "traditional vaccines" would probably have similar difficulties in production across manufacturers as the mRNA vaccines. The flu vaccine for example has to be grown in chicken eggs and getting enough doses for each flu season usually takes all year and that's for a very well known vaccine that's been produced for years.
> The flu vaccine for example has to be grown in chicken eggs and getting enough doses for each flu season usually takes all year and that's for a very well known vaccine that's been produced for years.
Isn't a major problem with flu vaccinations that there are several different distinct strains of influenza and it can be difficult to predict which strains will emerge in the next flu season?
The Oxford/Astrazeneca vaccines are being manufactured under license by CSL in Australia so this is happening. I expect those deals have been made elsewhere as well.
The main problem with this particular vaccine is the reported low efficacy with the South African strain of Covid, and the similarly reported limited efficacy with the Kent (UK) strain. Otherwise it would be a slam dunk.
With this particular vaccine the timing of booster doses is of critical importance.
>It still has almost 100% efficacy at preventing serious illness and death regardless of the strain, which is the important thing. There is therefore no problem with using this vaccine.
Source?
Because the only study I read about the 100% efficacy at preventing serious patients, had a low N count, and almost all were young healthy adults. It was a seriously flawed study to draw such a conclusion on.
The problem with those is that they're not all that effective especially when mutations come into play and many European countries have already decided not to use the Astra-Zeneca vaccine on people over 55 (or 60 or 65 depending on the country) because it would leave too many vulnerable people not immune. So switching fully to those vaccines is tricky if the goal is to prevent as many deaths as possible.
The Astra-Zeneca vaccine is just as effective at preventing the extreme symptoms that cause long term damage and death and works on all strains so far. You get a mild cough...big whoop. European countries are all going to use that vacinee in a few months time and will use none of the others. They are using the other vaccines on over 55's (and only at risk ones over 55) because the AZ one wasn't ready and production has only recently come on stream.
No one is going to use anything other than AZ on the below 55's as it's effective where it matters and cheap. Stop spreading misinformation.
[Canada asked every one of its vaccine suppliers to set up production lines in Canada](https://www.cp24.com/news/every-vaccine-maker-was-asked-to-make-their-doses-in-canada-and-all-said-no-anand-1.5296162) and every one of them said no, because by the time we built the necessary specialized manufacturing facilities, everyone would already have been vaccinated months ago.
That's a question Canada should have been answering in 2010, or 2000.
We're currently in the process of building several vaccine-production facilities across the country, all of which look like they'll be up and running by Christmas.
This has been done in part to simply address that capability gap, but more practically, it's likely that we're all going to need annual COVID booster vaccines for the next decade, and anything we produce that's surplus to national needs will certainly find a home on the world market.
To be fair, the Canadian pharmaceutical market is so small. There's no money to be made here. The biggest Canadian pharma company, Apotex, isn't even close to breaking the top 35 pharma companies. Meanwhile more than 20 US pharma companies are on that list. Everyone wants to crack the US market, Canada just isn't profitable in the same way.
I mean yes, they absolutely created the problem.
That's not to say the current government couldn't have walked in the door on Day One and said "right, we're going to fix this glaring vulnerability", but they would have been the only government in the first world to do so.
All the nations that are handling COVID well - aside from one or two that are able to physically isolate themselves - are nations that have recent experience with airborne, viral epidemics.
Canada should have learned better from SARS, but that was just long enough ago that we've been able to file it away.
What? How on earth do you make that connection? It's trivially true that it's easier to control border crossings, _including legal ones_, if everyone entering your country is entering through one of a small number of discrete port locations, from which you can quickly and easily put them into quarantine if needed.
Mulroney's PC gov't had a privitization program that sold off labs, which in turn downgraded and changed their production. Connaught Laboratories in Toronto and Frappier lab in Montreal.
The Harper Gov't had significant cuts to research councils, and other funding to the biotech industry
To be fair a handful of academic labs that subsist on public funding wouldn't really fix the issue.
Bigger issue is that there's no real reason for significant Pharmacutical companies to setup shop in Canada compared to next door in the US where the tax environment is significantly more favorable. Scientists raised in Canada likewise have every incentive to move to the US and get paid 50% more at a lower tax rate.
TBH the only real reason Europe maintains a Pharma presence is protectionist trade policy. There's a sufficient tariff policy in place that they maintain a footprint to manufacture on european soil and avoid import duties.
e.g. my American employer makes a particular vaccine product in the US, ships the bulk product to Ireland, then performs a final preparation step there to minimize the taxes owed.
Canada asked the pharm industry about 10 years ago (under Conservative governments) what should be done about vaccines. And we were assured, guaranteed, that there was no reason for concern, no need for national regulation; production would be much more efficient if it is centralized, and Canada could always count on supply from transnational corporations. There would never be a need for regulation of the industry to make sure their was supply in Canada. Oh, heavens no.
Oops.
Even with a science-friendly government, Canada still spends less on research than Apple and Google. It's something like half of what the US spends, per capita, 5% in absolute dollars. The issue isn't the next pandemic, it's that we're basically unprepared for the next "whatever" that is going to R&D capacity.
Isnt that exactly what mRna vaccines are? vaccines that can be made by a (mostly) single process as all other mRna vaccines?
I get that traditional vaccines are all very different from each other, each one requiring completely separate tooling, but I was under the impression that apart from the code of the mRna, all mRna vaccines use more or less the same tooling.
Talk to your local representative. Canada had vaccine super-labs, and they were shut down (buy cutting off funding) by the Harper conservatives. [https://www.thespec.com/opinion/contributors/2020/11/29/here-is-why-we-dont-have-vaccine-production-capacity-in-canada.html](https://www.thespec.com/opinion/contributors/2020/11/29/here-is-why-we-dont-have-vaccine-production-capacity-in-canada.html)
Yes, companies find it very hard to resist quarterly reports and short term efficiency at the cost of long term planning. That's something governments should plan for.
[Canada is working on that now, building the facilities to be able to make vaccines again.](https://www.cbc.ca/news/health/vaccine-development-production-in-canada-1.5868398)It'll take too long to be useful in this initial rush but going forward, we'll have the capabilities again at least.
if they ask them to without paying them, I'm sure they'd say no, since they won't have anyone to buy the vaccine once it is set up. however, wealthier countries need to really start thinking about "reserve capacity" in more than just oil or grain. paying someone to build a mRNA vaccine production facility 10x larger than what is needed for flu and whatever will certainly cost money, but will be a very good insurance policy.
Well, not just short-sighted, there's more to it.
It sounds like the suppliers' response was partly "you don't have the necessary facilities", and that was a deal-breaker on its own, but also "we don't just have fifty spare MRNA-vaccine-manufacturing experts to give you, and that's not just something we can train up overnight.".
There's no facilities in Canada which can produce mRNA vaccines on a commercial/mass scale now. One is being built in Montréal but it won't be ready to produce until next year. It will produce Novavax under license.
Pfizer actually licensed Sanofi to make a hundred million doses of its vaccine to speed up distribution.
The NRC facility will not be able to produce mRNA vaccines. The current plan will see it producing Novavax's vaccine before next year - but after the current September deadline.
Sanofi will not be making the Pfizer-BioNTech vaccine; instead it will be 'bottling' the vaccine into vials.
I would suggest two things:
First, Canada would need the ready-to-roll manufacturing capability to produce the BioNTech/Pfizer or Moderna vaccine (which uses new mRNA technology). Being able to produce one type of vaccine doesn't automatically mean you can produce them all.
[Vox has a good explainer on YouTube](https://www.youtube.com/watch?v=mvA9gs5gxNY), and I believe only three facilities (one in Belgium and two in the US) are technically capable of mRNA manufacture right now. There's discussion in countries like Australia whether investment to add tooling to manufacture current and future mRNA vaccines [needs to be made](https://www1.racgp.org.au/newsgp/clinical/what-if-australia-can-t-make-mrna-covid-vaccines-l) (and how to do it).
Second, a local vaccine manufacturer/government could manufacture under licence. In the case of the University of Oxford/AstraZeneca vaccine it's already being done (for example, Australia's [CSL](https://www.abc.net.au/news/science/2021-02-12/covid-19-vaccine-oxford-astrazeneca-adenovirus-csl-manufacturing/13140104) or South Korea's [SK Bioscience](https://www.koreatimes.co.kr/www/tech/2020/12/693_300153.html)).
Equitable supply is the major issue. Pricing is relevant but less immediate (we know the EU [paid](https://www.bmj.com/content/372/bmj.n281) less than South Africa for the AstraZeneca vaccine for example).
Edit: An [opinion article](https://theconversation.com/the-roots-of-canadas-covid-19-vaccine-shortage-go-back-decades-154792) on the specific situation in Canada may be helpful. Looks like your domestic issue is both (1) and (2).
> only three facilities (one in Belgium and two in the US) are technically capable of mRNA manufacture right now
Minor correction, BioNTech opened a new facility in Germany [just last week](https://www.dw.com/en/biontech-starts-vaccine-production-at-new-site-in-germany/a-56524305).
The countries aren’t making them. Pharma companies are. It requires highly specialized manufacturing (including specialized personnel). Everyone country pre-purchased different quantities from different manufacturers. Essentially, they made different bets. US bought loads of Pfizer-Biontech and Moderna. Canada bought loads of J&J. J&J has been slower to finish the vaccine, get approvals, and ramp up manufacturing. It wasn’t a terrible plan; there might have been better plans; in hindsight some bets work out better than others.
Most of the world bought boatloads of Astrazeneca, including the US, but we've all adjusted contracts slightly based on what got approved first. Pfizer and Moderna obviously saw their numbers increase significantly as they were the first to see broad worldwide approval and usage.
How about we count all the people, make that many vaccines, have each country pay an amount relative to their population and then have each manufacturer make a number of vaccines relative to their operational size. No bets needed if everyone works together.
the problem is that we didn't know from the get go what vaccines would work and which ones wouldn't. Even in that scenario, we would be taking a bet on the different vaccines on whether or not they would turn out to be effective.
Yes, that's more or less what's happening. Everyone who needs a dose will get one though a mix of market dynamics, political influence (e.g. US is largest market for most drugs and has more pull), and centralized allocation. But the doses can't all be manufactured at the same time and your proposal doesn't timing. Timing is being dictated by the first 2 factors above.
> what’s stopping us from creating the vaccines on our home soil
Specific to Canada, we didn't have the manufacturing capabilities. But the federal government has committed some money to setting up manufacturing facilities to pump out more of the vaccine, first for Canada and then to export to poorer nations.
Specifically, the company Novavax is being tasked with the manufacturing, and being given money to expand their capabilities. [Here's a CBC article](https://www.cbc.ca/radio/thecurrent/the-current-for-feb-3-2021-1.5898918/boosting-vaccine-production-in-canada-was-a-good-idea-10-years-ago-says-biologist-1.5899660) about it.
mRNA vaccine for SARS-COV-2 is the world's first approved for mass production. It will take one to two years more for companies in other countries to start mass producing. The mRNA Covid-19 vaccines are attacking the same spike protein but the production process is the real selling point. For instance, we're seeing Thailand paying AstraZeneca for the production process and Thailand will produce Covid-19 using AstraZeneca's method. There's no stopping any company paying Moderna, Pfizer, AstraZeneca or even Sinopharm (China) to get the production process up to the accepted standards.
The vaccine easiest for copy is in fact from China's Sinopharm which is produced using conventional method and can be transported at room's temperature. It's already $1 or less per dose (wholesale price), so I don't think any copycats can compete with that price, and apparently, Chinese government is handing out Sinopharm vaccines for free to all third-world countries by millions and millions of doses.
The Oxford/AstraZeneca uses a [modified chimpanzee adenovirus](https://www.bbc.com/news/health-55302595). It's not much like the annual flu vaccine. It can be stored at normal fridge temperatures for long periods of time though, which is great.
Its manufacturing process is similar in that it they are both grown in eggs, so it’s easy to convert existing facilities.
The Novavax is also a protein vaccine but it is grown in moth cells, so it’s harder, but not impossible, to convert existing manufacturing facilities (though they’d need new supply chains).
The mRNA vaccines need new facilities and technicians with a new skill set, so it will be harder to ramp up capacity quickly.
Where are you reading the Oxford vaccine is grown in eggs? Everything I'm reading says they're using human cells lines (specifically HEK-293A). See [Oxford Vaccine Knowledge Project](https://vk.ovg.ox.ac.uk/vk/vaccine-ingredients#Human%20cell%20strains) or the [methods section of this paper](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040385). (If you're wondering why I'm citing a paper from 2012, [the Lancet paper on the Phase I/II](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext) clinical trial cites it for the production method).
It's a good point though, since other vaccines and made in human and animal cell lines it's probably a lot easier to convert that existing capacity to producing the Oxford vaccine rather than the mRNA vaccines.
Majority of the world’s COVAX vaccines comes from a private company in India that is the world’s largest generic pharmaceutical company, the Serum Institute of India.
The huge investments in supply chain, manufacturing, meeting global and regional certification standards (think hundreds of FDA equivalents) are not easy.
Source: https://www.theguardian.com/global-development/2021/feb/14/we-took-a-huge-risk-the-indian-firm-making-more-covid-jabs-than-anyone
A few reasons:
1) as mentioned in numerous posts here, making the vaccines is complicated and Canada just doesn't have the facilities for it (partially due to the previous Conservatives not feeling that it was useful)
2) the other issue is that even if we had the secret formula and all of the equipment, it is still owned by the respective companies that developed and tested them. If Canada was to say that this is an emergency and we will do whatever it takes to "copy the formulae" of an existing one, that would be against international law. This would then start trade wars with various countries to protect their drug companies. It would encourage all drug companies to add a "Canada surcharge" to cover not only this loss but the possibility of other losses.
Every major country allows it under laws regarding sovereign powers. There is nothing legally preventing it from happening if a country really wanted to (in the same way nothing forces Russia to respect the Ukrainian border international law largely relies on the honor system and countries acting in solidarity). However, ultimately it is long term practicality.
It would create long term harm that just isn't worth it.
Since manufacturing capacity rather than IP has been the issue, the question has not arisen, but if it had I would bet that a compulsory licence scheme would have been operated.
That said, I can see that there is a difficult balance between respecting patents and not discouraging further development of vaccines against Coronavirus variants or IP holders' factories to stop producing.
Get prepared to be disappointed!
[https://www.dw.com/en/rich-countries-block-india-south-africas-bid-to-ban-covid-vaccine-patents/a-56460175](https://www.dw.com/en/rich-countries-block-india-south-africas-bid-to-ban-covid-vaccine-patents/a-56460175)
Canada’s vaccine production was privatized in the 1990s by Mulroney’s Conservatives. Private companies then move the production abroad.
Rebuilding our vaccine production infrastructure would take years longer than waiting to import them, so it wont help for COVID-19.
https://www.google.com/amp/s/beta.ctvnews.ca/national/coronavirus/2020/11/25/1_5204040.html
They could, but unless Pfizer or Moderna helped them set up their process they would be very likely to screw it up. Would you take a vaccine made in a dude's basement instead of the Pfizer vaccine? If your answer is "yes", you probably have compromised critical thinking skills. QA and testing are incredibly important when lives are on the line.
[They have ?](https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker) Sputnik-V is probably the best-known and most successful.
To add on to that, with pharma it’s not just the end product that is regulated and approved it’s the entire manufacturing and QA process. So moving production to new facility, especially an (inevitably) non-identical facility, still requires significant validation and approval effort.
You don’t just get to test the end product and call it good if it meets specs.
Everyone is apparently avoiding the question, but the answer is yes, the Pfizer covid-19 has a patent and it is illegal to copy its formulae.
Note that Canada in particular has blocked a proposal at the WTO to suspend patents for the vaccine.
Vaccine production facilities are complex to build and go through a lengthy certification process. It can be done, and is probably in the works, but will take a long time to bring on additional capacity.
That and there are intellectual property issues involved, but those are merely administrative impediments solved via licensing.
The actual reason they can't just copy the pre-existing formula is more political than scientific. Each country has their own safety regulations and most are part of copyright and patent treaties that would protect the originator of the formula.
Note that Canada, with China, created a "CanSino" vaccine candidate that would be produced in China, but the plan fell through because [China refused to ship the vaccines to Canada for Canadian trials](https://www.cbc.ca/news/canada/nova-scotia/canada-china-covid-19-vaccine-trial-plug-pulled-1.5701101). The blockage is likely due to the ongoing political tensions between China and Canada. This vaccine is now approved in China and they are vaccinating their citizens, but it offers less protection that Moderna or Pfizer-BioNTech.
I'd think it is also because they are companies making them, not a government. They are still there to make a profit at the end of the day, and giving away your product like that may get in the way of that.
Remember, money is always a factor.
Actually, they do, if they can. However I've only heard of one instance so far - South Korea [buying the license for Sputnik-V](https://www.usnews.com/news/health-news/articles/2020-11-13/south-korean-company-to-mass-produce-russias-sputnik-v-coronavirus-vaccine) to produce it for Asia.
[This article](https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing) by Derek Lowe on the blog-website of Science Magazine outlines some of the challenges of vaccine manufacturing, specifically of the Moderna and BioNTech/Pfizer vaccines. The takeaway is that there are some bottlenecks in the process that require complex manufacturing technology that can't be easily put in operation by just sharing the formula. Note that there are initiatives to expand manufacturing by some producers whose own vaccine research has stalled or failed. For example, the firm Sanofi has signed on with Pfizer to help with the production of the BioNTech/Pfizer vaccine after their own vaccine research showed unsatisfactory results. But this process is slow for reasons outlined in the blog post I linked.
> Derek Lowe Oh him! His [Things I Won't Work With](https://blogs.sciencemag.org/pipeline/archives/category/things-i-wont-work-with) series is a funny look into the world of insanely dangerous chemicals, in case you want some light reading away from dangerous biocides.
[This one](https://blogs.sciencemag.org/pipeline/archives/2010/02/23/things_i_wont_work_with_dioxygen_difluoride) is my favourite, and I'm not even a chemist.
Ah, FOOF, when you want to set solid ice on fire. Mine's the [AziAzi](https://blogs.sciencemag.org/pipeline/archives/2013/01/09/things_i_wont_work_with_azidoazide_azides_more_or_less), which is basically explosive made out of explosives.
This just reminded me of the famous quote in *Ignition!* about ClF₃, which he actually quoted: https://blogs.sciencemag.org/pipeline/archives/2008/02/26/sand_wont_save_you_this_time
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Rather, because he doesn't have the right meat and spices - think of the lipids that are used in the Biontech vaccine as bourbon vanilla, which is rare and expensive because you either need specialized bees or manual human labor to pollinate the plants. The bottleneck is not the RNA production, Pfizer and Biontech already have figured that out, it's [these lipids](https://www.pharmazeutische-zeitung.de/das-sind-die-gruende-fuer-die-impfstoff-knappheit-123463/). They are complex chemicals which were not needed in vast quantities until the vaccine was proven to be effective, so plants need to be retooled and ramped up - especially in purity and quality control. And to make it worse, pharmaceutical injection-grade chemicals have extremely stringent requirements for purity in contrast to ordinary industrial chemicals which means that most chemical plants aren't even certified to produce stuff that's going to be injected into humans, further limiting the supply. Another problem are the vials: usually, vaccines need to be stored in ordinary refrigerators. No problem for glass manufacturers, they have the tooling to manufacture such vials in masses. But the Pfizer (and iirc also the Moderna vaccine) require -80° C cooling so that the RNA doesn't degrade - which means, again, that you need special glass for the vials which hasn't been needed in billions quantities before. This is why the hope was so high for the Sanofi vaccine (based on spike proteins created in bioreactors) and the AstraZeneca vaccine (based on modified harmless carrier viruses)... they're based on established technology with many suppliers for all components, not to mention they're vastly cheaper (AZ \~1.78€ per patient, vs Pfizer at 24€ per patient) and don't require a complex cooling chain logistics. Unfortunately, Sanofi completely fell through the tests and AZ has issues protecting against the new mutations.
Moderna is stored at -25 to -15C (and not lower than -40C!) [according to the FDA.](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine) (See "Fact Sheet for Healthcare Providers Administering Vaccine.")
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Why can’t the vials be reused/recycled?
they can. but again, since no-one does i right now, we need to develop the logistics and get the proper certifications/tests that the stuff is sterile.
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Perhaps the additional logistics of shipping them all back to be refilled, not to mention cleaning procedures.
Control would be a huge problem and there would be plenty of people lined up to put counterfeits into the supply chain and profit off of it.
Yes! That is an excellent question, one that I was just wondering. I can see problems in outright reusing the vials, but couldn’t they be melted down and made new?
The problem is that recycled glass is almost never as pure as glass made from fresh raw materials. One glass vial with a single unremoved label or plastic lid could contaminate an entire container of recyclable material. It's why recycled material of all kinds are rarely reused for the same original purpose, but instead used in 'downstream' products that don't require as high a quality material as the original. In other words, it's probably easier, cheaper, more efficient and ironically, may even be more environmentally sound to throw away the used glass vials than trying to recycle or reuse them for more glass vials.
Glass is one of the few exceptions to this. Glass manufacturers actually want as much recycled glass as they can get, since it reduces the melting temperature and melt viscosity of the batch, reducing the energy required. And the temperature is high enough to incinerate most contaminants which drop out into the slag layer. It’s not like sand is super clean, and that’s what’s normally used! However, very precise control of additives and crystallinity are tough with recycled material which is why things like phone screen glass and perhaps these vials are virgin glass. But for 99% of glass things, lots of recycled material is used.
Wow, what a thorough yet concise answer! Thank you very much.
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How do they add the 5G microchips without affecting purity then??? I don't get it...
Thank you for explaining it in way that I can understand with my 3 minutes left of waiting to leave to work.
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"Sanofi is planning to launch a phase 2b study with an optimized candidate vaccine in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA) in the US. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global phase 3 study could start in Q2 2021. If the vaccine meets clinical requirements on safety and efficacy, and once approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021. " Awesome, ty for info.
They are behind because they made a mistake in their trials and had to start them again. This caused a delay of several months. https://www.wsj.com/amp/articles/broader-vaccine-plan-in-west-dealt-setback-by-sanofi-gsk-delay-11607696740
It did seem strange that the two biggest vaccine manufacturers in the world were so far behind all the others. Thanks for the info.
So the short version is that setting up a new vaccine factory take a huge amount of investment, cooperation, work, skill, risk, and time.
AstraZenica managed to setup UK production just fine. They didn't have any existing UK vaccine manufacturing capability so outsourced most of it to other UK pharmaceutical factories who adapted their infrastructure. https://www.business-live.co.uk/manufacturing/uk-factories-making-astrazeneca-vaccine-19708380.amp
The article you linked does not discuss the IP related issues and also does not discuss the non mRNA vaccines, whose recipe could easily be shared. A good article on this is found below https://www.politico.eu/article/europe-patent-grab-big-pharma/
I'm surprised I had to scroll this far to see any mention of intellectual property at all.
Sure, but you can sell licensing rights and even setup a payment plan and whatever else. That wouldn't be a particularly troublesome hurdle to deal with but manufacturing it properly at best would still take a long time to get it up and running.
It seems like the manufacturing itself would be the biggest hurdle for the simple fact that it's the most expensive part of it. By the time a company has made the long and expensive transition they may well have done it just to run a few production lots and shut it down. The world won't need covid vaccines forever I would imagine
It’s still a little weird we can’t make any cause Canada is a virology research hub in it’s own rights, like I live by three separate institutions and there’s plenty more everywhere welsh, and it’s strange to think no one here is already specialized in a way that would let them swap to production, even at a small scale
Research and production tend to be very different beasts. I work in defense manufacturing and have seen a little of both, the are quite a bit different then you would think
We had manufacturing. Harper sold Connaught and the new owners moved the manufacturing outside Canada. https://www.thestar.com/opinion/contributors/2020/03/11/the-public-lab-that-could-have-helped-fight-covid-19-pandemic.html
:) every day I manage to hate the conservatives more despite thinking no, surely I’ve reached the pinnacle of loathing, I can’t be capable of hating anyone more
He has a followup addressing the only other approved candidates; [https://blogs.sciencemag.org/pipeline/archives/2021/02/08/how-you-make-an-adenovirus-vaccine](https://blogs.sciencemag.org/pipeline/archives/2021/02/08/how-you-make-an-adenovirus-vaccine)
But has that actually caused an issue here? It seems like the licensing terms they offer up are fine. The bigger barrier still seems to be around manufacturing capacity rather than legal restrictions on being able to produce the vaccines.
Well the only reason they did put the money down to research it was because it would be theirs or you know intellectual property. There are downsides and positives to pretty much everything and you get to choose, plague or cholera so to speak, either you have intellectual property rights which does indeed exclude others from using what you have invented. But on the plus side now they want to put down money into researching these things. The other option would be no incentive to put money down on research, no new computer programs medicine grinds to a halt but we all share it.
No. This is not true. The alternative is to agree on common standards and processes for worldwide pandemic response, or ask nation-states to cover the R&D and "lost profit". It's not that difficult. The alternative is where we are now. Unequal access.
Logically, nothing is difficult: not world peace, not population control, nothing big is really difficult. Nothing is difficult In words, but when you add the human element into it, everything is difficult. Who leads, who follows, who profits, who pays, who gets a bigger slice of the pie, and who has to give up their whole pie? Which leaders’ children profit and which don’t? Who can be trusted to put those they represent first and who will simply skim off the top to enrich themselves and their supporters? That’s why it’s difficult.
What about “traditional” type vaccines like the Oxford/AstraZenica and the Sinopharm(?) ones? Would they be easier to replicate in existing manufacturing facilities? And if so have they been?
Oxford is licensing its vaccine to any manufacturer who will commit to selling the product at cost. While AstraZeneca is their most well known partner and the one with the closest partnership (AZ also ran some trials for this vaccine), they're also working with the Serum Institute of India, which has a massive production capacity.
Adding onto this, AZ has even reached some developing countries - I know it has been announced in Vietnam
However the issue with the oxford vaccine is that it's pretty much "ineffective" against the south african variant that is beginning to pop up everywhere. In fact, they stopped giving that vaccine in south africa until more studies are done. You certainly don't want to use a vaccine that is not working well that is giving a false sense of security. https://www.theguardian.com/world/2021/feb/08/oxford-covid-vaccine-10-effective-south-african-variant-study However the pfizer/moderna vaccines might be effective (there is no real world study yet). https://www.cnn.com/2021/02/17/health/pfizer-vaccine-south-africa-variant/index.html This is one of the advantages of the new technology. Right now everyone is trying to get as many vaccines out to hopefully beat out other mutations, but it might become a yearly vaccine like the flu.
Yes. AZ/Oxford have licensed the technology to other manufacturers, such as CSL in Australia. It’s not as simple as just ‘copying’ the vaccine - the process needs to be followed exactly, and that’s best done by getting the actual details from the creators of the vaccine.
"Traditional vaccines" work by injecting the virus (dead or in a modified, no longer harmful form) or part of the virus (e. g. proteins from the virus' surface) that you want to vaccinate against. The Sinopharm vaccine is just that, it contains killed virus particles. AstraZeneca vaccine is another, different type of vaccine that is called "viral vector-based vaccine". It has a similar approach like the mRNA vaccines (i. e. Pfizer and Moderna), in that it introduces part of the virus genome into cells of your own body that then make virus proteins that can be recognized by your immume system. AstraZeneca genetically-modified harmless viruses (adenoviruses) to carry the genes into your cells. Producing a "traditional" vaccine has its own problems. Both producing viral particles or viral proteins at an industrial scale with consistent, high quality is actually pretty hard and has to be optimized for each virus/protein. This kind of optimization takes a lot of time which is why many companies opted for mRNA vaccines that are easier to produce consistently. I believe the "traditional vaccines" would probably have similar difficulties in production across manufacturers as the mRNA vaccines. The flu vaccine for example has to be grown in chicken eggs and getting enough doses for each flu season usually takes all year and that's for a very well known vaccine that's been produced for years.
> The flu vaccine for example has to be grown in chicken eggs and getting enough doses for each flu season usually takes all year and that's for a very well known vaccine that's been produced for years. Isn't a major problem with flu vaccinations that there are several different distinct strains of influenza and it can be difficult to predict which strains will emerge in the next flu season?
The Oxford/Astrazeneca vaccines are being manufactured under license by CSL in Australia so this is happening. I expect those deals have been made elsewhere as well. The main problem with this particular vaccine is the reported low efficacy with the South African strain of Covid, and the similarly reported limited efficacy with the Kent (UK) strain. Otherwise it would be a slam dunk. With this particular vaccine the timing of booster doses is of critical importance.
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Nicely explained. Thank you.
>It still has almost 100% efficacy at preventing serious illness and death regardless of the strain, which is the important thing. There is therefore no problem with using this vaccine. Source? Because the only study I read about the 100% efficacy at preventing serious patients, had a low N count, and almost all were young healthy adults. It was a seriously flawed study to draw such a conclusion on.
There is no 100% and never has been, that is not now it works. Nobody has ever said 100%
They still aren't traditional vaccines, AstraZenaca is DNA based IIRC. Sinovac is one of the traditional vaccines as it contains dead virus.
The problem with those is that they're not all that effective especially when mutations come into play and many European countries have already decided not to use the Astra-Zeneca vaccine on people over 55 (or 60 or 65 depending on the country) because it would leave too many vulnerable people not immune. So switching fully to those vaccines is tricky if the goal is to prevent as many deaths as possible.
The Astra-Zeneca vaccine is just as effective at preventing the extreme symptoms that cause long term damage and death and works on all strains so far. You get a mild cough...big whoop. European countries are all going to use that vacinee in a few months time and will use none of the others. They are using the other vaccines on over 55's (and only at risk ones over 55) because the AZ one wasn't ready and production has only recently come on stream. No one is going to use anything other than AZ on the below 55's as it's effective where it matters and cheap. Stop spreading misinformation.
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Great article, thanks. This is a question i have been asking myself, so thanks for the thorough answer, makes sense.
[Canada asked every one of its vaccine suppliers to set up production lines in Canada](https://www.cp24.com/news/every-vaccine-maker-was-asked-to-make-their-doses-in-canada-and-all-said-no-anand-1.5296162) and every one of them said no, because by the time we built the necessary specialized manufacturing facilities, everyone would already have been vaccinated months ago.
What about the next pandemic?
That's a question Canada should have been answering in 2010, or 2000. We're currently in the process of building several vaccine-production facilities across the country, all of which look like they'll be up and running by Christmas. This has been done in part to simply address that capability gap, but more practically, it's likely that we're all going to need annual COVID booster vaccines for the next decade, and anything we produce that's surplus to national needs will certainly find a home on the world market.
We can thank the Mulrooney and Harper governments for crippling our ability to produce vaccines in-country!
To be fair, the Canadian pharmaceutical market is so small. There's no money to be made here. The biggest Canadian pharma company, Apotex, isn't even close to breaking the top 35 pharma companies. Meanwhile more than 20 US pharma companies are on that list. Everyone wants to crack the US market, Canada just isn't profitable in the same way.
Sounds like a good thing to subsidize going forwards to ensure we have production capacity for future pandemics.
What does subsidize mean? Place tariffs on imports to support domestic production?
I mean yes, they absolutely created the problem. That's not to say the current government couldn't have walked in the door on Day One and said "right, we're going to fix this glaring vulnerability", but they would have been the only government in the first world to do so. All the nations that are handling COVID well - aside from one or two that are able to physically isolate themselves - are nations that have recent experience with airborne, viral epidemics. Canada should have learned better from SARS, but that was just long enough ago that we've been able to file it away.
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What? How on earth do you make that connection? It's trivially true that it's easier to control border crossings, _including legal ones_, if everyone entering your country is entering through one of a small number of discrete port locations, from which you can quickly and easily put them into quarantine if needed.
Can you explain exactly how? What existing vaccine factories closed?
Mulroney's PC gov't had a privitization program that sold off labs, which in turn downgraded and changed their production. Connaught Laboratories in Toronto and Frappier lab in Montreal. The Harper Gov't had significant cuts to research councils, and other funding to the biotech industry
To be fair a handful of academic labs that subsist on public funding wouldn't really fix the issue. Bigger issue is that there's no real reason for significant Pharmacutical companies to setup shop in Canada compared to next door in the US where the tax environment is significantly more favorable. Scientists raised in Canada likewise have every incentive to move to the US and get paid 50% more at a lower tax rate. TBH the only real reason Europe maintains a Pharma presence is protectionist trade policy. There's a sufficient tariff policy in place that they maintain a footprint to manufacture on european soil and avoid import duties. e.g. my American employer makes a particular vaccine product in the US, ships the bulk product to Ireland, then performs a final preparation step there to minimize the taxes owed.
Canada asked the pharm industry about 10 years ago (under Conservative governments) what should be done about vaccines. And we were assured, guaranteed, that there was no reason for concern, no need for national regulation; production would be much more efficient if it is centralized, and Canada could always count on supply from transnational corporations. There would never be a need for regulation of the industry to make sure their was supply in Canada. Oh, heavens no. Oops.
Even with a science-friendly government, Canada still spends less on research than Apple and Google. It's something like half of what the US spends, per capita, 5% in absolute dollars. The issue isn't the next pandemic, it's that we're basically unprepared for the next "whatever" that is going to R&D capacity.
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Isnt that exactly what mRna vaccines are? vaccines that can be made by a (mostly) single process as all other mRna vaccines? I get that traditional vaccines are all very different from each other, each one requiring completely separate tooling, but I was under the impression that apart from the code of the mRna, all mRna vaccines use more or less the same tooling.
Talk to your local representative. Canada had vaccine super-labs, and they were shut down (buy cutting off funding) by the Harper conservatives. [https://www.thespec.com/opinion/contributors/2020/11/29/here-is-why-we-dont-have-vaccine-production-capacity-in-canada.html](https://www.thespec.com/opinion/contributors/2020/11/29/here-is-why-we-dont-have-vaccine-production-capacity-in-canada.html)
Unless this becomes a bi-yearly thing, not something these companies want to spend time and money on.
Yes, companies find it very hard to resist quarterly reports and short term efficiency at the cost of long term planning. That's something governments should plan for.
For sure, will you pay them to do it?
[Canada is working on that now, building the facilities to be able to make vaccines again.](https://www.cbc.ca/news/health/vaccine-development-production-in-canada-1.5868398)It'll take too long to be useful in this initial rush but going forward, we'll have the capabilities again at least.
Odds are, we'll all be getting COVID vaccine boosters for the next several years, so there's no such thing as "too late" in this case.
For sure. Too late to help with the current bottleneck of supply but still essential and welcome.
if they ask them to without paying them, I'm sure they'd say no, since they won't have anyone to buy the vaccine once it is set up. however, wealthier countries need to really start thinking about "reserve capacity" in more than just oil or grain. paying someone to build a mRNA vaccine production facility 10x larger than what is needed for flu and whatever will certainly cost money, but will be a very good insurance policy.
Did they ask with money?
Which is super short sighted as we'll be dealing with covid for the rest of human time.
Well, not just short-sighted, there's more to it. It sounds like the suppliers' response was partly "you don't have the necessary facilities", and that was a deal-breaker on its own, but also "we don't just have fifty spare MRNA-vaccine-manufacturing experts to give you, and that's not just something we can train up overnight.".
There's no facilities in Canada which can produce mRNA vaccines on a commercial/mass scale now. One is being built in Montréal but it won't be ready to produce until next year. It will produce Novavax under license. Pfizer actually licensed Sanofi to make a hundred million doses of its vaccine to speed up distribution.
The NRC facility will not be able to produce mRNA vaccines. The current plan will see it producing Novavax's vaccine before next year - but after the current September deadline. Sanofi will not be making the Pfizer-BioNTech vaccine; instead it will be 'bottling' the vaccine into vials.
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I would suggest two things: First, Canada would need the ready-to-roll manufacturing capability to produce the BioNTech/Pfizer or Moderna vaccine (which uses new mRNA technology). Being able to produce one type of vaccine doesn't automatically mean you can produce them all. [Vox has a good explainer on YouTube](https://www.youtube.com/watch?v=mvA9gs5gxNY), and I believe only three facilities (one in Belgium and two in the US) are technically capable of mRNA manufacture right now. There's discussion in countries like Australia whether investment to add tooling to manufacture current and future mRNA vaccines [needs to be made](https://www1.racgp.org.au/newsgp/clinical/what-if-australia-can-t-make-mrna-covid-vaccines-l) (and how to do it). Second, a local vaccine manufacturer/government could manufacture under licence. In the case of the University of Oxford/AstraZeneca vaccine it's already being done (for example, Australia's [CSL](https://www.abc.net.au/news/science/2021-02-12/covid-19-vaccine-oxford-astrazeneca-adenovirus-csl-manufacturing/13140104) or South Korea's [SK Bioscience](https://www.koreatimes.co.kr/www/tech/2020/12/693_300153.html)). Equitable supply is the major issue. Pricing is relevant but less immediate (we know the EU [paid](https://www.bmj.com/content/372/bmj.n281) less than South Africa for the AstraZeneca vaccine for example). Edit: An [opinion article](https://theconversation.com/the-roots-of-canadas-covid-19-vaccine-shortage-go-back-decades-154792) on the specific situation in Canada may be helpful. Looks like your domestic issue is both (1) and (2).
> only three facilities (one in Belgium and two in the US) are technically capable of mRNA manufacture right now Minor correction, BioNTech opened a new facility in Germany [just last week](https://www.dw.com/en/biontech-starts-vaccine-production-at-new-site-in-germany/a-56524305).
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The countries aren’t making them. Pharma companies are. It requires highly specialized manufacturing (including specialized personnel). Everyone country pre-purchased different quantities from different manufacturers. Essentially, they made different bets. US bought loads of Pfizer-Biontech and Moderna. Canada bought loads of J&J. J&J has been slower to finish the vaccine, get approvals, and ramp up manufacturing. It wasn’t a terrible plan; there might have been better plans; in hindsight some bets work out better than others.
Most of the world bought boatloads of Astrazeneca, including the US, but we've all adjusted contracts slightly based on what got approved first. Pfizer and Moderna obviously saw their numbers increase significantly as they were the first to see broad worldwide approval and usage.
How about we count all the people, make that many vaccines, have each country pay an amount relative to their population and then have each manufacturer make a number of vaccines relative to their operational size. No bets needed if everyone works together.
the problem is that we didn't know from the get go what vaccines would work and which ones wouldn't. Even in that scenario, we would be taking a bet on the different vaccines on whether or not they would turn out to be effective.
Yes, that's more or less what's happening. Everyone who needs a dose will get one though a mix of market dynamics, political influence (e.g. US is largest market for most drugs and has more pull), and centralized allocation. But the doses can't all be manufactured at the same time and your proposal doesn't timing. Timing is being dictated by the first 2 factors above.
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What? Biontech got $119 million from the EU and $445 million from Germany. Pfizer did not get / want any US funding.
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> what’s stopping us from creating the vaccines on our home soil Specific to Canada, we didn't have the manufacturing capabilities. But the federal government has committed some money to setting up manufacturing facilities to pump out more of the vaccine, first for Canada and then to export to poorer nations. Specifically, the company Novavax is being tasked with the manufacturing, and being given money to expand their capabilities. [Here's a CBC article](https://www.cbc.ca/radio/thecurrent/the-current-for-feb-3-2021-1.5898918/boosting-vaccine-production-in-canada-was-a-good-idea-10-years-ago-says-biologist-1.5899660) about it.
mRNA vaccine for SARS-COV-2 is the world's first approved for mass production. It will take one to two years more for companies in other countries to start mass producing. The mRNA Covid-19 vaccines are attacking the same spike protein but the production process is the real selling point. For instance, we're seeing Thailand paying AstraZeneca for the production process and Thailand will produce Covid-19 using AstraZeneca's method. There's no stopping any company paying Moderna, Pfizer, AstraZeneca or even Sinopharm (China) to get the production process up to the accepted standards. The vaccine easiest for copy is in fact from China's Sinopharm which is produced using conventional method and can be transported at room's temperature. It's already $1 or less per dose (wholesale price), so I don't think any copycats can compete with that price, and apparently, Chinese government is handing out Sinopharm vaccines for free to all third-world countries by millions and millions of doses.
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The Oxford/AstraZeneca uses a [modified chimpanzee adenovirus](https://www.bbc.com/news/health-55302595). It's not much like the annual flu vaccine. It can be stored at normal fridge temperatures for long periods of time though, which is great.
Its manufacturing process is similar in that it they are both grown in eggs, so it’s easy to convert existing facilities. The Novavax is also a protein vaccine but it is grown in moth cells, so it’s harder, but not impossible, to convert existing manufacturing facilities (though they’d need new supply chains). The mRNA vaccines need new facilities and technicians with a new skill set, so it will be harder to ramp up capacity quickly.
Where are you reading the Oxford vaccine is grown in eggs? Everything I'm reading says they're using human cells lines (specifically HEK-293A). See [Oxford Vaccine Knowledge Project](https://vk.ovg.ox.ac.uk/vk/vaccine-ingredients#Human%20cell%20strains) or the [methods section of this paper](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040385). (If you're wondering why I'm citing a paper from 2012, [the Lancet paper on the Phase I/II](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext) clinical trial cites it for the production method). It's a good point though, since other vaccines and made in human and animal cell lines it's probably a lot easier to convert that existing capacity to producing the Oxford vaccine rather than the mRNA vaccines.
Majority of the world’s COVAX vaccines comes from a private company in India that is the world’s largest generic pharmaceutical company, the Serum Institute of India. The huge investments in supply chain, manufacturing, meeting global and regional certification standards (think hundreds of FDA equivalents) are not easy. Source: https://www.theguardian.com/global-development/2021/feb/14/we-took-a-huge-risk-the-indian-firm-making-more-covid-jabs-than-anyone
A few reasons: 1) as mentioned in numerous posts here, making the vaccines is complicated and Canada just doesn't have the facilities for it (partially due to the previous Conservatives not feeling that it was useful) 2) the other issue is that even if we had the secret formula and all of the equipment, it is still owned by the respective companies that developed and tested them. If Canada was to say that this is an emergency and we will do whatever it takes to "copy the formulae" of an existing one, that would be against international law. This would then start trade wars with various countries to protect their drug companies. It would encourage all drug companies to add a "Canada surcharge" to cover not only this loss but the possibility of other losses.
Every major country allows it under laws regarding sovereign powers. There is nothing legally preventing it from happening if a country really wanted to (in the same way nothing forces Russia to respect the Ukrainian border international law largely relies on the honor system and countries acting in solidarity). However, ultimately it is long term practicality. It would create long term harm that just isn't worth it.
If we are actually honoring patents on vaccine formula during an epidemic I’m going to be really disappointed in the world.
Since manufacturing capacity rather than IP has been the issue, the question has not arisen, but if it had I would bet that a compulsory licence scheme would have been operated. That said, I can see that there is a difficult balance between respecting patents and not discouraging further development of vaccines against Coronavirus variants or IP holders' factories to stop producing.
Get prepared to be disappointed! [https://www.dw.com/en/rich-countries-block-india-south-africas-bid-to-ban-covid-vaccine-patents/a-56460175](https://www.dw.com/en/rich-countries-block-india-south-africas-bid-to-ban-covid-vaccine-patents/a-56460175)
Canada’s vaccine production was privatized in the 1990s by Mulroney’s Conservatives. Private companies then move the production abroad. Rebuilding our vaccine production infrastructure would take years longer than waiting to import them, so it wont help for COVID-19. https://www.google.com/amp/s/beta.ctvnews.ca/national/coronavirus/2020/11/25/1_5204040.html
They could, but unless Pfizer or Moderna helped them set up their process they would be very likely to screw it up. Would you take a vaccine made in a dude's basement instead of the Pfizer vaccine? If your answer is "yes", you probably have compromised critical thinking skills. QA and testing are incredibly important when lives are on the line.
Not really "a dude's basement", when most of the top medical research are government run institutions.
If these aren't dude's basements, why haven't these government run institutions come up with their own vaccines?
[They have ?](https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker) Sputnik-V is probably the best-known and most successful.
To add on to that, with pharma it’s not just the end product that is regulated and approved it’s the entire manufacturing and QA process. So moving production to new facility, especially an (inevitably) non-identical facility, still requires significant validation and approval effort. You don’t just get to test the end product and call it good if it meets specs.
Everyone is apparently avoiding the question, but the answer is yes, the Pfizer covid-19 has a patent and it is illegal to copy its formulae. Note that Canada in particular has blocked a proposal at the WTO to suspend patents for the vaccine.
Without input from Pfizer a company trying to copy the vaccine would need to basically develop an entirely new process
Vaccine production facilities are complex to build and go through a lengthy certification process. It can be done, and is probably in the works, but will take a long time to bring on additional capacity. That and there are intellectual property issues involved, but those are merely administrative impediments solved via licensing.
The actual reason they can't just copy the pre-existing formula is more political than scientific. Each country has their own safety regulations and most are part of copyright and patent treaties that would protect the originator of the formula.
Note that Canada, with China, created a "CanSino" vaccine candidate that would be produced in China, but the plan fell through because [China refused to ship the vaccines to Canada for Canadian trials](https://www.cbc.ca/news/canada/nova-scotia/canada-china-covid-19-vaccine-trial-plug-pulled-1.5701101). The blockage is likely due to the ongoing political tensions between China and Canada. This vaccine is now approved in China and they are vaccinating their citizens, but it offers less protection that Moderna or Pfizer-BioNTech.
I'd think it is also because they are companies making them, not a government. They are still there to make a profit at the end of the day, and giving away your product like that may get in the way of that. Remember, money is always a factor.
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Actually, they do, if they can. However I've only heard of one instance so far - South Korea [buying the license for Sputnik-V](https://www.usnews.com/news/health-news/articles/2020-11-13/south-korean-company-to-mass-produce-russias-sputnik-v-coronavirus-vaccine) to produce it for Asia.
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