Manufacturing mRNA Vaccines is Surprisingly Straightforward

And the world can’t afford to be half vaccinated

Cory Doctorow
Medium Coronavirus Blog

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The Earth, floating in space, with its southern hemisphere in flames; it is being irradiated by a beam-weapon fired by a Death Star-style coronavirus molecule, bearing the Pfizer logo.

The poorest 125 countries on Earth — pop. 2.5b—have not yet received a single covid vaccine dose. The 85 poorest countries on Earth project full vaccination in 2023 or 2024.

This isn’t just a humanitarian catastrophe, it’s a civilizational risk, an epidemiological game of Russian roulette. Every infected person makes billions and billions of copies of the virus, and every copying operation represents a small — but cumulative — chance for a mutation to emerge. Some mutations will make the virus easier to spread. Some will make it more deadly. Some will confer the ability to infect vaccinated people. Some might do two of these things at once. Some might do all three.

Even if you don’t care about poor people, brown people, and the Global South being devastated by the virus, you should still want to see everyone vaccinated, as soon as possible, to save the lives of everyone you love (and to save your own ass).

The good news is, countries in the Global South are really good at making vaccines. Many of the world’s largest vaccine factories are in poor countries. Indeed, the largest vaccine production facility in the world is in India.

There’s just one problem: the patents and related information necessary to make these vaccines. Just a few months ago, Oxford University was pledging to make its vaccine publicly available, both because this is epidemiologically sound, and because the underlying science was financed at public expense, so selling an exclusive license to a pharma company would be indefensible.

Enter Bill Gates.

The Gates Foundation convinced the Oxford team to do an exclusive deal with AstraZeneca. In support of this proposition, Gates argued that without a profit motive, the pharma giants would abandon human society and risk civilizational collapse.

Despite his cuddly reputation as a philanthropist, Gates has always pursued the ideology that the world should be guarded over by monopolist-kings, dependent on their largesse (guided by their superhuman judgment) for progress.

It’s been his brand since he was a kid, excoriating his friends in the Homebrew Computer Club for working collaboratively to invent modern computer programming.

Gates’s 1976 letter to the Homebrew Computer Club

Gates’s core belief is that everything can be improved by converting it to a form of property, and then allowing the super-intelligent latent god-kings among us to monopolize it:

Some of the poorest, most populous countries on Earth have petitioned the WTO for a patent waiver to allow them to manufacture generic versions of vaccines. There’s enormous, global support for this, both from people who care about humanitarian causes and from people who just don’t want to die of a mutant strain incubated half a world away. You don’t have to be a latent god-king to recognize the problems of a swimming pool where only one end has a “no pissing rule.”

The very idea of this is an affront to Gates and his ideology. Small wonder, then, that he and his foundation are peddling the racist lie that patents aren’t the reason that poor countries aren’t making their own vaccines — instead, they are simply not “developed” enough to do science (again, the world’s largest existing vaccine factories are in the Global South).

The Foundation’s talking points have been picked up by pharma shills in D.C. and their allies. Howard Dean, one-time “liberal lion,” now a lobbyist for Big Pharma, has had this lie in heavy rotation:

As has the pharma industry writ large, with over 200 paid lobbyists in D.C. pushing against a WTO patent-waiver. As with Dean and Gates, these pandemic profiteers say that the issue of patents is a “distraction” because poor countries simply lack the wherewithal to use them.

They’ve got some strange — if predictable — bedfellows. The industry associations representing the Big Four movie studios, the Big Three record labels and the Big Four publishers have cosigned an objection to the WTO patent waiver, peddling the nonsensical line that this will endanger movie studios, novels, and pop music (no, really).

So, is it a lie? MRNA vaccines are super-new tech. Maybe their manufacture is so esoteric that only the richest, most powerful countries can make them?

Nope.

“Rapid development and deployment of high‐volume vaccines for pandemic response” (DOI: 10.1002.amp2.10060) is an open access, peer-reviewed paper in the American Institute of Chemical Engineers’ Journal of Advanced Manufacturing and Processing.

Its co-authors are an interdisciplinary team of chemical engineers, infectious disease specialists and vaccine specialists from Imperial College London and the International AIDS Vaccine Initiative.

The authors aren’t specifically addressing themselves to the question of global development of mRNA vaccine production, but are instead concerned with any kind of generic ramp-up in production — either in response to a new virus, or because of an mRNA-based vaccine breakthrough for an existing virus. They reason that any kind of annual covid shot will occupy the majority of existing mRNA vaccine production facilities, so any new global vaccination project will require that new production sites be built.

To that end, they’ve devised a process for building factories that can turn out mRNA vaccines at scale [emphasis mine]:

Based on our techno‐economic assessment, the RNA vaccine production process can be two to three orders of magnitude smaller than conventional vaccine production processes in terms of facility scale, and can be constructed in less than half the time with 1/20 to 1/35 of the upfront capital investment, as shown in Figure 1B. It therefore presents a strong advantage of requiring small‐scale, high‐capacity facilities, which can be constructed more rapidly and could make wide use of single‐use disposable equipment. Due to its small scale, the RNA vaccine drug substance production process could be placed in a small part of an existing conventional vaccine facility, for example in a room, and still produce more doses worth of drug substance than the entire original conventional vaccine production facility. To rapidly establish such an RNA vaccine drug substance production line, off‐the‐shelf single‐use equipment can be used to build the entire process. Once such a process is established and validated based on readily available single‐use equipment, the technology can be transferred to other facilities for scaling out purposes, thereby reducing process and quality control design and development timelines and streamlining validation and start‐up activities.

Moreover, the RNA vaccine platform technology offers the flexibility of producing a very large range of vaccine products using the same production process, quality control system and facility, rapidly and at high capacity. Therefore, the production of new vaccines can be achieved around 10× faster compared to conventional vaccine production technologies, as shown in Figure 1C. In such a scenario, the cost of an RNA vaccine drug substance manufacturing facility, besides scale also depends on the grade of the clean rooms or required containment level. If the RNA production can take place in a closed system,[48] then lower grade facilities and rooms can even be used, which would cost substantially less to construct, operate and maintain compared to high grade clean room containing facilities, of course, following the appropriate regulatory and compliance guidelines.[49]

I know, I just blockquoted all of that, so it would be redundant to bullet it below, but JESUS FUCKING HOLY GODDAMNED SHITBALLS, does this ever bear repeating:

  • New facilities will be 99–99.9% smaller than conventional vaccine facilities
  • They will be 95–99.7% cheaper than conventional vaccine facilities
  • You could use a single room in a conventional vaccine factory to make more vaccine doses of mRNA vaccines than the entire output of the rest of the factory
  • New vaccines can be made 1,000% faster than previous vaccines

There’s more, like the fact that you only need part of the facility to be a high-spec clean-room, and the rest can be built on more conventional lines.

For $20m, they say they can build a facility where, for $100m/year, they can turn out 1b doses/year, using a single 5L bioreactor.

Wanna try your hand at Sim mRNA Factory Operator? Here’s their Superpro Designer files on Github:

They mention some important caveats, like none of this solves the problem of clinical trials, material pipelines, or distribution — except to the extent that you could more easily produce samples for trial, factories that are closer to the materials, and ease distribution through widespread manufacturing (they mention some serious cold-chain logistics savings here and that’s a very big deal, too).

This is nothing short of amazing. It’s Clarke’s Law/indistinguishable-from-magic amazing. The kind of gains we’re used to seeing in things like GPUs and solid-state drives, but it’s nanoscale chemistry.

This is the dividend of patient, large-scale, long-term public funding into basic scientific research. It did not come about as a result of a pharma monopolist betting that they could make a buck off of the risk of human extinction.

The world can’t afford to be half-vaccinated. MRNA vaccines are miraculous, but not just because of how fast they are to develop and how quickly they can be produced — they’re miraculous because this publicly funded know-how can be replicated around the world, ending Vaccine Apartheid forever.

Biotech is not the exclusive realm of rapacious monopolists. Cuba is a biotech powerhouse, and has five vaccines in production, two in Stage III trials. They got there by building a cooperative vaccine sector based on knowledge sharing and open science. The Cuban state — like the American state — has contributed significantly to that science, but with a key difference: the dividends from those contributions are part of our common scientific heritage. That’s what real “philanthropy” is — not enclosing the commons on behalf of a monopolist who needs to be bribed to spare his neighbors from civilizational collapse.

Cory Doctorow (craphound.com) is a science fiction author, activist, and blogger. He has a podcast, a newsletter, a Twitter feed, a Mastodon feed, and a Tumblr feed. He was born in Canada, became a British citizen and now lives in Burbank, California. His latest nonfiction book is How to Destroy Surveillance Capitalism. His latest novel for adults is Attack Surface. His latest short story collection is Radicalized. His latest picture book is Poesy the Monster Slayer. His latest YA novel is Pirate Cinema. His latest graphic novel is In Real Life. His forthcoming books include The Shakedown (with Rebecca Giblin), a book about artistic labor market and excessive buyer power; Red Team Blues, a noir thriller about cryptocurrency, corruption and money-laundering; and The Lost Cause, a utopian post-GND novel about truth and reconciliation with white nationalist militias.

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