How can enough Covid-19 vaccine be made quickly for 7.8 billion people and should New Zealand produce its own vaccine?
Finding a Covid-19 vaccine is only one part of the challenge facing the world. A potentially bigger challenge is making billions and billions of doses.
Most vaccine companies can produce millions of doses, or even hundreds of millions of doses a year. No company at present could pump out 7.8 billion doses in a hurry.
It’s not as simple as building a huge manufacturing plant while scientists toil and trials are underway. A vaccine using RNA technology will need a different set-up to a vaccine using inactivated virus.
Another unknown is how many doses of a vaccine might be needed per person. It might be one dose, or it could be three. People who have recovered from the virus can’t be ruled out of the equation either. Little is known about how long any immunity lasts. It’s possible they may need a booster shot.
As the Malaghan Institute’s director of research, Professor Graham Le Gros, points out: “If it’s a three-shot thing, then do the numbers.”
Doing the numbers shows it’s a daunting 23.4 billion-dose problem.
Like other New Zealand scientists and medical experts who signed an article in the New Zealand Medical Journal calling for us to have our own vaccine programme, he’s worried about how long the wait for a vaccine to reach our shores could take when billions of people want the same thing.
“We’ve got the skills, the talent and the infrastructure to develop a vaccine really quickly. We’ve just got to choose the right one, get it into production, design it right away and get on with it.”
What’s going on globally
Some worldwide investment is being made to scale-up manufacturing capability.
Johnson & Johnson is involved in a $1 billion partnership with a United States biomedical government agency. If their vaccine is successful, some of the funds will be used to increase manufacturing capability to produce a billion doses a year.
Billionaire Microsoft founder and philanthropist Bill Gates is prepared to lose cash. He told The Daily Show the Bill and Melinda Gates Foundation is funding the upscaling of seven different facilities aimed at different vaccines. He expects perhaps two of the projects he’s backing will be needed.
“It’ll be a few billion dollars we’ll waste on manufacturing for the constructs that don’t get picked because something else is better. But a few billion in this situation we’re in, where there’s trillions of dollars…being lost economically, it is worth it.”
Even with the investments being made, billions of doses of a vaccine can’t be whisked up as soon as a vaccine is approved for use.
Some people will be vaccinated first, others will need to wait. While the World Health Organisation would like access to vaccines to be equitable, there’s no international framework in place to make this happen for a coronavirus vaccine.
Already there are murmurings of the potential for vaccine hoarding.
CureVac, a German business developing a vaccine in cooperation with a publicly funded German institute, is denying it received an offer of purchase from United States President Donald Trump to secure exclusive rights to a vaccine being developed.
The rumoured offer was condemned by German ministers. Despite denials, the CEO of CureVac, a U.S citizen who was reportedly approached by Trump with the offer, was swiftly replaced by the company.
Compulsory licensing
There is a World Trade Organisation agreement, TRIPS (trade-related aspects of intellectual property rights), which could be called into effect should exclusive rights and hoarding be an issue.
The agreement includes the ability for the compulsory licensing of pharmaceuticals. This is when a government allows someone else to produce a patented product or process without the consent of the patent owner.
In theory, this could mean if a country comes up with a successful vaccine but isn’t able to produce enough to satisfy demands, another country could use the same vaccine ‘recipe’ themselves in their local production facilities for their own population.
Reasonable payment would still need to be made to the patent holder, but this approach could shortcut a long wait for orders.
Theory and practice are different things, however. Copying a vaccine isn’t as easy as following a recipe to bake a loaf of bread. Most are closer to trying to make sourdough, which needs a starter culture.
Often a cell line is needed. This means the development process would need to start from scratch but it would be like trying to start after lockdown commenced and when supplies are scarce.
New Zealand should start now
South Pacific Sera’s production director Dr William Rolleston has a different analogy for the hope that compulsory licensing is the answer.
He thinks trying to replicate somebody else’s vaccine using the TRIPS compulsory licensing agreement would be like “having the training methods without the racehorse”.
Breeding and raising the racehorse would chew up precious time we could be putting to good use now by working on development.
His biotechnology company could produce some – but not all – types of vaccines.
“It doesn’t mean we could just switch them on. We have the physical buildings, we might need to put some equipment in, and validate it all, but we have that possibility.”
He put this in a letter to the Prime Minister, Jacinda Ardern, just over a month ago, saying subject to current customer and regulatory requirements its services are at the nation’s disposal.
Rolleston has received phone calls in response seeking detail on South Pacific Sera’s capabilities, but no request for help as yet.
In the meantime, he’s been trying to assist other local entities with their vaccine research so if they’re successful their efforts might end up in clinics and not just be of academic interest.
“We’re working with them so when it comes to manufacture they haven’t slipped up from a regulatory point of view. The regulations are really, really tough. If you get it wrong at any stage, it’s back to square one and you can lose months.”
University of Otago associate professor James Ussher, who was pivotal in the published call for a New Zealand vaccine, wants to get a conversation going and “move things along”. The Medical Journal article points out the tourism industry is worth $17 billion a year to the country. A vaccine would contribute to human and economic health.
He says there’s both the capability for New Zealand scientists to create a vaccine, and to manufacture one to contribute to global efforts.
With some infrastructure investment, he sees three different vaccine technologies New Zealand could pursue: an inactivated virus vaccine, a protein-based vaccine or a viral vector vaccine.
“Those three could be implemented in New Zealand with varying degrees of investment required.”
When asked what the response from the Government had been, there’s a pause: “Discussions are in progress.”
Le Gros isn’t waiting for discussions.
“We’re just getting on with it. We anticipate people will wise-up with time.”
He’s confident if a proven technique is used, rather than experimental RNA or DNA approaches, New Zealand could even lead the vaccine race. His preferred vaccine type for this virus is a spike protein vaccine.
“It’s a standard, non-fancy way to make a vaccine. We’ve got very good skills to do that here. We should learn from all the other issues people are revealing and put it into our vaccine design and we’ll finish first.”
He doesn’t doubt, with this approach that there’s local capability to manufacture a vaccine.
“We’ve been trying to hammer away at the Government and say,’ look guys, get it together’.”
He worries the reason for the official reticence is an aversion to risk and a reliance on solutions coming from offshore. He also thinks there’s a lack of belief in local capabilities.
He points out New Zealand is working with CAR T-cell cancer therapy.
“That’s top shelf stuff. We’ve done that in New Zealand, so surely we can make a bloody coronavirus vaccine.”
