How to make a vaccine: it’s complicated ...
A vaccine is widely seen as the best hope for ending the Covid19 pandemic, so finding one is currently the holy grail of medical research. But the science, logistics, business and politics of developing vaccines are highly complex.
To find out more about what’s involved in the development of vaccines, Joanna Bostock spoke to Dimitri Eynikel, an advisor on access to medicines for Médecins Sans Frontières.
Who’s involved in current efforts to develop a vaccine for Covid19?
For the coronavirus vaccine there are at least 108 vaccines being researched or developed at the moment. Most of them by one or more companies or a company and a public institution working together, so it’s pretty hard to draw the line between an academic and a private venture.
Are universities and the pharmaceutical companies doing the same research?
It’s rare that a pharmaceutical company will do some early basic, scientific research into a disease or a virus, this usually happens at public institutions like universities which develop some leads, some discoveries, or technologies which can potentially be used, and they sell them to pharmaceutical companies.
A vaccine consists of several components: a host cell, some DNA, some RNA, maybe some adjutants that are being used in different technologies to process and develop a vaccine. Several of these components and technologies are potentially used by different partners or different companies, so all this technology, all this knowledge, all the science have to come together somehow. This is why companies often work together, or public institutions and private companies work together on the development of a vaccine.
With so many actors involved, who owns the property rights over the final vaccine?
It often ends up being one of the large pharmaceutical companies, which have the deepest pockets. They have the means, when they see the potential in research and technology, to make financial arrangements with all the other actors involved to buy out their rights or to get access to these technologies, to test those vaccines for efficacy and safety and then to manufacture and distribute them. So although they are the ones holding the rights, they may not necessarily be the ones who made the most important discoveries.
How much competition is there?
The stakes are quite high, there’s a large interest in being the first to develop and bring a vaccine to the market. It’s quite likely this disease will stay around for a long time; it may become endemic. So initial sales are going to be for the entire planet, there’s going to be a global need, and after that it’s going to continue to be sold for the rest of our lives probably, there will be a need for this vaccine. So anyone who is the first to claim they made a significant discovery and patent it an indeed bring that product to the market can make potentially very large revenues.
How much money goes into the development of a vaccine?
We don’t know for sure because pharmaceutical companies tend to shield quite well how much it really costs to do research and development, because it helps them in the end to set a price without being too accountable. They can often say that research and development costs are very high, and this justifies high profit margins or a high price for certain products without having to show the real numbers. There’s a lack of accurate data on this, but it is significant that a research consortium, the Coalition for Epidemic Preparedness Innovations has just asked for a pledge of two billion dollars for the research and development, plus support for manufacturing and distribution, of three vaccines. That gives us some indication of how much money is involved.
Why does it cost so much?
It’s a very lengthy process with a lot of actors, technologies, high-tech equipment and components involved. It also needs lengthy clinical trials with large groups of people who need to be tested with this vaccine. That means they will have the vaccine administered to see how they react to it, whether it really functions, whether it’s safe, that there are no adverse reactions. So, it’s definitely a costly effort.
Should pharmaceutical companies get funding from the state?
That’s a good question. In theory, large pharmaceutical companies could potentially finance the development to a large extent by themselves, but the reality is that public funding helps to correct a business failure.
What we saw for example after the Ebola outbreak in 2014 is that despite there having been significant scientific progress in the development of a vaccine for Ebola, it was not developed further by pharmaceutical companies because there was no commercial interest. It was a sporadic outbreak of the disease, they had very little commercial interest to invest a lot of money in the development, knowing that it could potentially never work or would not have been safe, so they didn’t take if further.
For the Coronavirus it’s quite similar. Scientists have long been warning of the risk of a Coronavirus epidemic or pandemic, but companies have not really invested in it because you don’t know if there really WILL be an epidemic and therefore if you will ever be able to sell your product.
This is why public funding is interesting – to make sure that we all, as a society, invest together to make sure we have the products we need, to address those needs and to correct the lack of commercial interest. It is important that we ask for some guarantees in return so that if there is a large amount of money being invested by the public, that we also ask for some conditions with regards to who owns the rights, how it will be manufactured, ensuring sufficient supplies, and who sets the price.
That would suggest that things that are so important for public health shouldn’t be a purely commercial venture to begin with...?
That’s our view as well. There’s a shared responsibility to address these needs where definitely the private sector has important expertise, manufacturing capacities etc. This is precisely where we have questions regarding the final ownership of the products and the decision-making over where they will be made available and the price, because production is a key issue. Usually companies receive patents on vaccines or medical tools, which means they alone have all the rights to produce and distribute these medicines, in this case a vaccine. But which company can produce enough quantities in a short period of time to meet global demand in this case? We really need to look at ways in which we can seek collaboration and ensure that there’s going to be manufacturing across the world by different companies or institutions to meet this huge demand.
Recently the European Commission announced that world leaders, international organisations and companies have pledged €7.4 billion to develop new tools to detect, treat and prevent the novel coronavirus. What’s your reaction to this?
It’s very welcome that countries are coming together to ensure that there is the necessary research and development of vaccines, treatments and diagnostics, because all these tools are urgently needed. However, it is also important that we understand what the financial arrangements are.
€7.4 billion Euros is supposedly just the beginning because the pledging will continue, and that means there must be accountability: what will the financial arrangements with private partners receiving this money be? What will the arrangements be for production? Where will the vaccine be made available? Who will set a price? If so much money is being brought in by the public sector, who will have the ownership rights for these products?
These are all very important details that we need to sort out. In the past there have been difficulties with many medicines that were priced out of reach for patients, where a lot of public money was involved. So, we need to make sure that this cannot happen when such amounts are being pledged. There has to be accountability, transparency and because the money is coming from all corners of the world there has to be a governance structure in which all these forces are brought together, low income countries, high income countries, private partners, and civil society; we all need to be able to see what arrangements are being made.
Publiziert am 15.05.2020