When Ebola hit West Africa last year, it was a disease with no sign of a vaccine or cure. To those affected that may have been an indication that the wider world didn't care about them or the diseases that affected them, but in truth there has simply been no incentive for anyone to develop these therapies. Yet now pharmaceutical companies are racing to produce an effective vaccine, and on 23 January the British company GlaxoSmithKline shipped the first 300 doses of its candidate to Liberia to start phase II trials.
At an event in the UK Houses of Parliament to discuss the economics of developing such vaccines, Jon Pender, a vice president of GSK, said he had been surprised, in the circumstances, that companies had any possible candidates at all on their shelves which could be developed and tested. He challenged suggestions that this was just because Ebola epidemics happened in poor countries where there was little scope for profit.
A recent priority
“That isn't the reason why we don't have vaccines for Ebola. The reason we don't have a vaccine is because it wasn't a priority for anyone, and there are understandable reasons for that.... The number of people affected each year was very small and the overall disease burden, in comparison to other disease like malaria or HIV, is tiny. The fact is that in the forty years that we have known about Ebola, including the present outbreak, there have been about 24,000 known cases. There are that many cases of malaria every hour.”
Now, clearly, it has become a priority. So if it isn't just about money, how do you persuade the pharmaceutical industry to work on a normally obscure disease like Ebola? Adrian Thomas is a vice-president at Janssen Pharmaceutical Companies, which is also now working to get an Ebola vaccine to market. He says, “The first question is, what is the strength of the science? The second thing is to what extent there is a reward for innovation or a willingness to risk-share. And the third is, will we actually reach people? I think we have to understand what are the clear priorities for global health...
“Some companies do it for the reputation, others do it for the science or for alternative incentives. Other companies do it for direct financial reward, and I think you have to understand what are the different incentives that are necessary across that spectrum.”
Profit may not be everything, but the companies are not setting out to lose money. In this case they have been incentivized with public money – American, Canadian or European – to pay development costs, and assurances from the global vaccine alliance GAVI that there will be a market for any successful vaccine they produce, with up to $300 million available to pay for it.
Blank cheques
Médecins Sans Frontières has been campaigning on the high and rising price of vaccines and the lack of transparency in the pharmaceutical industry, and earlier this month it published a new edition of its campaign document, the Right Shot.
Rohit Malpani is director of policy and analysis for MSF's Vaccine Access Campaign. He told IRIN that despite substantial sums of public money poured into the development of an Ebola vaccine, very little was being demanded of the companies in return. “These vaccines are being developed with full public funding,” he says, “compensating the manufacturers for whatever investments they have to make, and for the cost of the clinical trials. Yet at this stage it is very non-transparent what the costs of development are, and not clear what guarantees there are about the outcomes and how they will ensure affordability. Governments are just writing them blank cheques.”
MSF welcomes the fact that GAVI has earmarked money to buy any successful vaccine, since that sends a signal to the manufacturers that there is a market, but thinks that GAVI should also be more demanding. Malpani says, “We are still not sure at what price it will be sold to GAVI. MSF would prefer that it is sold at or near cost. And if any cost is not covered by public funding, it's better for that to be compensated directly, rather than through higher prices for the vaccine. The idea would be to de-link the cost of development from the final price.”
GAVI negotiates lower prices for the vaccines it buys for developing countries, but it is likely that the US or European governments will also want to stockpile some of these vaccines for their own use, and they are likely to have pay more. Malpani says MSF accepts that, but remarks that “if these countries have already paid for the development, it does seem inappropriate that they should pay all over again through high prices.”
MSF is certainly not against the development of Ebola vaccines, and intends to take part in some of the phase II clinical trials, probably at its facilities in Guinea. Julien Potet, their policy advisor on vaccines, says that planning the trial has been "a bit of a moving target".
“Cases are declining a lot, and to demonstrate a protective effect is more difficult in a setting where there are limited or no cases. But we hope to vaccinate two groups - health workers because they are particularly exposed to the virus, and also to ring-vaccinate people who have been in contact or have a case in their neighbourhood. This is the plan today, but of course it could change.”
Panic has led to a lot of short cuts
Others working on the response to the epidemic have more reservations about the vaccine programme. Mukesh Kapila, professor of global health at Manchester University, has just returned from West Africa. He found the affected countries alive with all kinds of stories and rumours, and he worries that time isn't being taken to prepare people for the idea of the vaccine trials. “I am afraid they are going to think, 'Oh, all these companies are coming to test some half-baked vaccines on black people here in Africa'. And the impact might be to put off people at risk from coming to get help, because they think, 'Oh God, I'm going to be vaccinated'. When we do these trials for antibody response, it's important that we do them on white people as well as black people, partly because it is important scientifically, but also because it's important for public perception.”
More widely, Kapila thinks the rush for a vaccine may be counter-productive. “The panic associated with this epidemic has led to a lot of short cuts, with people rushing through the early phases so that human trials can start quickly. Everything may be fine, but we still don't know how effective the vaccines are going to be. Are they going to give 90 percent protection? 80 percent? Or only 50 percent? That wouldn't be enough."
Kapila told IRIN: “People are expecting a vaccine to be the solution to this epidemic and it can't be. A vaccine is no substitute for the laborious public health measures of identifying index cases, tracing and isolating contacts. By looking to a Promised Land where a vaccine is going to come and solve all our problems, we risk undermining these more important public health efforts. A huge amount of public money is going into vaccines. Once we have started we might as well finish, but I am sceptical whether it is a useful effort, on either public health or social and economic grounds.”
hb/am
At an event in the UK Houses of Parliament to discuss the economics of developing such vaccines, Jon Pender, a vice president of GSK, said he had been surprised, in the circumstances, that companies had any possible candidates at all on their shelves which could be developed and tested. He challenged suggestions that this was just because Ebola epidemics happened in poor countries where there was little scope for profit.
A recent priority
“That isn't the reason why we don't have vaccines for Ebola. The reason we don't have a vaccine is because it wasn't a priority for anyone, and there are understandable reasons for that.... The number of people affected each year was very small and the overall disease burden, in comparison to other disease like malaria or HIV, is tiny. The fact is that in the forty years that we have known about Ebola, including the present outbreak, there have been about 24,000 known cases. There are that many cases of malaria every hour.”
Now, clearly, it has become a priority. So if it isn't just about money, how do you persuade the pharmaceutical industry to work on a normally obscure disease like Ebola? Adrian Thomas is a vice-president at Janssen Pharmaceutical Companies, which is also now working to get an Ebola vaccine to market. He says, “The first question is, what is the strength of the science? The second thing is to what extent there is a reward for innovation or a willingness to risk-share. And the third is, will we actually reach people? I think we have to understand what are the clear priorities for global health...
“Some companies do it for the reputation, others do it for the science or for alternative incentives. Other companies do it for direct financial reward, and I think you have to understand what are the different incentives that are necessary across that spectrum.”
Profit may not be everything, but the companies are not setting out to lose money. In this case they have been incentivized with public money – American, Canadian or European – to pay development costs, and assurances from the global vaccine alliance GAVI that there will be a market for any successful vaccine they produce, with up to $300 million available to pay for it.
Blank cheques
Médecins Sans Frontières has been campaigning on the high and rising price of vaccines and the lack of transparency in the pharmaceutical industry, and earlier this month it published a new edition of its campaign document, the Right Shot.
Rohit Malpani is director of policy and analysis for MSF's Vaccine Access Campaign. He told IRIN that despite substantial sums of public money poured into the development of an Ebola vaccine, very little was being demanded of the companies in return. “These vaccines are being developed with full public funding,” he says, “compensating the manufacturers for whatever investments they have to make, and for the cost of the clinical trials. Yet at this stage it is very non-transparent what the costs of development are, and not clear what guarantees there are about the outcomes and how they will ensure affordability. Governments are just writing them blank cheques.”
MSF welcomes the fact that GAVI has earmarked money to buy any successful vaccine, since that sends a signal to the manufacturers that there is a market, but thinks that GAVI should also be more demanding. Malpani says, “We are still not sure at what price it will be sold to GAVI. MSF would prefer that it is sold at or near cost. And if any cost is not covered by public funding, it's better for that to be compensated directly, rather than through higher prices for the vaccine. The idea would be to de-link the cost of development from the final price.”
GAVI negotiates lower prices for the vaccines it buys for developing countries, but it is likely that the US or European governments will also want to stockpile some of these vaccines for their own use, and they are likely to have pay more. Malpani says MSF accepts that, but remarks that “if these countries have already paid for the development, it does seem inappropriate that they should pay all over again through high prices.”
MSF is certainly not against the development of Ebola vaccines, and intends to take part in some of the phase II clinical trials, probably at its facilities in Guinea. Julien Potet, their policy advisor on vaccines, says that planning the trial has been "a bit of a moving target".
“Cases are declining a lot, and to demonstrate a protective effect is more difficult in a setting where there are limited or no cases. But we hope to vaccinate two groups - health workers because they are particularly exposed to the virus, and also to ring-vaccinate people who have been in contact or have a case in their neighbourhood. This is the plan today, but of course it could change.”
Panic has led to a lot of short cuts
Others working on the response to the epidemic have more reservations about the vaccine programme. Mukesh Kapila, professor of global health at Manchester University, has just returned from West Africa. He found the affected countries alive with all kinds of stories and rumours, and he worries that time isn't being taken to prepare people for the idea of the vaccine trials. “I am afraid they are going to think, 'Oh, all these companies are coming to test some half-baked vaccines on black people here in Africa'. And the impact might be to put off people at risk from coming to get help, because they think, 'Oh God, I'm going to be vaccinated'. When we do these trials for antibody response, it's important that we do them on white people as well as black people, partly because it is important scientifically, but also because it's important for public perception.”
More widely, Kapila thinks the rush for a vaccine may be counter-productive. “The panic associated with this epidemic has led to a lot of short cuts, with people rushing through the early phases so that human trials can start quickly. Everything may be fine, but we still don't know how effective the vaccines are going to be. Are they going to give 90 percent protection? 80 percent? Or only 50 percent? That wouldn't be enough."
Kapila told IRIN: “People are expecting a vaccine to be the solution to this epidemic and it can't be. A vaccine is no substitute for the laborious public health measures of identifying index cases, tracing and isolating contacts. By looking to a Promised Land where a vaccine is going to come and solve all our problems, we risk undermining these more important public health efforts. A huge amount of public money is going into vaccines. Once we have started we might as well finish, but I am sceptical whether it is a useful effort, on either public health or social and economic grounds.”
hb/am
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