Ebola Vaccines: Why Clinical Trials Are Just the First Step

With clinical trials for Ebola vaccines now under way, and with governments and manufacturers stepping up to fund them, there is an almost palpable sense that the panic is over and the problem solved.

With clinical trials for Ebola vaccines now under way, and with governments and manufacturers stepping up to fund them, there is an almost palpable sense that the panic is over and the problem solved. The reality, however, is that even if a safe and effective vaccine emerges and the epidemic is brought under control, we are still in many ways no better prepared for future outbreaks than we were a year ago.

So how is it that we can spend billions of dollars every year keeping fleets of nuclear-armed submarines permanently patrolling our oceans, to protect us from a threat that will almost certainly never happen, and yet invest virtually nothing into the prevention of something as tangible and evolutionarily certain as virulent infectious disease?

Even now, with more than 5,000 people dead and 14,000 confirmed cases of Ebola in eight countries, it is still not clear who will pay if, or when, a vaccine becomes available. Millions of doses will be needed, and not just to help end the current epidemic but also, crucially, as a stockpile to prevent future outbreaks from getting out of control.

What is now clear though is that West Africa needs a vaccine, and needs one now. Modeling carried out by the London School of Hygiene and Tropical Medicine, on behalf of the World Health Organization, suggests that even if the outbreak was already in decline by the time a viable vaccine becomes available, it could still help prevent tens of thousands of deaths between now and the end of 2015. And in the worst-case scenario, if the virus were to continue to spread and become endemic, this figure could rise well into the millions.

The problem is that there is no market. It's one thing developing and approving a vaccine, and quite another getting it out to the people who need it the most. Just ask the 15 million predominantly poor children who still don't receive any of the basic vaccines that you and I take for granted.

It can take a billion dollars to bring a vaccine to market. Yet with diseases like Ebola, which kills ferociously but occurs sporadically, usually with only a few hundred cases every few years, and in poor African countries that can ill-afford to pay top dollar, manufacturers would be unlikely to see a return on that investment. Even now, with the virus having reached the Western world, the financial incentives are just not there.

So with no market, even if one of these candidate Ebola vaccines receives clinical approval, we'll still be left with a significant funding gap standing between the vaccine and the people in West Africa who desperately need it. Not just in terms of who pays for the doses, but also the significant costs involved in scaling-up to commercial production, the costs involved in delivery and deployment and for stockpiling to ensure we are prepared for the next outbreak. That means making funds available to not only improve on the first wave of vaccines so that they include more than one strain of Ebola and are easier to store and use, but also to develop vaccines for other virulent diseases, such as Marburg, which also have the same devastating potential but for whom there is also no market.

Such market failures are nothing new in global health, and one of the reasons why in 2000 Gavi, the Vaccine Alliance, was created; to find innovative solutions to help poor countries pay for existing vaccines for infectious diseases, and to incentivise manufacturers to develop new ones. This has led to the development of new approaches to funding which have already proved extremely effective when dealing with vaccines for more common - and in terms of headcount far more deadly - infectious diseases, such as measles, hepatitis B, pneumonia and diarrhoea.

So in the case of Ebola, one approach we are currently considering has the potential to plug the funding gap that exists in the scaling-up of vaccine production, which would be necessary both for mass vaccination programmes and stockpiling. This could take the form of an advanced purchase commitment, where donor funds are committed to guarantee manufacturers an agreed price once the vaccine has been developed. This sort of pull mechanism could involve frontloaded incentives to make it attractive for industry to make the necessary investments to scale-up production.

Similarly it may be possible to plug the future procurement gap by using long-term flexible guaranteed funding, like the International Finance Facility for Immunisation (IFFIm), to pay for doses to be stockpiled. IFFIm currently works by using long-term government donor pledges, from a range of governments, to sell "vaccine bonds" in capital markets, making large volumes of long-term funds available immediately for vaccine programs at the point in time when funds are required.

So in theory we could have a flexible standing fund available to scale-up production, pay for vaccines, assist countries with rollout and the restocking of a stockpile when they are needed. But there is a catch. For it to work we need to change our attitude towards infectious disease. We need to stop waiting for evidence of a disease becoming a global threat before we treat it like one. If we want to prevent major outbreaks of diseases like Ebola then we need to invest in vaccine stockpiles and start viewing them as though they were nuclear submarines; willing to pay for them and at the same time praying we never have to use them.

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