The Devil is in the Details: A new stockpile for Ebola vaccines
Julien Potet, MSF Access Campaign Policy Advisor, NTDs and Vaccines
As vaccines against the coronavirus begin to be rolled-out around the world — albeit almost exclusively in rich countries for the moment — there is another piece of good news about a vaccine against another terrifying viral disease — Ebola.
This week brings the launch of an international stockpile of effective Ebola vaccines. It is to be managed by the International Coordinating Group on vaccine provision (ICG), under the auspices of the World Health Organization (WHO), with MSF participating as a member of this group.
This is positive overall, and could save many lives, but sometimes, as we know in the access to medicines movement, the devil is in the details. And some of the details in this week’s announcement are not so great and should give us pause for thought before throwing our collective hats up in the air.
So, let’s start with the good part. The ICG is committed to shipping doses of the vaccine to countries in need within seven days of a request being submitted. And that’s because the stockpile is primarily meant to vaccinate communities during outbreaks, and not to provide vaccines during inter-epidemic times. This commitment means the vaccines should arrive in time to contain a nascent outbreak.
However, there’s already a caveat here, because the only vaccine in the stockpile right now is the vaccine Ervebo (aka rVSV-EBOV), marketed by the pharmaceutical company Merck. It certainly is a very efficacious vaccine, but it has a major drawback in that it requires an ultra-cold chain to stop it from spoiling. That means the vaccine has to be stored — just like the Pfizer COVID-19 vaccine — at incredibly low temperatures of -70°C, and then for no more than two weeks at 2–8°C when deployed. This is likely to present severe logistical challenges for implementers in the places where the vaccine needs to be rolled out — at least given where the outbreaks have taken place to date — in countries in West, Central and East Africa.
There is another licensed Ebola vaccine (Zabdeno/Mvabea, aka Ad26.ZEBOV/MVA-BN-Filo), marketed by the pharmaceutical company Johnson&Johnson (J&J), which is not included in this agreement. J&J’s vaccine can be stored at conventional refrigerated temperatures (2–8°C) but it requires two doses to be given 56 days apart, and therefore is not optimal for reactive vaccination during outbreaks, where speedy protection through full vaccination is absolutely essential to contain the spread of infection.
Now for the more problematic aspects of this deal. The target size of the ICG/WHO stockpile is 500,000 doses, but it will actually take several years before this target is reached. It will start with just 6,890 doses in January 2021. That’s all. We will just have to hope there’s no serious Ebola outbreak in the coming months…
So why is vaccine supply running so far behind the ambition of the agreement? There are a couple of factors here. I suspect Merck is still struggling to ramp up production in its dedicated facility in Germany. Short supplies of the vaccine in 2019, while an outbreak was raging in Nord Kivu in the Democratic Republic of Congo (DRC), led WHO at that time to recommend the use of fractional doses of vaccine.
A second factor is that there is another customer in the mix to satisfy, namely the US Strategic National stockpile. We don’t know how the available doses have been divvied up between the two stockpiles, but it would be helpful to understand what’s happening here in more detail to shed light on potential supply shortfalls to the ICG/WHO stockpile. It’s clear that the priority should be given to stockpiles destined for African countries, given that the risk of outbreak is much higher in this region of the world than anywhere else.
In fairness, over the last few years, the US Biomedical Advanced Research Authority (BARDA) has donated doses to the government of DRC to control outbreaks. We are hopeful that this collaborative spirit will continue to prevail if ever there weren’t enough doses in the ICG/WHO stockpile to contain an ongoing outbreak in Africa.
Now, let’s get to the finances. The stockpiled ICG/WHO vaccine doses are paid for by Gavi, the Vaccine Alliance. Gavi will distribute a total of US$178 million for its Ebola vaccine programme for the period of 2020–2025. It’s a welcome move, but Gavi donors may want to reflect on that sum, because the price agreed works out to be a staggering $98.60 for a single dose!
Maybe there is an explanation for this, but my colleagues and I at MSF cannot find a clear justification for this high price Merck is charging. It is true that the number of doses produced annually will be fairly low, hence the admittedly limited economies of scale. But almost $100 for a single dose? — that’s a crazy price, particularly given the vast amount of public money that was invested in the development of this vaccine.
A bit of history is needed here: the development of Ervebo was heavily supported by funding from not-for-profit foundations and the public sector from the start. The vaccine was actually discovered and developed by research teams affiliated with, and therefore funded by, the Public Health Agency of Canada. Additional funding of more than $119,000,000 came from the US government from 2008 to 2016. Finally, the pivotal randomised clinical trial demonstrating the clinical efficacy of the vaccine was primarily designed and implemented by WHO and the government of Guinea in 2015 and 2016.
So, it’s abundantly clear that only a (small) portion of the total development costs for this vaccine was shouldered by Merck. This makes it very hard indeed to see how the corporation can justify charging such an eyewatering price for the vaccine — donors to Gavi at least should take a much closer look at the finances of this arrangement that they will have to pay for, to learn lessons for the future if this deal cannot be improved upon.
Tracing the chequered story of the vaccine back further, we should remember how NewLink, a tiny US-based company, first licensed the vaccine from the Canadian government in 2010 for just $200,000. The company did absolutely nothing to advance the development of the vaccine and instead left it on the shelf, finally selling the license on to Merck for $50 million in 2014, whilst the West African Ebola outbreak was raging. This is profiteering at its worst. And the waste of human lives that resulted from this saga of neglect is devastating.
So this week’s announcement is a bit of a mixed bag. On the plus side, we at last have a good vaccine for Ebola in an international stockpile that can rapidly be deployed in times of need. On the down side, there might not be enough doses in 2021 to protect people, should a significant outbreak occur in Africa. And the agreement struck between Merck and Gavi is most definitely not a great example of price fairness and market shaping.
For a sustainable future, African countries need to be able to purchase a fairly priced and truly affordable vaccine for Ebola to protect against a repeat of the terrible loss of lives in the outbreak in West Africa in 2014–2016. “Never again,” we said. So, let’s make sure that we learn from this episode, and redouble our efforts to ensure that people, not profits, come first in the development of new vaccines.