Devil is in the details: A new stockpile for Ebola vaccines

As vaccines against the COVID-19 pandemic 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.

An international stockpile of effective Ebola vaccines was launched on Jan. 11. It is to be managed by the International Coordinating Group (ICG) on Vaccine Provision, under the auspices of the World Health Organization (WHO), with Doctors Without Borders (MSF) as a group member.

This is positive overall, and could save many lives; however, sometimes, as we know in the access to medicines movement, the devil is in the details. And some of the details in the recent announcement are not so great and should give us pause for thought before throwing our collective hats 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 Ervebo (aka rVSV-EBOV), marketed by the German 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 spoiling.

Just like the Pfizer COVID-19 vaccine, it has to be stored at a very low temperature of minus 70 degrees Celsius, and then for no more than two weeks at 2-8 degrees Celsius 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 American multinational pharmaceutical company Johnson & Johnson (J&J), which is not included in this agreement.

This can be stored at conventional refrigerated temperatures (2-8 degrees Celsius) but it requires two doses to be given 56 days apart, and therefore is not optimal for use as a 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.

That, of course, raises the question as to why vaccine supply is 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.

Shortages in the supply of the vaccine in 2019, while an outbreak was raging in Nord Kivu in the Democratic Republic of Congo (DRC), led the WHO at that time to recommend the use of fractional doses.

A second factor is that there is another customer in the mix to satisfy, namely the U.S. Strategic National Stockpile. We don’t know how the available doses have been divided up, but it would be helpful to understand what’s happening here in more detail to shed light on potential supply shortfalls in regard 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 there than anywhere else.

In fairness, over the last few years, the U.S. Biomedical Advanced Research Authority (BARDA) has donated doses to the DRC to control outbreaks. We can hope 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 $178 million for its Ebola vaccine program for the period of 2020-25. It’s a welcome move, but Gavi donors may want to reflect on that sum, because the price agreed works out at a staggering $98.6 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.

However, 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 non-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 million came from the U.S. government from 2008 to 2016. Finally, the pivotal randomized clinical trial demonstrating the clinical efficacy of the vaccine was primarily designed and implemented by the 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, 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 U.S.-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, while 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, the recent 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 downside, 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.

Julien Potet is MSF access campaign policy advisor, NTDs and vaccines.