By Seth Berkley
The current Ebola outbreak in the Democratic Republic of Congo is a cause for serious concern. It has already taken the lives of 25 people, and the disease has spread to the provincial capital Mbandaka, a city of more than one million.
But this time we have a new weapon to add to our arsenal in the fight against Ebola – a vaccine. Already, 300,000 investigational doses are available despite the fact that this vaccine, though proved to be safe and effective in clinical trials, is yet to be licensed by regulatory authorities.
These vaccines will not end the outbreak by themselves – they are part of a far larger national and international effort which will be crucial to containing the disease. However, the fact that they are already being used as an integral part of the response marks a historic first.
One of the central issues with vaccine development and supply is that it is not driven by the risk a disease poses, but rather by economics. The size of the potential market matters more than the scale of devastation a disease can cause.
Ebola is no exception. This disease is among the deadliest in existence, with mortality rates that can be as high as 90%, and no licensed treatment available. In fact, I gave a TED talk on this challenge in 2015 and held up two Ebola experimental vaccines on the TED stage, one of which is the vaccine currently in use.
Yet in the four decades between Ebola’s discovery and the 2014 West Africa outbreak, there were just a few thousand cases in some of the poorest countries in the world. There was no incentive to take a vaccine through the lengthy, costly licensing process needed for public use. Though researchers developed several promising Ebola vaccines, none left the laboratory.
The West Africa outbreak was as a wake-up call. As the disease rapidly spread from Guinea to Liberia and Sierra Leone, raising alarm in capitals across the world, the need for an effective, approved vaccine had never been more pronounced.
In August 2014, the same month that the WHO declared Ebola to be a public health emergency, Canada’s federal government donated a vaccine for use in Africa that it had researched for biodefense purposes. The Public Health Agency of Canada licensed its manufacture to NewLink Genetics and eventually to Merck.
In 2015, this experimental vaccine, called rVSV-ZEBOV, was tested in Guinea where health officials, together with the WHO, the Norwegian Institute of Public Health, MSF and Health Canada, implemented the “Ebola, ça suffit” (“Ebola, that’s enough”) vaccination trial. Almost 12,000 people who had come into contact with someone who had shown symptoms of the disease were vaccinated in a ring vaccination approach either immediately or after 21 days.
Guinea was declared Ebola-free on 29 December 2015. The trial ended in January 2016, after the final participants had completed their 84-day follow-up. The vaccine proved to be well tolerated and, most importantly, showed a point estimate of 100% efficacy [95% C.I. 79-100%].
Although it was too late for it to contribute fully to the response in West Africa, there was hope that the vaccine could help stop an outbreak of this size from ever happening again.
But, as attention shifted away from Ebola and onto the next global crisis, there was a real danger that the rVSV-ZEBOV vaccine could end up stalled in the licensing process for years, leaving the world exposed to another major outbreak.
So in 2015, my organization, Gavi, the Vaccine Alliance, made a unique offer to all manufacturers that had a vaccine in Phase I clinical trials and beyond. We offered a pre-paid commitment to buy doses of licensed vaccines as and when the vaccine becomes available, confirming to the manufacturers that there was a guaranteed market for an effective Ebola vaccine.
In return we set three conditions: that the manufacturer submits an application for licensure by a set date; that they receive a special classification from the WHO that would allow it to be used in case of a public health emergency; and, most importantly, that they make a stockpile of investigational doses available in case of an outbreak while the vaccine is going through the licensing process.
In January 2016, we announced at Davos that Merck had agreed to our terms. An advance purchase commitment of $5 million – the first of its kind – was signed. Hailed as a “bold step” by Merck’s Executive Vice-President and former CDC Director, Dr. Julie Gerberding, this agreement meant that 300,000 investigational doses of the rVSV-ZEBOV vaccine would be available, including 100,000 doses that can be shipped within 24 hours. These doses are now being used to protect thousands of people at risk in the DRC.
Too often, our response to disease outbreaks is purely reactive. It is not until people start to die that governments and aid agencies spring into action. The development and availability of rVSV-ZEBOV show that it doesn’t need to be this way.
The vaccine is the result of years of energy and commitment from Merck; the generosity of Canada’s federal government; leadership by WHO; strong support to test the vaccine from both NGOs such as MSF and the countries affected by the West Africa outbreak; and the rapid response and dedication of the DRC Minister of Health, who was vaccinated this weekend, sending a signal of trust. Without these efforts, it is unlikely this vaccine would be available for several years, if at all.
The Democratic Republic of the Congo Minister of Health Dr. Oly Ilunga Kalenga receives the Ebola vaccine
The agreement between Gavi and Merck was one of many factors following the West African Ebola outbreak which helped rally governments and aid agencies around the importance of global health security. This resulted in the creation of a new organization, the Coalition for Epidemic Preparedness Innovations (CEPI), which was launched at Davos the following year. CEPI is now working with the private sector to incentivize the development of a host of new vaccines for diseases that could become the next epidemic, from Nipah virus to Lassa fever.
I am immensely proud that Gavi played its part in making this vaccine available. I was honored to witness the very first vaccination in Mbakanda last week, and more take place in Bikoro and Iboko this week. We must now hope that the vaccine can play its part in stopping this outbreak from becoming another pandemic.
Seth Berkley is CEO of Gavi, the Vaccine Alliance, and was formerly with the U.S. Centers for Disease Control and Prevention and the Rockefeller Foundation.
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