Ebola Vaccines, Justice, and the crazy confluence of life imitating art

Eleven years ago, in the wake of potentially the hardest month of our lives (death of our dearest friend, separation from our kids, staring down our own mortality as we waited through 21 days of Ebola incubation), I wrote a book for our kids that helped us all honor Dr. Jonah's sacrifice and process our own grief.  Last Fall, it was published. The plot involves a hemorrhagic virus, political corruption and intrigue, potential immunity, risk, friendship, mystery.  I know I'm not objective but it's actually a good read. ( I wish more people would buy it and read it, but I'm stymied on how to promote that . . . . message me if you have an address for me to send copies to anyone famous . . . ).

officially enrolled, standing outside the doors of the NIH

Tuesday, Scott and I drove to the NIH in Bethesda, Maryland, where we were enrolled in a trial to study the newest attempt at an Ebola vaccine. VSV-EBOV was developed by a scientist hired in the Canadian public health system. Like many advances in science, this one came from alertness to unexpected results. Because Canada 20 years ago lacked adequate high-security biocontainment laboratory facilities, while such level-4 labs were in process Dr. Feldman used a safer method of studying Ebola.  He attached an Ebola glycoprotein to an unrelated virus called VZV, vesicular stomatitis virus, a virus not particularly dangerous to humans that caused disease in sheep and cows. He was infecting mice with this modified VZV-EBOV virus, and noticed that they were not getting sick. He wondered if the glycoprotein was inducing immunity, so got permission to try a real Ebola virus on the mice.  They survived. This research was picking up in the early 2000's, and post 9-11 there was renewed interest and funding for combatting bioterrorism.  The US military paid to test the potential VZV-EBOV in monkeys.  It was effective. A small US company bought the rights to the vaccine but then nothing happened to develop it for almost a decade.  The decade in which our Bundibugyo epidemic occurred, though this strain was different so the vaccine may not have helped us. Why the long dormancy? Ebola occurs sporadically, in rural African places, affecting predominantly poor and isolated populations. That was not enough to drive the market towards profitability for vaccine development.

Then in 2014-2015, an Ebola epidemic in West Africa raged out of control. There was panic that this disease would spread out of Africa. It became clear that a larger company would need to buy the vaccine rights to move forward on testing and development. Merck bought the vaccine, and GAVI stepped in to push development forward. Pharmaceutical companies are profit-driven entities, and there is not much profit in Ebola. I know that many people put faith in the free market to solve our problems, but in this case we would NOT be where we are today without GAVI. GAVI is an organization seeded with funding from the Bill and Melinda Gates foundation that now includes dozens of other private foundations and national entities, a massive alliance to bridge the gap between need and profit.  Simply by infusing 5 million dollars into Merck to get the vaccine up and running for clinical trials, and promising up to 300 million dollars into the future, we went from a monkey-experiment to viable human use. By the time they were able to field test, the massive multi-country West African epidemic was nearly over, and those trials were not sufficiently powerful to prove the vaccine's effectiveness. However the capacity was now primed to be ready for the next disaster. GAVI continued to push behind the scenes from 2016-2018, actually quite remarkably they went against their own policy in order to fund a vaccine that was not yet licensed.  When Ebola was confirmed in North Kivu province, Eastern DRC, on August 1, 2018, they were ready.

This epidemic is not showing signs of control yet

Over the last ten months 122,695 people have been vaccinated in a ring strategy: once a diagnosis is confirmed, all the contacts of that person then all their contacts are vaccinated. Initial results from this epidemic show 97.5% efficacy for this vaccination, though it takes about ten days to see immunity so the post-exposure strategy has some drawbacks. Health care workers have been immunized in the region pre-exposure as well. The VSV-EBOV vaccine still has not been adequately studied for licensure: dose, duration of immunity, need for a booster dose, safety in children and pregnant women, etc. are all unanswered questions. Our Serge medical workers in DRC and Uganda received the vaccine, but we sadly missed the moment when it was being offered. The hospital where we work is probably the closest in Uganda to the DRC border, about 60 miles from Beni and 100 from Butembo/Katwa, the disease epicenters, with thousands of people crossing the borders and dozens of alerts for potential cases we have felt both vulnerable to exposure, and awed that none has yet occurred. We assumed that if a case was documented in Uganda, we would be offered the vaccine then, and hoped it wouldn't be too late.

the location of the disease does not inspire action . . . this is a close-up of the DRC-Uganda border zone. We live in the whitish grey area just above the top blue line

Darker maroon = more poverty. Note DRC and Madagascar . . 

However, even GAVI support and good testing results and 1877 cases with 1248 deaths demonstrating need are not enough to overcome the "opportunity cost" for Merck to devote more factory time to Ebola vaccine production. As they clearly state, there just may not be enough money in it for them. Generally the insecurity in Eastern DRC (132 attacks on health facilities over 10 months killing 4 and wounding 38) also produces some victim-blaming and hand-up-in-the-air-what-can-we-do disinterest. If the market is only governments and NGO's, and the ongoing potential is limited, they just might not scale up. So a couple of weeks ago, it was announced that going forward vaccine dosing would be cut in half or quarter. Having already faced Ebola in Bundibugyo (both of us) and Liberia (Scott) with no vaccine, and knowing there is a very effective vaccine now, we decided to pursue a back-door option.

The National Institutes of Health here in the USA are studying the VSV-EBOV, and graciously agreed to enroll us.  We had to spend a day at the main hospital, having blood drawn (9 tubes each!!), a physical exam, signing consents, waiting for the live-virus (the animal mouth-sores one that carries the Ebola protein, not an actual Ebola virus) to thaw from its storage at negative-60 degrees, then being injected with the very painful solution. The next 48 hours were a bit rough for me, basically like the flu with aches, fatigue, and a pretty high fever. Now we will return in 30 days for titres, then every time we are in the USA for more to follow our immunity over time. At 18 months we will be randomized to get a booster or no booster. This will help governments like the DRC or Uganda, and international organizations like the WHO or UNEPI, decide whom to immunize, when, with what dose, and how often.

About to be jabbed

Probably more than you wanted to know about Ebola vaccines. There are a dozen more in earlier stages of development. But I found the story instructive. Science is driven by brilliant people paying attention to incongruity, but it only moves forward with financial support. The original researchers were working in the public health lab, but they patented and sold their method. The geographical and economic gap between disease and the capacity to address it means that pure market forces will not lead to the capacity and innovation that the majority world needs. If HIV/AIDS had not spread in the American blood supply and gay community, would we have the incredibly effective medications we do today? Most likely not. For majority-world problems that actually harm/kill/lose years of life on the most massive scale, we need the kind of public-private partnerships that are driven by justice and not just by self-interest and profit. The global connectedness means that a dedicated research nurse in Bethesda, Maryland, who took time to listen to our story and accommodate us in a trial, can be impacting the course of an epidemic ten thousand miles away. GAVI just approved another $9million for this epidemic response. There are good people making good decisions out there, which gives us all hope.

A decade ago, a vaccine for Ebola was a dream in a book. Now we actually got one.  Amazing.