The U.S. Food and Drug Administration recently approved an important vaccine against Ebola, five years after an epidemic in West Africa killed 11,310 people and after more than 2,200 have died of it in the Democratic Republic of Congo in the last 18 months.
Alex Azar, who heads the U.S. Department of Health and Human Services, quickly congratulated his department’s funding and “American global health leadership” for the vaccine, which is called Ervebo. As recently detailed in STAT, the reality is quite different: Canadian public institutions and funding outside the United States were primarily responsible for the vaccine. Without the work of one Canadian government laboratory in particular, more lives would surely have been lost.
A search that we performed across thousands of documents obtained through a freedom of information request revealed that a small group of scientists working at Canada’s National Microbiology Laboratory in Winnipeg, Manitoba, with limited support from U.S. researchers funded by the U.S. Department of Defense, not only discovered the vaccine in 2001, but proved it safe and highly effective in animals in 2005. These Canadian scientists developed clinical-grade vaccine suitable for clinical trials, sought and obtained Canadian government funding for this research, and did all the development work.
Meanwhile, the private sector promised much and delivered little. In 2007, a small Iowa company called BioProtection Systems Corporation approached the Canadian lab to obtain rights to the vaccine in return for helping manufacture larger quantities of high-quality vaccine, conducting expensive clinical experiments, and obtaining regulatory approval.
Our analysis, published Thursday in the Journal of Law and the Biosciences, of more than 1,600 pages of Canadian government records, however, reveals that the company did little more than participate in teleconferences and meet with officials at the U.S. FDA to gain insight into the agency’s expectations regarding the vaccine.
Many scientists at the Canadian lab, facing funding and other constraints, sought greener pastures and left the lab. By late 2010, the lab contemplated halting work on the vaccine. If not for the efforts of a single scientist, Judie Alimonti — working on a nonpermanent contract — who set up a skunk works operation at the lab, it is doubtful that a clinical-grade vaccine suitable for clinical trials would have been produced.
In the end, it was a combination of funding by the Canadian government, work by Canada’s National Microbiology Laboratory, and persistence by Alimonti that made it possible for Canada to contribute clinical-grade vaccine during and following the Ebola epidemic in West Africa from 2014 to 2016.
In collaboration with the World Health Organization, Guinea’s Ministry of Health, Doctors Without Borders, and other nongovernmental organizations on the ground in West Africa and the Democratic Republic of Congo, public-sector science also designed, paid for, and carried out the clinical trials that ensured last month’s approval of Ervebo.
Far from American leadership, this was a collective effort to improve global health.
Azar’s false claim of credit matches another reality, however: It was BioProtection Systems that garnered the financial benefit from these public investments when it sold the patent rights to Merck for $50 million in 2014 at the height of the West African epidemic, and it is Merck that is now being credited for bringing the vaccine to market.
The real issue is neither the money that BioProtection Systems made nor the credit given to Merck. Rather, it is the general assumption that only the private sector can advance drug and vaccine development.
There is little market interest in diseases like Ebola that disproportionately affect the world’s poor. Still, we turn to the private sector to commercialize a vaccine on the strength of the assumption that it is better positioned to bring such therapies to market even when most small-to medium-sized biotech companies, including BioProtection Systems, have never done so and likely never will. For four years before the Ebola epidemic in West Africa, BioProtection Systems failed to deliver a single written report of its progress. And we found no evidence it ever conducted even a single scientific experiment with the vaccine.
The story of Ervebo offers several lessons. It illustrates that health research is international and that the United States does not always lead. It shows how even precarious public-sector science can do so much more than pure discovery research. It reveals how tired our approach to medical innovation has become. And it underscores growing concerns that important interventions like lifesaving vaccines may be neglected, delayed in development, or priced beyond reach unless and until we entertain alternative ways of bringing innovations to market.
Matthew Herder is director of the Health Law Institute at Dalhousie University in Halifax. Janice E. Graham is a university research professor of medicine at Dalhousie University. Richard Gold is a professor of medicine and law at McGill University in Montreal.