Canada’s efforts to develop an Ebola vaccine were hampered early on by an ineffective private-sector partner and a lack of predictable funding from Ottawa, according to a new study based on 1,600 pages of internal government documents.
The report, published Thursday in the Journal of Law and the Biosciences, is the culmination of five years of work by a trio of Dalhousie University researchers who wanted to better understand what stalled the development of rVSV-ZEBOV, a vaccine designed at Canada’s National Microbiology Laboratory (NML) in Winnipeg.
At the end of 2019, rVSV-ZEBOV became the first Ebola vaccine to be approved by regulators in Europe and the United States.
But that landmark could have been reached sooner, the authors argue, if Canada had not relied on the private sector to develop an experimental vaccine that was unlikely to turn a profit.
“Instead of celebrating this milestone,” they write of the vaccine’s approval, “our analysis raises the question as to whether rVSV-ZEBOV could have been available earlier if public laboratories had taken a different approach to the vaccine’s development.”
The study’s critical take is at odds with the plaudits that drug maker Merck, which now controls the vaccine, and its partners in the international health community have received for getting an Ebola vaccine over the regulatory finish line.
Matthew Herder, director of the Health Law Institute at Dalhousie and one of the authors of the new study, said he became interested in rVSV-ZEBOV in late 2014, when he read media stories about how NewLink Genetics, a small Iowa biotech company, had allowed development of the vaccine to languish.
At the time, the worst Ebola epidemic in history was ravaging Guinea, Sierra Leone and Liberia.
Dr. Herder and his colleagues, Janice Graham and Richard Gold, filed a Freedom-of-Information Act request in late 2014 asking the Public Health Agency of Canada (PHAC), which oversees the NML, for 14 years of documents related to licensing of experimental vaccines for hemorrhagic fevers, including the Ebola vaccine.
They found that in December of 2007, BioProtection Systems, Inc., a startup company later acquired by NewLink, submitted a vaccine development plan to PHAC promising to, “carry out additional preclinical vaccine testing, perform safety and toxicology studies, assist with manufacturing of the vaccine, and conduct clinical trials with rVSV-ZEBOV."
PHAC and BioProtection Systems signed a licensing agreement in 2010.
The deal gave BioProtection Systems sole right to license the vaccine for sale, but allowed PHAC to keep using the patent rights for research and in the context of an international emergency. (It was that carve out in the deal that allowed the NML to contract with a German vaccine-maker to produce high-quality vials of the vaccine for research purposes, 800 of which Canada donated to the World Health Organization during the 2014 outbreak.)
The researchers were “stunned,” Dr. Herder said, to find that BioProtection Systems Inc., never completed any of its objectives.
“There was a requirement to report on [BioProtection Systems Inc.’s] progress in the contract and we didn’t see one single report in 1,600 pages of government records,” Dr. Herder said.
NewLink, which bought BioProtection Systems in 2011, did not respond to requests for comment.
Gary Kobinger, chief of special pathogens at the National Microbiology Lab from 2008 to 2016, said in an interview that BioProtection Systems did little more than participate in perfunctory phone calls with the NML once a year.
“We totally knew that, for them, this product was not important at all,” Dr. Kobinger, now director of the Research Centre on Infectious Diseases at Laval University in Quebec, said. “They were trying to look good to investors. I mean, they told us that. There’s no secret to this.”
The Iowa company’s foot-dragging wasn’t the NML’s only challenge. Cuts to federal funding during the Stephen Harper era led the NML, "to contemplate cancelling the rVSV-ZEBOV project altogether,” according to internal e-mails the researchers obtained.
PHAC did not respond to a request for comment before deadline.
Even the pharmaceutical giant Merck, which in 2014 swooped in when it became clear that NewLink did not have the expertise to develop rVSV-ZEBOV, comes in for criticism in the study.
The authors point out that government agencies and international organizations, not Merck, funded the four clinical trials of rVSV-ZEBOV for which Merck is listed as a sponsor.
Elise Giasson, a spokeswoman for Merck Canada, said by e-mail that the company has “allocated significant resources and expertise from across the company – including hundreds of employees – to support the development and production" of the vaccine.
Merck has donated more than 275,000 doses to the continuing Ebola outbreak in the Democratic Republic of Congo, she added.
Dr. Kobinger said the Dalhousie paper is important because it allows scientists, governments and drug companies to look back and identify shortcomings in the development of rVSV-ZEBOV, now marketed under the name Ervebo.
But he said that shouldn’t overshadow the achievement of the NML, its international collaborators or Merck, which has promised to make the vaccine available to the world’s poorest countries at a low, non-profit price.
“Without Merck,” Dr. Kobinger added, “this vaccine would still be in the freezer.”
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