A new study published this week tells a darker story about one of Canada’s key scientific discoveries — the development of the world’s first approved Ebola vaccine.
Dalhousie University law professor Matthew Herder used Canada’s Access to Information Act to obtain hundreds of documents to track the development of the vaccine (rVSV-ZEBOV) from the first experiments at Winnipeg’s National Microbiology Laboratory in the early 2000s through to the Ebola epidemic in West Africa in 2014.
The documents reveal Canadian government scientists struggling against federal funding cuts and industry indifference to push the discovery forward.
After spending five years piecing the story together, Herder said Canada’s Ebola vaccine experience challenges the dogma that drug companies are the only way to commercialize academic drug discoveries.
Herder’s analysis suggests that Canada’s scientists did most of the technical development work — even generating hundreds of doses of manufactured vaccine — while the private sector allowed the discovery to languish.
In the paper, published in the Journal of Law and the Biosciences, Herder concludes “the private sector was not only unnecessary to its development, but also likely slowed it down.”
“We have this dogmatic reliance upon the private sector,” Herder said. “That is not always warranted. Our case study of this Ebola vaccine shows the public sector can and in fact does do far more in important instances.”
How it all started
The Ebola vaccine research had a serendipitous start in Canada more than two decades ago. German scientist Heinz Feldmann had already been studying hemorrhagic fevers when he joined the Public Health Agency of Canada’s National Microbiology Laboratory (NML), which had recently opened in Winnipeg.
Once settled in the high security lab, he designed an experiment trying to identify the key protein that made Ebola so deadly. He didn’t get the answer he expected. What he discovered instead was that the experimental mice were protected against the Ebola virus. It was the first evidence that an Ebola vaccine was possible.
At the time, the world had not yet experienced the full terror of an Ebola epidemic. That changed in 2014, when the virus ravaged West Africa, killing more than 11,000 people. Today, Congo is still struggling to control an outbreak that has killed more than 2,200 people.
But in the early 2000s, the Ebola researchers in Canada had difficulty securing the funding they needed as they competed for money with other public health priorities.
Still, they managed to scrounge enough resources to conduct preliminary animal and toxicology studies as they tried to find a drug company interested in taking their promising vaccine research to market.
But the documents reveal there was little commercial interest in an Ebola vaccine, especially in the years before the first major outbreak.
So the scientists pushed onward, struggling to find funding and doing much of the development work normally done by industry. That included getting more than 1,000 doses of vaccine manufactured for use in human clinical trials.
Herder points to that as proof that governments can, under certain circumstances, make life-saving medicines that have little commercial appeal.
“It provides evidence that a lot of that later-stage drug development or vaccine development can happen within the public sector,” said Herder.
A small biotechnology company in Iowa called BioProtection Systems Inc., which later became NewLink Genetics, eventually stepped forward in 2006 offering to take the discovery to market.
Herder said he examined a copy of the agreement between the Public Health Agency of Canada and NewLink and discovered that the company failed to deliver on commitments it made in exchange for the patent.
“There’s very little evidence in the documents that they were doing anything beyond taking part in meetings,” Herder said.
NewLink Genetics did not respond to CBC’s request for comment.
Lab ‘thought seriously about stopping’ work
The documents also reveal that, by 2010, the vaccine project was at risk of being shelved due to lack of funding and the fact the lead researchers had left the NML for positions at other research institutions.
“We have evidence in the records that we obtained that the lab in Winnipeg thought seriously about stopping this work,” Herder said.
But one dedicated researcher managed to keep the project going.
Judie Alimonti was a contract scientist at the NML. Despite her precarious position, she volunteered to take over the floundering Ebola vaccine file.
Herder said she played a pivotal role. Without Alimonti’s perseverance, the vaccine might never have been available for emergency use when Ebola ravaged West Africa in 2014.
“And so by virtue of it being ready, I’m sure she helped save lives in the middle of that epidemic.”
Despite her commitment to developing the Ebola vaccine, Alimonti’s contract was not renewed and she left the NML in 2015. She died of cancer two years later at age 57.
Ebola vaccine ‘sitting on shelf’
Herder’s research suggests that it was only after Ebola began spreading in West Africa and threatening the world that the vaccine project was treated with more urgency.
“Questions began to be raised publicly about the delay in development of a vaccine that had been shown to be 100% effective in animal models as early as 2004,” Herder writes, citing a 2014 New York Times article with the headline: “Ebola Vaccine, Ready for Test, Sat on the Shelf.”
Canada donated 800 doses of its experimental vaccine for use during the outbreak. The federal government also continued to provide support for the clinical trials, including a Phase 1 trial at the Canadian Centre for Vaccinology in Halifax.
Meanwhile, in the midst of the 2014 outbreak, NewLink transferred the Ebola vaccine patent to Merck for $50 million US.
At the same time, funding for the research continued to be provided by public sector sources with more than $120 million from the Canadian and U.S. governments and the World Health Organization to support clinical trials during the epidemic, according to the paper.
Herder was unable to access the pharmaceutical industry documents, leaving him with questions about Merck’s role.
“What the record does establish is that it was the public sector, not Merck, that provided all of the financing, including for clinical trials, during the West African epidemic, in addition to providing the technical expertise, human resources, and infrastructure that was necessary to carry out the trials,” Herder writes.
Merck spokesperson Elise Giasson told CBC News in an email that after acquiring the licence from NewLink in 2014, the companies “worked together on moving it into additional Phase 1 trials as well as Phase 2/3 clinical trials.”
“Merck is proud to be part of the unprecedented global collaborations to aid in the fight against Ebola.”
The vaccine, now known as Ervebo, was approved for commercial sale by the U.S. Food and Drug Administration and the European Medicines Agency over the past two months.
It’s a milestone that took too long, Herder suggests in his paper.
“Instead of celebrating this milestone, our analysis raises the question as to whether [the Ebola vaccine] could have been available earlier if public laboratories had taken a different approach to the vaccine’s development.”
View original article here Source