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Paper raises new questions about the federal government’s decision to sell licensing rights to Ebola vaccine

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The U.S. drug company that has made tens of millions of dollars licensing the Canadian-developed Ebola vaccine did “next to nothing” to get that vaccine into production, the lead author of a newly published paper charges.


A young woman reacts as a health worker injects her with the Ebola vaccine, in Goma, Democratic Republic of Congo, August 5, 2019.


Baz Ratner / REUTERS

The U.S. drug company that has made tens of millions of dollars licensing the Canadian-developed Ebola vaccine did “next to nothing” to get that vaccine into production, the lead author of a newly published paper charges.

Instead, it was Canadian scientists — including a former Ottawa woman who never had a permanent job in Canada’s national microbiology laboratory — and others supported by public funding, who did the crucial work that enabled the vaccine to be used experimentally during the 2014-2015 West African Ebola outbreak, potentially saving thousands of lives.

The paper was published Thursday in the Journal of Law and the Biosciences and is based on 1,600 partly redacted documents obtained through access to information by authors Matthew Herder, director of Dalhousie University’s Health Law Institute, Janice Graham of Dalhousie’s department of pharmacology and Richard Gold of the faculty of law at McGill University.

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In 2010, the Public Health Agency of Canada granted sole license of the vaccine that was created in its labs to a small Iowa-based startup called BioProtection Systems Inc. (BPS) for around $205,000 Canadian, according to the authors. The company, which had never developed a product through to regulatory approval, later sublicensed it to Merck for $50 million (U.S). Merck is now producing the vaccine, which became the world’s first licensed Ebola vaccine last month.

The paper is raising new questions about the federal government’s decision to sell licensing rights for the vaccine to the small company, BPS, which was later bought by NewLink Genetics Corporation. It also raises questions about the prevailing theory that only private industry can bring drugs and vaccines to market, saying the Ebola vaccine example suggests otherwise.

Although Merck earned recognition for its support of the clinical trials that were run partway through the West African Ebola epidemic, the record shows that “it was the public sector, not Merck, that provided all of the financing, including for clinical trials, during the West African epidemic,” write the authors.

The paper questions whether the vaccine could have been available earlier, at the beginning of the deadly outbreak, if the federal government had taken a different approach to its development.

Critics have, in the past, raised concerns that the company that bought licensing rights to the Ebola vaccine allowed it to languish during the deadly Ebola outbreak, despite requirements under the licensing agreement that it actively move it toward production. The paper supports those concerns.

The vaccine was developed at the Public Health Agency of Canada’s National Microbiology Laboratory in Winnipeg, a project that began in 1999 when the lab recruited Heinz Feldmann from the University of Marburgh in Germany to be the chief of its special pathogens program. Within three years, he and his colleagues developed an Ebola vaccine candidate, which still had to be tested on humans in a series of clinical trials before it could be licensed. The government sold sole licensing rights to the vaccine under a contract that required BioProtection Systems Inc. to make reasonable efforts to commercialize the vaccine and to deliver written reports on its progress.

The agreement spelled out that shelving the vaccine would be tantamount to “fundamental breach” of the contract, according to the paper. The agreement between the Public Health Agency of Canada and the small Iowa-based startup also included an agreement that BPS would make “reasonable efforts” to develop the vaccine and deliver written reports on the progress.

But Herder said the documents obtained by the authors show BPS did “virtually nothing.”

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“Contrary to the terms of the license, BPS failed to deliver a single written report of its commercialization progress during 2010-2014 (the four years leading up to the West African epidemic),” according to the paper. “Other documentation betrays a pattern of delay,” when it came to running pre-clinical experiments.

Among actions the company did take were meeting with the Federal Drug Administration to clarify what types of testing would be needed for a Phase 1 trial. It took a year and a half, according to the paper, for the company to arrange that meeting.

“In short, BPS did not complete any of the experimental objectives outlined in its vaccine development plan.”

The paper also highlights the work done by former Ottawa resident Julie Alimonti, an immunologist who volunteered to take over as project manager for the vaccine at a time when the project was at risk of being scrapped as scientists left the Public Health Agency of Canada.


Judie Alimonti.

Postmedia

In an interview, Herder said Alimonti, who was precariously employed by the Public Health Agency of Canada and never had a permanent contract, deserves recognition for the crucial role she played in getting the vaccine candidate ready to be used in clinical trials in West Africa.

“She is an unsung hero who has, to date, in my view not received the credit she deserves.”

He said he is “highly skeptical” that the vaccine could have been used in clinical trials during the West African outbreak without her intervention.

Alimonti died of cancer in 2017. She was 57 years old. Before her death, she left the Public Health Agency of Canada and was working at the National Research Council on a Zika vaccine.

The research paper also raises broader questions about the prevailing theory of drug and vaccine development — that only the private sector can do it.

Herder said that needs to be rethought and public institutions like the National Microbiology Laboratory, which has faced ongoing budget cuts, need to be properly funded to allow such work to flourish. The issue is particularly important, the paper suggests, at a time of exorbitant drug costs.

Development of the Ebola vaccine is a case study of why that thinking should change, according to the paper.

Instead of celebrating the milestone of the Canadian-developed vaccine finally obtaining market approval, the paper says, “our analysis raises the question as to whether (the vaccine) could have been available earlier if public laboratories had taken a different approach to the vaccine’s development.”

The article can be found at: https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsz019/5706941

 

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Governments seek buyer as Quebec COVID-19 vaccine manufacturer Medicago set to close

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MONTREAL — The Quebec government says it’s looking to find a buyer for Medicago Inc., the Quebec-based COVID-19 vaccine manufacturer that will be shut down by parent company Mitsubishi Chemical.

Quebec Economy Minister Pierre Fitzgibbon said Friday the province has had preliminary talks with potential buyers in the pharmaceutical sector to keep Medicago’s expertise and skilled workforce in Quebec. He said both the Quebec and federal governments would be willing to put in money to secure a deal.

“We can’t operate it ourselves; the government will not be the main shareholder,” Fitzgibbon said. “But if there is a pharmaceutical company that considers it’s worth continuing, we’re ready to help.”

Mitsubishi Chemical said Thursday it would stop marketing the Medicago-produced Covifenz vaccine, which is plant-based and was approved by Health Canada one year ago for adults aged 18 to 64.

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The Japanese chemical company said it had been preparing to commercially produce the Covifenz vaccine but decided against doing so because of the “significant changes” in the COVID-19 vaccine environment. The company said it would dissolve Medicago because it is no longer “viable” to continue marketing its products.

“In light of significant changes to the COVID-19 vaccine landscape since the approval of Covifenz, and after a comprehensive review of the current global demand and market environment for COVID-19 vaccines and Medicago’s challenges in transitioning to commercial-scale production, the (company) has determined that it will not pursue the commercialization of Covifenz,” Mitsubishi Chemical said in a statement.

Following the announcement, Medicago issued a statement thanking its employees. “The Medicago team has pushed scientific boundaries and we know that they will continue to make incredible contributions to innovation and biopharmaceutical’s sector.”

Canada invested $173 million in Medicago in 2020 to support development of the Covifenz vaccine and help Medicago expand its production facility in Quebec City.

On Thursday, Innovation, Science and Industry Minister François-Philippe Champagne told reporters the federal government is in “solution mode.”

“Our first order of business is really to try to find a partner who can help us preserve the jobs, preserve the technology and the intellectual property,” Champagne said.

The minister acknowledged that mRNA vaccine technology for COVID-19 became dominant as it “seemed to be most effective.”

But Medicago’s plant-based vaccine was still “promising,” Champagne said.

“Everyone agreed that the plant-based vaccine could very well help in a future pandemic,” Champagne said.

Speaking to reporters on Montreal’s South Shore Friday, Fitzgibbon said the company informed the province at the end of December it intended to pull the plug on Medicago.

In May 2015, Quebec and Ottawa announced loans of $60 million and $8 million, respectively, for the construction of a complex in the Quebec City region to house Medicago’s activities.

“The challenge is not (getting the loan repaid), it’s how we can save the jobs, save this company,” Fitzgibbon said.

While Canada authorized Medicago’s vaccine in February 2022, it was rejected for emergency use by the World Health Organization in March because tobacco company Philip Morris was a minority shareholder in the company, contravening a policy adopted in 2005 by the United Nations agency.

Quebec City Mayor Bruno Marchand said on Twitter he was saddened by the closure of the company.

“My thoughts are with the families who learned some very sad news,” Marchand said Thursday evening. “We have to roll up our sleeves to keep all this expertise in the field of health innovation in Quebec City.”

This report by The Canadian Press was first published Feb. 3, 2023.

 

Sidhartha Banerjee, The Canadian Press

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Bird flu keeps spreading beyond birds. Scientists worry it signals a growing threat to humans, too

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As a deadly form of avian influenza continues ravaging bird populations around much of the world, scientists are tracking infections among other animals — including various types of mammals more closely related to humans.

Throughout the last year, Canadian and U.S. officials detected highly pathogenic H5N1 avian flu in a range of species, from bears to foxes. In January, France’s national reference laboratory announced that a cat suffered severe neurological symptoms from an infection in late 2022, with the virus showing genetic characteristics of adaptation to mammals.

Most concerning, multiple researchers said, was a large, recent outbreak on a Spanish mink farm.

Last October, farm workers began noticing a spike in deaths among the animals, with sick minks experiencing an array of dire symptoms like loss of appetite, excessive saliva, bloody snouts, tremors, and a lack of muscle control.

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The culprit wound up being H5N1, marking the first known instance of this kind of avian influenza infection among farmed minks in Europe, notes a study published in Eurosurveillance this month.

“Our findings also indicate that an onward transmission of the virus to other minks may have taken place in the affected farm,” the researchers wrote.

Eventually, the entire population of minks was either killed or culled — more than 50,000 animals in total.

That’s a major shift, after only sporadic cases among humans and other mammals over the last decade, according to Michelle Wille, a researcher at the University of Sydney who focuses on the dynamics of wild bird viruses.

“This outbreak signals the very real potential for the emergence of mammal-to-mammal transmission,” she said in email correspondence with CBC News.

It’s only one farm, and notably, none of the workers — who all wore face shields, masks, and disposable overalls — got infected.

But the concern now, said Toronto-based infectious disease specialist Dr. Isaac Bogoch, is if this virus mutates in a way that allows it to become increasingly transmissible between mammals, including humans, “it could have deadly consequences.”

“This is an infection that has epidemic and pandemic potential,” he said. “I don’t know if people recognize how big a deal this is.”

 

‘Explosive’ avian flu surge hits global bird populations

Global bird populations are being ravaged by a deadly strain of avian flu, wiping out flocks of domestic poultry and killing wild birds. Some researchers warn the virus could eventually evolve to better infect humans and potentially start a future pandemic.

H5N1 has high mortality rate

Among birds, the mortality rate of this strain of highly pathogenic avian influenza can be close to 100 per cent, causing devastation to both wild bird populations and poultry farms.

It’s also often deadly for other mammals, humans included.

The World Health Organization (WHO) has documented 240 cases of H5N1 avian influenza within four Western Pacific countries — including China, Cambodia, Laos, and Vietnam — over the last two decades. More than half of the infected individuals died.

Global WHO figures show more than 870 human cases were reported from 2003 to 2022, along with at least 450 deaths — a fatality rate of more than 50 per cent.

Bogoch said the reported death toll may be an overestimate, since not all infections may be detected, though it’s clear people can “get very, very sick from these infections.”

Most human infections also appeared to involve people having direct contact with infected birds. Real-world mink-to-mink transmission now firmly suggests H5N1 is now “poised to emerge in mammals,” Wille said — and while the outbreak in Spain may be the first reported instance of mammalian spread, it may not be the last.

“A virus which has evolved on a mink farm and subsequently infects farm workers exposed to infected animals is a highly plausible route for the emergence of a virus capable of human-to-human transmission to emerge,” she warned.

Louise Moncla, an assistant professor of pathobiology at the University of Pennsylvania school of veterinary medicine, explained that having an “intermediary host” is a common mechanism through which viruses adapt to new host species.

“And so what’s concerning about this is that this is exactly the kind of scenario you would expect to see that could lead to this type of adaptation, that could allow these viruses to replicate better in other mammals — like us.”

Government workers wear protective gear to collect poultry for slaughter during an outbreak of avian influenza on the Ivory Coast. More than 70 countries have reported cases this year, according to the World Organisation for Animal Health.
Government workers wear protective gear to collect poultry for slaughter during an outbreak of avian influenza on the Ivory Coast. More than 70 countries reported cases in 2022, according to the World Organisation for Animal Health. (Legnan Koula/EPA-EFE)

Surveillance, vaccines both needed

What’s more reassuring is the ongoing development of influenza vaccines, giving humanity a head start on the well-known threat posed by bird flu.

Wille noted the earlier spread of H7N9, another avian influenza strain which caused hundreds of human cases in the early 2010s, prompted similar concern that the virus would acquire the mutations needed for ongoing human-to-human transmission.

“However, a very aggressive and successful poultry vaccination campaign ultimately stopped all human cases,” she added.

But while several H5N1 avian influenza vaccines have been produced, including one manufactured in Canada, there’s no option approved for public use in this country.

To ward off the potential threat this strain poses to human health, Bogoch said ongoing surveillance and vaccine production needs to remain top-of-mind for both policy makers and vaccine manufacturers.

Dr. Jan Hajek, an infectious diseases physician at Vancouver General Hospital, also questioned whether it’s time to wind down global mink farming, given the spread of various viruses, from avian influenza to SARS-CoV-2, the virus behind COVID-19.

“We’re closely related to minks and ferrets, in terms of influenza risks … if it’s propagating to minks, and killing minks, it’s worrisome to us,” he said.

In 2021, B.C. officials announced an end to mink farming across the province, saying the farms can be reservoirs for viruses and represent an ongoing danger to public health. All mink farm operations must be shut down, with all of the pelts sold, by April 2025.

However, other provinces — and plenty of countries — do intend to keep their mink farms operating.

“Is it responsible to have these kinds of farming conditions where these types of events can occur?” questioned Moncla. “If we’re going to keep having these types of farms, what can we do to make this safer?”

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6,654 students facing suspension due to out-of-date immunization records

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The Windsor-Essex County Health Unit (WECHU) has issued about 6,654 suspension orders to students who do not meet immunization requirements.

WECHU completed a review of all elementary student immunization records in December and more than 12,000 students received a notice.

These students were either overdue for one or more vaccines required to attend school, or their immunization records were not updated with the health unit.

“While many of these vaccines are normally administered by primary health care providers, parents and guardians of children who received their vaccines from their health care provider still need to report this information to the health unit,” said a WECHU news release.

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The Immunization of School Pupils Act (ISPA) (1990), Section 11, Subsections (1) and (2) requires public health units to maintain and review vaccine records for every student attending school and to enforce a school suspension for incomplete immunization information. As the next step of the ISPA enforcement process, orders were mailed out to students that do not meet this requirement.

WECHU said this is the final notice.

The suspension order notifies parents and guardians that immunization records must be updated to the WECHU by Thursday, March 16, at 6 p.m. or their child will be suspended for up to 20 days from school, starting Monday, March 20, 2023. Once parents and guardians provide the missing immunization information to the WECHU, the student is removed from the suspension list and can attend school again.

Under the ISPA , children can be exempted from immunization for medical reasons or due to conscience or religious belief.

Families can book immunization appointments with their health care provider and are reminded to update their child’s immunization records online at immune.wechu.org.

Catch-up immunization clinics are also being offered at the WECHU Windsor and Leamington offices and will continue until the end of March. Families can book an appointment at a WECHU clinic by visiting wechu.org/getimmunized or by calling the WECHU at 519-960-0231.

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