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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.”

Related

“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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Kevin Neil Friesen Obituary 2024 – Crossings Funeral Care

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It is with heavy hearts that we announce the peaceful passing of Kevin Neil Friesen age 53 on Thursday, March 28, 2024 at the Bethesda Regional Health Centre.

A funeral service will be held at 2:00 pm on Thursday, April 4, 2024 at the Bothwell Christian Fellowship Church, with viewing one hour prior to the service.

A longer notice to follow.  

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Spring allergies: Where is it worse in Canada? – CTV News

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The spring allergy season has started early in many parts of Canada, with high levels of pollen in some cities such as Toronto, Ottawa and Montreal.

Daniel Coates, director of Aerobiology Research Laboratories in Ottawa, expects the elevated amounts to continue next week for places, such as most of Ontario, if the temperature continues to rise. Aerobiology creates allergen forecasts based on data it collects from the air on various pollens and mould spores.

Pollens are fertilizing fine powder from certain plants such as trees, grass and weeds. They contain a protein that irritates allergy sufferers.

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Although pollen levels declined after a cold spell in some places, he said they are soaring again across parts of Canada.

“So the worst is definitely British Columbia right now, followed by Ontario and Quebec and then the Prairies and Atlantic Canada for the upcoming weeks,” said Coates in a video interview with CTVNews.ca. “We are seeing pollen pretty much everywhere, including the Maritimes.”

He said pollen has increased over the past 20 years largely due to longer periods of warm weather in Canada.

Meanwhile, the Maritimes is one of the best places to live in Canada if you have seasonal allergies, in part because of its rocky territory, Coates said.

With high levels of cedar and birch pollen, British Columbia is the worst place for allergy sufferers in Canada, he added.

“British Columbia is going strong,” Coates explained, noting the allergy season started “very early” in the province in late January. “It has been going strong since late January, early February and it’s progressing with high levels of pollen, mostly cedar, but birch as well, and birch is highly allergenic.”

Causes of high pollen levels

Coates expects a longer allergy season if the warm weather persists. He notes pollen is increasing in Canada and worldwide, adding that in some cases the allergy season is starting earlier and lasting longer than 15 years ago.

He says tree pollen produced last year is now being released into the air because of warmer weather.

“Mother nature acts like a business,” he said. “So you have cyclical periods where things go up and down. … So when it cooled down a little bit, we saw (pollen) reduce in its levels, but now it’s going to start spiking.”

Along with warmer weather, another factor in higher pollen levels is people planting more male trees in urban areas because they don’t produce flowers and fruits and are less messy as a result, he said. But male trees produce pollen while female ones mostly do not.

Moulds

Coates said moulds aren’t as much of a problem.

“They’ve been mainly at lower levels so far this season,” he explained. “Moulds aren’t as bad in many areas of Canada, but they’re really, really bad in British Columbia.”

In B.C., moulds are worse because of its wet climate and many forested areas, he said.

Coping with allergies

Dr. Blossom Bitting, a naturopathic doctor and herbal medicine expert who works for St. Francis Herb Farm, says a healthy immune system is important to deal with seasonal allergies.

“More from a holistic point of view, we want to keep our immune system strong,” she said in a video interview with CTVNews.ca from Shediac, N.B. “Some would argue allergies are an overactive immune system.”

Bitting said ways to balance and strengthen the immune system include managing stress levels and getting seven to nine hours of restful sleep. “There is some research that shows that higher amounts of emotional stress can also contribute to how much your allergies react to the pollen triggers,” Bitting said.

Eating well by eating more whole foods and less processed foods along with exercising are also important, she added. She recommends foods high in Omega-3 Fatty Acids such as flaxseeds, flaxseed oil, walnuts and fish. Fermented foods with probiotics such as yogurt, kimchi and miso, rather than pasteurized ones, can keep the gut healthy, she added. Plant medicines or herbs such as astragalus, reishi mushrooms, stinging nettle and schisandra can help bodies adapt to stressors, help balance immune systems or stabilize allergic reactions, she said.

To cope with allergies, she recommends doing the following to reduce exposure to pollen:

  • Wear sunglasses to get less pollen into the eyes;
  • Wash outdoor clothes frequently, use outer layers for outside and remove them when you go inside the house;
  • Use air purifiers such as with HEPA (high efficiency particulate air) filters;
  • Wash pets and children after they go outside;
  • Keep the window closed on days with high pollen counts.

Mariam Hanna, a pediatric allergist, clinical immunologist and associate professor with McMaster University in Hamilton, Ont., says immunotherapy can help patients retrain their bodies by working with an allergist so they become more tolerant to pollens and have fewer symptoms.

“Some patients will need medications like over-the-counter antihistamines or speaking with their doctor about the right types of medications to help with symptom control,” she said in a video interview with CTVNews.ca.

Coates recommends people check pollen forecasts and decrease their exposure to pollen since no cure exists for allergies. “The best is knowing what’s in the air so that you can adjust your schedules, or whatever you’re doing, around the pollen levels.”

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Do you need a spring COVID-19 vaccine? Research backs extra round for high-risk groups

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Recent studies suggest staying up-to-date on COVID shots helps protect high-risk groups from severe illness

New guidelines suggest certain high-risk groups could benefit from having another dose of a COVID-19 vaccine this spring — and more frequent shots in general — while the broader population could be entering once-a-year territory, much like an annual flu shot.

Medical experts told CBC News that falling behind on the latest shots can come with health risks, particularly for individuals who are older or immunocompromised.

Even when the risk of infection starts to increase, the vaccines still do a really good job at decreasing risk of severe disease, said McMaster University researcher and immunologist Matthew Miller.

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Who needs another COVID shot?

Back in January, Canada’s national vaccine advisory body set the stage for another round of spring vaccinations. In a statement (new window), the National Advisory Committee on Immunization (NACI) stated that starting in spring 2024, individuals at an increased risk of severe COVID may get an extra dose of the latest XBB.1.5-based vaccines, which better protect against circulating virus variants.

That means:

  • Adults aged 65 and up.
  • Adult residents of long-term care homes and other congregate living settings for seniors.
  • Anyone six months of age or older who is moderately to severely immunocompromised.

The various spring recommendations don’t focus on pregnancy, despite research (new window) showing clear links between a COVID infection while pregnant, and increased health risks. However, federal guidance does note that getting vaccinated during pregnancy can protect against serious outcomes.

Vaccinated people can also pass antibodies to their baby through the placenta and through breastmilk, that guidance states (new window).

What do the provinces now recommend?

Multiple provinces have started rolling out their own regional guidance based on those early recommendations — with a focus on allowing similar high-risk groups to get another round of vaccinations.

B.C. is set to announce guidance on spring COVID vaccines in early April, officials told CBC News, and those recommendations are expected to align with NACI’s guidance.

In Manitoba (new window), high-risk individuals are already eligible for another dose, provided it’s been at least three months since their latest COVID vaccine.

Meanwhile Ontario’s latest guidance (new window), released on March 21, stresses that high-risk individuals may get an extra dose during a vaccine campaign set to run between April and June. Eligibility will involve waiting six months after someone’s last dose or COVID infection.

Having a spring dose is particularly important for individuals at increased risk of severe illness from COVID-19 who did not receive a dose during the Fall 2023 program, the guidance notes.

And in Nova Scotia (new window), the spring campaign will run from March 25 to May 31, also allowing high-risk individuals to get another dose.

Specific eligibility criteria vary slightly from province-to-province, so Canadians should check with their primary care provider, pharmacist or local public health team for exact guidelines in each area.

WATCH: Age still best determines when to get next COVID vaccine dose, research suggests:

 

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Age still best determines when to get COVID vaccines, new research suggests

It’s been four years since COVID-19 was declared a pandemic, and new research suggests your age may determine how often you should get a booster shot.

Why do the guidelines focus so much on age?

The rationale behind the latest spring guidelines, Miller said, is that someone’s age remains one of the greatest risk factors associated with severe COVID outcomes, including hospitalization, intensive care admission and death.

So that risk starts to shoot up at about 50, but really takes off in individuals over the age of 75, he noted.

Canadian data (new window) suggests the overwhelming majority of COVID deaths have been among older adults, with nearly 60 per cent of deaths among those aged 80 or older, and roughly 20 per cent among those aged 70 to 79.

People with compromised immune systems or serious medical conditions are also more vulnerable, Miller added.

Will people always need regular COVID shots?

While the general population may not require shots as frequently as higher-risk groups, Miller said it’s unlikely there will be recommendations any time soon to have a COVID shot less than once a year, given ongoing uncertainty about COVID’s trajectory.

Going forward, I suspect for pragmatic reasons, [COVID vaccinations] will dovetail with seasonal flu vaccine campaigns, just because it makes the implementation much more straightforward, Miller said.

And although we haven’t seen really strong seasonal trends with SARS-CoV-2 now, I suspect we’ll get to a place where it’s more seasonal than it has been.

In the meantime, the guidance around COVID shots remains simple at its core: Whenever you’re eligible to get another dose — whether that’s once or twice a year — you might as well do it.

What does research say?

One analysis, published in early March in the medical journal Lancet Infectious Diseases (new window), studied more than 27,000 U.S. patients who tested positive for SARS-CoV-2, the virus behind COVID, between September and December 2023.

The team found individuals who had an updated vaccine reduced their risk of severe illness by close to a third — and the difference was more noticeable in older and immunocompromised individuals.

Another American research team from Stanford University recently shared the results from a modelling simulation looking at the ideal frequency for COVID vaccines.

The study in Nature Communications (new window) suggests that for individuals aged 75 and up, having an annual COVID shot could reduce severe infections from an estimated 1,400 cases per 100,000 people to around 1,200 cases — while bumping to twice a year could cut those cases even further, down to 1,000.

For younger, healthier populations, however, the benefit of regular shots against severe illness was more modest.

The outcome wasn’t a surprise to Stanford researcher Dr. Nathan Lo, an infectious diseases specialist, since old age has consistently been a risk factor for severe COVID.

It’s almost the same pattern that’s been present the entire pandemic, he said. And I think that’s quite striking.

More frequent vaccination won’t prevent all serious infections, he added, or perhaps even a majority of those infections, which highlights the need for ongoing mitigation efforts.

Lauren Pelley (new window) · CBC News

 

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