Manufacturing and distributing a Covid-19 vaccine
Mark Lievonen, the co-chair of Canada's Covid-19 Vaccine Task Force, discusses the process of securing vaccines for Canadians
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Mark Lievonen knows firsthand the process behind manufacturing and distributing a vaccine. Lievonen, the Co-Chair of Canada’s Covid-19 Vaccine Task Force, served as President of Sanofi Pasteur Limited, the iconic Toronto vaccine producer, for more than 17 years.
With Health Canada’s approval of Pfizer-BioNTech's Covid-19 vaccine last week, and the first Canadians preparing to be inoculated this week, Lievonen (photo below) discussed the vaccine process on the NPC Podcast, a podcast for life sciences managers, hosted by Peter Brenders. Brenders is the CEO of the New Brunswick Health Research Foundation. (Listen to the episode here.)
“Vaccines are very complicated, but it's fascinating as we go to new technologies and new ways of manufacturing them,” Lievonen said. “Traditionally, for an existing vaccine, it would take anywhere from 18 to 24 months to prepare the product and to get it ready for market. What we see now is changing that paradigm.”
Lievonen joined the Canadian vaccine division of Sanofi in 1983. Under his leadership, Sanofi Pasteur developed into a billion-dollar enterprise, manufacturing over 50 million doses of vaccines for both domestic and international markets.
He noted that Canada's recent suggestion has lost its vaccine production capacity is inaccurate, pointing to the history of Connaught Laboratories, which is now part of Sanofi Pasteur. Sanofi Pasteur has a facility in Toronto with 1,500 employees producing vaccines for the global marketplace, Lievonen said.
Additionally, GSK has a facility in Laval, Que., where it produces a flu vaccine.
“They are part of global organizations, companies that are not owned in Canada without head offices here, but they are a fundamentally part of the global manufacturing of vaccines,” Lievonen explained.
According to Lievonen, Canada’s ability to produce vaccines is not directly correlated to securing Covid-19 vaccines for Canadians. He added that while there was a time when the site in Toronto was one of four major Sanofi Pasteur vaccine plants in the world, there are now eight or 10 around the world.
“The plant in Toronto, for example, makes tetanus, diphtheria, pertussis, polio vaccines for the world. It's at full capacity. It's exporting 90 per cent-plus of what it manufactures,” said Lievonen. “There is not necessarily a direct linkage between what manufacturing activities are going on in Canada right now and the procurement of Covid-19 vaccines.”
Addressing the notion that Canada will need to manufacture its Covid-19 vaccine before Canadians have access, Lievonen said the Vaccine Task Force recognized early on, as they reviewed the leading vaccine candidates, that the first vaccines would not be made in Canada.
“These vaccines are made in the U.S. and Europe, they're going to come from different places, and that's where we will secure them,” he said. “The sole Canadian candidate at this point is from Medicago, a virus-like particle that is grown in plants. They've just announced their phase I data, which was quite strong, and they are one of the seven candidates.”
Lievonen said he’s heard critics asking questions regarding technology transfers, in-licensing, and domestic filling and packaging capabilities throughout the process. However, he concluded the best short-term solution is to import the vaccine.
“If you look at worldwide vaccine production across all vaccines, and Covid-19 vaccines, the constraint is really filling and finishing. There's bulk manufacturing capacity that's easier to bring on more than fill and finish,” Lievonen explained. “It may very well be that for some of these products, the bulk is imported into Canada, and Canada can fill and finish it.
“The point is, even at the fastest that could happen, [would not be] faster than importing these vaccines. Establishing production facilities in Canada, or licensing in and filling and packaging, will take years. It's very viable, but it's not the short term answer. The best way to get vaccines in the short run is to import the vaccines that we are procuring.”
The takeaway: The Covid-19 pandemic has shown how well governments, Pharma and academia can work together in a time of crisis. Lievonen said it is important to learn from the experience created by the pandemic.
“I remember at Sanofi Pasteur, there was nothing like a crisis to get us going forward,” he said. “I’d throw somebody a crisis, everybody would work together, it was collegial, and it required working extra hours. That's what we see here. Let's not waste this crisis; let’s learn from it and go forward in that regard.
“I think it's important to try to look at [the pandemic] and say, ‘everybody's trying to do their best.’ It's very easy to criticize governments and industry when things go wrong. I think a whole lot of people are working very hard on this. They're well-intended. They're doing their best. There is going to be bumps along the way, but let's support that and try to be part of the effort to be successful in this area and not throw stones at it.”
Further reading: Covid-19 isn’t only changing the vaccine process but also altering how businesses conduct their hiring process. Story here.
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The consumer group, Public Citizen, has demanded the Office of the Inspector General for the U.S. Department of Health and Human Services investigate an “inappropriate collaboration” between the U.S. FDA and Biogen over Biogen’s submission of the Alzheimer’s drug aducanumab. In March 2019, Biogen, and its partner Eisai, announced they were discontinuing aducanumab trials in patients with mild cognitive impairment from Alzheimer’s after an independent data monitoring committee indicated the trials were unlikely to hit their primary endpoints in a futility analysis. However, in October 2019, the companies indicated that after discussions with the FDA and further analysis of the data, they would pursue the drug's regulatory approval.
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NATIONAL PHARMA CONGRESS WINTER WEBINAR
As announced during the final session of the 14th National Pharmaceutical Congress, plans are in the works for a winter webinar scheduled for Wednesday, February 10, 2021. Be sure to subscribe to the NPC HealthBiz Weekly for updates on the winter meeting.
CANADIAN HEALTHCARE MARKETING HALL OF FAME
The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our avocation and are an inspiration to others.
More than 100 honourees have been selected during the past 18 years. In the selection committee's view, they stand for a representative cross-section of the qualities that make our business unique and fulfilling. Each week, NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honouree.
2015 Inductee
John Haslam
Alexion Pharmaceuticals Inc.
Vaughan, Ont.
Editor’s note: John Haslam served as the Canadian general manager of Alexion Pharmaceuticals from 2009 to 2017. He is currently the president and general manager of Horizon Therapeutics Canada.
John Haslam’s message for anyone in the pharmaceutical —novice or experienced—is to never “underestimate the power that you can have as an individual to make a difference in the lives of patients.” Haslam entered the pharmaceutical industry after obtaining a Bachelor of Science in microbiology from the University of Toronto and a Masters of Business of Administration from McMaster University in Hamilton.
“I thought that the pharmaceutical industry would be a great fit for somebody who loves science and business,” said Haslam. However, it was the ability to improve patients’ lives that kept him working in the field.
“I can honestly say in the 25 years that I have been in this industry, I have loved coming to work every day,” said Haslam. “I have loved the ability just to help patients face some of the challenges that we have faced in our industry and to honestly make a difference for patients.”
Haslam began his career working in the field—“carrying the bag”—at Bayer Healthcare and promoted sales and marketing roles. He moved to Hoffmann-La Roche as a Product Manager and Senior Product Manager. He also led a business unit at Biogen Idec. In 2006, he started his own company, SBP Launch Specialists, which helped companies launch pharma products into the Canadian market.
In 2009, he was appointed to his current role with Alexion—a company specializing in products for rare diseases of which the lead compound is Soliris. It is used to treat a rare blood disease known as paroxysmal nocturnal hemoglobinuria.
“What separates [Alexion] from other companies is our mission to discover, develop, and deliver the highest level of medical advancements and to really serve the very few patients who would otherwise suffer or die from these diseases,” said Haslam.
He said working with Alexion has been very rewarding yet also a challenging experience. Because patients with rare diseases represent only two or three out of a million people in the population, it is very difficult to run clinical trials. “You may have to go to 30 or 40 countries to get enough patients to do clinically meaningful research, and that is only step one,” he said.
Other challenges Alexion faces include finding rare disease patients. It can be like “finding a needle in a haystack” since these patients can be misdiagnosed for years, and help patients access funding to the therapies they require.
“What I have seen with Alexion is that total dedication and commitment to the patients and that drive never to stop when it comes to making a difference. Because often we ask the question, ‘if we do not help these patients, then who will?’”
NEXT WEEK
Chronicle Companies wishes you a happy holiday season. Please look for the next issue of NPC Healthbiz Weekly when we return on Tuesday, January 12, 2021. Subscribe to NPC Healthbiz Weekly and have each issue sent directly to your phone or inbox.