Why Canada should have known Big Tobacco ties would risk COVID-19 vaccine approval
Philip Morris ownership risks future of Medicago shot with WHO
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Canada should have known the World Health Organization likely wouldn't accept Medicago's COVID-19 vaccine over its close ties with tobacco giant Philip Morris — before deciding to invest millions of dollars of taxpayer money in the company.
The WHO told CBC News on March 25 the biopharmaceutical firm's request for emergency use authorization of its Covifenz vaccine had "not been accepted" due to the company's "linkage with the tobacco industry" and was now "on hold."
Marlboro cigarette manufacturer Philip Morris International owns 21 per cent of Medicago shares and the WHO reiterated it has long had a "strict policy" on "not engaging with companies that promote tobacco" and that Medicago had been informed of the decision.
That leaves Medicago's vaccine in limbo, after the federal government gave the company $173 million in 2020 to develop the vaccine, build a new production facility and purchase 20 million doses with an option for 56 million more.
Canada has approved the vaccine and is expected to distribute it next month, but it's the only country so far and use of the shot worldwide would be severely hampered without WHO approval.
"Medicago now has to face the consequences of their choice," said Dr. Gaston De Serres, a medical epidemiologist at the Quebec National Institute of Public Health (INSPQ).
"It's not something they overlooked. It's a decision they took understanding its implications, understanding this would come with big problems when dealing with WHO."
Medicago knew working with WHO would be 'difficult'
De Serres said the problems Medicago would have had in getting a COVID-19 vaccine with close ties to the tobacco industry approved by the WHO were "quite obvious," and that the federal government "should have known" this issue would arise before investing in it.
"They wouldn't have to work hard to know that Philip Morris was also an important shareholder," he said.
"And WHO I think is fully entitled to say tobacco is the largest preventable cause of premature death and we don't want to have anything to do with the tobacco industry."
Since the beginning of the pandemic, there have been over six million confirmed deaths from COVID-19 worldwide. The WHO estimates tobacco kills more than eight million people each year.
Medicago produces its vaccine with the plant species Nicotiana benthamiana, a close relative of the tobacco plant that is used for pharmaceutical development — largely because of the high number of viruses that can successfully infect it.
But the WHO's policy on Big Tobacco is no secret, and Canada signed the legally binding WHO Framework Convention on Tobacco Control in 2005 committing to "protect" public health policies "from the commercial and other vested interests of the tobacco industry."
A spokesperson for the Public Health Agency of Canada (PHAC) told CBC News the federal government "studied the matter of its investment in Medicago carefully" and believes it is still "compliant with its treaty obligations related to tobacco control" with the WHO.
But Medicago told Global News last year that it even had trouble getting a "formal invitation" to attend WHO meetings and was never able to get in "through the big door."
"WHO, although they love the product and the technology, they have to deal with the fact that we're supported by tobacco," Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, said in the January 2021 interview.
"It's difficult for Medicago to be associated with WHO."
Can tobacco companies 'redeem themselves'?
This also isn't the first time a Canadian health product has faced challenges getting WHO approval over controversial tobacco industry ties.
The experimental Ebola drug ZMapp, which was partially developed in PHAC's National Microbiology Lab, faced similar hurdles getting WHO authorization for emergency use during the devastating West Africa Ebola outbreak in 2014 before finally getting approved.
"We've seen this problem before with the WHO and it may be that they are going to need to look at this policy that they have around involvement with tobacco," said Alison Thompson, an associate professor of bioethics at the University of Toronto.
"It's not as simple anymore as saying we're not going to get into bed with tobacco or nobody in tobacco should be profiting from this, because it's one possible way for tobacco companies to redeem themselves."
But Dr. Gary Kobinger, a Canadian immunologist and virologist at the Galveston National Laboratory at the University of Texas who helped develop Zmapp, said investors were similarly hesitant to fund the drug over its ties to the Reynolds American tobacco company.
The solution is to get Philip Morris out of Medicago, and if WHO still will not approve the vaccine … then it's going to be an expensive lesson.- Cynthia Callard, Physicians for a Smoke-Free Canada
"I do understand the policy [the WHO] has in place. We all do. The question is, what is the solution?" he said.
"Can entities that were found guilty of causing so many human deaths be redeemed ? Can they produce live-saving solutions and contribute, with or without profit, to now save lives?"
Kobinger said he does not believe the tobacco industry is "essential to vaccine development," but that if they do get involved in developing new shots they should at least ensure that they can get WHO approval before bringing them to market.
WHO debating tobacco industry investment 'trend'
WHO officials now say they have yet to make a final decision on whether or not to continue reviewing the Medicago vaccine, and are holding ongoing talks about how to better address the "general trend" of tobacco companies investing in the health industry.
When asked by CBC News during a virtual press conference Wednesday when a final decision on the shot could be made, Mariangela Simao, WHO's assistant director-general for drug access, vaccines and pharmaceuticals, said it could be coming soon.
"We're seeing an increasing trend globally of the tobacco industry diversifying their portfolio by engaging with the pharma industry," she said.
"So this process is still on hold but we should have a decision on the continuation or not of the process in the next few weeks."
WATCH | What the WHO's decision on Medicago vaccine means for Canada:
'Throw away' technology due to tobacco ties?
Alyson Kelvin, a virologist at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan, said that tobacco plants have been used for scientific discovery for years and could lead to a promising vaccine technology going forward.
"We understand that tobacco is probably the most dangerous plant in the world, causing the most deaths — but do we throw away all that technology because of that?" she said.
"Medicago's technology is robust. It's led to a fantastic vaccine with a good safety profile and good effectiveness. I feel that there's a path forward that needs to be explored and it's unfortunate that there are ties to tobacco companies."
The efficacy of the vaccine against all variants studied prior to the emergence of Omicron was 71 per cent, and even slightly higher for the Delta variant at 75 per cent against infections of any severity, according to data released by Medicago in December.
International Development Minister Harjit Sajjan urged the WHO to approve the Medicago shot so that 20 million doses could be donated to the global vaccine-sharing initiative COVAX and used in countries with lower vaccination rates.
But WHO officials said Wednesday that COVID-19 vaccine supply in lower income countries has actually "stabilized" this year due to donations from COVAX, despite the fact that one-third of the world still hasn't had a first dose — including 83 per cent of Africa.
Thompson, the bioethicist, said if the WHO were to ultimately approve the Medicago shot, it would be one way for Canada to address the global inequities it has contributed to by vaccine hoarding.
"There are competing harms here — there's the harm of allowing Philip Morris to potentially profit from this, but there's also the harm of withdrawing the opportunity for millions of people to receive a vaccine," she said.
"And I think I know which side I would come down on — I think the moral importance of saving a life is greater."
Canada working on 'solutions' with Medicago
Innovation Minister François-Philippe Champagne said last week that the federal government is working with Medicago to find a solution "because we want that vaccine to be available for the world.
Conservative MPs called on Champagne and Health Minister Jean-Yves Duclos this week to answer to the health committee on the WHO decision and explain what the federal government's plan is moving forward.
"There needs to be transparency when the government invests $173 million," Conservative MP and health critic Michael Barrett said in a statement.
Champagne said the company is aware that its involvement with the tobacco industry presents a problem, and implied it was talking to Phillip Morris about divesting. Philip Morris International did not respond to a request for comment.
"With respect to shareholding, there'll be solutions," he said. "The company is aware and they're working on that."
Cynthia Callard, executive director for Physicians for a Smoke-Free Canada, said the government should try to resolve the situation with the WHO by ensuring Philip Morris is no longer an investor in the company — and hope for the best with the pending approval.
"Medicago is not a one off," she said. "The solution is to get Philip Morris out of Medicago, and if WHO still will not approve the vaccine … then it's going to be an expensive lesson."
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