Canada was investing nearly $139 million in Medicago, a Quebec-based firm, to help produce the country’s first homegrown vaccine against the virus and build a production facility that would shore up domestic biomanufacturing capacity. Jean-Yves Duclos, now Canada’s health minister, said one word came to mind: Pride.
Health Canada gave the green light to domestic use of Medicago’s plant-based Covifenz vaccine last month. But its use around the world is in jeopardy: The World Health Organization is balking at the vaccine because of the manufacturer’s ties to tobacco giant Philip Morris International, which owns a roughly one-third equity stake in Medicago.
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The WHO said in a statement that Medicago’s application for emergency use authorization is “on hold” and “has so far” not been accepted “because of the linkage with the tobacco industry and WHO’s strict policy on not engaging with companies that promote tobacco.”
“WHO is currently holding discussions on how to address a general trend of the tobacco industry investing in the health industry,” it said. “We are exploring different policy options for potentially valid health products that are linked to the tobacco industry.”
Takashi Nagao, president and chief executive of Medicago, said the WHO communicated in an email that it had updated the vaccine’s status to “not accepted” and told the firm that a rationale was forthcoming.
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“Once we receive this, we will review the rationale and continue to discuss next steps with our partners and shareholders,” he said in a statement. “It is our understanding that this decision is linked to Medicago’s minority shareholder and not the demonstrated safety and efficacy profile of our coronavirus vaccine.”
Thomas Bollyky, director of the global health program at the Council on Foreign Relations, said “the company should have expected” the decision and that the WHO has been “particularly zealous” about enforcing the Framework Convention on Tobacco Control, a treaty to which Canada is one of 182 parties.
“There’s a long history of this issue, specifically on the involvement of the tobacco industry in supporting tobacco plant research as the basis for vaccines,” he said. “This particular effort is swimming upstream against an established practice and well-established concerns on the part of WHO about tobacco industry sponsorship of health-related activities.”
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A spokesman for Innovation, Science and Economic Development Canada said that “after significant due diligence,” Medicago’s “ownership structure was determined not to prevent investment in the project.”
Health Canada has authorized the vaccine for adults 18 to 64. It said two doses administered 21 days apart were found to be 71 percent effective against symptomatic co-19 and 100 percent effective against severe disease. It uses an adjuvant, a substance boosting immune response to a vaccine, from GlaxoSmithKline.
Medicago’s “virus-like particle vaccine” is made up of particles that mimic the structure of the virus that causes co-19, allowing them to be easily recognized by the immune system and to induce a response. The particles for the vaccine are grown in plants similar to tobacco.
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Supriya Sharma, chief medical adviser at Health Canada, told reporters last month that vaccines for hepatitis B and the human papilloma virus are also virus-like particle vaccines, but that Medicago’s coronavirus vaccine was thought to be the first that uses a plant as the host to make the virus-like particles.
Canada is the only country that has authorized use of the vaccine.
The WHO has called plant-based vaccines “a new and exciting possibility” because they can be “produced cheaply in high amounts,” the antigens created “are stable” and have a long shelf life, and “the likelihood that contamination by a plant virus would have an adverse effect on humans is almost negligible.”
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Bollyky said the WHO’s concerns in this case are “not specific to the tobacco plant,” but to “the involvement of a company that is owned in part by the tobacco industry.”
Antismoking groups have applauded the WHO’s stance and called on the Canadian government to find an investor to replace the maker of Marlboro cigarettes.
“The WHO should not be bullied into contravening its own public health treaty by approving the Philip Morris vaccine,” Les Hagen, director of Canada’s Action on Smoking and Health, said in a statement. “We respect the WHO’s decision to live by the treaty and reject participating in a tobacco industry corporate whitewash scheme.”
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Flory Doucas, a spokesman for the Quebec Coalition for Tobacco Control, said that “a bit of political courage by our governments” could convince Philip Morris “to withdraw as a shareholder of Medicago, which would solve the problem.”
Canada entered into an advance purchase agreement with Medicago to secure access to 20 million doses, with the option of adding 56 million more. Howard Njoo, Canada’s deputy chief public health officer, told reporters last month that the Medicago doses are “in the mix” of those the country planned to contribute to COVAX.
Nearly 85 percent of people in Canada have been fully vaccinated against the coronavirus.
Philip Morris International charged that the WHO is undercutting global vaccine equity efforts and that “emergency use authorization of a coronavirus vaccine has absolutely nothing to do with tobacco control.”
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“The WHO’s assertion that a potentially lifesaving coronavirus vaccine is poised to be rejected due to PMI’s minority stake in Medicago is extremely disturbing and diametrically opposed to their repeated calls to urgently accelerate vaccination globally,” said Corey Henry, a spokesman for Philip Morris International.
The WHO said the “COVAX vaccine supply at the moment far surpasses the demand from the participating countries” and that the focus is on “supporting the countries to vaccine the populations, starting with the most at-risk, and on building manufacturing capacity in lower-income countries.”
François-Philippe Champagne, Canada’s innovation minister, told reporters on Thursday that the government has been in touch with Medicago and that “their shareholding of the company is something that we’re working on.”
“To every challenge, there’s a solution,” he said.
