Why is WHO pushing back on a Health Canada–approved Medicago SARS-CoV-2 vaccine?

Health Canada approved Covifenz, the first Canadian SARS-CoV-2 vaccine, in February. But so far, Canada is the only country to do so, and a World Health Organization (WHO) official said it’s unlikely the vaccine will be approved for emergency use internationally because of the company’s links to the tobacco industry.

Tobacco giant Phillip Morris International Inc. (PMI) owns a one-third equity stake in Medicago, the Quebec-based company that developed Covifenz with help from the federal government.

The deal raised eyebrows among public health advocates, some of whom argued the government’s partnership with Medicago conflicts with Canada’s international commitments on tobacco control.

Notably, Medicago was headed by PMI’s former vice-president of regulatory and scientific affairs when the federal government struck the deal to buy 76 million doses of the Covifenz vaccine in addition to investing $173 million in support.

“It’s well known the WHO and the UN have a very strict policy regarding engagement with the tobacco and arms industry,” said Mariângela Simão, WHO’s assistant director-general for drug access, vaccines, and pharmaceuticals, in a media briefing. As such, “it’s very likely [Covifenz] won’t be accepted for emergency use listing.”

A guidance document dated March 2 on the WHO website listed the vaccine as “not accepted.”

Some experts have argued that approval of the vaccine would violate the spirit if not the letter of the WHO Framework Convention on Tobacco Control (FCTC). Canada is one of 182 signatories to the treaty, which aims to protect public health policy-making from tobacco industry interference, among other goals.

Guidelines on implementing the treaty state that governments should not “accept, support, or endorse partnerships” with the tobacco industry or “any entity or person working to further its interests.”

“It’s imperative for countries to refrain from colluding and collaborating with tobacco companies,” said Les Hagen of the tobacco control advocacy group Action on Smoking and Health.

He and others worry that even indirect partnerships may give the industry political leverage and a backdoor route to influence policy-makers.

A 2018 review found that tobacco industry interference “continues to be the largest barrier to FCTC implementation worldwide.”

Prior to the Medicago deal, Canada was regarded as a leader on tobacco control, ranking alongside New Zealand, Thailand, and India as a key proponent of the FCTC.

Now, “not only are we seeing Big Tobacco getting into pharma and COVID-19 vaccines, but we are also seeing an act of collaboration with the federal government,” said Hagen.

Canada defends Medicago partnership

While Health Canada publicly reports meetings with tobacco industry lobbyists, they do not report on meetings with Medicago. A federal spokesperson said this is because the department “has not held meetings with Medicago on matters related to tobacco control.”

The spokesperson also noted that the Medicago deal is just one of more than $1.115 billion in investments that the government has made to establish or expand Canadian production facilities for vaccines and therapeutics on the advice of the COVID-19 Vaccine Task Force.

According to Health Canada, the federal government is “compliant with its treaty obligations” because the FCTC specifically requires parties to protect against industry interference “with respect to tobacco control.” As the government sees it, that doesn’t preclude collaboration on ventures unrelated to tobacco, like vaccine procurement and development.

The WHO and other organizations appear to take a different view. Medicago has reported difficulties getting a seat at WHO meetings alongside other pharmaceutical companies, and The Lancet allegedly declined to publish early research on the Covifenz vaccine.

Tarik Jašarević of the WHO said the organization disapproves of tobacco industry involvement in drug companies and “encourages Medicago to disengage from its links with PMI, which would allow WHO to be able to work with them like with other pharmaceutical companies.”

According to the WHO, “there is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests.”

For its part, Medicago says it is “committed to upholding and conducting business ethically and transparently.”

A spokesperson told CMAJ that the company’s “top priority at the moment is to help fight the COVID-19 global pandemic,” and they are “grateful” for PMI’s investment.

The spokesperson did not answer questions about how Medicago manages potential conflicts of interest, nor directly address concerns about its association with the tobacco industry, deferring to PMI for further comment.

Both companies stressed that PMI currently holds a minority stake in Medicago and doesn’t control the company’s board of directors.

A spokesperson for PMI’s Canadian subsidiary Rothmans, Benson & Hedges said the investment in Medicago is part of a broader strategy to “expand the business beyond tobacco and nicotine.”

Health, science, technology, and sustainability are “at the heart of PMI’s future,” the spokesperson said. They did not answer how the company manages conflicts between those aims and tobacco business interests.

Big Tobacco rebranding

It’s not the first time PMI has ventured into the health sector. Last year, the company acquired Fertin Pharma, which specializes in oral drug delivery systems, and Vectura, a British inhaler maker, ostensibly as part of the same move “beyond nicotine.”

Some clinicians and scientists rallied against the latter acquisition, leading at least one major medical conference to cut ties with Vectura.

According to Rothmans, Benson & Hedges, “our ambition is to replace cigarettes with science-based, smoke-free alternatives and eliminate smoking by 2035 or sooner.”

David Hammond of the University of Waterloo said that tobacco companies have repeatedly claimed they would phase out conventional cigarettes going back to the 1950s — a claim that would be more credible if they weren’t still promoting the products and challenging tobacco control.

“These claims are neither new nor are they compelling when you interpret them within their broader corporate actions,” Hammond said.

Beyond concerns about industry interference in policy-making, some question the ethics of collaborating with companies that generate profit for an industry linked with more than eight million deaths each year. Canada alone spends billions of dollars annually on the direct health care costs of tobacco use.

“If these companies want to reinvent themselves, they’ve got to stop selling cigarettes,” said Robert Schwartz, a professor of public health policy at the University of Toronto and executive director of the Ontario Tobacco Research Unit.

Others are concerned that the incursion of Big Tobacco into vaccine manufacturing may undermine public trust in COVID-19 shots.

Given the tobacco industry’s history of downplaying health harms, “these are companies with difficult paths in terms of respect for the public good,” said Chris MacDonald, an associate professor of business ethics at Ryerson University. “We are justified in not trusting them at this point, and we need to be able to trust vaccine companies.”

Since Medicago signed the deal with the federal government, the company appears to be distancing from PMI. Takashi Nagao, a former executive of Mitsubishi Tanabe Pharma Corporation, has taken over as Medicago’s president and CEO from Bruce Clark, who was previously a PMI executive.

PMI has also put out the word that it is seeking offers from investors who might be “better suited to help Medicago on the next phase of its journey.”

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