The Quebec biopharma company’s request for pre-qualification of its Covifenz shot was not accepted, according to the WHO’s guidance document dated March 2.

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Medicago Inc.’s COVID-19 vaccine is poised to become the first Western shot to be rejected by the World Health Organization, because of the company’s links to cigarette-maker Philip Morris International Inc.

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The Quebec biopharma company’s request for pre-qualification of its Covifenz shot was not accepted, according to the WHO’s guidance document dated March 2. That means the WHO is unlikely to approve the vaccine for emergency use, which would also keep it out of the Covax global vaccine-sharing facility.

“Due to its connections — it’s partially owned by Philip Morris — the process is put on hold,” Mariangela Simao, WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, said at a media briefing on Wednesday. “The WHO and the UN have a very strict policy regarding engagement with the tobacco and arms industry, so it’s very likely it won’t be accepted for emergency use listing.”

Covifenz is the world’s first plant-based COVID inoculation. It’s made from proteins, grown in plants, that look like the virus that causes COVID to the human immune system. The vaccine also uses GlaxoSmithKline Plc’s pandemic adjuvant, a substance that boosts the immune system’s response. It was jointly developed by Medicago, which is owned by Mitsubishi Chemical and Philip Morris, and Glaxo. The Canadian government provided $173 million in funding to its development and is so far the only country that has cleared it for use.

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Anti-tobacco groups argue that financing and approving a drug that has links to the tobacco industry violates the WHO Framework Convention on Tobacco Control that came into force in 2005. The global treaty calls for tighter tobacco controls and emphasizes the need for public health policies to be protected from commercial and other vested interests of the tobacco industry.

Representatives for Health Canada and Medicago didn’t immediately respond to requests for comment.

Medicago has a contract with the Canadian government to supply up to 76 million doses of the vaccine and is in talks with other countries about potential agreements, chief executive officer Takashi Nagao has said.

“Even if it’s not a violation of the letter, it’s definitely a violation of the spirit of the convention,” said Les Hagen, executive director at Action on Smoking and Health in Edmonton. “This is not Canada’s proudest moment in public health.”

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The situation highlights the difficulties Big Tobacco faces as companies increasingly seek to expand further into the health and wellness sector. Philip Morris, which sells Marlboro cigarettes outside the US, has made a series of acquisitions that included inhaled-therapy maker Vectura Group Plc, a move that caused public outcry. British American Tobacco Plc has set up a new biotech arm, KBio Holdings, that will focus on developing treatments and vaccines for rare and infectious diseases using plant-based technology.

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China’s IMBCAMS’s expression of interest in pre-qualification of its inactivated COVID vaccine was also not accepted, with the WHO noting that shot was still under initial development.

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