The Canadian biopharma company’s request for pre-qualification of its Covifenz shot wasn’t 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.

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. 

Canada has studied the government’s investment in Medicago carefully and considers that it is compliant with its treaty obligations, a spokeswoman for Health Canada wrote in an emailed response to questions. She said the treaty doesn’t preclude the government from working with Medicago on vaccine development and procurement to ensure that a ready and effective supply of vaccines is available for its population.

“The Department’s interactions with the tobacco industry will continue to be transparent in accordance with Health Canada’s openness and transparency requirements and in alignment with guidelines under the WHO FCTC,” she wrote. 

Medicago Chief Executive Officer Takashi Nagao said late Wednesday that the company hadn’t yet received any official communication from the WHO. 

“It is our understanding that this decision is linked to Medicago’s minority shareholder and not the demonstrated safety and efficacy profile of our COVID-19 vaccine,” he said. 

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, 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, a public health charity. “This is not Canada’s proudest moment in public health.”

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 U.S., 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.  

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

Medicago has been in contact with the European Medicines Agency, which would be ready to study an application if it makes one, Marco Cavaleri, the EU regulator’s head of biological health threats and vaccines strategy, said at a weekly briefing on Thursday.

Michael R. Bloomberg, founder and majority owner of Bloomberg News parent Bloomberg LP, has been a longtime champion of tobacco-control efforts. 

—With assistance from Brian Platt.