Quebec's Medicago COVID-19 vaccine faces WHO rejection over company's tobacco ties

A plant-based COVID-19 vaccine developed by a Quebec biopharmaceutical firm will "very likely" not be approved for emergency use because of the company's ties to the tobacco industry, a World Health Organization official said Wednesday.

The WHO has paused the process for pre-qualification of Medicago's new Covifenz shot due to its link to Marlboro cigarette manufacturer Philip Morris International. 

"Due to its connections — it's partially owned by Philip Morris — the process is put on hold," said Mariangela Simao, WHO's assistant director-general for drug access, vaccines and pharmaceuticals, at a Wednesday media briefing.

"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." 

In what the Quebec City-based biopharma company calls a world first, the two-dose shot uses plant-derived, virus-like particles, which resemble the coronavirus behind COVID-19 but don't contain its genetic material.

It was approved for use by Health Canada in February for adults 18 to 64 years of age.

Health Minister Jean-Yves Duclos said Thursday he and Innovation Minister François Philippe Champagne are following the process with WHO very closely.

"Minister Champagne and I have contacted Medicago to make sure that its contact with WHO is done properly," he said.

The Canadian government floated $173 million in 2020 to help the company develop the vaccine and develop its production facility in Quebec. It also signed a deal to buy 20 million doses of the vaccine, with an option for 56 million more.

Canada is so far the only country to approve the shot, which is expected to be made available to the public in May.    

Canada had planned to donate any excess doses to low-income countries through the COVID-19 Vaccines Global Access (COVAX), a global vaccine-sharing initiative.

According to a WHO document dated March 2, the Medicago vaccine is listed as "not accepted," and an official rejection could limit where in the world the vaccine can be used.

Base decision on efficacy, safety of shot: Medicago

In a statement, Medicago says it has not received any official communication from the WHO. 

"It is our understanding that the WHO has made a decision to pause the approval of the vaccine and that this decision is related to Medicago's minority shareholder, and not to the efficacy and safety of the vaccine, which was demonstrated with the approval by Health Canada," the statement reads. 

"Medicago believes that these decisions should be based on the quality, efficiency and safety of the vaccine."

Philip Morris Investments, a subsidiary of Philip Morris International, has been a shareholder of Medicago since 2008 and currently holds an approximately one-third equity stake, according to its website. It says it has supported the company's "innovative plant-derived research and development focused on vaccines."

These decisions should be based on the quality, efficiency and safety of the vaccine.- Medicago

Medicago uses the plant species nicotiana benthamiana, a close relative of tobacco plants that is used for pharmaceutical development, to produce its vaccine, largely because of the high number of viruses that can successfully infect it. 

Clinical trials have shown the vaccine's overall efficacy rate against all virus variants studied was 71 per cent, with a higher efficacy rate of 75 per cent against COVID-19 infections of any severity.

The vaccine would be the first Western-manufactured COVID-19 shot to be rejected by the WHO, according to Bloomberg.

Vaccine should go forward as 'one-off,' says bioethicist

In a global health emergency, the WHO prioritizing morality over access to life-saving vaccines is murky from an ethics standpoint, said Kerry Bowman, a bioethicist at the University of Toronto.

"You've got a company investing in something as important as a vaccine during an emergency that also ... has tobacco investments. What a shame that people did not see this coming and this was not dealt with before," said Bowman. 

While Bowman respects the health agency for standing to its policies, he said the vaccine should move forward in the approval process as a "one-off" case in the context of the pandemic. 

"I'm not going to say that this is not ethically complicated; I think it is. And I don't criticize the WHO or the UN for having these policies in the least," said Bowman. 

Despite the vaccine's production involving a relative of the tobacco plant, that doesn't mean the company has to market tobacco, he says. 

"We have to look at what a huge threat that tobacco is ... and lots of companies are going to have to make hard decisions about how to move forward."

WHO's stance 'not new,' says epidemiologist

Dr. Gaston De Serres, a medical epidemiologist with Quebec's public health institute, says Medicago made the choice to accept Philip Morris International as one of its shareholders knowing "full well" the health agency's position on cigarettes.

"The WHO has been clear for years that one of the biggest killers in the world are cigarettes and have said firmly that they will not encourage their products or producers," he said in a French radio interview on Radio-Canada's Tout un matin. 

"This is not new."

Whether or not the WHO's decision is correct can be debated, De Serres says. However, he says the agency is following its "robust logic, which is to say that there is no place for tobacco companies in the health world."