Medicago’s tobacco connections endanger the company’s expansion in the COVID shot market.

(Reuters) Canadian vaccine maker Medicago’s COVID-19 vaccine, which was approved in Canada last month, is expected to see limited growth in the near term due to the World Health Organization declining to review the vaccine due to the company’s ownership by US-Swiss tobacco company Philip Morris (NYSE:PM), according to health experts.

The WHO said at a briefing this month and in a subsequent statement to Reuters that it had not approved an application for the vaccine due to its 2005 public health treaty prohibiting any association with companies that manufacture or promote tobacco-based goods.

Canada, which has invested millions of dollars in the company’s research and committed to purchasing up to 76 million doses, defended its approval of the vaccine, arguing that it needs a domestic biomanufacturing sector to prepare for future pandemics.

Health Canada said that it thinks it is in accordance with the World Health Organization’s tobacco control treaty.

According to Reuters, the WHO tobacco treaty “does not restrict the Government of Canada from collaborating with Medicago on vaccine research and procurement to guarantee that a timely and effective supply of vaccinations is accessible for its people.”

According to experts, WHO approval is critical since it allows the vaccine to be included in the COVAX global vaccination programme for low- and middle-income nations. While a large portion of the industrialised world has been vaccinated, Africa continues to be in severe need of vaccinations. The WHO’s clearance may also serve as a substitute for nations without their own drug regulatory organisations.

Additionally, the business has positioned the platform as being adaptable to new vaccinations in the event of a future pandemic. Additionally, it is developing flu vaccinations using the platform.

“I believe that the WHO guidelines would obstruct vaccine adoption,” said Amesh Adalja, an infectious disease specialist at the Johns Hopkins Center for Health Security.

Medicago would now have to contact European and US agencies individually, as well as any other specific nations, to get approvals, a more challenging but not insurmountable obstacle to overcome, Adalja said.


Medicago said that it is in talks with more prospective clients internationally.

The business has begun the application process with the US Food and Drug Administration (FDA) for approval of its COVID-19 vaccine, Medicago Chief Executive Officer Takashi Nagao said in an emailed statement.

Additionally, the business has begun an early- to mid-stage trial of the shot in Japan and aims to submit a regulatory application in the spring, Nagao said.

It said that although it has not received an official letter from the WHO, it believes the decision was made in response to its minority shareholder and not due to the safety and effectiveness profile of its COVID-19 vaccine.

Philip Morris, the Swiss-American tobacco giant, holds a 21% interest in the Quebec corporation. The remainder of Medicago is owned by Mitsubishi Tanabe Pharma, a subsidiary of Mitsubishi Chemical Holdings Corp.

Quebec Coalition for Cigarette Control, a Canadian health organisation, called on Canada this week to demand that Medicago replace Philip Morris as a shareholder owing to its tobacco business. Since 2008, Philip Morris has had a share in the corporation.

According to a Philip Morris representative, the WHO’s stance contradicts its own push for global immunisation acceleration.

“Authorization for emergency use of a COVID-19 vaccination has nothing to do with tobacco control,” the representative said. “WHO policy should prioritise medical advancement and innovation.”

Covifenz, manufactured by Medicago, is the only approved COVID-19 vaccine that is plant-based. To create the vaccine, the business grows non-infectious virus-like particles that imitate the coronavirus in miniature bioreactors made from nicotiana benthamiana, a relative of the tobacco plant. It is combined with a stimulating substance developed by Glaxosmithkline of the United Kingdom (LON:GSK).

The United States and Europe, which already have several vaccines approved for use, may still want Medicago’s shot due to its plant-based technology, which could be used to develop a vaccine against the next difficult pathogen, according to Prashant Yadav, a lecturer and supply chain expert at Harvard Medical School.

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