At a briefing earlier this month, the WHO said it did not accept the Medicago application for review because of its 2005 public health treaty requiring no involvement with any company that produces or promotes tobacco-based products.

The government in Ottawa, which has provided millions of Canadian dollars in development funding to the company and has agreed to buy up to 76 million doses, defended its emergency use authorization, saying it needs a domestic manufacturer to help prepare for future pandemics.

A spokesperson for national health agency Health Canada told the Reuters news agency it believes it is in compliance with the WHO tobacco rule that "does not preclude the government of Canada from working with Medicago on vaccine development and procurement to ensure that a ready and effective supply of vaccines is available for its population."

Others said a WHO authorization is key because the vaccine can then be part of the global COVAX program for low- and middle-income countries. Up to now, Africa has come up short on vaccines, despite recent pledges by the manufacturers to provide more doses for the continent. 
 

As the world health agency’s approval can benefit countries without their own drug regulatory agencies, barring its approval, Medicago will need to apply to all regulatory authorities separately to obtain the necessary approvals, said Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security.

Medicago told Reuters it has started the filing process with the US Food and Drug Administration (FDA). It has also started an early-to-mid stage study of the shot in Japan and plans to file for regulatory approval there this spring.

The Swiss-American tobacco giant owns a 21% stake in the Quebec-based vaccine maker, with the remaining shares held by Japan's Mitsubishi Tanabe Pharma. Canadian health group Quebec Coalition for Tobacco Control is pressing Health Canada to demand that Medicago replace Philip Morris as a stakeholder.

Covifenz, the only authorized Covid-19 vaccine that is plant-based, uses nicotiana benthamiana, a cousin of the tobacco plant, as small bioreactors, growing non-infectious virus-like particles that mimic the coronavirus. It contains an adjuvant made by UK drugmaker Glaxosmithkline (GSK).

Author: Dede Williams, Freelance Journalist