Medicago’s tobacco ties jeopardize growth of its COVID shot

By Amruta Khandekar and Mrinalika Roy

(Reuters) – Canadian vaccine maker Medicago’s COVID-19 vaccine, accepted final month in Canada, is going through restricted development within the near-term after the World Well being Group mentioned it will not overview the vaccine as a result of the corporate is partly owned by U.S.-Swiss tobacco firm Philip Morris, well being consultants say.

The WHO mentioned at a briefing this month and in a follow-up assertion to Reuters that it has not accepted an software for the vaccine due to its 2005 public well being treaty requiring no involvement with any firm that produces or promotes tobacco-based merchandise.

Canada, which has supplied tens of millions of {dollars} in growth funding to the corporate and has agreed to purchase as much as 76 million doses, defended its authorization of the vaccine, saying it wants a home bio-manufacturing trade to arrange for future pandemics.

Well being Canada mentioned it believes it’s in compliance with the WHO tobacco treaty.

The WHO tobacco treaty “doesn’t preclude the Authorities of Canada from working with Medicago on vaccine growth and procurement to make sure that a prepared and efficient provide of vaccines is on the market for its inhabitants,” a Well being Canada spokesperson informed Reuters.

Consultants say a WHO authorization is essential as a result of the vaccine can then be a part of the COVAX world vaccine program for low- and middle-income nations. Whereas a lot of the developed world has already been vaccinated, Africa remains to be in determined want of vaccines. WHO’s approval may also stand in for nations that do not need their very own drug regulatory companies.

The corporate has additionally pitched the platform as simply adaptable for brand spanking new vaccines ought to there be a subsequent pandemic. It’s growing flu vaccines on the platform as nicely.

“I feel that the WHO requirements are going to pose a barrier to the uptake of the vaccine,” mentioned Amesh Adalja, an infectious illness skilled on the Johns Hopkins Heart for Well being Safety.

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Medicago would now have to method European and U.S. regulators in addition to another particular person nations one after the other to realize approvals, a harder however not not possible barrier to make use of, Adalja mentioned.

GLOBAL CUSTOMER BASE

Medicago mentioned it’s in discussions with different potential prospects worldwide.

The corporate has began the submitting course of for approval of its COVID-19 vaccine with the U.S. Meals and Drug Administration (FDA), Medicago Chief Government Officer Takashi Nagao mentioned in an emailed assertion.

The corporate has additionally began an early-to-mid stage examine of the shot in Japan, and plans to file for regulatory approval within the spring, Nagao mentioned.

It mentioned it has not obtained an official communication from the WHO, however believed the choice was linked to its minority shareholder and never the protection and efficacy profile of its COVID-19 vaccine.

Swiss-American tobacco big Philip Morris owns a 21% stake within the Quebec firm. Japan’s Mitsubishi Tanabe Pharma, a unit of Mitsubishi Chemical Holding Corp, owns the remainder of Medicago.

Canadian well being group Quebec Coalition for Tobacco Management this week known as on Canada to demand that Medicago substitute Philip Morris as a stakeholder resulting from its tobacco enterprise. Philip Morris has had a stake within the firm since 2008.

A Philip Morris spokesperson mentioned that the WHO’s place was in opposition to its personal name to speed up vaccinations world wide.

“Emergency use authorization of a COVID-19 vaccine has completely nothing to do with tobacco management,” the spokesperson mentioned. “WHO insurance policies ought to give attention to accelerating medical progress and innovation.”

Medicago’s Covifenz is the one approved COVID-19 vaccine that’s plant-based. To make the vaccine, the corporate makes use of nicotiana benthamiana, a cousin of the tobacco plant, as small bioreactors, rising non-infectious virus like particles that mimic the coronavirus. It’s given with a boosting compound from British drugmaker Glaxosmithkline.

The US and Europe, which have already got a number of vaccines cleared to be used, should still need Medicago’s shot due to its plant-based expertise, which might be helpful to create a vaccine in opposition to the following problematic pathogen, in accordance with Prashant Yadav, lecturer and provide chain skilled at Harvard Medical Faculty.

(Reporting by Mrinalika Roy and Amruta Khandekar in Bengaluru; modifying by Caroline Humer and Nick Zieminski in New York)