Medicago's tobacco ties jeopardize growth of its COVID shot

Mitsubishi Chemical

28/03/2022 11:00

(Repeats March 27 story with no changes to text or headline)
    By Amruta Khandekar and Mrinalika Roy
    March 27 (Reuters) - Canadian vaccine maker Medicago's
COVID-19 vaccine, approved last month in Canada, is facing
limited growth in the near-term after the World Health
Organization said it would not review the vaccine because the
company is partly owned by U.S.-Swiss tobacco company Philip
Morris, health experts say.
    The WHO said at a briefing this month and in a follow-up
statement to Reuters that it has not accepted an application for
the vaccine because of its 2005 public health treaty requiring
no involvement with any company that produces or promotes
tobacco-based products.
    Canada, which has provided millions of dollars in
development funding to the company and has agreed to buy up to
76 million doses, defended its authorization of the vaccine,
saying it needs a domestic bio-manufacturing industry to prepare
for future pandemics. 
    Health Canada said it believes it is in compliance with the
WHO tobacco treaty.
    The WHO tobacco treaty "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," a Health Canada
spokesperson told Reuters.
    Experts say a WHO authorization is key because the vaccine
can then be part of the COVAX global vaccine program for low-
and middle-income countries. While much of the developed world
has already been vaccinated, Africa is still in desperate need
of vaccines. WHO's approval can also stand in for countries that
do not have their own drug regulatory agencies. 
    The company has also pitched the platform as easily
adaptable for new vaccines should there be a next pandemic. It
is developing flu vaccines on the platform as well.
    "I think that the WHO standards are going to pose a barrier
to the uptake of the vaccine," said Amesh Adalja, an infectious
disease expert at the Johns Hopkins Center for Health Security.
   Medicago would now need to approach European and U.S.
regulators as well as any other individual countries one by one
to attain approvals, a more difficult but not impossible barrier
to use, Adalja said.
    
    GLOBAL CUSTOMER BASE 
    Medicago said it is in discussions with other potential
customers worldwide.
    The company has started the filing process for approval of
its COVID-19 vaccine with the U.S. Food and Drug Administration
(FDA), Medicago Chief Executive Officer Takashi Nagao said in an
emailed statement. 
    The company has also started an early-to-mid stage study of
the shot in Japan, and plans to file for regulatory approval in
the spring, Nagao said.
    It said it has not received an official communication from
the WHO, but believed the decision was linked to its minority
shareholder and not the safety and efficacy profile of its
COVID-19 vaccine.
    Swiss-American tobacco giant Philip Morris  PM.N  owns a 21%
stake in the Quebec company. Japan's Mitsubishi Tanabe Pharma, a
unit of Mitsubishi Chemical Holding Corp  4188.T , owns the rest
of Medicago. 
    Canadian health group Quebec Coalition for Tobacco Control
this week called on Canada to demand that Medicago replace
Philip Morris as a stakeholder due to its tobacco business.
Philip Morris has had a stake in the company since 2008.
    A Philip Morris spokesperson said that the WHO's position
was in opposition to its own call to accelerate vaccinations
around the world. 
    "Emergency use authorization of a COVID-19 vaccine has
absolutely nothing to do with tobacco control," the spokesperson
said. "WHO policies should focus on accelerating medical
progress and innovation." 
    Medicago’s Covifenz is the only authorized COVID-19 vaccine
that is plant-based. To make the vaccine, the company uses
nicotiana benthamiana, a cousin of the tobacco plant, as small
bioreactors, growing non-infectious virus like particles that
mimic the coronavirus. It is given with a boosting compound from
British drugmaker Glaxosmithkline  GSK.L . 
    The United States and Europe, which already have several
vaccines cleared for use, may still want Medicago's shot because
of its plant-based technology, which would be useful to create a
vaccine against the next problematic pathogen, according to
Prashant Yadav, lecturer and supply chain expert at Harvard
Medical School.

 (Reporting by Mrinalika Roy and Amruta Khandekar in Bengaluru;
editing by Caroline Humer and Nick Zieminski in New York)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))