Tag: Medicago

Plant-Based Biologics Market Thriving

Photo: Kentucky Bioprocessing
The global plant-based biologics market is anticipated to generate a revenue of $182.9 million by 2031, expanding a compound annual growth rate of 4.8 percent from 2022, according to a new report published by Research Dive.
Plant-based biologics are medical products that are produced by utilizing bioengineered plants to create complex molecules like proteins, antibodies, and vaccines. These biologics are produced more sustainably and economically than conventional animal cell-based biologics. The use of plant-based biologics may have substantial effects on the pharmaceutical industry by lowering the costs of medicine development and production and addressing ethical concerns about the use of animals in medical research.
Tobacco continues to be the most widely used plant for the manufacture of pharmaceuticals. Due to their high biomass yield, ease of genetic modification and quick growth rate, tobacco plants are well-suited for biologics production. Several companies, including Medicago, Baiya Phytopharm and Kentucky Bioprocessing have used tobacco to developed vaccines and other medical treatments.
According to Research Dive, North America dominated the global plant-based biologics market in 2021. Not only does the continent offer a sizable market, but it also offers a supportive regulatory environment and strong research infrastructure.
Tobacco Reporter explored tobacco’s potential as a “green bioreactor” in its April 2022 issue.
July 6, 2023
PMI, Medicago Cut Ties After WHO Rejection

Credit: Antonioguillem
Philip Morris International and the health group Medicago have severed ties after the World Health Organization rejected Medicago’s Covid-19 vaccine, according to a tobacco control body.
Covifenz, the world’s first plant-based Covid-19 vaccine, was jointly developed by Medicago, which is owned by Mitsubishi Chemical, Philip Morris and Glaxo, according to Bloomberg. The Canadian government, which provided $173 million in funding for its development, has cleared it for use.
The government of Quebec previously said it wanted to help Medicago replace its shareholder PMI with another investor so that the biotech firm can distribute its Covifenz Covid-19 vaccine internationally.
“Tobacco corporations, vaccines and governments don’t mix well, and we applaud the expulsion of Philip Morris from the Medicago collaboration,” Les Hagen, the executive director of not-for-profit organization ASH Canada, said in a statement.
Medicago’s request for an emergency-use listing was denied earlier this year by the World Health Organization because of the links with tobacco industry.
Earlier this year, Medicago announced it would cut 62 jobs at its manufacturing facility in Durham, North Carolina, USA, which played a key role in producing the company’s tobacco plant-based Covid-19 vaccine.
December 26, 2022
Medicago Cuts Jobs at Covid Vaccine Facility

Photo: Miljan Živković
Medicago is cutting 62 jobs at its manufacturing facility in Durham, North Carolina, USA, which played a key role in producing the company’s tobacco plant-based Covid-19 vaccine, reports the Triangle Business Journal.
In a notice to the North Carolina Department of Commerce, the Canadian biopharmaceutical company said the layoffs are the result of Medicago “restructuring its workforce to align with its changing business needs.”
Using tobacco plants, the company developed a Covid vaccine called Covifenz, which Canadian regulators approved earlier this year. The country’s government committed to purchasing 20 million doses of the vaccine with an option to purchase 56 million more.
No other country has approved Covifenz, however. The World Health Organization, meanwhile, has been reluctant to grant the vaccine emergency approval due to Medicago’s ties with Philip Morris International, which owns about a third of the biopharmaceutical company.
Headquartered in Quebec City, Medicago employs 600 people.
The company built out its facility in Durham through a 2010 partnership with the U.S. Defense Advanced Research Projects Agency, which included $21 million in funding from the federal agency. The facility features greenhouse space and an automated extraction and purification system.
November 1, 2022
Quebec to Help Medicago Cut PMI Ties

Photo: Leigh Prather
The government of Quebec wants to help Medicago replace its shareholder Philip Morris International with another investor so that the biotech firm can distribute its Covifenz Covid-19 vaccine internationally, reports CTV News.
In February, Health Canada approved Covifenz, a tobacco plant-based coronavirus vaccination developed by Medicago and GlaxoSmithKline, for adults aged 18 to 64. In December 2021, the company said its two-dose vaccine was 71 percent effective in preventing Covid-19 infections, according to a large study that included several variants.
However, in May, the World Health Organization rejected Covifenz, citing Medicago’s firm’s links to PMI, which owns 21 percent of Medicago shares. Article 5.3 of the WHO Framework Convention on Tobacco Control obliges parties to ensure that their policies are protected “from commercial and other vested interests of the tobacco industry.”
The Canadian government has signed a contract to purchase up to 76 million doses of Covifenz. Canada had planned to donate any excess vaccines to low-income countries through the Covax vaccine-sharing alliance. Since the WHO has denied Medicago’s request, Canada will not be able to donate doses of Covifenz.
Quebec Economy Minister Pierre Fitzgibbon has been talking with Medicago’s other shareholder, Mitsubishi Tanabe Pharma, about the possibility of buying out PMI. Mitsubishi has asked the Quebec government for support so that Medicago’s vaccines “can receive a favorable reception from the WHO and be marketed on a large scale,” according to a recent entry in the Quebec Registry of Lobbyists.
Canadian health groups applauded the efforts to replace PMI as a major shareholder.
“Philip Morris’s involvement in Medicago is the main obstacle to widespread international distribution of the plant-based Covid-19 vaccine,” said Flory Doucas of the Quebec Coalition for Tobacco Control in a statement. “Medicago has previously signaled that alternative investors would help facilitate this outcome. Quebec’s intentions to buy out Philip Morris’s shares from Medicago is the logical path to the eventual approval for this vaccine by the World Health Organization.”
June 21, 2022
The Virtuous Weed

Artwork: Dan Kurtz
When tobacco heals instead of hurts
By Taco Tuinstra
The health consequences of tobacco use have been well documented. According to the World Health Organization, more than 8 million people worldwide succumb to tobacco-related illnesses, such as lung cancer, heart disease and chronic obstructive pulmonary disease, every year. For every person who dies due to tobacco, at least 30 people live with a serious tobacco-related illness, according to a 2019 policy brief by Tobacconomics.
Tobacco also carries a significant economic toll. A report prepared by the World Bank Group Global Tobacco Program expected the worldwide economic cost of smoking to reach $1.4 trillion in 2017, equivalent to 1.8 percent of the world’s gross domestic product that year. Little wonder, then, that many view the tobacco plant as evil.
Yet there is another, decidedly more benign, side to the Wicked Weed. When dried, set on fire and inhaled, the tobacco plant wreaks havoc; when deployed as a “green bioreactor,” the golden leaf has the potential to help address some of the world’s most vexing public health challenges, including, ironically, certain respiratory afflictions.

Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials in April 2022.
(Photo: Baiya Phytopharm).
Among the most striking examples of tobacco’s potential to heal rather than hurt are recent endeavors to develop an inoculation against the novel coronavirus. In February, Health Canada approved Covifenz, a tobacco plant-based Covid-19 vaccination developed by pharmaceutical giant GlaxoSmithKline and Medicago, a biopharmaceutical company backed by Philip Morris International. According to Health Canada, Covifenz is the world’s first vaccine approved for human use that utilizes a plant-based protein technology.
As it turns out, plants—and especially tobacco plants (see sidebar)—lend themselves exceptionally well to developing pharmaceutical compounds. In many ways, they are better suited to the task than the man-made bioreactors used in traditional vaccine development.
To create a vaccine, scientists must produce antigens—molecules that trigger an immune response to a specific virus or bacteria. Antigens for conventional vaccines are made by infecting cells from insects, monkeys, hamsters or other sources in the laboratory with a virus or a bit of viral genetic code that tricks the cells into making copies of the virus or antigen. The cells incubate in bioreactors for extended periods of time and then undergo a complex purification process before being packaged into vials.
Bioreactors are expensive, however, and their operation requires trained personnel. They are also susceptible to contamination, forcing vaccine developers to keep bioreactors growing different types of antigens far apart and under sterile conditions.
Dahlia Garwe
Plants are natural bioreactors, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. “They are able to perform eukaryotic post-translational modifications that are often essential for biological activity of many mammalian proteins,” she explains. When infected with DNA from Covid-19 or other viruses, plant cells will make millions of copies of virus-like particles that can serve as antigens without being infectious.
Using plants instead of mechanical bioreactors offers many benefits, notes Garwe. Plants are cheap to grow, easy to manipulate and resistant to contaminations that could present problems for humans. “Green bioreactors do not suffer the same risk of pathogen contamination as seen in mammalian cell culture as there are no known cross-kingdom pathogens,” she says.
With light as their primary energy source, plants are less expensive to work with than traditional cell culture systems, allowing for inexpensive and nearly unlimited scalability. Because plant systems are robust and inert, they are also easier to handle and purify than other systems.

Medicago is not the only company that has grasped the promise of plants in the development of vaccines and therapeutics. At least three other organizations are using Nicotiana benthamiana, a close relative of the tobacco plant used in cigarettes, to develop Covid-19 vaccines. In December 2020, the U.S. Food and Drug Administration approved an investigational new drug application for a Covid-19 vaccine by BAT subsidiary Kentucky Bioprocessing (KBP, now part of KBio). The company is currently conducting Phase I clinical trials, which are the first steps in testing the safety and side effects of a pharmaceutical in humans.
According to BAT, plant-based vaccines have several advantages over serums developed with conventional technologies, including speed and thermostability. Whereas traditional methods can take months to yield the desired vaccine ingredients, KBP’s tobacco plants do so within six weeks. And unlike some of the existing Covid-19 vaccines, KBP’s vaccine candidate has the potential to be stable at room temperature, an important benefit, especially for public health networks in countries with warm climates and few refrigerated trucks and warehouses.
Fearing supply constraints and “vaccine nationalism” at the start of the pandemic, scientists in Thailand have joined the race as well. Baiya Phytopharm, a plant-produced biologics company, is working with tobacco in part because that crop can be easily and inexpensively cultivated domestically, thus reducing Thailand’s reliance on foreign-made vaccines. According to the Bangkok Post, Thailand has more than 10,000 tobacco growers.
Waranyoo Phoolcharoen
In an email exchange, Baiya Phytopharm co-founder Waranyoo Phoolcharoen told Tobacco Reporter that the company had finished Phase 1 clinical trials and was happy with the data. Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials this month (April). If the vaccine candidate does well in subsequent trials, it could be available in Thailand by the end of the year, according to Phoolcharoen.
Meanwhile, Akdeniz University in Turkey is using a protein produced by tobacco plants to develop a Covid-19 vaccine. Its technology is based on an angiotensin-converting enzyme 2 and can be administered as an injection or through a spray. According to an April 2021 report in Hurriyet Daily News, tests on mice have demonstrated a high level of inhibition of the Covid-19 virus from entering the cell. At the time of publication, Akdeniz University was seeking funding to conduct clinical trials in humans.
In addition to Covid-19, scientists have sought to tackle many other diseases with the help of tobacco. In response to concerns about bioterrorism following the September 11 attacks in the United States, researchers at the University of Central Florida used tobacco plants to create a protective antigen against anthrax. According to an article published in Environmental Health Perspectives, mice immunized with the agent survived anthrax injections of 1.5 times the deadly dose.
In 2014, KBP, working in cooperation with the U.S. Biomedical Advanced Research and Development Authority, developed, tested and used ZMapp, an antibody cocktail to treat infection from the Ebola virus, which was raging in west Africa at the time. In under six weeks, KBP completed cGMP manufacturing of each of the three monoclonal antibodies comprising the ZMapp cocktail, which received temporary emergency authorization from the FDA.
Pushing the envelope further still, Collplant of Israel is using tobacco to generate human tissue and organs. Collplant’s technology allows for the production of large quantities of medical grade human collagen, which is a primary building block for the human body and essential for tissue repair. Physicians use collagen products to treat chronic wounds, burns and other afflictions. Deriving collagen from tobacco rather than from traditional sources, such as cadavers, cows or pigs, offers several advantages, including stable fibrillates, pure molecular structures and no immunogenic responses, according to Collplant.
While the endeavors described above are only a sample of the many ways in which tobacco is deployed to produce pharmaceutical and other useful compounds, they vividly illustrate the potential of the golden leaf to help solve rather than create problems—a side that is often overlooked due to the health toll extracted by smoking.
The Green Bioreactor
While despised in the court of public opinion, tobacco is highly valued among plant scientists.
For starters, the species has good physiology for research. “Seeds are easily sterilized, and germination is very quick, so generating experimental material is easy,” says David Norman, senior scientist at Demeetra AgBio, a company that is using gene editing for crop trait development and that also works with tobacco (see “Genetic Scissors,” Tobacco Reporter, August 2021). “Tobacco grows fairly fast compared to many plants, to where flowering and mature seeds can be attained in just a couple months.”
The soft tobacco leaf is ideal for transfection, allowing researchers to easily introduce DNA or RNA into its cells. What’s more, regeneration mechanisms from callus in tobacco are extremely efficient. In addition to allowing genetic modifications on leaf material, tobacco is also easily propagated as a cell culture or protoplast culture.
The fact that tobacco is neither a food nor a feed crop makes it even more attractive as a plant for conducting research, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. Using tobacco, she says, reduces the likelihood of transgenic material contaminating food or feed supply chains—an important consideration when many consumers remain wary of genetically manipulated foods.
Tobacco is also well understood from a genetic engineering and molecular biology standpoint; it has been more characterized than any other plant system. Scientists have been researching and genetically modifying tobacco since the early 20th century.
Meanwhile, biochemists have been able to produce many recombinant proteins in tobacco, with the plants serving as bioreactors for largescale production of pharmaceutical and industrial compounds. “Tobacco can easily take in DNA to produce these compounds when injected into the leaf or through vacuum infiltration of whole plants,” says Norman.
The vacuum infiltration method, in particular, can be scaled up to infect many plants at one time, according to Norman. “After infiltration, tobacco transiently expresses the DNA introduced for a short while and makes the protein of interest in the leaves.
“While the protein production in plants may not be that impressive on a per plant scale, up to a few percent depending on the protein of interest, you have to consider the yield per acre for tobacco. On an average acre of tobacco, the yield can be several tons of leaf material. With that scale of leaf material per acre, suddenly those small protein yields add up to being significant and potentially economically viable.”–T.T.
The Plant-Based Vaccine: A Late Bloomer?
In February, Medicago’s Covifenz Covid-19 vaccine received the green light from Health Canada, making it the world’s first plant-based vaccine approved for human use. Considering how long scientists have known about the potential of plant-based vaccines—the proof of concept dates back some 30 years—it may seem surprising that the first regulatory approval for such a product was granted only this year.
While the U.S. Department of Agriculture in 2006 gave the thumbs-up to a plant-derived vaccine to inoculate chickens against the lethal Newcastle disease, most of the projects targeted at human vaccines never even made it to end-stage clinical trials. The FDA did approve Protalix’s plant-based drug to treat Gaucher’s disease in humans in 2012 and in 2014 gave emergency authorization to ZMapp, a plant-based biological medicine manufactured by KBP (now part of KBio) to treat Ebola, but the first was not a vaccine, and the second was approved under special conditions.
Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Board in Zimbabwe, suspects the “delay” in approving plant-based vaccines is due to regulatory issues and public perceptions of genetically modified organisms (GMOs). “Most vaccines produced in plants would most likely be classified as GMOs, which automatically makes them ‘undesirables,’” she ventures.
Kathleen Hefferon, who teaches microbiology at Cornell University, acknowledges that public perception may be part of the problem but believes that many consumers would accept plant-made vaccines just as they have accepted vaccines produced in eggs and mammalian cells. “They are familiar with the GM technology when used for medical purposes,” she says. “It is when it comes to genetic modification in food products that some people seem to raise concerns.”
Hefferon suspects that the absence of a clear regulatory path represents the greatest obstacle as it may have made pharmaceutical companies wary of investing in this technology. The carrot suspension cell culture that Protalix used for its Gaucher’s disease drug somewhat resembles Chinese hamster ovary cell culture, she notes. “That made it a little easier for regulators.”
Patrick Doyle, CEO of KBio Holdings, a company set up by BAT to accelerate the development and production of novel treatments with plant-based technology, says it is important to remember that in a normal R&D cycle, medicines and vaccines on average take over 10 years, even when using a proven technology or approach.
“In fact, as a result of the global health crisis presented by Covid[-19], development, regulatory review and approval timelines were accelerated to support the delivery of much-needed vaccines,” he says. “Before gaining approval for any vaccine, manufacturers must generate sufficient data to demonstrate the efficacy and safety of the candidate and technology, which takes time. For example, the mRNA platform, first discovered in the early 1960s, was a genetic technology that had long held huge promise but only received the first FDA [Food and Drug Administration] emergency use authorization for the prevention of Covid-19 disease in individuals 16 years of age and older on Dec. 20.”
According to Doyle, the positive data generated and the subsequent approval of Medicago’s vaccine is both a positive in terms of creating another approved treatment option for Covid-19 and reinforcing the potential of plant-based vaccines.
Hefferon agrees that Medicago’s success could set the stage for plant-made pharmaceutical commercialization in future years, and her optimism appears to be shared by others. Research and Markets expects the value of the global plant-based vaccines market to reach $2.62 billion by 2028—more than double the 2021 figure. Tobacco companies seem well attuned to the potential as evidenced by PMI’s investment in Medicago and by BAT’s creation of KBio. Doyle says KBio will explore new opportunities to develop its plant-based production system, which has the potential to offer greater speed, thermostability and scale-up opportunity and.
Hefferon says she’s very happy about the growing momentum for plant-based vaccines. “Too bad it took a pandemic to make it happen.” –T.T.
Uphill Battle: Tobacco-Backed Vaccines Continue To Face Skepticism From Health Authorities
While tobacco plants lend themselves exceptionally well to the creation of pharmaceutical compounds, vaccinations and treatments developed by tobacco-backed organizations still face an uphill battle as demonstrated by recent World Health Organization actions.
During a March 16 media briefing, the WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, Mariangela Simao, said the global health body had paused the process for pre-qualification of Medicago’s new Covifenz Covid-19 shot due to the biopharmaceutical firm’s link to Philip Morris International, which owns about one-third of the Canadian company.
“The WHO and the U.N. have a very strict policy regarding engagement with the tobacco and arms [industries], so it’s very likely it won’t be accepted for emergency use listing,” said Simao. The WHO persists in its opposition despite Health Canada’s February approval of Covifenz for adults between the ages of 18 and 64.
In a statement published by the CBC, Medicago said it believes authorization decisions should be based on the quality, efficiency and safety of the vaccine, not who owns shares in the manufacturer.
“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.
Derek Yach, a global health consultant, was aghast by the WHO’s suggestion that it might reject Medicago’s vaccine based on the company’s relationship with PMI.
“‘Pikuach nefesh’ is the ethical principle in Jewish law that the preservation of human life overrides virtually any other religious rule,” he said. “Most other religions support a variant of this. WHO violates this ethical principle when it denies people access to a lifesaving vaccine.”
If the WHO follows through, the vaccine would be the first Western-manufactured Covid-19 shot to be rejected by the global health body, according to Bloomberg. —T.T.
Taco Tuinstra is Tobacco Reporter’s editorial director.Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors.On his watch, Tobacco Reporter has won several awards for editorial excellence.Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.

April 1, 2022
WHO To Review Policies After Denying Vaccine

Photo: Tom
The World Health Organization is reviewing its policies after the global health body denied Medicago’s Covifenz Covid-19 vaccine emergency-use approval, according to The Times Colonist.
The WHO denied the vaccine due to the company’s ties with the tobacco industry; Philip Morris is a minority stakeholder in Medicago.
“Medicago was informed of this decision and has been apprised of WHO’s policies on tobacco,” the WHO stated.
However, the WHO’s policies may change as the organization reevaluates its policies following the tobacco industry’s attempts to diversify into other categories.
“WHO is currently holding discussions on how to address a general trend of the tobacco industry investing in the health industry,” the WHO said.
Once the WHO makes a decision on its policies, the Medicago vaccine application could be reviewed.
Medicago is waiting on a response from the WHO detailing why the vaccine application was denied. “Once we receive this, we will review the rationale and continue to discuss next steps with our partners and shareholders,” said Takashi Nagao, Medicago’s president.
March 29, 2022
‘Medicago and PMI Talk About Disinvestment’

Photo: Leigh Prather
Medicago is talking to its shareholder Philip Morris about disinvesting to clear the way for the biopharmaceutical company’s Covid-19 vaccine, reports The Globe and Mail, citing Canada’s innovation minister, Francois-Philippe Champagne.
In a briefing last week, the World Health Organization suggested it would reject Medicago’s Covifenz inoculation because of the company’s ties to the tobacco industry. Philip Morris Investments owns about one-third of the Canadian biopharmaceutical company.
Earlier, Health Canada approved Covifenz for use in adults 18 to 64 years of age.
On March 24, a WHO spokesperson told The Globe and Mail that Medicago’s request for an emergency use listing has been denied. He said the decision was made “because of the linkage with the tobacco industry and WHO’s strict policy on not engaging with companies that promote tobacco.”
An emergency use listing is required in order for vaccines to be used by COVAX, a global initiative to share vaccines with low-income and middle-income countries.
The WHO Framework Convention on Tobacco Control prohibits collaboration with the tobacco industry. According to The Globe and Mail, Health Canada believes the treaty does not preclude investment in vaccine development.
But according to the WHO’s treaty implementation guidelines, signatories shouldn’t let any branch of government accept contributions from the tobacco industry or those working with it. The implementation guidelines also state that signatories should not “endorse, support, form partnerships with or participate in activities of the tobacco industry described as socially responsible.”

The WHO will punish industry by preventing sale of less hazardous products and declining distribution of a vaccine tangentially connected to a tobacco company, both of which will inevitably cause even more disease and death.
Martin Cullip
Tobacco harm reduction advocates were aghast by the WHO’s rejection of Covifenz. Cameron English of the American Council on Science and Health described the global health body’s attitude as “shameless moral preening” that potentially puts many millions of people at risk.
Cameron noted that the tobacco industry has a long history of investing in companies that sell smoking cessation aids. “Is the WHO going to publicly oppose the use of nicotine gum because cigarette makers have a vested interest in selling it?”
Martin Cullip, an international fellow at The Taxpayers Protection Alliance’s Consumer Center, said the WHO is engaged with points-scoring against industry rather than saving people from dying of the disease in low-income and middle-income countries.
“Their unethical and depraved reasoning seems to be that because cigarettes have caused so much harm, the WHO will punish industry by preventing sale of less hazardous products and declining distribution of a vaccine tangentially connected to a tobacco company, both of which will inevitably cause even more disease and death,” he wrote for Townhall.
March 28, 2022
Medicago Urged to Ditch Philip Morris

Photo: evannovostro
A coalition of health groups have called on the Canadian government to replace Philip Morris International as a major shareholder in Medicago.
In late February, Health Canada authorized Medicago’s Convifenz Covid-19 vaccine, which is manufactured with the help of tobacco plants. Soon after, the World Health Organization signaled it was unlikely to grant the vaccine emergency approval due to Medicago’s ties to the tobacco industry. PMI owns about a third of the biopharmaceutical company.
“There is a simple pathway to get this vaccine approved. Our governments should stand up to Philip Morris,” said Flory Doucas, co-director of the Quebec Coalition for Tobacco Control.
“Instead of asking the WHO to contravene its own tobacco control treaty, which was ratified by Canada and 181 other countries, the federal Minister of Health and his Quebec counterpart should focus their energies on convincing the tobacco giant to withdraw as a shareholder of Medicago.”
According to the health groups, Medicago has already signaled that it is seeking alternative investors. The Canadian and Quebec governments, they say, should help facilitate such a transition.
The health groups cite Article 5.3 of the WHO Framework Convention on Tobacco Control, which obliges parties to ensure that their policies are protected “from commercial and other vested interests of the tobacco industry.”
“Guidelines for implementing this obligation make clear that ‘the tobacco industry should not be a partner in any initiative linked to setting or implementing public health policies, given that its interests are in direct conflict with the goals of public health,’” the organizations wrote in a press release. “Parties are directed that they ‘should not endorse, support, form partnerships with or participate in activities of the tobacco industry described as socially responsible.’”
March 25, 2022
WHO Likely to Reject Medicago Covid Vaccine
The World Health Organization is unlikely to grant emergency approval Medicago’s tobacco plant-based Covid-19 vaccine due to the company’s ties to the tobacco industry, the CBC reported on March 17.
The global health body has reportedly paused the process for pre-qualification of Medicago’s new Covifenz shot due to its link to Philip Morris International, which owns about one-third of the Canadian biopharmaceutical company.
“Due to its connections [to PMI], the process is put on hold,” said Mariangela Simao, the WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, at a March 16 media briefing.
“The WHO and the U.N. have a very strict policy regarding engagement with the tobacco and arms [industries], so it’s very likely it won’t be accepted for emergency use listing,” she said.
In February, Health Canada approved Covifenz for adults 18 to 64 years of age, making it the world’s first vaccine approved for human use that utilizes a plant-based protein technology. The Canadian government floated CAD173 million ($136.74 million) to help the company develop the jab and is so far the only country to approve it.
In October 2020, Canada signed a deal to buy 76 million doses of Medicago’s vaccine, and the shot is expected to be made available to the public in May.
In a statement published by the CBC, Medicago said it believes authorization decisions should be based on the quality, efficiency and safety of the vaccine, not who owns shares in the manufacturer.
“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.
Derek Yach, a global health consultant, was aghast by the WHO’s suggestion that it would reject Medicago’s vaccine based on the company’s relationship with PMI.
“‘Pikuach nefesh’ is the ethical principle in Jewish law that the preservation of human life overrides virtually any other religious rule,” he said. “Most other religions support a variant of this. WHO violates this ethical principle when it denies people access to a lifesaving vaccine.”
If the WHO follows through, the vaccine would be the first Western-manufactured Covid-19 shot to be rejected by the global health body, according to Bloomberg.
March 17, 2022
Canada Approves Medicago’s Vaccine

Photo: M.Rode-Foto
Health Canada has approved Covifenz, a tobacco plant-based coronavirus vaccination developed by GlaxoSmithKline and Medicago, a biopharmaceutical company backed by Philip Morris International.
“The approval of our Covid-19 vaccine is a significant milestone for Canada in the fight against the pandemic. We appreciate Health Canada’s timely review,” said Takashi Nagao, president and CEO of Medicago, in a statement. “We’re also grateful for the government of Canada’s support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order.”
“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable Covid-19 vaccines to help protect people against Covid-19 disease,” said Roger Connor, president of GSK Vaccines. “We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”
The government of Canada has a contract with Medicago to supply the Covid-19 vaccine.
“As one of our government’s top priorities has been to reverse the 40-year decline faced by Canada’s biomanufacturing sector, we are pleased to see Medicago’s vaccine approval. It is a great milestone for Canada’s biotechnology sector and for homegrown innovation. We will continue to support companies that want to produce vaccines in Canada and join the growing national biomanufacturing sector,” said François-Philippe Champagne, minister of innovation, science and industry.
Health Canada based its decision on scientific data shared by Medicago as part of its rolling submission that began in April 2021 under an Interim Order and concluded with the filing of a New Drug Submission-CV.
“Today is a great day for Medicago as Covifenz becomes its first approved vaccine,” said Yosuke Kimura, chief scientific officer at Medicago. “I’d like to thank the clinical investigators involved in our trials as well as Medicago’s passionate and curious team of over 500 scientific experts and employees. Today only reinforces our commitment to using our technology to provide rapid responses to emerging global health challenges and to advancing therapeutics against life-threatening diseases worldwide.”
Covifenz uses coronavirus-like particle technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles co-administered with GSK’s pandemic adjuvant. The vaccination regimen calls for two doses given intramuscularly 21 days apart (3.75 micrograms of coronavirus-like particle antigen in combination with GSK pandemic adjuvant in the same injection). The vaccine is stored at 2 degrees Celsius to 8 degrees Celsius. The Covifenz antigen will be manufactured in Canada and in North Carolina, USA.
February 25, 2022