Category: Covid-19

  • BAT South Africa to Restructure Operations

    BAT South Africa to Restructure Operations

    Photo: Tobacco Reporter archive

    BAT is looking to restructure its South African business following a drop in legal cigarette sales. The process may affect 200 jobs.

    The cigarette maker attributed its predicament in part to the five-month cigarette sales ban that South Africa implemented in 2020. Intended to help prevent the spread of Covid-19, the measure was later declared unconstitutional by country’s Supreme Court.

    By then, however, the damage had been done, according to BAT.

    “The 2020 tobacco sales ban resulted in an explosion of growth for the illicit market. This has continued even after the ban on tobacco sales was lifted,” the company said in a statement.

    In 2019, BAT South Africa permanently employed around 1,800 staff across its South African operations. Since 2020, it has been forced to retrench more than 30 percent of its workforce, the company said.

    Over the same period, the company’s cigarette sales dropped by around 40 percent as the illicit market accelerated, it said.

    Based on independent studies, BAT South Africa estimates that the illicit cigarette trade accounts for up to 70 percent of South Africa’s total cigarette market. This illegal trade has severely impacted the sustainability of the legal tobacco industry and is a source of funds for criminal organizations in South Africa,” BAT wrote.

    The company urged for stronger enforcement and new policies to combat the illicit trade.

    “While BAT South Africa applauds recent efforts by the South African Revenue Service (SARS) and law enforcement agencies to clamp down on the illicit cigarette market, it also calls for even stronger action, given that the current approach has not stopped the growth of illicit cigarettes.

    “SARS has issued important new policies, but now it is time to audit manufacturer policy compliance. To support law enforcement agencies and increase their effectiveness, as well as help consumers differentiate between illicit and legal market offers, a minimum retail price policy is required.

    “The illicit trade robs South Africa of billions of rands in much-needed tax revenue, and the impact of this is now clearly being seen on legitimate businesses, their operations, and, unfortunately, the livelihoods of those in their value chains. Legitimate businesses cannot operate competitively if the country’s laws are not enforced.”

    BAT did not give details of how it would restructure its business or which jobs might be cut.

  • Medicago Cuts Jobs at Covid Vaccine Facility

    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.

  • More Danes Quit Smoking During Covid

    More Danes Quit Smoking During Covid

    Photo: sezerozger

    Danish smokers bought less tobacco, and more of them quit smoking than usual during the Covid-19 pandemic, according to new research from the University of Copenhagen that monitored cigarette purchases from the March 2020 lockdown through the end of the year. Those who kept puffing also purchased significantly less tobacco, the study showed.

    Among other things, the figures reveal that regular smokers bought 20 percent fewer cigarettes each week than before the pandemic. Meanwhile, the number of those who quit increased by 10 percent from the year prior.

    “The big picture is that cigarette consumption fell during the pandemic,” said study author Toke Reinholt Fosgaard, associate professor at the University of Copenhagen’s Department of Food and Resource Economics. “It comes as somewhat of a surprise as one would expect to see people smoking more during a pandemic, a time when people felt worse psychologically and had fewer opportunities to move about. Yet, the opposite occurred.”

    Fosgaard attributes the decline in tobacco consumption to the fact that smokers are at greater risk of developing severe Covid symptoms. “For a smoker, the consequences of smoking became more immediate, rather than a consequence in old age, as smokers suffer more severe cases of Covid,” he said.

  • Canada Working on Medicago’s ‘Tobacco Problem’

    Canada Working on Medicago’s ‘Tobacco Problem’

    Photo: Auramar, artwork: Dan Kurtz

    The government of Canada is “working on a solution” to help Medicago donate its Covid-19 vaccine to low-income countries, reports CTV News.

    In February, Health Canada approved the pharmaceutical firm’s Covifenz vaccine for people aged 18–64. The federal government has signed a contract to buy up to 76 million doses with plans to donate vaccines to low-income countries.

    However, the World Health Organization has rejected the vaccine because Philip Morris is a minority shareholder in Medicago, and the U.N. agency has a strict policy about engagement with the tobacco industry. Donations are not allowed without WHO approval.

    Medicago’s majority shareholder, Mitsubishi Tanabe Pharma, has approached the Quebec government for support so Medicago’s vaccines “can receive a favorable reception from the WHO and be marketed on a large scale,” according to an entry in the Quebec Registry of Lobbyists.

    During a meeting with Mitsubishi executives in Japan, Innovation, Science and Industry Minister Francois-Philippe Champagne indicated that there were discussions about the future of Medicago as a global vaccines manufacturer.

    While ruling out buying shares in Medicago for the time being, Champagne indicated that the government was looking at other ways to help make Medicago a “global champion.”

    Quebec Economy Minister Pierre Fitzgibbon said in June that he has been in discussions with Mitsubishi Tanabe Pharma executives to resolve the impasse, but the Japanese company must first negotiate the purchase of Philip Morris’ stake itself.

  • Quebec to Help Medicago Cut PMI Ties

    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.”

  • Top Court: South Africa Tobacco Ban Invalid

    Top Court: South Africa Tobacco Ban Invalid

    Photo: Alexlmx – Dreamstime.com

    South Africa’s Supreme Court of Appeal (SCA) on June 14 upheld a high court judgement that declared the ban on tobacco products sales during the Covid-19 pandemic unconstitutional, reports Times Live.

    In March 2020, Co-Operative Governance and Traditional Affairs Minister Nkosazana Dlamini-Zuma banned the sale of tobacco products to contain the spread of Covid-19.

    In June 2020, British American Tobacco,  JT International and several tobacco product consumers asked a court to invalidate the ban.

    The matter was heard by a full bench of the court in August 2020 and judgment was reserved. Later that month, the minister lifted its tobacco sales ban.

    Despite the lifting of the ban, the court passed judgment in December 2020 declaring the regulation inconsistent with the constitution and invalid.

    The government appealed the ruling, but lost.

    In its June 14 judgment, the SCA said assuming there was a causal link between smoking and the risk of contracting a more severe form of Covid-19, the minister would have had to show that stopping smoking during the tobacco ban would have reversed or  reduced the risk of contracting a severe form of Covid-19.

    The SCA said this had not been established as evidence.

    As regulation 45 was not necessary to achieve any of the purposes listed in section 27 of the Disaster Management Act, it was invalid, the court noted.

    Section 27 states that in the event of a national disaster the minister may make regulations dealing with steps that may be necessary to prevent the escalation of the disaster or to alleviate, contain and minimize the effects of the disaster.

  • Health Crises Worsened Vaping Confusion: Study

    Health Crises Worsened Vaping Confusion: Study

    Photo: kues1

    A new study led by researchers at the American Cancer Society (ACS) shows perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019-2020 and perceptions of e-cigarettes as “less harmful” declined between 2018-2020.

    The study also found that an increase in cigarette smoking prevalence in 2019-2020 was restricted to those who perceived e-cigarettes as “more harmful” than cigarettes, while increases in prevalence of e-cigarette use was restricted to those who perceived e-cigarettes as “less harmful” than cigarettes.

    Prevalence of dual use of both products increased only among those who perceived these products as “equally harmful” or “as harmful.” The results coincide with the e-cigarette or vaping use-associated lung injury outbreak (Evali) and the Covid-19 pandemic. The data was published in the American Journal of Preventive Medicine (AJPM).

    “While all tobacco products, including e-cigarettes, pose a risk to the health of the user, major health events, such as the Evali epidemic in late-2019 and the Covid-19 pandemic in 2020, paved the way to new smoking/e-cigarette health risks,” the ACS wrote in a press release.

    “During this time, the quality and type of information individuals were exposed to may have shaped how they compare the potential harms of tobacco products, which in turn, may have altered tobacco use behaviors.”

    How individuals perceive the harm of e-cigarettes vs. traditional cigarettes can predict their individual decision to use tobacco products, but according to the study authors, this is the first study to provide evidence this relationship translates to population-based prevalence changes. 

    “While this study showed sharp changes in public perceptions of e-cigarette vs. cigarette harms during Evali and Covid-19, the more relevant finding for public health is that increases in cigarette smoking and e-cigarette use prevalence occurred primarily in individuals who perceived their preferred product as relatively less harmful,” said Priti Bandi, principal scientist, risk factors and screening surveillance research at the American Cancer Society and lead author of the study. “This suggests that public perceptions of e-cigarettes vs. cigarettes harms influences population tobacco use patterns.”

    In this study, researchers analyzed data from the National Cancer Institute-sponsored Health Information National Trends Survey collected from more than 10,000 U.S. adults from 2018-2020. The results showed perceptions of e-cigarettes as “more harmful” than cigarettes doubled each year, increasing most between 2019-2020 (2018: 6.8 percent, 2019: 12.8 percent, 2020: 28.3 percent), while uncertainty (responses of “don’t know”) in relative harm declined (2018: 38.2 percent, 2019: 34.2 percent, 2020: 24.7 percent). “Less harmful” relative perceptions declined (2018: 17.6 percent, 2019: 15.3 percent, 2020: 11.4 percent), while “as harmful” perceptions remained steady (2018: 37.4 percent, 2019: 37.7 percent, 2020: 35.6 percent).

    Exclusive cigarette smoking increased between 2019-2020 among those who perceived e-cigarettes as relatively “more harmful” (2018: 18.5 percent; 2019: 8.4 percent; 2020: 16.3 percent), exclusive e-cigarette use increased linearly among those who perceived them as relatively less harmful (7.9 percent; 15.3 percent, 26.7 percent), and dual use increased linearly in those who perceived them as harmful (0.1 percent, 1.4 percent; 2.9 percent).

    “It is challenging for individuals to make conclusions about the short- and long-term health effects of tobacco products without clear, effective, and ongoing communication from public health authorities, especially when new contextual events that change health harms happen,” said Bandi.

    “There is a need for behavioral interventions to encourage individuals to be informed consumers of available scientific findings and appreciate that while no tobacco products is safe, there are inherent differences between relative and absolute harms between tobacco products that can influence behavior. In turn, public health education campaigns must facilitate informed decision making by translating emerging scientific evidence accurately to appropriate audiences.”

  • The Virtuous Weed

    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.
  • WHO To Review Policies After Denying Vaccine

    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.

  • ‘Medicago and PMI Talk About Disinvestment’

    ‘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.