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British American Tobacco (BAT) has joined the race to develop a vaccine for COVID-19, with plans to potentially manufacture 1 million to 3 million doses of vaccine per week. While vaccine development typically takes years, and even then has a poor track record when it comes to safety testing, BAT’s potential COVID-19 vaccine is already in preclinical testing.
Further, BAT, which is working in conjunction with its U.S. biotech subsidiary, Kentucky BioProcessing (KBP), stated that if testing goes well, and “with the right partners and support from government agencies,” they could potentially begin manufacturing the experimental vaccine in June 2020.1
Experimental COVID-19 Vaccine Using Tobacco Plant Technology
KBP made headlines in 2014 when it manufactured ZMapp, an experimental Ebola drug. BAT’s U.S. subsidiary Reynolds American Inc. acquired KBP that year “with the aim of using some of its unique tobacco extraction technology to aid further development of its new category noncombustible products.”2
The experimental COVID-19 vaccine in development uses fast-growing tobacco plant technology, which BAT says has the following advantages over conventional vaccine production:3
- Tobacco plants can’t host pathogens that cause human disease
- It’s faster because the elements of the vaccine accumulate in tobacco plants in six weeks versus several months for conventional methods
- While conventional vaccines often require refrigeration, KBP’s vaccine formulation is stable at room temperature
- It has the potential to deliver an immune response in a single dose
KBP’s proprietary technologies involve temporarily encoding tobacco plants with genetic instructions to produce specific target proteins.4 To create the experimental vaccine, KBP cloned a portion of COVID-19’s genetic sequence to develop an antigen, which is a substance that induces an immune response in the body, particularly the production of antibodies.
“This antigen was then inserted into tobacco plants for reproduction and, once the plants were harvested, the antigen was then purified, and is now undergoing preclinical testing,” BAT noted.5 As for the tobacco industry’s unlikely foray into public health, Hugh Haydon, KBP’s chief executive officer, told Politico, “People can be cynical. But the fact is that we might be able to help.”6
The fact is, the move to medicine comes out of necessity, not altruism. With U.S. cigarette smoking rates at an all-time low among adults, dropping to 13.7% in 2018 — a decline of about two-thirds in the 50 years since the Surgeon General first warned of smoking’s health effects7 — tobacco giants had no choice but to regroup.
As such, James Figlar, KBP’s executive vice president of research and development, told Politico they’ve been “pulling apart the tobacco plant” looking for new business prospects.8 While the COVID-19 vaccine is a novel use of tobacco plant technology, plant-based vaccines have been attempted in the past.
Are There Risks to Plant-Based Vaccines?
“Plant-made or “biofarmed” viral vaccines are some of the earliest products of the technology of plant molecular farming,” researchers wrote in Virology Journal in 2014, noting “the use of plants and plant cell cultures to produce high-value recombinant proteins, started with the production via transgenic tobacco and sunflower of chimaeric human growth hormone in 1986, then of monoclonal antibodies in transgenic tobacco in 1989.”9
In 2010, the Pentagon’s research and development branch Darpa (Defense Advanced Research Projects Agency) gave $40 million to Texas A&M University and G-Con, a pharmaceutical company, to speed up flu vaccine production using tobacco plants.10 While the use of tobacco plants may make vaccine production faster, the question remains of whether the resulting vaccines are effective and safe.
One potential risk is that while the manufacturers state that plants don’t carry pathogens that can infect humans, this is up for debate. A number of viruses do infect plants, and it’s possible they could infect humans.
In 2010, for instance, researchers identified pepper mild mottle virus, a plant virus, in the stool of healthy subjects.11 Further, those who had the plant virus in their stool were significantly more likely to have fever, abdominal pain and itching, symptoms that may have been attributable to the virus.
In a review published in the Indian Journal of Virology, researchers from the Indian Agricultural Research Institute, plant virology unit, division of plant pathology, further noted, “There is no rigid rule that plant virus cannot break the barrier of their host kingdom and invade human or animal. It is possible that some plant virus may have direct or indirect role as human pathogen …”12
Novel Vaccine Technology Being Tested in Humans
BAT is just one company banking on a novel type of COVID-19 vaccine. Biotech company Moderna began the first clinical trial for a COVID-19 vaccine in March 2020. This is particularly risky, not only because it skipped animal trials to go straight to human testing, but also becomes it’s using a novel form of vaccine production using a technology that has not been approved by the U.S. Food and Drug Administration.
While conventional vaccines use modified or killed forms of virus, Moderna is using genetically engineered fragments of the COVID-19 virus’ genetic code.13 As noted in The Conversation:14
“The trial is … unprecedented in that it involves testing a completely new therapeutic substance in humans … Testing a substance on humans that has received a minimal assessment of its safety poses potential risks. It could cause unexpected effects in the study participants, including severe illness and even death.
It’s also possible that an untested vaccine could even accelerate or enhance the effects of the virus instead of blocking them. Speeding up the approval process and recruitment of participants also runs the risk of eroding ethical requirements relating to consent, privacy and the protection of vulnerable people, especially where payments may be involved. This could both increase the risks to volunteers and undermine public trust in clinical research.”
Moderna, which is partnering with the National Institute of Allergy and Infectious Diseases (NIAID), is using synthetic messenger RNA (mRNA) to instruct DNA to produce the same kind of proteins COVID-19 uses to gain access into our cells. As reported by STAT News, the idea is that “Once those … dummy virus particles are there … our bodies will learn to recognize and clobber the real thing.”15
In all, 45 men and nonpregnant women between the ages of 18 and 55 will be paid $1,100 to receive two injections of the vaccine, 28 days apart. The side effects at three different dosages will be evaluated. Biotech company Inovio, which is funded by the Bill & Melinda Gates Foundation, is the second company to start testing an experimental COVID-19 vaccine in humans in the U.S.16
Inovio’s trial will include 40 healthy volunteers, each of whom will receive two doses, four weeks apart. Inovio expects early safety results by late summer 2020; if all goes well the study will move into the efficacy phase.
Inovio indicated they are already ramping up for global demand of 1 million doses to start out, but these clinical trials are taking place before there’s any scientific evidence that the vaccines actually work as intended and don’t cause severe side effects.
Fast-Tracking Vaccines Carries Risks
Nearly two dozen potential COVID-19 vaccines are under development, each of them likely attempting to be fast-tracked to the market.17 Under normal circumstances, a vaccine may take five to 10 years to be developed, and pushing rapid progress comes with significant safety concerns.
In the case of coronavirus, this could even mean making infection worse, as vaccine-induced immune enhancement became evident during the development and testing of a vaccine for severe acute respiratory syndrome (SARS), which is caused by a coronavirus.18
Dr. Peter Hotez is dean of the National School of Tropical Medicine at the Baylor College of Medicine, a vaccine developer, a former president of the Sabin Vaccine Institute and director of the Texas Children’s Center for Vaccine Development.
And, he has gone so far as to say that the movement calling for increased scientific study into vaccine efficacy and risks, and calling for protection of informed consent, should be “snuffed out,” i.e., crushed or killed, acknowledged this. According to Reuters:19
“‘I understand the importance of accelerating timelines for vaccines in general, but from everything I know, this is not the vaccine to be doing it with,’ Dr Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told Reuters.
Hotez worked on development of a vaccine for SARS (Severe Acute Respiratory Syndrome), the coronavirus behind a major 2003 outbreak, and found that some vaccinated animals developed more severe disease compared with unvaccinated animals when they were exposed to the virus. ‘There is a risk of immune enhancement,’ said Hotez …”
Narcolepsy and Increased Coronavirus Risk Revealed
Other unexpected risks can also occur, as happened with the H1N1 swine flu vaccine released in Europe during the swine flu pandemic of 2009-2010. Its approval process was accelerated, with most safety and efficacy tests bypassed.20 Years later, the ASO3-adjuvanted swine flu vaccine Pandemrix (used in Europe but not in the U.S. during 2009-2010) was causally linked to childhood narcolepsy.21
Then, in 2019, researchers described a “novel association between Pandemrix-associated narcolepsy and the noncoding RNA gene GDNF-AS1”22 — a gene thought to regulate the production of glial cell line-derived neurotrophic factor or GDNF, a protein that plays an important role in neuronal survival.
According to the researchers, “Changes in regulation of GDNF have been associated with neurodegenerative diseases. This finding may increase the understanding of disease mechanisms underlying narcolepsy.”23 Other notable unintended consequences may also occur following vaccination, including raising the risk of respiratory viruses.
A 2020 study published in the journal Vaccine stated, “Receiving influenza vaccination may increase the risk of other respiratory viruses, a phenomenon known as virus interference.”24
While the study did not find that influenza vaccination increased the risk of all respiratory viruses, it did reveal that it raised coronavirus risk, noting, “Vaccine derived virus interference was significantly associated with coronavirus and human metapneumovirus” (hMPV).
Those who had received a seasonal flu shot were 36% more likely to contract coronavirus infection and 51% more likely to contract hMPV infection than unvaccinated individuals.25
With so many unanswered questions surrounding the safety and efficacy of fast-tracked vaccinations, and the likelihood that it could be at least a year before a COVID-19 vaccine is found to be effective against the virus,26 prevention — in the form of washing your hands, wearing a mask and eating right — remains the best option.