In yet another blow to South Africa’s flagging vaccination programme, millions of the Johnson & Johnson vaccine doses meant to be used have been declared unfit for use. This is due to contamination concerns at one of the group’s facilities in the US.
The US Food and Drug Administration said that the doses were not suitable for use. Upon reviewing this decision, the South African Health Products Regulatory Authority (SAHPRA) said in a statement that it had decided “not to release vaccine produced using the drug substance batches that were not suitable”.
J&J’s Emergent plant was ordered to pause production in April several weeks after it was determined that batches of a substance used to produce the vaccine were cross-contaminated with ingredients from another jab made by Anglo-Swedish pharma giant AstraZeneca. The FDA is yet to allow the factory to reopen.
Acknowledging the setback in South Africa’s vaccination programme, acting Health Minister Mmamoloko Kubayi-Ngubane said Saturday that the batches concerned were stored in a high-security laboratory in Port Elizabeth belonging to drugmaker Aspen. Aspen meanwhile promised that it is ramping up production elsewhere to meet the shortfall, and President Ramaphosa said that he discussed with President Biden the possibility of receiving US vaccine donations.
Along with other countries South Africa, is pushing for a patent waiver on COVID vaccines to allow low cost production of generics.
“If we are to save lives and end the pandemic, we need to expand and diversify manufacturing and get medical products to treat, combat and prevent the pandemic to as many people as quickly as possible,” President Cyril Ramaphosa told the G7 group of wealthy nations meeting in Britain on Sunday. The country needs 31 million doses of the J&J vaccine to help vaccinate its population of 59 million.
South Africa has secured 30 million doses of the highly effective Pfizer-BioNTech vaccine, but is a two-dose vaccine which has significant cold chain requirements.
Emergency shipment
SAHPRA stated that there is a new delivery of approximately 300 000 J&J doses “that have been cleared by the US FDA that meet the requirements and will subsequently be released and shipped to South Africa.” The expiry date of these doses have been extended, and will be ready for administration to South African teachers within days.
Vaccinations were already paused in April after reports of rare cases of blood clots. And in February, South Africa rejected over 1.5 million doses of AstraZeneca’s vaccine as it was deemed ineffective. The J&J vaccines were already facing expiry as they had been removed from long term storage.
South Africa has only vaccinated just over 1% of its population but as far as can be ascertained with limited testing in Africa is the hardest hit by COVID on the continent, with over 1.7 million recorded cases. Source: Eyewitness News
sA new study has shown that children between the ages of 3 and 5 have difficulty in recognising the emotions of people wearing surgical masks. This collateral effect from this measure to prevent COVID transmission could influence the correct development of children’s capabilities of social interaction.
To provide guidance for decision-makers, the World Health Organization (WHO) and UNICEF compiled a document discouraging exposure to the use of facemasks when dealing with children aged up to five years old. In addition, even for older children, WHO recommends weighing up the benefits of wearing facemasks in against potential negative impacts that could include social and psychological problems, and difficulties in communication and learning.
To investigate such possible negative impacts, a study was carried out by the U-Vip (Unit for Visually Impaired People) research team led by Monica Gori at the IIT- Istituto Italiano di Tecnologia (Italian Institute of Technology). The findings were published in Frontiers in Psychology.
A research team led by Monica Gori at the Istituto Italiano di Tecnologia (IIT) focused on the pre-school age group, helping define the measures that can be taken to reduce the impact of the use of surgical masks amongst children. While the wearing of facemasks is not mandatory from 3 to 5 years of age, children are in any case exposed to the use of such preventive measures in various everyday social and educational contexts.
The IIT researchers prepared a quiz containing images of people with and without facemasks, and displayed them on screens to 119 individuals comprising 31 children aged between 3 and 5 years old, 49 children between 6 and 8 years old, and 39 adults between 18 and 30 years old. The participants, independently or with parental assistance in the case of the youngest participants, were asked to try to recognise the faces’ expressions, with and without facemask, conveying different emotions such as happiness, sadness, fear and anger.
When those faces were covered with a facemask, the 3-5 years olds only managed to recognise facial expressions conveying happiness and sadness 40% of the time. The percentages were higher for other age groups: 6-8 years olds had a 55-65% success rate, and 70-80% adults. Generally, however, all age groups displayed some difficulty in interpreting these emotions expressed while the face was partially covered by a facemask. There were better results with other expressions, but the pre-school age children still had the greatest difficulty.
“The experiment was performed in the earliest phases of the 2020 pandemic, and at that time facemasks were still a new experience for everyone,” said Monica Gori. “Children’s brains are highly flexible, and at the moment we are performing tests to ascertain whether children’s understanding of emotions has increased or not.”
“In the study, we worked with children and adults with no forms of disability”, explained Maria Bianca Amadeo, IIT researcher, “of course, these observations are even more important when considering children affected by disabilities.” “Indeed”, added co-author Lucia Schiatti, IIT researcher, “for example visual impairment implies difficulties in social interaction. For such individuals in particular, it will be even more necessary to concentrate on possible preventive measures or specific rehabilitation activities”.
Further research is needed over the next few years to assess the actual impact of this mask wearing on the ability of children with and without disabilities to interact. In the meantime, the findings suggest the use of transparent facemasks for all operators in contact with children in the 3-5 year-old age group, or developing training activities to teach children how to recognise emotions by looking at the eyes.
Journal information: Gori, M., et al. (2021) Masking Emotions: Face Masks Impair How We Read Emotions. Frontiers in Psychology. doi.org/10.3389/fpsyg.2021.669432.
As COVID cases and deaths continue to rise in the Free State, with schools being closed, it is unclear when the province’s teachers will receive their vaccinations.
The deaths of six learners, 75 teachers, and three support staff from COVID have been reported in the Free State since March 2020.
While teachers await their vaccines, COVID still claims lives in the school system – and not just older teachers and staff. Quincy Tsoenyane lost a daughter to COVID-related complications, 18 year-old Nomthandazo Ngcoyi, who was a learner at Lephola Secondary school in Welkom. Nomthandazo was one of 11 learners at the school who tested positive for COVID in May. Tsoenyane, who is a father to two surviving children, said it pains him to know that his daughter got sick at school.
According to the Department of Basic Education (DBE), Nomthandazo developed a cough at school and was tested for COVID along with other learners. On 19 May, she tested positive and was sent home to self-isolate. She died at home six days later.
A rare case
Dr Cloete van Vuuren, an Infectious Disease Specialist in the Department of Internal Medicine at the University of Free State, said that Nomthandazo’s death is a rare case as it is uncommon for young people to die from the SARS-CoV-2 virus.
The DBE figures show that since March 2020, the Free State has recorded a total of 2101 positive cases among teachers in schools: 1377 among learners, and 461 among non-teaching staff. Outbreaks of COVID cases have forced several shutdowns of Free State schools.
Holding out for vaccines
As COVID numbers climb in Free State schools, teaching federations and unions are urging that teachers be vaccinated as soon as possible.
From 26 July, children from Grades R to 7 will return to in-person classes. In a media statement, the National Professional Teachers Organisation of South Africa (Naptosa) said that they are pleased to hear that the education sector will receive 500 000 doses of the Johnson & Johnson vaccine.
However, the union said they are still in limbo because the doses must still require verification by the Food and Drug Administration (FDA) and will expire on 28 July.
As of Thursday, there were 591 new COVID cases in Free State, with a new case incidence rate of 17.8 per 100 000 people.
Teachers need to protect themselves and others
Dr Kerrin Begg, Public Health Specialist in the Faculty of Health Sciences at the University of Cape Town reminded teachers that although it is understandable for them to be anxious about the vaccination, each and every person has the responsibility to educate themselves.
“Teachers need to be teaching themselves about the virus just like they do in their everyday line of work of teaching children.
“At the Colleges of Medicine of South Africa, we have produced school guidelines on measures to take to reduce the transmission of COVID in the school environment,” she said. She said that socialising outside of class was where most of the transmission took place, and that learners now no longer adhered to social distancing.
“We remind parents and teachers to remember that protecting themselves is not to be practiced during school hours only, but there are three major focal points of transmission which are before, during, and after school hours.
“Teachers need to understand that the environment of the classroom is very important. Fresh air is better than artificial air, outside is better than inside. Schools also need to continue to promote personal and physical distancing, and hygiene measures daily,” Dr Begg said.
Researchers have demonstrated that normal breathing can transport viruses in saliva droplets up a distance of up to 2.2 metres in 90 seconds.
The World Health Organization and the Centers for Disease Controlrecommend social distancing to prevent the spread of COVID. The distances are estimated from various studies, but there is a need for further research into how viruses are transported from one person to another. Previous studies considered aerosol transport after coughing or sneezing, while this study focused on normal human breathing, using computer simulations with a more realistic model than prior studies. A normal breath produces periodic jet flows that contain saliva droplets, but those jets’ velocity is less than a tenth that of a cough or sneeze.
Wearing a face mask greatly reduces the distance which these droplets can travel. Saliva droplets restricted by a mask had travelled only 0.72 metres after two minutes, far short of the distance of 1.8 metres suggested by the CDC.
The investigators found even normal breathing produces a complex field of vortices that can move saliva droplets away from the person’s mouth. The role of these vortices has not previously been understood.
Study author, Ali Khosronejad, American Institute of Physics said: “Our results show that normal breathing without a facial mask generates periodic trailing jets and leading circular vortex rings that propagate forward and interact with the vortical flow structures produced in prior breathing cycles.”
This complex vorticity field can enable the transport of aerosol droplets over long distances despite the slow speeds. A face mask serves to dissipate the kinetic energy of the jet produced by an exhaled breath, thereby disrupting the vortices and limiting the travel of virus-laden droplets.
The researchers also took into account evaporation of the saliva droplets. With no mask, they found the saliva droplets near the front of the plume of exhaled breath had partially evaporated, reaching a size of only one-tenth of a micrometre. In stagnant indoor air, it would take days for droplets this small to settle to the ground.
Masks partially redirect the exhaled breath downward, significantly restricting forward motion of the plume, so the risk of suspended droplets remaining in the air is substantially reduced.
“To simplify the breathing process, we did not consider the flow of air-saliva mixture through the nose and solely accounted for the flow through the mouth,” Khosronejad said. “In future studies, we will explore the effect of normal breathing via both the nose and mouth.”
Journal reference: Khosronejad, A., et al. (2021) A computational study of expiratory particle transport and vortex dynamics during breathing with and without face masks. Physics of Fluids. doi.org/10.1063/5.0054204.
In addition to traditional subcutaneous administration for the vaccine candidate, the trial will measure immune responses generated by sublingual and nasal administration routes. Photo by Gustavo Fring from Pexels
The Phase I clinical trial of ImmunityBio’s experimental COVID vaccine, designed to be effective against COVID variants, is about to be expanded to include different administration routes as well as effectiveness in people who previously had COVID.
Co-investigator Prof Graeme Meintjes, second chair in the Department of Medicine at UCT, said that the Phase I trial has started and is still ongoing at the Wellcome Centre for Infectious Diseases Research in Africa’s (CIDRI-Africa) Khayelitsha clinical research site.
He said that the first two cohorts of ten participants each both received two subcutaneous injections of the vaccine, three weeks apart, with one cohort receiving a higher dose.
“The purpose of that was to assess safety, so participants were followed up very carefully for side effects and for reactions to the vaccine. And the review of that suggests no major safety concerns,” he explained. He added that the Phase I trial design has since been adapted to include four more cohorts, which is going through the approval process. These four additional cohorts will include people who have had COVID because the researchers want to look at the effect the vaccine will have on boosting existing immunity against COVID. Each cohort will have ten participants, bringing the expected total number of participants for Phase I to 60 people.
New administration routes
To see whether different administration routes produce a sufficient immune response, each participant in these new cohorts will receive one dose of the vaccine through one of four routes. These would be either a subcutaneous injection, a sublingual route, a combination of subcutaneous injection and sublingual method, or an intranasal route.
“We’ll be measuring the antibody responses as well as the T-cell responses to the vaccine, but we do not have results yet,” said Meintjes. He added that enrolment should be complete in the next two months, pending the outcome of the approval process.
Phase II/III trial plans
Phase II and Phase III trials in South Africa are being planned, which will be headed by the South African Medical Research Council (SAMRC), Mentjes confirmed.
Details will be made available once the trial has been approved by SAHPRA. It is unlikely that placebos will be used, now that vaccines are shown to be effective; rather different vaccines will be compared.
Broader immune response with two-pronged defence
The vaccine has been designed to potentially offer a broader, long-lasting immune response, Mentjes noted. In this way it should also provide improved protection against COVID variants.
Currently, most of the COVID vaccines are designed to produce an immune response against the spike protein of the virus, but it mutates rapidly, allowing certain variants to partially or fully escape vaccines.
The ImmunityBio vaccine aims to offer a two-pronged or dual defence, Meintjes said, with the vaccine containing two proteins from the SARS-CoV-2 virus: the spike protein along with the more stable nucleocapsid protein. The nucleocapsid is an RNA-binding protein which is critical for viral replication and genome packaging.
He explains that targeting nucleocapsid could potentially provide more durable and long-term protection against different variants of the SARS-CoV-2 virus because the immune system will recognise the nucleocapsid even when the spike protein changes.
“The hope is that by including the nucleocapsid you would generate a vaccine response that covers emerging variants, those that have emerged and those that might emerge in the future,” he says.
Human-adenovirus based vaccine carrier
The ImmunityBio vaccine will use an adenovirus vector to deliver the antigens. Director of the Africa Health Research Institute (AHRI), Professor Willem Hanekom, explained that a vector is needed in order to stimulate the immune system’s response, and a viral vector is effective since it is foreign to the immune system, helping provoke an immune response. The virus is designed to simply carry the antigens into the body.
The AstraZeneca vaccine uses a modified chimpanzee adenovirus while Johnson & Johnson’s uses the human adenovirus Ad26, which has been used before in a number of vaccines including HIV. ImmunityBio’s vaccine uses the human adenovirus hAd5, which was initially used in failed gene therapy trials — but which proved to be an excellent vaccine delivery system. However, its development over the past two decades has been halting.
According to Prof Hanekom, if there is previous immunity against the adenovirus being used in a vaccine, the immune system will destroy it before the antigens inside are released. This has been circumvented with the ImmunityBio vaccine so that the immune system doesn’t immediately recognise the hAd5 vector. There was concern that the Johnson & Johnson vaccine would have limited efficacy in sub-Saharan Africa due to the fact that about half the population have immunity to Ad26.
“They’ve modified the adenovirus so it will still work and still be seen by the immune system even if there is pre-existing immunity because they’ve taken out the parts that the pre-existing immunity sees,” Prof Hanekom said.
Enhanced T-cell response
The vaccine is specifically designed to elicit strong T-cell responses to the nucleocapsid, and this has been seen in animal studies, Mentjes noted.
“Obviously one purpose of these studies is to see whether this design element generates those strong T-cell responses in humans as well,” he says. “All COVID vaccines elicit T and B cell responses, it’s not one or the other. But this (vaccine) is specifically designed to enhance those T-cell responses.”
B-cells and T-cells form part of the body’s adaptive immune response. B-cells form the antibodies to respond to a pathogen, and when the virus is introduced again, memory B-cells provide the antibodies to respond quickly.
Vardas says that with the ImmunityBio vaccine, B-cells and memory B-Cells will be formed that will remember the spike protein and the nucleocapsid and how to attack it. She likens this to a sniper attack. She explains that when a memory B-cell detects the spike or nucleocapsid protein, it signals for the production of B-cell antibodies. These antibodies then coat the outside of the virus, which signals the T-cells to attack and essentially “eat up” the virus-infected cells.
There are two types of T-cells, explains Vardas – CD4 cells which attack the virus, and CD8 cells, which also form a memory cell as the B-cell does. “You’ll have groups of CD4 and CD8 cells that are spike protein-specific and groups that are nucleocapsid specific, so improving that kind of attack to two sides of the war,” said Vardas.
As interest mounts in the ‘lab leak’ hypothesis for the origin of SARS-CoV-2, more scientists are starting to take it seriously, especially because of the important implications of its actual origins.
MedPage Today reported that many experts it approached for the story were hesitant to speculate on its exact implications, they agreed that further research into its origins is important to ward off future pandemics.
A natural origin’s implications
Back in 2007, scientists who were studying coronaviruses warned: “The presence of a large reservoir of SARS-CoV–like viruses in horseshoe bats… is a time bomb. The possibility of the re-emergence of SARS and other novel viruses… should not be ignored.”
On May 26 2021, in the midst of the greatest disaster the world has faced since World War II, US President Joe Biden gave US intelligence 90 days to reach a “definitive conclusion” on the origins of SARS-CoV-2.
Vincent Racaniello, PhD, professor of microbiology and immunology at Columbia University, said finding an answer is unlikely within Biden’s deadline. After all, it took 14 years to find the ancestor of the first SARS virus in wildlife.
For Prof Racaniello, this renewed concern underscores the need for better surveillance of viruses in wildlife.
“All human viruses begin in nature. There’s an overwhelming preponderance of data that shows that, so it makes sense to look in nature when we’re looking for the source of new viruses,” Prof Racaniello told MedPage Today.
As a result of human population pressure, more viruses are spilling over into humans from nature. Examples of this include Ebola, SARS-1, MERS, and bird and swine flu. Because of the evolutionary closeness of mammals and humans, they are major pathogen sources. Rodents and bats (accounting for 20% of mammals), as well as various species of birds are good places to look. However our surveillance of wildlife is spotty, so we have “very little” understanding of the viruses these types of animals harbour, and which ones could be threats to humans, Prof Racaniello warned.
“We need to do more wildlife sampling, to find out what’s out there and what’s potentially a threat,” he said. “More investment in this could have prevented the trillions of dollars that we’ve spent to take care of this pandemic.”
A lab leak’s implications
On the other hand, Richard Ebright, PhD, a molecular biologist and professor of chemistry and chemical biology at Rutgers University in New Jersey, believes the real issue lies in addressing the potential for future pandemics that could originate from lab accidents, a discussion that “needs to begin now.”
“Irrespective of whether COVID originated in a natural accident or a lab accident, the risk of a future pandemic originating in a lab accident is real,” he told MedPage Today.
Prof Ebright explained that, in the US and other countries, only voluntary biosafety guidelines exist, and these are about preventing accidental release of pathogens. While the US has legal regulations against several pathogens that could be used as biological weapons, there are no biosecurity regulations for other pathogens. In most of the world, no biosecurity regulations exist for pathogens other than smallpox, not even voluntary ones, Prof Ebright said.
In 2017, the US implemented a bio-risk policy requiring a risk-benefit analysis before federal funding can be approved for high-risk research, such as ‘gain of function’ research that could be used to increase a pathogen’s transmissibility or pathogenicity to better understand and control it, Prof Ebright said. But this bio-risk policy has been essentially ignored by federal agencies, and the other countries with bio-risk policies only apply it to smallpox.
“Discussion now, especially among policy makers and the public, needs to turn to the inadequacy of biosafety, biosecurity, and biorisk-assessment standards worldwide, and to the essentially complete absence of biosafety regulation worldwide,” he said.
The return of the lab leak hypothesis
While evidence is largely circumstantial, the basic idea is that a laboratory at the Wuhan Institute of Virology had been experimenting on a virus called RaTG13 (a coronavirus closely related to SARS-CoV-2, which infects horseshoe bats), and genetically manipulating other horseshoe bat viruses collected around China. It is thought that one of these laboratory viruses could have infected a staffer at the institute, who then transmitted it to the broader public, Dr Ebright explained.
Following the WHO’s March 30 SARS-CoV-2 origins investigation report, there was a sudden about-face and the lab leak theory began to be taken seriously. Though investigators classified a laboratory origin as “extremely unlikely”, they said the conclusion was reached on the evidence made available.
Even the Director-General of the WHO, Dr Tedros Ghebreyesus, said at the time that he did not believe the assessment of a laboratory origin was “extensive enough,” that this hypothesis “requires further investigation,” and that “this report is a very important beginning, but it is not the end.”
“At this point in time, all scientific data related to the genome sequence of SARS-CoV-2 and the epidemiology of COVID are equally consistent with a natural-accident origin or a laboratory-accident origin,” Ebright said.
While the WHO report does not propose a follow-up study for laboratory origins, it acknowledges that both “follow-up of new evidence” and “regular administrative and internal review of high-level biosafety laboratories worldwide” is needed.
COVID cases map. Photo by Giacomo Carra on Unsplash
A surge in COVID cases in many parts of Africa could mean a continental third wave, the World Health Organization warned, posing a great threat for a continent where immunisation drives have been hamstrung by funding shortfalls and production delays for vaccine doses.
The WHO said that over the last week, test positivity had risen in 14 African countries, with eight reporting a surge of over 30% in new cases. Infections are steadily climbing in South Africa, where four of nine provinces are battling a third wave and the positivity rate was 14.2% as of Sunday. Uganda has also seen sharp increases, with hospitals overwhelmed with COVID patients and a lockdown being considered.
Weak compliance with social restrictions, increasing travel and the arrival of winter is behind the rise in cases, the WHO said. Experts also believe that new variants are also driving the numbers up.
Although Africa has reported less than 3 per cent of global coronavirus cases, the WHO said that the continent accounted for 3.7 percent of total deaths. This is likely an underestimate, given the lack of formal reporting for deaths.
“The threat of a third wave in Africa is real and rising,” said Dr Matshidiso Moeti, WHO regional director for Africa, in a statement. “It’s crucial that we swiftly get vaccines into the arms of Africans at high risk of falling seriously ill and dying of Covid-19.”
While many wealthier countries have vigorous vaccination campaigns and some are on track to fully reopen, many of Africa’s poorer countries face a huge challenge in accessing vaccines.
Out of 1.3 billion people on the continent, only 31 million have received at least one dose, Dr Moeti said, and only seven million are fully vaccinated. Just 1386 people in Kenya have received two doses of a vaccine, out of a population of 50 million.
Countries like Ghana and Rwanda have run through their first deliveries of vaccines through Covax, the global facility working to ensure the equitable distribution of vaccines.
In some countries, vaccine hesitancy has been so high that it even caused stocks of vaccines to expire. Possible contamination in Johnson & Johnson vaccine doses detected at a US manufacturing plant has resulted in yet another delay to South Africa’s immunisation programme.
Meanwhile, fake vaccines and PPE pose another problem; last November a police raid in South Africa found almost 2400 doses of fake vaccine.
The WHO warned that the surge of causes could swamp the limited capacities of healthcare systems. To stave off a full-blown crisis, Dr Moeti urged “countries that have reached a significant vaccination coverage to release doses and keep the most vulnerable Africans out of critical care.”
Only about two per cent of the population has received at least one vaccine dose, compared with the 24 per cent global figure.
“While many countries outside Africa have now vaccinated their high-priority groups and are able to even consider vaccinating their children, African countries are unable to even follow up with second doses for high-risk groups,” said Dr. Moeti. “I’m urging countries that have reached a significant vaccination coverage to release doses and keep the most vulnerable Africans out of critical care.”
Patients hospitalised with active cancer are more likely to die from COVID than those with a cancer history or diagnosis, according to a new study.
The findings published by Wiley early online in CANCER, a peer-reviewed journal of the American Cancer Society, also indicate that the greatest risk of death due to COVID was in those with active blood cancers. No mortality risk increase was found in patients who received cancer treatments in the three months (or longer) prior to hospitalisation.
To find out how cancer, or the various therapies used to treat it, could affect the health of patients with COVID infections, a team analysed the NYU Langone Medical Center’s records of 4184 hospitalised patients who tested positive for SARS-CoV-2, the virus that causes COVID.
This group included 233 patients who had a current, or ‘active’, cancer diagnosis. They found that more patients with an active cancer diagnosis (34.3 percent) were likely to die from COVID than those with a history of cancer (27.6 percent) and those without any cancer history (20.0 percent).
Among patients with active cancer, those with blood-related cancers had the greatest risk of death. However, undergoing systemic anticancer therapy, including chemotherapy, molecularly targeted therapies, and immunotherapy, within three months prior to hospitalisation was not linked to a higher risk of death, and the investigators found there were no differences according to the type of cancer therapy being received.
Senior author Daniel Becker, said, “We completed a large chart review-based study of patients hospitalised with COVID and found that patients with active cancer, but not a history of cancer, were more likely to die. Notably, however, among those hospitalised with active cancer and COVID, recent cancer therapy was not associated with worse outcomes.”
“People with active cancer should take precautions against getting COVID, including vaccination, but need not avoid therapy for cancer.”
University of Queensland scientists used a ‘patch’ to deliver a US-developed COVID vaccine without the jab, and successfully protected mice from the virus.
The vaccine candidate from University of Texas Hexapro was delivered via the high-density microarray patch (HD-MAP) and provided protection against COVID disease with a single, painless ‘click’ from a handheld applicator.
Dr David Muller, from UQ’s School of Chemistry and Molecular Biosciences, said the vaccine patch produced strong immune responses that were shown to be effective when the mice were exposed to SARS-CoV-2.
“When the Hexapro vaccine is delivered via HD-MAP applicator – rather than a needle – it produces better and faster immune responses,” Dr Muller said.
“It also neutralises multiple variants, including the UK and South Africa variants.
“And it’s much more user-friendly than a needle – you simply ‘click’ an applicator on the skin, and 5000 microscopic projections almost-imperceptibly deliver vaccine into the skin.
“The UQ team, together with Vaxxas, hope to take the technology to the world and are looking for funding opportunities to accelerate to clinical trials as soon as possible.” Dr Muller said that Hexapro, delivered by the high-density microarray patch, could dramatically assist global vaccine rollout effort, particularly for billions of vulnerable people in low- and middle-income countries.
“We’ve shown this vaccine, when dry-coated on a patch, is stable for at least 30 days at 25 degrees Celsius and one week at 40 degrees, so it doesn’t have the cold chain requirements of some of the current options.”
High-density microarray patch (HD-MAP)
Vaxxas was founded in 2011 with the help of University of Queensland. The company’s president and CEO, David L Hoey, said he was extremely excited about the findings.
“These results are extremely clear – vaccination by HD-MAP produces much stronger and more protective immune responses against COVID-19 in model systems than via needle or syringe,” he said.
“We thank and recognise our incredible research collaborators at UQ for these important findings.
“The prospect of having a single-dose vaccine, that could be easily distributed and self-administered, would greatly improve global pandemic vaccination capabilities,” said Hoey
The research is currently undergoing peer review and has been published in BioRxiv (DOI: 10.1101/2021.05.30.446357).
An investigation by The BMJ uncovered undisclosed financial links between certain authors and the tobacco and e-cigarette industry in a number of COVID research papers, which had suggested that smokers were less likely to develop COVID.
In April 2020, two French studies (in preprint and not yet peer reviewed) suggested that nicotine might have a protective effect against COVID, which was coined the ‘nicotine hypothesis’.
The studies were reported on widely by the media, causing fears that it could undermine decades of tobacco control. What should have been an opportunity for promoting cessation of this practice which every year kills five million people around the world.
Since then, the ‘nicotine hypothesis’ has been soundly disproved, with several studies showing that, to the contrary, smoking is associated with an increased chance of COVID related death.
Journalists Stéphane Horel and Ties Keyze investigated the circumstances of these reports. They pointed out that one of the study authors, Professor Jean-Pierre Changeux, has a history of receiving funding from the Council for Tobacco Research, whose purpose was to fund research that would cast doubt on the dangers of smoking and focus on the positive effects of nicotine.
From 1995 to 1998, documents from the tobacco industry show that Changeux’s laboratory received $220,000 (£155,000; €180,000) from the Council for Tobacco Research.
When approached by The BMJ, Changeux assured them that he has not received any funding linked “directly or indirectly with the tobacco industry” since the 1990s.
In late April 2020, Greek researcher Konstantinos Farsalinos was the first to publish the ‘nicotine hypothesis’ formally in a journal, in an editorial in Toxicology Reports.
That journal’s editor in chief, Aristidis Tsatsakis was a co-author, as was A Wallace Hayes, who in 2013 had been a member of Philip Morris International’s scientific advisory board, and had served as a paid consultant to the tobacco company.
Another co-author is Konstantinos Poulas, head of the Molecular Biology and Immunology Laboratory at the University of Patras, where Farsalinos is affiliated.
The laboratory has been receiving funding from Nobacco, the market leader in Greek e-cigarettes and the exclusive distributor of British American Tobacco’s nicotine delivery systems since 2018. However, in their published scientific articles, neither Farsalinos nor Poulas had ever declared this Nobacco funding.
Yet the journalists showed that two grants were attributed in 2018 by the Foundation for a Smoke Free World—a non-profit established by tobacco company Philip Morris International in 2017—to ‘Patras Science Park’.
The grants, which according to tax documents came close to €83 000, went to NOSMOKE, a university start-up incubator headed by Poulas, which markets an ‘organic’ vaping product.
Last month, the European Respiratory Journal retracted a paper with Poulas and Farsalinos as co-authors, after two other authors failed to disclose conflicts of interest.
The retracted article had found that “current smoking was not associated with adverse outcome” in patients admitted to hospital with COVID, and it claimed that smokers had a significantly lower risk of acquiring the virus.
The foundation has invested heavily in the COVID/nicotine hypothesis, said Horel and Keyzer.
In June 2020 it set aside €900 000 for research “to better understand the associations between smoking and/or nicotine use, and COVID-19 infection and outcome.”
Its request stated that the pandemic offered “both an opportunity and a challenge for individuals to quit smoking or transition to reduced risk nicotine products.”
They concluded that, in 2021, “amid a global lung disease pandemic, tobacco industry figures are increasingly pushing the narrative of nicotine as the solution to an addiction that they themselves created, with the aim of persuading policy makers to give them ample room to market their “smoke-free” products. This makes studies on the hypothetical virtues of nicotine most welcome indeed.”
Article information: Covid 19: How harm reduction advocates and the tobacco industry capitalised on the pandemic to promote nicotine, The BMJ, DOI: 10.1136/bmj.n1303 , www.bmj.com/content/373/bmj.n1303
