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Ethical decisions: Weighing risks and benefits of COVID-19 vaccination in children ages 5-11
When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.
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The U.S. Food and Drug Administration has approved Pfizer’s COVID-19 vaccine for use in children ages five to 11. Pfizer’s clinical trial results indicate the vaccine is safe and effective in this age group.
This is an important development. COVID-19 infections are on the rise in children across Canada.
It is now up to Health Canada to consider the data and to decide whether to authorize this COVID-19 vaccine for children. Once it is authorized in Canada, the National Advisory Committee on Immunization (NACI) will have to decide whether to recommend vaccination for all children in this age group.
This raises the question of how this decision ought to be made.
Making an ethical decision
As a moral philosopher who has collaboratively researched ethical issues relating to the vaccination of children, I believe it is important to answer this question, for two reasons.
First, whatever the decision, the principles on which it is based — and should be based — must be clear and transparent.
Second, surprisingly little attention has been paid to this issue in Canada, despite the decision to vaccinate children being a matter of science and ethics. Science can clarify some of the costs and benefits of vaccination, but it cannot tell us which costs and benefits matter and when a cost-benefit ratio is favourable.
Fortunately, there is no need to generate a decision-making procedure from scratch. The procedure used by the United Kingdom’s Joint Committee on Vaccination and Immunisation (JCVI) in deciding whether to vaccinate healthy children aged 12-15 in the U.K. can provide important lessons about what not to do.
Risks and benefits
The most important factor is whether the benefits of vaccination outweigh its risks, and the degree to which the benefits outweigh the risks. In weighing these, the JCVI relied on what it called the “health perspective.”
Reasoning from this perspective, the JCVI held (in a series of public statements) that the chief benefits of vaccination against COVID-19 were the prevention of death, hospitalization, intensive care unit (ICU) admissions and pediatric inflammatory multisystem syndrome (PIMS) or multisystem inflammatory syndrome (MIS-C).
The chief harms of vaccination were myocarditis, or inflammation of the heart, and pericarditis, inflammation of the thin sack surrounding the heart, though it said these were rare and “typically self-limiting and resolved within a short time.”
The JCVI argued that the benefits of vaccination in this age group are only “marginally greater” than the harms and that therefore vaccination would not be offered to all members of this group.
NACI disagreed, but did not outline the ethical principles it relied on in recommending vaccination for children ages 12-17.
JCVI’s decision not to offer all children vaccination against COVID-19 was flawed in numerous respects. (It was later overruled by the chief medical officers of the U.K.‘s four nations.) NACI will do well to avoid these mistakes in making its decision about vaccinating children ages five to 11.
The Independent Scientific Advisory Group for Emergencies (Independent SAGE, a group of British scientists offering independent scientific advice on the prevention of COVID-19) has raised a number of concerns about the JCVI’s decision-making process.
One concern is the way in which the JCVI calculated the benefits of vaccination, basing these calculations on risk to the population of all children of death, hospitalization, ICU admission and so on from COVID-19 infection, rather than the risks of these to children with a confirmed infection of COVID-19.
Another concern Independent SAGE raised was that the JCVI did not state which vaccine it considered when it examined the risks, a relevant concern since heart inflammation rates appear to be higher after the Moderna vaccine than after the Pfizer vaccine.
Direct and indirect benefits
Some of JVCI’s other mistakes related to value judgments, relying on the health perspective to make its decision. However, the JCVI was not consistent on what this included.
As noted, the JCVI mentioned the prevention of death, hospitalization, ICU admission and PIMS or MIS-C. These are not the only health benefits of vaccination against COVID-19. Some direct and indirect health benefits of vaccination were not clearly included.
The direct benefits include the prevention of long COVID — a condition affecting anywhere from two to 14 per cent of children infected with COVID-19 — and potential neurological and cognitive deficits caused by COVID-19 infection.
Preventing the negative mental and physical health effects associated with school closures, limits on sporting and other such activities and physical distancing requirements are among the indirect benefits (though these were rightly noted by NACI in its recommendation to vaccinate adolescents). These health effects are important when deciding whether to vaccinate.
These are the known risks and benefits. However, the JCVI’s refusal to recommend vaccination to all children aged 12-15 was due to the uncertainties “regarding the magnitude of the potential harms” of vaccination, including myocarditis.
Although it gave considerable weight to unknown harms or uncertainties of vaccination, the JVCI did not consider potential unknown benefits of vaccination, or uncertainties about benefits. There was no reason to rule these out. Uncertainties about benefits seem to be of as much importance in thinking about the risk benefit profile of COVID-19 vaccination as uncertainties about risks. These, again, matter greatly to this decision.
The JCVI made another ethical error when it said the harms of vaccination should be given greater weight (relatively speaking) than the benefits.
There is no good reason to place a higher relative value on harms compared to benefits. Harms caused by vaccines are not worse than harms caused by COVID-19. It does not appear to be true that the rare and typically mild pericarditis or the myocarditis caused by vaccination is any worse than the pericarditis or the myocarditis caused (at greater frequency) by COVID-19 infection. This is not in line with other treatments considered for children, for which harms are not typically weighed more heavily than benefits.
The well-being perspective
It was a mistake for JCVI to make the decision about vaccination against COVID-19 in children purely on the basis of the health perspective. Health is important. But it is not the only value in the lives of children. Health is a priority because without it many other important benefits — enjoying friends, connecting with relatives, absorbing oneself in homework or music lessons — become much more difficult, if not impossible.
The JCVI mentioned the beneficial effects of vaccination on education. But it did not factor these benefits into the decision relating to vaccinating children against COVID-19.
Educational and other benefits afforded to children by vaccination matter greatly and must be factored into this decision. Moving beyond the health perspective into the well-being perspective encompasses a larger range of benefits and protections from vaccination, including safe and stable learning environments, time with extended family, sport, music performances and the many other things that make life happy and meaningful for children.
When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on both sound science and sound ethics. They must in particular consider all the health and well-being impacts of vaccination more generally; they must consider the uncertain harms and benefits of vaccination; and they must treat benefits and harms symmetrically.
Doing so will show that vaccinating children is, all things considered, beneficial.
Do you have a question about COVID-19 vaccines? Email us at ca‑vaccination@theconversation.com and vaccine experts will answer questions in upcoming articles.
Anthony Skelton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.
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International
Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records
Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records
Federal police in Brazil have indicted former President Jair…
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Federal police in Brazil have indicted former President Jair Bolsonaro for falsifying his Covid-19 vaccine card in order to travel to the United States and elsewhere during the pandemic.
Federal prosecutors will review the indictment and decide whether to pursue the case - which would be the first time the former president has faced criminal charges.
According to the indictment, Bolsonaro ordered a top deputy to obtain falsified Covid-19 vaccine records of himself and his 13-year-old daughter in late 2022, right before he flew to Florida for a three-month stay following his election loss.
Brazilian police are also waiting to hear back from the US DOJ on whether Bolsonaro used said cards to enter the United States, which would open him up to further criminal charges, the NY Times reports.
Bolsonaro has repeatedly claimed not to have received the Covid-19 vaccine, but denies any involvement in a plan to falsify his vaccination records. A previous investigation by Brazil's comptroller general concluded that Bolsonaro's vaccination records were false.
The records show that Bolsonaro, a COVID-19 skeptic who publicly opposed the vaccine, received a dose of the immunizer in a public healthcare center in Sao Paulo in July 2021. [ZH: hilarious, Reuters calling the vaccine an 'immunizer.']
The investigation concluded, however, that the former president had left the city the previous day and didn't leave Brasilia until three days later, according to a statement.
The nurse listed in the records as having applied the vaccine on Bolsonaro denied doing so and was no longer working at the center. The listed vaccine lot was also not available on that date, the comptroller general's office said. -Reuters
"It's a selective investigation. I'm calm, I don't owe anything," Bolsonaro told Reuters. "The world knows that I didn't take the vaccine."
During the pandemic, Bolsonaro panned the vaccine - and instead insisted on alternative treatments such as Ivermectin, which has antiviral properties against Covid-19. For this, he was investigated by Brazil's congress, which recommended that the former president be charged with "crimes against humanity," among other things, for his actions during the pandemic.
In May, Brazilian police raided Bolsonaro's home, confiscating his cell phone and arresting one of his closest aides and two of his security cards in connection to the vaccine record investigation.
Brazil's electoral court ruled that Bolsonaro can't run for public office until 2030 after he suggested that the country's voting system was rigged. For that, he has to sit out the 2026 election.
International
This gambling tech stock is future-proofing the world’s casinos
Supported by the universal thrill of a quick payout and the need for leisure, gambling stocks make a compelling case for long-term returns.
The post This…
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Supported by the universal human thrill of a quick payout, and the need for leisure and entertainment to bring enjoyment to adult life, casinos will remain essential spaces for people to dream and play for the foreseeable future, making gambling stocks a prospective space to look for long-term returns.
According to Research and Markets, the global casino industry was valued at US$157.5 billion in 2022, and it will grow to US$224.1 billion by 2030 at a compound annual growth rate of 4.5 per cent. This trend includes:
Approximately 100 million gamblers in the United States, who generated US$66.5 billion in revenue in 2023, a 10 per cent gain from 2022, which itself was a record year A little fewer than 20 million gamblers in Canada, who generated about C$15 billion in revenue in 2023 A global addressable market of thousands of casinos, and more than 4.2 billion people who gamble at least once every year, according to a 2016 study by Casino.orgThe main challenge with attracting these billions through casino doors is they sway heavily toward middle age. The mean age of U.S. casino visitors has hovered around 50 for the past decade, with a similar trend across the world, forcing casinos to attract younger, tech-savvy customers, many with less gambling experience, to continue growing profits for their stakeholders over the long term.
Investors seeking exposure to a leadership position in building the bridge between casinos and the next generation of gamblers should evaluate Jackpot Digital (TSXV:JJ). The Vancouver-based company is a manufacturer of dealerless electronic table games that deliver immersive experiences tailored to the digital age, while earning casinos attractive returns on investment.
The gambling technology stock benefits from no direct competition in the dealerless poker space, with orders spanning North America, Europe, Asia, Africa and the Caribbean, a long-established presence with major cruise ship brands, such as Carnival, Princess Cruises and Holland America, and a growing land-based presence with orders or ongoing installations across 12 U.S. states. Its highlight partnership to date is a master services agreement with Penn Entertainment, the country’s largest regional gaming operator with 43 properties across 20 states.
Jackpot Digital’s differentiated technology and well-rounded management team are at the heart of its success in landing several blue-chip casino gaming companies as customers.
Jackpot BlitzThe gambling technology stock’s flagship product, Jackpot Blitz, is a dealerless poker table featuring three of the world’s most popular variations – Texas Hold’ em, Omaha, and Five-Card-Omaha – brought to life through slick 4k graphics on a 75-inch touchscreen, and offered in three formats – pot-limit, no-limit and fixed-limit – designed to attract a diversity of revenue from casual to experienced players.
Spokesperson and NFL championship-winning coach Jimmy Johnson explains the benefits of the Jackpot Blitz. Source: Jackpot Digital.The table also comes equipped with house-banked mini-games, including blackjack, baccarat and video poker, as well as side bets on the main poker game, such as Bet the Flop, all of which keep players engaged and entertained between, and even during, poker hands. The stunning Jackpot Blitz machine also offers multi-venue “Bad Beat” jackpot functionality, allowing casinos to offer a “Poker Powerball” with massive Jackpots, further enhancing the attractiveness of Jackpot Blitz to new players.
It’s by striking a balance between the needs of the modern gambler, and efficiency and profitability that in-person operators couldn’t hope to match – unless they ordered the machine for themselves – that Jackpot Digital has earned itself the top spot in dealerless poker.
Player benefitsWhen a veteran or novice gambler takes a seat at the Jackpot Blitz, his or her experience begins with an easy-to-use interface, laid out in a modern and stylish design, programmed to respond to hand gestures that bring real casino play into the digital age, including card bending and chip jingling.
Source: Jackpot Digital.The table’s intuitive controls, combined with instant payouts and its dealerless nature, translate into faster game play, which maximizes playing time and player excitement, while minimizing human error and the intimidation new gamblers might feel about approaching an analog poker table. The gambling technology stock’s in-house development team is also constantly working on new games to keep content fresh, with a special focus on bringing international games and regional versions of poker to casino audiences in Asia, South America and the Indian subcontinent.
As hands are laid down and pots pile up, players can also track game stats in real time, which inform future strategy and enhance the thrill of the moment with an added element of competition.
Operator benefitsFrom an operator’s perspective, a floor of automated gaming tables can meaningfully and instantly reduce casino staff expenditures and management pain points, while avoiding wage inflation, labour shortages and supply costs.
The Blitz is no slouch on revenue either, dealing more hands per hour, resulting in higher revenue and higher profitability, which is further enhanced by onboard side bets and mini-games that can be played while players are engaged in a poker hand.
The Jackpot Blitz’s economics are attractive to operators thanks to its ability to accommodate non-stop play, while monetizing downtime through side games and bets. While a human dealer must spend time shuffling, interacting with players, and consulting with colleagues, the Jackpot Blitz can accept wagers 100 per cent of the time, making sure gamblers get the action they came for and operators see a return on their investment.
Source: Jackpot Digital.
Beyond gaming revenue, casinos are further incentivized to onboard the Jackpot Blitz because of its fully customizable advertising functions, including logos, card backs, chips and felt colors, all of which bolster casino culture and enable the pursuit of revenue from third-party advertising partners.
The Blitz ties its value proposition together by generating automatic reports – including demographics and consumer behaviour through a rewards card system – and plugging directly into most back-end management systems, saving casinos the hassle of manual tracking, while also minimizing tampering, money-laundering and theft through the use of isolated servers.
Whether it’s streamlining the player experience or putting automation at the service of operators’ bottom lines, Jackpot Digital’s flagship product is positioned to create value, and plenty of it.
Jackpot Digital’s path to profitabilityAfter existing as an exclusively cruise-ship-based operation since 2015, Jackpot Digital suffered a steep decline in revenue during the COVID pandemic, falling from C$2.18 million in 2019 to C$0.42 million in 2021.
Management quickly pivoted in the face of uncertainty, redesigning the Blitz to execute on a land-based expansion strategy – backed by Gaming Labs International certification in fall 2023 – which is bringing about a successful turnaround after the re-emergence of the casino business. Revenue more than tripled to C$1.43 million in 2022, and reached C$1.57 million through three quarters of 2023, with the company expecting to ramp up significant recurring revenue after it installs several dozen machines currently in its backlog.
The Jackpot Blitz electronic gaming table in action. Source: Jackpot Digital.
The first installation of land-ready Jackpot Blitz machines is now completed at the Jackson Rancheria Casino in California, as the company announced today. The three-machine installation marks a new era of growth for the company, having announced 25 Blitz deals since November 2021 (slide 12), with many more across Canada and the United States in the works, in addition to a strong pipeline in Asia and Europe.
“Jackpot Digital could be a profitable company right now if it only focused on care and maintenance of the revenues it currently generates. But that’s not why we’re here,” Mathieu McDonald, Vice President of Corporate Development at Jackpot Digital, said in a recent interview with Stockhouse. “We intend to scale up to many multiples of the tables we have out right now, with the potential for up to 2,000 tables over the next three to five years.”
According to McDonald, the company is fielding three to five inquiries per week about the Blitz from casinos around the world that recognize the machines’ first-mover advantage in dealerless poker and potential expansion into other games in need of automation.
Jackpot Digital’s ambitious plan of action is supported by a management team of proven gambling, finance, advertising and legal professionals, many of which have been serving Jackpot stakeholders for more than two decades.
A long-tenured management teamThe management team behind Jackpot Digital is led by Jake Kalpakian, who has served as president and chief executive officer since 1999, including under the gambling technology stock’s former incarnation as Las Vegas From Home.com Entertainment Inc. Kalpakian brings more than 30 years of experience managing small-cap publicly listed companies, granting him a steady hand when it comes to maneuvering through the volatility of the economic cycle.
Kalpakian’s efforts are supported by three directors whose well-rounded expertise positions Jackpot Digital for long-term sustainable growth:
Gregory T. McFarlane, a director at Jackpot Digital since 1999, previously ran an independent advertising firm and holds a degree in mathematics from the University of Toronto. McFarlane is also a co-founder of the popular Control Your Cash personal finance website. Chief financial officer Neil Spellman, a director at the company since 2002, boasts an almost two-decade track record as vice president at Wall Street firm Smith Barney, where he developed a multi-industry understanding of the journey to profitability. Finally, Alan Artunian, a director since 2017, currently serves as CEO of Nice Guy Holdings, a corporate and legal consulting company advising clients across a diversity of sectors.Guided by a strategic management team, and benefiting from a macro-trend toward casino automation, Jackpot Digital is on course to ride a wave of millions of gamblers looking for an elegant, tech-informed alternative to traditional in-person play.
A multi-bagger opportunityThe Jackpot Digital opportunity sets up savvy investors who recognize the soundness of the company’s value proposition. The tremendous risk/reward value of Jackpot Digital gives investors the opportunity to ride the macro-trend toward casino automation, as deals for the Blitz keep pouring in, the company adds games to its portfolio, and the global casino industry adds hundreds of billions in revenue through this decade.
Join the discussion: Find out what everybody’s saying about this gambling technology stock on the Jackpot Digital Bullboard.
This is sponsored content issued on behalf of Jackpot Digital, please see full disclaimer here.
The post This gambling tech stock is future-proofing the world’s casinos appeared first on The Market Online Canada.
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Gates-backed PhIII study tuberculosis vaccine study gets underway
A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.
The Bill & Melinda Gates…
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A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.
The Bill & Melinda Gates Medical Research Institute (MRI) will test a tuberculosis vaccine’s ability to prevent latent infections from causing potentially deadly lung disease. Last summer the nonprofit said it would foot $400 million of the estimated $550 million cost of running the 20,000-person Phase III trial.
It’s a pivotal moment for a vaccine whose origins date back 25 years when scientists identified two proteins that triggered strong immunity to the bacterium that causes tuberculosis. A fusion of those proteins, paired with the tree bark-derived adjuvant that helps power GSK’s shingles shot, comprise the so-called M72 vaccine.
After decades of failures in the field, the vaccine impressed scientists in 2018 when GSK found that it was 54% efficacious at preventing lung disease in a 3,600-person Phase IIb study.
But the Big Pharma decided that a full-blown trial was too expensive to conduct on its own. Gates MRI stepped in to license the vaccine in early 2020, right before the Covid pandemic shifted global vaccine priorities towards the coronavirus, further stalling the tuberculosis shot.
“There’s been frustration that it’s taken so long to get this trial up and running,” Thomas Scriba, deputy director of immunology for the South African Tuberculosis Vaccine Initiative, told Endpoints News last summer.
At last, the vaccine is getting a chance to prove itself in a bigger study. If successful, it could lead to the first new shot for tuberculosis in over a century.
Emilio Emini, CEO of the Gates MRI, told Endpoints that the initial results may come in roughly four to six years. “Hopefully this will galvanize a refocus on TB,” he said. “It’s been ignored for many, many years. We can’t ignore it anymore.”
A substantial impact
Even though an existing vaccine helps protect babies and children against severe tuberculosis, the bacterium responsible for the disease still causes roughly 10 million new cases and 500,000 deaths each year.
Emilio EminiBy vaccinating adolescents and adults who test positive for infections but don’t have symptoms of lung disease, the Gates MRI hopes the shot will help prevent mild infections from becoming severe ones, curtail transmission of the bug, which is predominantly driven by people with lung disease, and reduce deaths.
“The impact would be substantial,” Emini said. But he cautioned that the biology behind mild and severe diseases is still mysterious. “The reality is that no one really knows what keeps it under control.”
The study, which will take place at 60 sites across seven countries, will include some people who are not infected with tuberculosis to ensure that the vaccine is safe in that broader population.
“Having to pre-test everybody is not going to make the vaccine easy to deliver,” Emini said. If the vaccine is ultimately approved, it will likely be used in targeted communities with high tuberculosis, rather than across a whole country, he added. “In practice, you would immunize everybody in those populations.”
Emini described the Gates MRI’s rights to the vaccine as “close to a worldwide license.” GSK retained rights to commercialize the vaccine in certain countries but declined to specify which ones.
A spokesperson for GSK said that the company “has around 30 assets under development specifically for global health … none of which are expected to generate significant return on investment.”
“It is not sustainable or practical in the longer term for GSK to deliver all of these alone. So we continue to work on M72, but in partnership with others,” the spokesperson added.
If the shot works, Emini said that the Gates MRI will sublicense it to a manufacturer that will be responsible for making and marketing the vaccine. The details are still being worked out, he noted.
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