Over the last couple of weeks there have been several developments with regard to a potential coronavirus vaccine.
On 16 November, Moderna Inc declared that its experimental vaccine is 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial. This follows on from Pfizer’s announcement on 12 November when it affirmed a 90 per cent effectiveness rate in late-stage clinical trials. As reported by Reuters, Soumya Swaminathan, the WHO’s chief scientist, noted that the Pfizer and Moderna candidate vaccines both use mRNA technology and appear to achieve high efficacy.
“But there are many, many questions still remaining about the duration of protection, the impact on severe disease, the impact on different sub-populations especially the elderly, as well as the adverse events beyond a certain period of time,” Swaminathan said.
Clinical trials must continue to collect more data, she said, adding that more results were expected in coming weeks from the other vaccine trials. “We are looking at least at the first half of the year as being a period with very, very limited doses. Supplies are going to be limited, there are bilateral deals that many of the companies have done, so many of the doses have already been booked by some countries,” Swaminathan said.
The Morrison government has secured access to four trialled drugs: the University of Oxford/AstraZeneca vaccine, the University of Queensland/CSL vaccine, the Pfizer vaccine, and the Novavax vaccine. To this end, Health Minister Greg Hunt announced that the government has ordered 10 million doses of the Pfizer vaccine, pending regulatory approval, to complement Australia’s existing arrangements that include 33.8 million doses of the Oxford-AstraZeneca vaccine and 51 million doses of a University of Queensland drug through CSL. The Minister added that the Oxford AstraZeneca vaccine will likely begin production by vaccine manufacturer CSL later this month.
Hunt has advised that first doses of a potential COVID-19 vaccine would be available to Australians by March next year, saying that priority would be given to health and aged care workers, as well as the elderly.
“That guidance has been reaffirmed in recent days and then it will be progressively rolled out through the course of the year,” he told The Herald Sun. “The expectation is that everybody who sought vaccination would be vaccinated well within 2021,” he continuer. “Our goal is to have the borders open, subject to vaccination and health advice, by the end of 2021.”
The Minister added said the government is aiming for herd immunity — or about two-thirds of the population to be vaccinated. Vaccinations are set to be free, but not mandatory, and it’s likely two doses will be required. The two doses are set to be received 30 days apart.
This two-third immunity threshold has been called into question previously. The journal Science has suggested that the herd immunity threshold for coronavirus could be as low as 43%. Further, as outlined by Rebecca Weisser in The Spectator Australia in September, far from having no immunity, the evidence shows the vast majority of the population has pre-existing, crossover T-cell immunity, developed through exposure to coronaviruses such as the common cold. This explains why most people have a mild or asymptomatic response.
It is not my intention here to engage in a detailed discussion on this topic. Rather, I wish to focus, first, on the statement by the Health Minister as part of his announcement that the vaccination will ‘not be mandatory’. He added: “We would like to see everyone who seeks to be vaccinated, on what would be a voluntary program, completed during the course of 2021 and the middle of the year seeing the vast bulk of the population given that access.” It has also been reported that Australia’s immunisation register is set to record every jab given to an Australian, enabling the government to track any issues that may arise. In this regard I note the Prime Minister’s comments from 5 November when he referred to the establishment of a “national vaccines policy” which would go through Cabinet again following consultation with the States and Territories, before heading for approval from the National Cabinet, “because the dissemination of any vaccine is done in partnership with the Commonwealth with the States and Territories.”
Those who choose to receive a coronavirus vaccine will be asked to report any adverse effects. The vaccination plan was subject to the approval of National Cabinet, which duly occurred at its last meeting on November 13. Priority will be given to certain groups as part of the national cabinet plan but vaccination will not be mandatory. Acting Chief Medical Officer Paul Kelly has said “vulnerable people” and “those at highest risk of transmission” would be on the priority list for early access to the vaccines. According to the policy, this includes health and aged care workers, other care workers, including disability support workers, and people in other settings where the risk of virus transmission is increased, which may include quarantine workers. Also on the priority list are those who had an increased risk, relative to others, of developing severe disease or outcomes from COVID-19 including Aboriginal and Torres Strait Islander people, older people and people with underlying select medical conditions, and those working in services “critical to societal functioning including select essential services personnel and other key occupations”. The report also notes that the national vaccines policy ensures that Canberra is in charge of securing, approving and arranging the transit of any successful drugs while state and territory governments are left with responsibility for the rollout of the workforce.
The statements regarding the proposed voluntary nature of the vaccine ‘roll-out’ are indeed interesting. Readers may recall the Health Minister and the Prime Minister’s declarations last August on the matter, as discussed in my August Flat White article. Initially, the Prime Minister, in his typically authoritarian manner, declared a coronavirus vaccine should be “as mandatory as possible”, and then, when he had to eat his words less than 12 hours later, the next day the Health Minister refused to rule out ‘incentives’, such as a denial of social security payments to those who did not vaccinate, no doubt upon the urging of his health Politburo. Readers may also recall Deputy Chief Health Officer Nick Coatsworth, at the same time, proposing extortionate measures such that dining out and international travel could be denied to those who did not vaccinate. Therefore, this apparent change of heart on the part of the Health Minister is welcome.
It remains to be seen if ‘voluntary’ does in fact really mean voluntary, and not tainted with some form of duress. On this subject, naturally the WA Premier, Mark McGowan, had to put his ten cents in, repeating his call to keep the nation’s international borders shut for as long as another year, until a vaccine could be rolled out. “The world appears to be on the cusp of a vaccine,” he said. “Hopefully by the end of next year we can roll it out to all our citizens. Why don’t we wait until then before we start opening international borders”, he said.
Under the national vaccines plan, it is outlined that there will be a national system to monitor immunisation levels and individual vaccination status. It must also be remembered that the Federal government’s budget key assumption is that a ‘population-wide’ vaccine is available and taken up within this timeframe. The Federal Government has agreed with CSL, in a deal worth $1.8bn, to build the largest biotech and vaccine manufacturing plant in the southern hemisphere. The plant, to be built in Melbourne and due for completion in 2026, will deliver the first “population-wide pandemic and seasonal flu vaccines for Australians, quarantining the nation from global supply chain shortages or queues”.
Readers may recall that on 24 August 2020 the Catholic Archbishop of Sydney, Anthony Fisher OP, raised serious ethical and moral considerations for his flock regarding the production of the Oxford coronavirus vaccine. In a post on his Facebook page, Archbishop Fisher stated that he had written to the Prime Minister outlining his concerns that the Oxford vaccine (to be manufactured by AstraZeneca), among others, is being produced from the cultured cell lines of an electively aborted foetus. This would present Catholics with a serious ethical dilemma, notwithstanding the cell-line is derived from an abortion that occurred in 1972. In this letter, which was also signed by Anglican Archbishop Glenn Davies and Greek Orthodox Archdiocese of Australia Archbishop Makarios, the Church leaders stated that they and their Churches are not opposed to vaccination. However, harvesting ‘foetal tissue was deeply immoral’ and thus, members of their congregations might consider their ‘individual conscience’ and refuse a vaccine even if no other alternative was available to them. To this statement, Coatsworth responded by stating that the vaccine was being produced by one of the world’s leading universities and ‘we can have every faith that the way they have manufactured the vaccine has been against the highest of ethical standards internationally.’
Despite Coatsworth’s assurances, in addition to the very valid ethical considerations raised by Archbishop Fisher, there are other good reasons why people should freely decide whether or not to have any coronavirus vaccination, and this relates to the corporate ethics of the companies involved.
When one looks closely at AstraZeneca’s litigation history, it seems compliance on its part with the ‘highest ethical standards’ is, if you will pardon the pun, voluntary. Its corporate practices have been investigated on numerous occasions by regulators in Europe and America. What should also be noted is how AstraZeneca, in an agreement signed with the Belgian Government (which is similar to that signed with the Australian Government), has apparently been granted a waiver of liability in relation to any side effects caused by the corona vaccine. As far as Australia is concerned, such an indemnity has indeed been provided. As reported by Tom Dusevic in The Australian on 11 November:
Buried deep in last month’s budget papers was notice Canberra has provided an indemnity to the suppliers of the first two vaccines, “covering certain liabilities that could result from the use of the vaccine”. Asked whether Novavax and Pfizer had been provided with an indemnity, a Health spokesman said: “The government acknowledges the need to appropriately share risks associated with achieving early access to a successful vaccine, and is engaging on indemnity positions with a number of potential COVID-19 vaccine suppliers.”
It is incumbent on the Federal Government, in the interests of transparency, to disclose the terms of such a waiver of liability, and whether one has indeed been agreed any other company contracted to produce a coronavirus vaccine — particularly given AstraZeneca’s well-documented history of litigation.
In terms of the other vaccine candidates, according to the Charlotte Lozier Institute, the Pfizer vaccine has not been created using foetal cells. However, Pfizer has also had serious legal and corporate ethical issues in the past, again in relation to off-label marketing. In this regard, the company reached a $US486 million settlement of litigation accusing it of causing big losses for shareholders by concealing safety risks associated with its Celebrex and Bextra pain-relieving drugs. This followed on from an agreement to pay $US2.3 billion to settle a US government investigation into the marketing of Bextra and other drugs. As noted at the time, this is the largest health care fraud settlement in the history of the Department of Justice to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.
As far as Moderna is concerned, the Charlotte Lozier Institute has also listed its coronavirus vaccine as ‘ethically uncontroversial’. However, this company, too, has been the subject of controversy in relation to its corporate practices, in particular, insider trading. Earlier this year, Accountable.US, in a letter to the US Securities and Exchange Commission, urged it to investigate top executives at Moderna for allegedly manipulating the stock market. “This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic,” stated the letter.
These are the companies governments around the world (including Australia’s) want to trust with producing a safe and effective vaccine. For those who place a high value on corporate ethics, their record in this regard could reasonably be seen as scandalous and thus present serious problems for their consciences, especially given the indemnities granted by the government covering liabilities that could result from the vaccine.
In view of the above, it is imperative that any coronavirus vaccination programme be truly voluntary. As Archbishop Fisher himself stated in The Catholic Weekly on 24 August:
Those who are troubled by (the coronavirus vaccine) will either have to acquiesce to the social pressure to use the vaccine on themselves and their dependents, or conscientiously object to it. If they resist they will suffer various disadvantages and their abstention may undermine the goal of ‘herd immunity’. Some will feel deeply conflicted whichever way they go. And it will be socially divisive.
Unnecessarily so. If the Government pursues an ethically uncontroversial vaccine this won’t be a problem. If it assures people that no one will be pressured to use such a vaccine or disadvantaged for failing to do so, it won’t be a problem. If it makes available an ethically-uncontroversial alternative vaccine if one is found, those who are troubled in conscience will be relieved. The key, then, is seeking solutions that protect the community’s physical health while also respecting its moral health and offering people choices.
It is to be hoped National Cabinet takes heed of His Grace’s sound advice and allows people a true choice, as well as an opportunity to be fully informed, before making a decision whether or not to have any coronavirus vaccine.
Dr Rocco Loiacono is Senior Lecturer at Curtin University Law School
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