3. The ethical issues in relation to the various mandates, lockdowns, vaccines, research, etc.
Summary:
The literature indicates significant concerns and potential significant violations of the dignity of the human person, in addition to human rights abuses resulting from the impositions made by governments and organizations.
- The question of ethics is very real in all that has been going on in relation to COVID-19. It becomes even more serious when it impacts children. While there is every likelihood that these sources will change depending on the desired narrative it is worth visiting the Research with Children FAQs, the OHRP Guidance on Coronavirus and the Code of Federal Regulations (CFR) Title 45, Part 46 on the Protection of Human Subjects government websites and being informed on what they say, most particularly in relation to the involvement of children in research. In the final document mentioned (CFR), note especially the following sections of the Code of Federal Regulations:
- §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, states that the “HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, only if the IRB finds that:
(a) The risk is justified by the anticipated benefit to the subjects; [NOTE: the risk is not justified given the higher propensity for significant side effects at all ages, but most especially in children relative to the extremely low morbidity rates observed – see VAERS and other data relating to vaccines in other sections of this document]
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and [NOTE: the risks associated with the vaccines far outweigh the alternative approaches or even not receiving the vaccine itself – see mortality rates and recovery rates in other sections of this document]
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in §46.408. [NOTE: This is also questionable given incidents of supposed/suspicious “incorrect administrations” of vaccines and the mandates requiring children to be vaccinated to attend school, which amounts to coercion]
Interpretation: The COVID-19 vaccines do NOT fit under the criteria set out by §46.405 of being research involving greater than minimal risk but presenting the prospect of direct benefit - §46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition states that “HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:
(a) The risk represents a minor increase over minimal risk; [NOTE: the risk of side effects in young people is disproportionally higher than minimal risk]
(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; [NOTE: Commensurate is defined as “corresponding in size, extent, amount or degree” . The reception of the COVID-19 vaccines and the subsequent potential consequences (e.g. pericarditis) do not compare, and are not “reasonably commensurate” to any normal experience of a child, physical, psychological, medical or educational.”]
(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and [NOTE: the COVID-19 vaccines have only yielded a significant concern in relation to the significant side-effects that have been observed across all ages, but most especially in children]
(d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in §46.408. [NOTE: See comment under (c) for §46.405]
Interpretation: The COVID-19 vaccines technically FIT under the description in the opening sentence of §46.406 of being research involving greater than minimal risk and no prospect of direct benefit. However, the COVID-19 vaccines do not fit under any of the criteria outlined in a-d. - §46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
Interpretation: The COVID-19 vaccines do NOT fit under the criteria set out by §46.407 as they do not help in the understanding, preventing or alleviating of problems that affect the health or welfare of children.
- §46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, states that the “HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, only if the IRB finds that:
- The ethical issues are highlighted in the following statement: “Since the incidence and disease burden of COVID-19 are very low in children, vaccination should not be primarily performed for their self-protection but for that of the community, mainly the elderly or high-risk individuals. Hence, each vaccine will have to be thoroughly tested and proven safe before being administered to children to respect the risk-benefit balance. Furthermore, pediatric COVID-19 vaccines would need to be proven efficient in the interruption or reduction of virus transmission. To date, no NHP [non-human primate] preclinical study has assessed the effect of vaccination in the prevention of transmission, and end-points of human COVID-19 vaccine trials focus on the induction of immunity and individual protection against disease.” (Eberhardt and Siegrist, 2021)
- Kowalik (2021)
- “…there is neither a moral obligation to vaccinate nor a sound ethical basis to mandate vaccination under any circumstances, even for hypothetical vaccines that are medically risk-free. Agent autonomy with respect to self-constitution has absolute normative priority over reduction or elimination of the associated risks to life. In practical terms, mandatory vaccination amounts to discrimination against healthy, innate biological characteristics, which goes against the established ethical norms and is also defeasible a priori.”
- “…there is neither a moral obligation to vaccinate nor a sound ethical basis to mandate vaccination under any circumstances, even for hypothetical vaccines that are medically risk-free. Agent autonomy with respect to self-constitution has absolute normative priority over reduction or elimination of the associated risks to life. In practical terms, mandatory vaccination amounts to discrimination against healthy, innate biological characteristics, which goes against the established ethical norms and is also defeasible a priori.”
- Giubilini et al. (2021)
- “Restrictions such as lockdowns and school closure compromise important societal and public goods and the well-being and health of young generations. Thus, a fairer way to protect vulnerable groups is to adopt focused protection strategies targeted at them: the burdens on them would be justified by the benefit they receive in terms of protection from COVID-19, something that is not true for young people.”
- “What matters, from an ethical point of view, is that the differential treatment is based not on arbitrary or irrelevant factors (which would make it discriminatory), but on morally relevant factors (eg, risks of COVID-19, individual benefit from restrictions, personal costs of restrictions, societal benefit and so on).”
- “The only reason why we have imposed this burden on children is to serve other people’s or broader societal interests. These measures have not been in the interest of children, nor where they intended to be. The burden on them has been vast and the benefit of lockdowns for the collective at the very least questionable”
- “Restrictions such as lockdowns and school closure compromise important societal and public goods and the well-being and health of young generations. Thus, a fairer way to protect vulnerable groups is to adopt focused protection strategies targeted at them: the burdens on them would be justified by the benefit they receive in terms of protection from COVID-19, something that is not true for young people.”
- Capozzo (2020)
- “Many have died in isolation. Dying alone is not justifiable, even in times of infection with a pandemic virus, particularly when the impact of imposing such a radical measure on the course of the epidemic is, at least, questionable.”
- “If we lose humanity, it will be our fault. We will not be able to blame it on the virus.”
- “Many have died in isolation. Dying alone is not justifiable, even in times of infection with a pandemic virus, particularly when the impact of imposing such a radical measure on the course of the epidemic is, at least, questionable.”
- Ussai et al. (2020)
- “The dignity of the dead, their cultural and religious traditions, and their families should be always respected and protected. Among all the threats, COVID-19 epidemic in Italy revealed the fragility of human beings under enforced isolation and, for the first time, the painful deprivation of families to accompany their loved ones to the last farewell. Ethics poses new challenges in times of epidemics.”
- Savulescu and Cameron (2020)
- “Ethically, selective isolation is permissible. It is not unjust discrimination. It is analogous to only screening women for breast cancer: selecting those at a higher probability of suffering from a disease. Even if it were unjust discrimination, it would be proportionate because it brings benefits to the elderly and is proportionate and necessary given the grave risks to the economy and subsequent well-being of the population of an indiscriminate lockdown. To oppose selective isolation of the elderly is to engage in levelling down equality which is itself morally repugnant.”
- “Ethically, selective isolation is permissible. It is not unjust discrimination. It is analogous to only screening women for breast cancer: selecting those at a higher probability of suffering from a disease. Even if it were unjust discrimination, it would be proportionate because it brings benefits to the elderly and is proportionate and necessary given the grave risks to the economy and subsequent well-being of the population of an indiscriminate lockdown. To oppose selective isolation of the elderly is to engage in levelling down equality which is itself morally repugnant.”
- Vojdani and Kharrazian (2020)
- “The promotion and implementation of such an aggressive “immune passport” program worldwide in the absence of thorough and meticulous safety studies may exact a monumental cost on humanity in the form of another epidemic, this time a rising tide of increased autoimmune diseases and the years of suffering that come with them.”
- “The promotion and implementation of such an aggressive “immune passport” program worldwide in the absence of thorough and meticulous safety studies may exact a monumental cost on humanity in the form of another epidemic, this time a rising tide of increased autoimmune diseases and the years of suffering that come with them.”
- Sun et al. (2020)
- This study investigated “clinically cured cases with positive results only in anal swabs, and investigate[d] the clinical value of anal swabs for SARS-CoV-2 detection”. Despite the invasiveness of the procedure and the fact that a three-year old was one of the subjects, the article violated one of the most essential rules of research with humans – informed consent.
- The ethics statement read as follows: “Ethical conduct of research: This study was approved by the Weihai Municipal Hospital review board, and the need for informed consent was waived.”
- [NOTE: Following concerns raised after publication, the article was first “corrected” to state “This study was approved by the Weihai Municipal Hospital review board, and written informed consent was retrospectively obtained from the patients in the study.” – Please note: there is NO such thing as retrospective consent.
- This article was “retracted from Future Microbiology as it did not meet the ethical standards of the Journal, owing to a lack of informed consent obtained from the patients, prior to publication”.]
- [NOTE: Following concerns raised after publication, the article was first “corrected” to state “This study was approved by the Weihai Municipal Hospital review board, and written informed consent was retrospectively obtained from the patients in the study.” – Please note: there is NO such thing as retrospective consent.
- This study investigated “clinically cured cases with positive results only in anal swabs, and investigate[d] the clinical value of anal swabs for SARS-CoV-2 detection”. Despite the invasiveness of the procedure and the fact that a three-year old was one of the subjects, the article violated one of the most essential rules of research with humans – informed consent.
Sammut Lab 