COVID-19 science should have set a new standard for vaccine safety research. Instead, it has lowered the bar. Hear this well: COVID-19 vaccines are not – and never were – a fait accompli. Unless the science being conducted on COVID-19 vaccines is held to the normative standards for ethical clinical research, no ethical physician, parent, or politician should support their general use – regardless of ACIP, CDC, WHO and AMA, AAP and FDA expected rubber-stamp recommendations. The regulatory system we have is fatally flawed and must be replaced with one free from profit motive. I call this Plan B, and I and my supporters will from this day make every effort to insure these obsolete and captured organizations’ impairment of bona fide evidence-based medicine in the US and abroad is brought to an end.
Most medical professionals and parents believe that vaccines are the best way forward to protect children from disease caused by infectious pathogenic agents. In a recent article, Bill Gates reports that he suspects ”the COVID-19 vaccine will become part of the routine newborn immunization schedule.”
Oxford has announced that its Phase II COVID-19 vaccine studies will include a group of children aged between 5-12 years. Given the low susceptibility of children to illness from SARS-CoV-2 infection, the inclusion of children is, according to Oxford, warranted so the differences between their immune systems and those of adults challenged with SARS-CoV-2 antigens can be better understood.
Any translational scientist or bioethicist should, on the grounds of elementary first principles of the ethics of clinical research, object vehemently to the inclusion of children in COVID-19 vaccine studies. Here, I lay those principles out in the current context.
1. There are no potential benefits to the child enrollees being experimented upon.The overall infection case fatality rate of SARS-CoV-2 is estimated by CDC at 0.26%. The risk of serious illness and death from SARS-CoV-2 infection in children is effectively zero. In fact, risk of serious/critical illness and death is isolated to known groups of individuals with diabetes or cardiovascular disease, and the elderly, and those with certain comorbidities (see CDC: Groups at Higher Risk for Severe Illness.)
There is, therefore, no potential benefit to any child who would be enrolled in COVID-19 vaccine studies, and the trial would only serve to benefit others. This is highly unethical.
There is also no expected population-level beneficial effect from the Oxford vaccine; all rhesus monkeys, vaccinated or not, with their vaccine, were still susceptible to SARS-CoV-2 infection. Thus, vaccination to prevent infection and transmission cannot be a justification for that particular vaccine: the virus should be expected to be freely transmitted throughout the population until it finds the immunocompromised and those at risk of serious and critical illness.
2. No free, prior and informed consent on risk is possible – for any COVID-19 human subject of any age.In SARS, MERS and other coronavirus vaccine research, unacceptably high risk of coronavirus disease enhancement was reported in animals vaccinated against the coronaviruses, and re-challenged with infection See “SARS-CoV-2 Vaccine Recommended Readings“. This critical animal safety study phase led to the termination of the development of SARS and MERS vaccines. That is not a failure of science, it is a success. The problem of disease enhancement from coronavirus vaccines has been misleadingly referenced as “immune enhancement”, a term that is an inexact reference to disease enhancement. It has been re-labeled “Pathogenic Priming”, a phrase that focuses the liability on the act of the exposure, not the passive liability on the human immune system (Lyons-Weiler, 2020).
The knowledge of whether disease enhancement will occur due to exposure to SARS-CoV-2 proteins in a vaccine will have to be gleaned from Phase 2 or 3 human subjects studies. The participants of such studies at any age cannot provide free, prior and informed consent – as required by US Federal Regulations – if participants do not know of the general possibility of risk, and worse, the specific likelihood of downstream serious/critical illness or death upon re-exposure.The all-important Phase 1 animal safety studies were specifically skipped prior to the Phase 2 trials of COVID-19 vaccines. This was done with the full knowledge of NIAID’s Anthony Fauci, who is partnering with Moderna on their RNA vaccine (See Live Science: “Researchers fast-track coronavirus vaccine by skipping key animal testing first” . Vaccinologist Paul Offit has called for skipping Phase 2 or combining Phase 2 and 3 trials on the basis of his perception of the seriousness COVID-19. Due to a lack of new cases in the UK, Oxford is relocating its human vaccine experimentation trials to Brazil, where pathogenic priming will likely show its face because, according to Forbes,
“As part of the Oxford trial’s design, participants will receive the vaccine and then continue being exposed to the virus normally in their day-to-day work.”
This means the effect of exposure to the virus following vaccination – and potential pathogenic priming is specifically being sought in human experimentation on a population in a developing country. Why not the UK? Is this imperial medical exploitation? This outsourcing of risk is unethical, and the lack of available clinical cases in some countries, including the UK begs the question of the plausibility and need of a COVID-19 vaccine program altogether.
3. Vaccines for Everyone At All Costs – Including Any Risk.In its publication, the Gates Foundation is apparently comfortable with COVID-19 vaccines being “brutal”, citing the experience with the polio vaccine leaving a large percentage of its recipients unable to go to school or work. The message “It might not be a perfect vaccine yet—and that’s okay” is a self-authorized permission slip to proceed not only to research on these vaccines – but also to begin production of billions of doses of the vaccine prior to knowledge of efficacy and safety.
Treating vaccine safety science as a token step toward FDA approval
We don’t yet know how “brutal” a SARS-CoV-2 vaccine might turn out to be. Gate’s message appears to be “COVID-19 vaccine regardless of any harm”. Gates is treating vaccine safety science as a token step toward FDA approval. Something is amiss with Gates’ moral algorithm: he favors benefit to a few at the potential high cost to the many.
One participant in the Moderna Phase 1 trial revealed his serious reaction to the vaccine. STAT News reported that, in spite of high fever and fainting, he is still, most unscientifically, a “believer”. Science is about empirical knowledge, not faith. It is unacceptable that we do not know whether he and all other participants in the early trial of Moderna’s vaccine study are now more susceptible to serious and critical illness or death from SARS-CoV-2 infection. This ignorance is not due to a lack of opportunity to know; Moderna has boasted about its animal studies which demonstrated antibody production. They had or have vaccinated animals; whether they simply have not challenged those animals with SARS-CoV-2 viral infection to check for pathogenic priming, or have done so but have not made those results public is unclear. If there was no pathogenic priming, they surely would have made the results public.
COVID-19 did not spread in the US due to a lack of a vaccine; it spread due to CDC’s botched strategy for early containment via testing and tracking: On January 16, 2020, CDC career scientists refused to adopt a validated test developed by Germany, and instead developed and shipped a flawed SARS-CoV-2 RT-PCR testing kit, which led to the spread of COVID-19 due to false negative results. This is why SARS-CoV-2 spread so fast in the US.
The world of diverse strategies
Empirical justification on the cost/benefit analysis of a vaccine strategy must be considered given a world of diverse strategies. We have known for some time that antivirals such as Remdesivir and Hydroxychoroquine may have a rational basis for use; a small study in China showed hydroxychloroquine to be effective. A study of 80 patients with Lupus taking hydroxychloroquine showed no COVID-19 development. Now, controversy looms of larger studies that were stopped – and restarted – after two major medical journals retracted the studies allegedly showing harm from Hydroxychloroquine. Numerous other pharmaceutical treatments are showing promise against SARS-CoV-2 as well.
Pharmaceutical drugs aside, we have also known for some time that plasma convalescent therapy is safe and effective. Early results from an ongoing Johns Hopkins University study of PCT in 16,000 COVID-19 patients is revealing a very low rate of adverse events, and the early estimate of the death rate of those infused with survivor plasma is about half that of patients who did not receive the plasma. Reports of zero mortality from small, independent medical facilities are leading to case reviews and potential clinical studies of other approaches. With an overall infected case fatality rate of 0.26%, and mounting evidence of effective prophylaxis and treatments, the case for universal vaccination may be dwindling. The public’s perception of the reality of the low threat from COVID-19 needs to be updated: as cases in the US dwindle, the mortality rate will also fall, and we may find that the annual numbers of death from COVID-19 may be fewer than Heart Disease (647,000), Alzheimer’s (141,000), diabetes (83,000), suicide (47,000), and less than the ill-conceived “lumped” estimate of deaths from “influenza” from CDC (55,000, actually due to influenza virus, 5,000). Why have we not locked down society until we find a cure for diabetes and learn how to prevent suicide?
Details of the ongoing and planned COVID-19 research are grounds for grave concern. The study of the efficacy and safety of the vaccines on the general population itself presumes that the vaccine is necessary to bring about protection of those at highest risk of serious illness and death. The vaccines are referenced as “COVID-19 Vaccines”, not SARS-CoV-2 vaccines, yet by far most of the infected will never develop COVID-19. Therefore, efficacy will have to be measured as susceptibility to infection. To begin with, one MD (Karl Friston) estimates that only 20% of people are susceptible to infection. Why are these studies not designed to assess the safety and efficacy of the at-risk population, where a vaccine would, if successful, have the largest clinical impact?
Herd immunity from vaccination is nice in theory, but it is not well-conceived given that the vaccine type tends to eventually differ from the circulating type. But even at 100% efficacy, what would a COVID-19 add to herd immunity? The coverage needed to acquire herd immunity is estimated at %C(overage) = 1-(1/R0), with R0 being the basic reproduction number, which varies with contextual settings. In settings where R0 is low (2.0), %C is 0.5, or 50%; where R0 is high (3.9), %C = 0.743, 74.3%. That means the highest percentage of the population that would need to be immune would be 75%. The possibility that as many as 80% of individuals are already immune to SARS-CoV-2 infection means that the general population already exceeds the percentage of immune individuals required to achieve herd immunity. If 80% of people are already immune, the vaccine is largely redundant (as, is for that matter, mask wearing).
Reason must prevail
The prolonged US lock-down has been overkill, and reason must prevail. A general lock-down is general physical distancing, which is overkill due to the attendant costs of deaths due to poverty, delayed “elective” surgeries, suicide from unemployment and social isolation. The only ethical use of a general lock-down in the US would have been short-term (2-3 weeks) combined with a shift in strategy that facilitated prophylactic use of antivirals, calls for general social distancing, and physical distancing of those at risk of serious illness and death. I proposed this more rational approach in February 2020: had the US public health leadership been like-minded, the economic effect of COVID-19 response would have been minimized.
A rapidly increasing battery of scientists have published their viewpoints that the cost of the prolonged general lock-down exceeds the benefit in terms of lives saved from COVID-19. Unlike CDC’s response to SARS, there never was a coherent strategy on the part of the US public health infrastructure to battle the SARS-CoV-2 virus; instead, ineptitude at morbidity rate estimation and test creation, the plea for a two-week general lock-down to allow the medical community to ready facilities for the surge was changed, by mission-creep and group-think, into permanent lock-down until a vaccine is available. This reckless message was decreed both by Bill Gates and by Anthony Fauci, both of whom we can thank, along with those at CDC who dropped the ball on early testing and contact tracing, for the destruction of the US and global economies.
The same people who prolonged the lock-down are calling for experimentation on children for the exclusive potential benefit of adults. That is unacceptable on its face, from first principles of the bioethics of clinical research.
Hear this well: COVID-19 vaccines are not – and never were – a fait accompli. Unless the science being conducted on COVID-19 vaccines is held to the normative standards for ethical clinical research, no ethical physician, parent, or politician should support their use.
Most of the studies conducted on vaccine safety rely on post-marketing surveillance using weak retrospective “association studies” with data from passively collected data sources (such as VAERS). Patients are not informed that they, or their children are, in fact, participating in a large non-randomized retrospective clinical trial. This practice is widespread, and violates provisions of the National Research Act [Title II, Public Law 93-348], Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research [45 CFR 46] and revisions of various regulations, rules, and laws ([21 CFR 50, [21 CFR 56], [45 CFR 46 Subpart D], [10 CFR 745]
Pregnant women and fetuses are afforded special protections by [45 CFR 46 Subpart B], and children are afforded additional protections by [45 CFR 46 Subpart D]. The rights of pregnant women and fetuses are violated with each and every vaccine administered to them because not only is there a paucity of pre-licensing clinical trials, no vaccine is actually licensed for use to protect fetuses, and pregnant women are not informed of these rights when they are pressured to vaccinate (FDA: Vaccines For Use in Pregnancy).
In the Common Federal Policy for the Protection of Human Subjects (“Common Rule”) [10 CFR 745] Sec 745.103(b)(3), none of these rights were revoked by any subsequent legislation, including [21 CFR 50.24], which allows the relaxation of requirements for informed consent during emergencies. In fact the Common Rule re-asserted safeguards both for informed consent, and for special protections against coercion:
46.116 General requirements for informed consent.
[See 46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 66 FR 20599, Apr. 24, 2001]
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”
The Nuremberg Code offers protection under international law to all individuals from enrollment in clinical trials without their informed consent, and stresses the rights of patients to refuse:
“Permissible Medical Experiments
The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.”
Rights to Informed Consent or Refusal of Medical Procedures
Under US Law, all individuals, and legal wards (custodians) of children have the right to choose or refuse medical procedures. The doctrine of informed consent is based upon the right of every individual to determine what shall be done to his or her body in connection with medical treatment. To exercise this right, the patient is entitled to information of a sufficient nature to allow him or her to make an informed decision on whether or not to consent or refuse treatment. Because patients are entitled to this information, physicians have a duty to make reasonable disclosures to their patients about the risks associated with proposed treatment. The duty to obtain a patient’s consent for treatment rests on the patient’s treating physician. Hospitals, nurses, surgical assistants, and referring physicians do not owe this duty to their patients. The treating physician’s duty to obtain a patient’s informed consent cannot be delegated. The duty is not eliminated, lessened, or spread by having the hospital nurse secure the patient’s consent prior to the procedure.”
The unethical COVID-19 vaccine experimentation must stop before Bill Gates, Anthony Fauci and other vaccine pushers inadvertently prime all of humanity to enhanced disease from coronavirus infections.
I thank Elizabeth Hart for stimulating discussion.