What Information and Advice is Expected from Medical Professionals Administering Covid-19 Vaccines?
This is a question now being asked in cases coming before the Courts. Medical professionals need to know how much they can rely on statements supplied by the Australian Department of Health and Aged Care, ATAGI and the TGA.
The AHPRA position statement of 9 March 2021 (click link for full document)
Medical Practitioners and other health workers registered under AHPRA were issued with a joint statement on 9 March 2021 telling all registered health professionals they were expected to fully assist with the national vaccination rollout program. Being carefully worded the AHPRA position statement did refer to the role of registered health professionals in
- “…providing accurate information and advice about COVID-19 vaccination including in social media and advertising; &
- “…ensuring they provide accurate, evidence-based information to patients about Covid-19 vaccination”.
However, such advice was given with a warning that regulatory action would be likely taken against recalcitrant practitioners who spoke against the vaccination program, which meant practitioners who also raised concerns about the ‘vaccines’. This intentional ambiguity was confirmed where AHPRA went on to state, “there is no place for anti-vaccination messages in professional health practice.”
While many health practitioners may have assumed the AHPRA statement of 9 March 2021 absolved them of legal responsibility to consider the health risks of administering Covid-19 vaccines still the subject of Phase III clinical trials to any of their patients, nothing could be further from the truth, nor is any such belief supported by Australian law. Moreover, neither AHPRA, the various National Boards (including the Medical Board of Australia), nor any Australian government afforded health practitioners any special legal protections in respect of the administration of Covid-19 ‘vaccines’.
Codes of Conduct for Health Professionals
The 15 National Boards who work with AHPRA issue Codes of Conduct for various health professionals. The Code of Conduct for Australian doctors contains very clear statements of their professional and ethical responsibilities.
- “In clinical practice, care of your patient is your primary concern” [at Cl. 3.1]. It is evident that this responsibility comes ahead of promoting any government public health policy. Considering the conduct necessary for good patient care, the Code of Conduct states good medical practice involves inter alia [at Cl.3.2.4]:
- “Considering the balance of benefit and harm in all clinical-management decisions”
- “Providing treatment options based on the best available information.”
- “Only recommending treatments when there is an identified therapeutic need…”.
The Code of Conduct endorses the principle of “Informed Consent” [at Cl.4.5], and states that good medical practice involves “Providing information to patients in a way they can understand before asking for their consent.” Legal opinion is that the Codes of Conduct have the status of statutory rules so that the obligations they impose upon practitioners are legal, and prevail over policy statements, or advices disseminated by government agencies. [fn. 1] Legal Ramifications for Registered Health Practitioners – MAAT’s Method (click link for full document)
Common Law Duty to Patient
Under the common law, a medical practitioner has a single comprehensive duty to exercise reasonable care and skill in the provision of professional advice and treatment. Except in cases of emergency such as the patient being unconscious, all medical treatment needs to be preceded by the patient’s choice to undergo it. To be valid, a patient’s consent to treatment needs to be informed with advice in broad terms of the nature of the procedure which is intended. The Australian High Court has said a patient’s capacity to make a choice is, in reality, a meaningless one unless it is made “on the basis of relevant information and advice.” [fn. 2]
In giving advice, a doctor has a duty to warn a patient of a material risk inherent in a proposed treatment. The risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it, or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. [fn. 2A]. Words such as “small risk”, “slight risk”, “rare” may not adequately or relevantly convey the true nature of a risk, and more specific information pertinent to the patients’ circumstances should be provided [fn. 3]
Technical Information being made available to Australian Medical Practitioners
The Australian Technical Advisory Group on Immunisation (ATAGI) recommend COVID-19 vaccination “for all people aged 5 years or older to protect against COVID-19”. The relevance of this recommendation rests on whether an Australian patient needs protection against COVID-19.
It is in addressing this question that doctors should be aware of their statutory and common law duties to each patient as they present to them, old or young, fit and healthy, in poor health or immune-compromised. The ATAGI advice deals with the immune-compromised: they have an increased risk of severe illness with COVID-19. However, mention is not made that the average age of those suffering a severe reaction to the virus was 84 years, and the median age of those who have died was 85.5 years [fn. 4]. The varying degrees of risks faced by healthy people, by people according to their age, and by people who have developed natural immunity to COVID-19 without being vaccinated is not discussed. Nor are the various risks posed by a vaccine that is still experimental, discussed for each of these classes of recipients.
Adverse Reactions
The occurrence of adverse events is acknowledged with a Reporting Rate of 2.1 per 1,000 doses. This figure is provided without any attempt to estimate the under-reporting rate [fn. 5]. An under-reporting rate of 30 times [The Time of Covid – Phillip M. Altman (click link for full document)]would bring the above adverse reaction result to around 5% of recipients, a figure that fits in with many people’s anecdotal experience [fn. 6].
Such a rate is consistent with the rising rate of hospital attendances unconnected to Covid-19 infection since the Covid-19 vaccination program began and the significant rise in unexplained deaths [fn. 7, 7A].
The TGA’S Safety Report of 3 November 2022 repeats that
- “Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks.”
Such advice on the safety and effectiveness of vaccination reads as a public health polemic addressed equally to all Australians whatever the state of their individual health, and immunity from infection.
What Australian evidence is there that COVID-19 Vaccines are the most effective way to reduce deaths and severe illness?
The TGA does not provide any analysis of Bureau of Statistics Covid-19 data nor its own adverse events data to support the conclusions it offers.
To help practitioners better inform their patients, SKIP Australia has compiled the following three tables from Australian data available from the Bureau of Statistics and the TGA’s own adverse reaction data set [Corporate Transformation Services – Lisa Mitchell (click link for full document)].
(A) TABLE 1. The numbers of Australians with serious illness including death with the virus a cause or an additional factor, and serious illness including death in recipients of one or more vaccinations.
(B) TABLE 2. Rates of serious reactions to vaccination in various age groups (from young to elderly).
(C) TABLE 3. Rates of serious reactions to the virus for the same or similar age groups as in Table 2 (but to 10 Oct 2021 when the age classes were altered).
TABLE 1: Comparison of SERIOUS ILLNESS & DEATHFROM: (a) COVID-19 and (b) ADVERSE VACCINATION REACTION
AUSTRALIAN DATA UP TO 30 JUNE 2022.
Notes:
** Lisa Mitchell – Australian Covid Analysis Table 1.
^^ This number sums results from 23 categories of adverse reactions treated or assumed to reflect a serious
incident. Lisa Mitchell – Australian Covid Analysis Table 1.
++ National Adverse Event Reporting Systems acknowledge a high under reporting rate. see fn. 6, above.
TABLE 2. PERCENTAGE OF SERIOUS ADVERSE EVENT CASES POST VACCINATION
(Source: Data from all available TGA’s DAENs sourced to 30 June 2022.)
TABLE 3. PERCENTAGE OF COVID CASES RESULTING IN DEATH UP TO 10 OCTOBER 2021 [fn9]
Note: Due to changes in data recording made by DAENs this table can only present data with the given age intervals up to October 2021. The Covid-19 deaths by age and sex recorded to 30 September 2022 indicate there has been no significant alteration in the distribution of severe COVID-19 cases. See Australian Bureau of Statistics COVID-19 Mortality in Australia Deaths registered until 30 September 2022, 27/10/2022.
Comment
TABLE 2 shows that around a third of all those under 30 years reporting an adverse reaction experienced a serious event, compared with a lower rate in older groups. In contrast TABLE 3 shows that when anyone in the same younger age group contracted the virus negligible numbers experienced a serious reaction.
ATAGI already advises severe COVID-19 in children is uncommon. The results in Table 3 suggest very uncommon, indeed rare. With the development of natural immunity in the unvaccinated group, there is no reason to think the health risks of the virus to those under 30 will alter. It is against such a background that the risks of an adverse reaction to the vaccines ought to be compared even if they too are currently described as rare by government health departments.
Patient’s Ultimate Source of Advice
Who do Australians turn to for patient-specific advice about receiving one of the vaccines? The answer is made clear in the TGA’s own releases [fn.10].
- “If you have any concerns about the COVID-19 vaccines, we encourage you to consult your healthcare professional for advice with regard to your particular situation”.
If the patient’s ultimate source of information and advice on COVID-19 vaccines is with their private medical practitioner, those practitioners are obliged to seek out more specific information beyond the generalised statements provided on the Australian Health Department website. They need to keep informed of the emerging experience and continuing research on the safety, efficacy and benefits of the vaccines being reported and commented upon across the world.
Ultimately, medical practitioners must recognise that their responsibility to the patient under the Codes of Conduct for Health Professionals and Common Law Duty to Patient, have not been altered in any way by the existence of the ‘AHPRA’s position statement’.
Weighing the Risks and Benefits
Health care workers need sufficient understanding to assist their patients to weigh up the risks and benefits unique to their specific circumstances.
The expected benefits of the vaccines appear greater in the elderly and those whose health is immune-compromised and therefore at greater risk from a respiratory infection. For such people the medical literature continues to support the benefit that vaccination and booster updates will help them overcome an infection and avoid hospitalisation.
To those healthy persons, especially children and young adults with little risk of experiencing a severe reaction to a Covid infection, questions about the long term safety of vaccines (officially still being tested) needs to be weighed against a vanishing set of benefits.
The widely disseminated advice given in 2021 that population-wide vaccination would prevent transmission of the virus has not occurred. The assumption that the vaccinated would gain increased immunity and longer protection from infection has also not materialised.
Covid-19 case rates in England provide a large data set for assessing the benefits of vaccination for different age groups:
The above bar chart compares reported cases of Covid infection for 7 age groupings depending on whether they have received one or more Covid vaccine injections or remained unvaccinated [fn. 10A].
Over the thirteen week period from the start of 2022 infection rates decline in the unvaccinated population but continue without significant change in the vaccinated population. With an inability to control transmission, continuing infection and re-infection and low hospitalisation rates for the general population, what are the ongoing benefits of receiving a vaccine injection?
There has been more time in the last year to collect and analyse data which sheds light on the effectiveness of the mRNA vaccines. For example, the results of a large Israeli study published in April 2022 involved 610,793 vaccinated patients and 62,883 unvaccinated patients who had acquired Covid-19 by 28 February 2021. The authors concluded:
“This analysis demonstrated that naturally acquired immunity affords longer lasting and stronger protection against infection and symptomatic disease due to the Delta variant of SARS-CoV-2, compared to the BNT162b2 2-dose vaccine-induced immunity.” [fn. 11]
Children:
For children there is a limited risk of severe illness due to COVID-19 [fn. 11A]. The relevance of several reports indicating a high level of protection afforded vaccinated children from the possibility of hospitalization should therefore be weighed against the very low incidence of hospitalization and death for all children.
Studies being published in the medical literature show the protection offered children against infection wanes more than natural immunity. A North Carolina study on Omicron Infections in Children found a rapid decline in 6 months in protection against further infection whereas the immunity conferred on unvaccinated children from was still 50% effective[fn. 12]. For most children, should the question be: “Is natural immunity following Covid infection more effective than Covid immunisation?”
Overseas Reporting of Severe Adverse Events:
Since the emergency authorisation of the Covid-19 vaccines, manufacturers have revealed higher than expected numbers of severe adverse events occurred amongst those who received the vaccines during clinical trials [fn. 12A]. Reports of severe side effects commenced with the start of the world-wide vaccination program and are continuing to be reported on Government vaccine safety reporting services. For example, on 20 July 2022 the German regulator responsible for vaccine safety indicated 1 in 5000 people suffered a serious side effect, such as heart inflammation after vaccination. After a four dose course of vaccination, it said 1 in 1250 people could expect a serious adverse event, described as meaning an event that results in hospitalisation, is life threatening or life changing [fn. 13].
The different types of serious adverse reactions that can occur should be considered by practitioners, according to the circumstances of each patient, in any advice given on receiving a vaccine [fn. 13A]. Myocarditis is an example of a specific risk on which doctors should be ready to give specific advice [fn. 14]. A large analysis of VAERS data in the USA showed the median age of 1991 myocarditis reports between Dec. 2020 to Aug. 2021 was 21 years. Given the “passive surveillance reporting” involved this statistic, the authors considered it a risk that should be considered in the context of the benefits of getting vaccinated [fn. 15].
A full account of the constituents of the mRNA vaccines has not been disclosed, nor has the possible impacts the new technologies may have on other body functions been properly assessed. The long term safety of gene-based vaccines is still to be established. The sensitivity of the reproductive system especially in all women of child-bearing age or younger, warrants special care. In recommending COVID-19 vaccines for pregnant women, reference is made to “a growing body of evidence supporting the safety of mRNA vaccines in pregnancy,” but not to other reports suggesting possible links between vaccination and miscarriages and impacts on male and female fertility, including in Pfizer documents subsequently released in the USA as a result of court order [see fn. 16]. In that country, for the 24 months to 25 November 2022 the VAERS database has recorded 4,565 foetal deaths as adverse reactions to Covid-19 injections. This statistic might be compared with 2,239 foetal deaths reported on the system in connection with any type of vaccine in the previous 30 years [fn. 17].
Conclusion:
This Bulletin has been prepared to prompt health professionals to think about what advice they need to give individual patients on the risks as well any benefits of receiving a Covid-19 vaccine injection. It questions whether it is enough for practitioners to look no further than the advice they find on Australian government websites on the safety and effectiveness of the available Covid-19 vaccines.
The TGA’s own data for children less than 11 years indicates that no children died from Covid-19 alone prior October 10th 2021 but, following the commencement of vaccinations for this age group, 5 deaths have been associated with the vaccines. Given the TGA place the onus on medical practitioners to adequately address patient concerns about mRNA vaccines, it is fitting that this information be made available to all patients prior to any request of consent.
It is suggested that reliance on broad policy statements encouraging vaccination cannot replace the need to assess what each individual patient might gain from receiving such an injection and what possible downsides they may suffer. Only then, when the patient has been able to weigh the risks and benefits specific to their circumstances, can it be said that patient has given an informed consent.
Footnotes
2. Rogers v Whitaker (1992) 175 CLR 479 at 489.
2A. Rogers v Whitaker (1992) 175 CLR 479 at 490
3. Karparti v Spira and Others (1995 NSW Sup Crt unreported, Spender AJ p.34)
4. Australian Bureau of Statistics
5. Covid-19 vaccine safety report – 03-11-2022 published by the Australian Government Department of Health and Aged Care
6. See Jessica Rose, “Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? “Science, Public Health Policy and the Law, Volume 3:100129, Oct 2021.
7. see for example EuroMONO (euromono.eu) 2022. Also see “Deaths Registered Weekly in England and Wales provisional: week ending 4 November 2022” at Deaths registered weekly in England and Wales, provisional – Office for National Statistics (ons.gov.uk).
7A. Australian Bureau of Statistics dated published by the OECD show 18,973 excess deaths in Australia for weeks 1 to 34, 2022 with excess deaths occurring in every week., see Mortality (by week) : Excess deaths by week, 2020-2022 (oecd.org)
8. According to the Australian Bureau of Statistics, “pre-existing chronic conditions were reported on 77.3% of death certificates due to Covid-19.”
9. The paediatric gene-based ‘vaccine’ was provisionally approved in Australia for children aged 5-11 years on 3 December 2021. Between December 2021 and May 2022 five adverse events resulting in death have been registered for this group in the DAENS reporting system.
10. See TGA advice published 23 July 2021) [https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-03-11-2022 – link for TGA’S Safety Report of 3 November 2022.
10A. The Chart has been assembled from data recorded in UKHSA Vaccine Surveillance Reports for the following three periods, (a) 3 weeks ending 16 Jan, 2022; (b) 3 weeks ending 13 Feb. 2022 and (c) 3 weeks ending 27 March 2022. UK Health Security Agency, Covid-19 Vaccine Surveillance Reports, various weeks see for example, COVID-19 vaccine surveillance report: week 7 (publishing.service.gov.uk).
11.Sivan Gazit et al, “Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort Study.” Clinical Infectious Diseases 2022; XX(XX):1–7,Published by Oxford University Press, and published on-line, 5 April 2022. https://doi.org/10.1093/cid/ciac262.
11A. See for example ABC Interview with Dr Margie Danchin, Paediatrician and Immunisation Expert, Murdoch Children’s Research Institute; abc.net.au/news/2021-09-22/the-risks-and-rewards-of-vaccinating-children/13552716.
12. Dan-Yu Lin, et al “Effects of Vaccination and Previous Infection on Omicron Infections in Children” N. Engl. J. Med. 2022; 387:1141-1143. DOI: 10.1056/NEJMc220937.
12A. In January 2022 Pfizer were ordered by a US Federal Judge to release thousands of pages of safety data. The releases can be read on the Public Health & Medical Professionals for Transparency Documents webpage.
13. UK Parliament Committee Debates 11 Nov. 2022, Sir. C. Chope MP.
13A. For a full list of adverse reactions sustained by participants in Pfizers clinical trials see Pfizer Documents reffered to in fn 12A.
14. Acknowledged on the Department of Health and Aged Care website “COVID-19 vaccine safety report 03-11-2022.
15. Oster et al (Jan 2022) “Myocarditis Cases Reported After mRNA-based Covid-19 Vaccination in the US From December2020 to August 2021.”
16. Documents disclosed by Pfizer as a result of orders made in the US Federal Court (se fn 12A) indicate the contents of the vaccine accumulates in the ovaries. These documents also show that 58% of pregnant mothers reporting a serious adverse reaction during the trial suffered a serious reaction affecting their child ranging from uterine contraction to foetal death. In Australia a Queensland gynaecologist has reported a 48% miscarriage rate in vaccinated patients of a Queensland between Sep. 2021 and Mar. 2022. The rate in previously unvaccinated patients was 20%. See. Doctors With Voices#6. A Club Grubbery Special Event with guest Dr Luke McLindon. (rumble.com).
17. US Centers for Disease Control (CDC), Vaccine Adverse Events Reporting Service (VAERS) search results for aborted pregnancy etc where vaccine is Covid-19 (www.vaers.hhs.gov)
SKIP Australia would like to thank the following contributors:
- Covid Medical Network
- Dr Phillip Altman
- Julian Gillespie LLB, BJuris and Peter Fam LLB
- Lisa Mitchell – Corporate Transformation Services