[A] Introduction (as at November 2021)

Public health crises such as pandemics place public health officials in often politically impossible situations which require them to sustain consistent messaging in uncertain environments, in order to maintain public trust. However, a measure of skill is the capacity to shift gears in uncertain, or grey environments, as the evidence shifts - in the public interest.

New Zealand has recently switched from a ‘zero Covid’ policy of stamping out the pandemic to acknowledging elimination is not possible.[i] Our island-status has created a means to slow the spread of this coronavirus, but due to massive complexities, recognised in the scientific literature, this virus cannot be stamped out, it will become endemic in the population.

Policy has appeared predetermined – or ‘locked-in’ and unable to reflect the changing state of knowledge in relation to risk.[ii] The state has ignored or marginalised data that demonstrates that most of the population will benefit from natural immunity; that the mRNA inoculant cannot prevent transmission of infection (is not sterile); and that multi-target treatments can dramatically reduce the risk of hospitalisation and death – including to previously vaccinated individuals who may experience waning before the 6-month hoped for period of mRNA treatment-derived immunity. These are key (in law) relevant considerations.

Government decision-makers have an obligation to not only provide top-down measures, but to promote bottom-up measures that protects health, particularly the health of vulnerable populations. Health equity concerns removing and reducing risk factors for low-income populations, including Māori and Pasifika that result in weakened immune systems and immunosuppression, particularly in younger groups. The government response has ‘blamed’ large households on the infection and risk rate in these populations, while ignoring structural inequities, low-incomes, racism and high housing costs that inevitably result in food insufficiency and dietary poverty. Dietary poverty has produced the chronic-disease burden across these populations. After age, obesity and diabetes and related metabolic syndrome are the number one risk factors for hospitalisation and death.[iii] [iv] No policy has been enacted in the last two years to improve the nutritional and immune status of these most at-risk populations.

Vaccination can lessen severity of outcome from infection and may play an important role in protecting at-risk groups but may not meaningfully reduce ongoing transmission. Vaccination may also be unsuitable for some groups who are at risk of adverse events or who are at low risk, and it may be inappropriate for healthy young people and children who are at minimal risk from hospitalisation and death following Sars-Cov-2 infection. Vaccine failure, including waning and breakthrough may be an issue for individuals with a weak immune system. For all groups, the vaccinated and unvaccinated, cheaper multi-target therapeutics can reduce the likelihood of short term acute COVID-19 related harms, and prevent hospitalisation and death. Treatments can be engaged also, to lessen the risk of long covid, as many indicators reflect classic post-viral syndrome. For these reasons, and more, stigmatising the unvaccinated is not justified.[v]

In contrast, the state has intervened to an unprecedented extent. Doctors have reported that policy measures have had a chilling effect on the practice of informed consent. Policy measures have prevented research and disincentivised integrative early treatments that respond to the multifactorial pathologies of COVID-19, in order to appropriately prevent hospitalisation and death.[vi]

Mandates have historically been undertaken for vaccines with a long history of safe use and that are sterile. The mRNA can promise reduction of symptoms, which place it in the ‘treatment’ or ‘inoculant’ category, rather than the category of ‘vaccine’. But it is not sterile, and the clinical trials for mRNA inoculants were not designed to assess whether COVID-19 vaccines prevent infection or transmission.[vii] Vaccinated and unvaccinated individuals carry similar viral loads and are equally able to pass on the sars-cov-2 infection. Unvaccinated individuals have a slightly increased risk of catching sars-cov-2.[viii] The primary goal of the vaccine continues to be the breaking of the link between infection and severe illness in the elderly and vulnerable populations. The manufacturers September 2021 U.S. application to FDA for approval of boosters emphasises that the purpose of boosters is related to symptom reduction. [ix] It is in such a climate that the state is attempting to mandate vaccination across the New Zealand workforce.

Informed consent is a well-established and respected principle to ensure patient autonomy and safety and it implicitly acknowledges the potential fallibility of medical treatment. Informed consent recognises that the balance of assessment of risk should be undertaken by the individual, as side effects and risk-benefit ratios strongly vary according to the health status of the individual. Measures to mandate appear based on early forecasting, and a limited spectrum of trial data. Without considerations to recognise individual risk, which varies markedly across the population, and in the absence of a sterile vaccine, state actions to proceed with mandates increasingly appear coercive, immoral, and unethical.

Major issues plague the policy environment:

Firstly, New Zealand Ministry of Health officials have not adequately deliberated across expert communities regarding safe and effective multi-target therapies, which include medical drugs and nutritional supplements that lessen risk of hospitalisation and death and reduce infectivity. For example, scientists have recently proposed that low serum Vitamin D levels may be a predictor rather than just a side effect of infection. [x] Hospitalised patients commonly present with nutrient deficiencies[xi], yet the current state approach has ignored the potential to test and treat for these deficiencies.

Secondly, the Ministry of Health’s narrow perspective has left government without the knowledge that robust natural immunity in the workplace is safer for surrounding clients and colleagues, than immunity from vaccination – natural immunity produces a broader structural response. This is particularly relevant in the health field, when patients can often present with weak immune systems. Professor of medicine at Harvard Medical School and a biostatistician at the Brigham and Women's Hospital Dr Martin Kulldorff has commented that ‘hospitals should hire nurses with natural immunity, not fire them.[xii]

It is largely unknown to what degree young adults and children have been exposed to the Sars-Cov-2 virus in New Zealand as tests that may have identified the presence of natural immunity have not been part of the science and communications response to Covid-19. There’s a substantial sociological literature that draws attention to the role ignorance plays in supporting policy that upholds the interests of powerful institutions and actors.

Thirdly, the narrative on vaccines continue to dismiss or downplay the evidence relating to risk presented in the scientific literature which demonstrates that healthy individuals may be at greater risk from an adverse event, than from infection by Sars-Cov-2. The mRNA vaccines should be controversial. The technology is novel and the technology contains a ‘blueprint’[xiii] – messenger RNA transfer that enable the cells to produce an antigen (the spike protein) which is designed to induce the immune system to produce protective antibodies against that antigen. The core competency of the technology was its potential to be rolled out quickly across large populations. Even the manufacturer has acknowledged there are categories of risk relating to adverse events, and extensive future uncertainties concerning this technology.[xiv]

Fourthly, the failure of the policy environment to adjust to the changing data landscape, has effectively blinkered the capacity across the machinery of government to appropriately recognise and deliberate on risk, and removed the potential for the fourth estate to adopt a critical perspective. The exclusion of certain forms of scientific knowledge and the failure to communicate different nuances of risk across the population has underpinned a ‘manufacturing of consent’ approach by the Ministry of Health. Such action implicitly infers that inoculation is the only possible alternative. It has produced ignorance in the public sphere. The failure of the state to communicate the changing science has resulted in prominent political commentators, talking heads, and media influences communicating a one-size-fits all approach, and claiming the vaccine will prevent infection. The fourth estate has not provided a safe place for contestation and informed discussion. Instead, the media have focussed on tracking cases, vaccination rollouts and the development of pharmaceutical treatments. These perspectives markedly differ from accounts in the scientific literature. As such they are incorrect, misleading and polarising. The status quo has resulted in the marginalisation of actors that sought to draw attention to the shifting pattern of risk. The result has resulted in a disproportionately arcane – and egregious – response that has failed the public interest and increasingly appears to compromise the human right to health, medical choice and freedom of movement.

Legally, all government measures must be ‘proportionate to the public health risk sought to be prevented, minimised, or managed’ and not be made or taken in an arbitrary manner. [xv] Yet this is not the case with COVID-19 and obligations requiring proportionality and respect for the individual in the Health Act, have not been appropriately weighted, nor responded meaningfully to the shifting scientific environment.

Failing to respond to new information in the scientific literature

New Zealand authorities have narrowed their scope of consultation in four ways. Firstly, they have delegated decision-making by relying on the decisions of scientists in other nations rather than broadly exploring the literature.[xvi] Secondly, they have dismissed and marginalised data through a process of ‘controlling the scope’ of what they will consider ‘legitimate’. By overly weighting randomised control trials for ‘evidence’, and down-weighting data that demonstrates clinical efficacy, such as observational studies, they have excluded knowledge of therapies that reduce and/or prevent the inflammatory storm.[xvii] These treatments are often complimentary with principles of mātauranga Māori. Thirdly, risk modelling to advocate for high vaccination rates has excluded new knowledge relating to waning and breakthrough, and failed to model risk for young people and children. It is not evident that natural immunity was included in the modelling. [xviii] A large Australian study ignored the influence of pre-existing immunity.[xix] October risk modelling in New Zealand do not mention the impact of variables of waning immunity, the potential for breakthrough infection and vaccine failure nor the potential for natural immunity to impact modelling.[xx] [xxi] [xxii] Finally, the doctors and health professionals that have sought to draw attention to the data gaps, the problematic modelling, and the historically non-controversial principle of informed consent, have been shamed and marginalised.

As of November 2021, the potential for vaccination to protect against severe disease continues to be the most compelling reason for vaccination in high-risk groups. The Delta variant is highly transmissible, with high viral loads detected in vaccinated and vaccinated.[xxiii] [xxiv] With Delta, breakthrough infections are increasingly common.[xxv] [xxvi] [xxvii] Unfortunately, it is not known exactly when a vaccine’s effectiveness will weaken against Delta.[xxviii] An October 2021 Pfizer funded study recently reported the Pfizer (BNT162b2) vaccine would prevent hospital admissions for up to 6 months. The study demonstrated that by the fifth month following vaccination, effectiveness against infection had declined to 47%.[xxix] Other measures, such as masking, remain locked into policy, yet for example, it’s evident that cloth masks are ineffective at preventing the spread of Sars-Cov-2.[xxx]

The public implicitly expects that as knowledge changes, so will the public health response. The latest government modelling[xxxi] on vaccine effectiveness ignores the potential for breakthrough infection and waning. Herd immunity acquired through natural infection has not been included in the modelling. The modelling, and government policy in general fails to have a nuanced discussion concerning the extremely rare risk in children and young people. [xxxii] The result is a narrowing of scope and a devolving of responsibility to offshore agencies which might not necessarily be reflective of the best interests for Aotearoa New Zealand.

Historically health is about top-down and bottom-up measures, which include paying attention to the dignity of the individual. Yet medical experts, scientists, public health researchers and medical practitioners have struggled to bring a broader health-based discussion into both media and public health discussion that particularly, pays attention to the risk for children. In response, ostracised practitioners and scientists have convened forums – in Canada[xxxiii], Europe[xxxiv], the USA, and New Zealand[xxxv]. The Global Covid Summit is an international platform.[xxxvi] These forums have created an inter-continental chain of knowledge, communicating the shifting – fluid - scientific evidence base in an effort to support global public health throughout the pandemic. Declarations such as the Rome Declaration[xxxvii] and Great Barrington Declaration[xxxviii] have been signed by scientists and physicians globally but have been largely ignored by COVID-19 response officials and dismissed as ‘fringe’ by mainstream media. These groups have paid particular attention to navigating the COVID-19 response and based on the fact that viruses will circulate until herd immunity is achieved following both natural infection and vaccination. In the history of science, natural immunity has never been excluded from modelling scenarios. These groups have also targeted their policies to serve the long-term interests of young people and children who present little risk from Sars-Cov-2 infection; while recommending treatments for those who are most at risk from infection of Sars-Cov-2 – the elderly and those with chronic disease such as obesity, diabetes, and associated metabolic and inflammatory conditions. Yet they have been marginalised and ostracised.

The scientific literature reveals a profile of public health risk which is not adequately reflected in New Zealand’s COVID-19 response:

Lack of risk to children and young people.
Risk in COVID-19 elevated in the aged and in those with metabolic and inflammatory diseases.
Disproportionate focus on cases instead of infection fatality rate (IFR).
Role of multi-target therapies including medical and nutritional treatments for at home treatment to reduce risk of hospitalisation and death.
Structural policy failure relating to healthy equity in high risk groups.
Importance of repurposed drugs which have a strong safety record and which reduce symptoms.
Problems of ignorance connected to a failure to access rapid antigen tests and tests which can draw attention to natural immunity.
Increased probability of vaccine waning and breakthrough infections.
Claims for vaccine passports & mandates which are unjustified if the above issues are considered.

NEXT: [B] Acting in the public interest: Uncertainty pervades public health crises

REFERENCES

[i] Frost N. Battling Delta, New Zealand Abandons Its Zero-Covid Ambitions. New York Times October 4, 2021. https://www.nytimes.com/2021/10/04/world/australia/new-zealand-covid-zero.html

[ii] Halperin et al. Revisiting COVID-19 policies: 10 evidence-based recommendations for where to go from here. BMC Public Health (2021) 21:2084 https://doi.org/10.1186/s12889-021-12082-z

[iii] Lohia et al. Metabolic syndrome and clinical outcomes in patients infected with COVID-19: Does age, sex, and race of the patient with metabolic syndrome matter? Journal of Diabetes. 2021;1–10

[iv] Korakis et al. Obesity and COVID-19: immune and metabolic derangement as a possible link to adverse clinical outcomes. Am J Physiol Endocrinol Metab. (2020) 1;319(1):E105-E109.

[v] Kampf 2021. Correspondence: COVID-19: stigmatising the unvaccinated is not justified. The Lancet 398

[vi] Borody et al. Combination Therapy for COVID-19 based on Ivermectin in an Australian population. October 2021. https://www.covidmedicalnetwork.com/media/TrialSite-media-release-19.10.2021.pdf

[vii] Doshi 2020. Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ 2020 371 doi 10.1136/bmj.m4037

[viii] Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. The Lancet (2021). Doi 10.1016/S1473-3099(21)00648-4

[ix] FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee Meeting. September 17, 2021. Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA). 4. Rationale for Booster Doses. https://www.fda.gov/media/152176/download

[x] Borsche et al. COVID-19 Mortality Risk Correlates Inversely with Vitamin D3 Status, and a Mortality Rate Close to Zero Could Theoretically Be Achieved at 50 ng/mL 25(OH)D3: Results of a Systematic Review and Meta-Analysis. Nutrients 2021. 13:3596 DOI 10.3390/nu13103596

[xi] Clemente-Suárez et al. Nutrition in the Actual COVID-19 Pandemic. A Narrative Review. Nutrients (2021) 13:1924. https://doi.org/10.3390/nu13061924

[xii] Epoch TV American Thought Leaders. October 26, 2021. https://www.theepochtimes.com/harvard-epidemiologist-martin-kulldorff-hospitals-should-hire-nurses-with-natural-immunity-not-fire-them_4068176.html

[xiii] mRNA vaccines to address the COVID-19 pandemic. BioNTech. Accessed October 31, 2021 https://web.archive.org/web/20210611134439/https://biontech.de/covid-19-portal/mrna-vaccines

[xiv] U.S. Securities and Exchange Commission Form 6-K. File No. 001-39081. BioNTech SE August 25, 2021. Dr Sierk Poetting. https://investors.biontech.de/static-files/6932835c-50c8-4b79-96dc-725cc6b7d0bb?fbclid=IwAR2bMkL4vi2ZtDwmyIVk6WDI2i7_CsPFk7A4Yavr8rTf8J8Dn0clN3ANsNs

[xv] Health Act 1956. 92F Principle of proportionality https://www.legislation.govt.nz/act/public/1956/0065/latest/whole.html#whole

[xvi] Ministry of Health. COVID-19 Science Updates. July 2021 https://www.health.govt.nz/system/files/documents/pages/csu_09_july_2021_covid-19_pharmaceutical_treatments.pdf

[xvii] Anglemeyer et al. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. (2014) Apr 29;2014(4):MR000034.

[xviii] Steyn et al. Modelling to support a future COVID-19 strategy for Aotearoa New Zealand. Te Pūnaha Matatini (2021)

[xix] Zachreson et al. How will mass-vaccination change COVID-19 lockdown requirements in Australia? Lancet Reg Health West Pac . 2021 Sep; 14:100224. doi: 10.1016/j.lanwpc.2021.100224.

[xx] Plank et al. Technical report: Modelling the August 2021 COVID-19 outbreak in New Zealand. Te Pūnaha Matatini October 18, 2021. https://cpb-ap-se2.wpmucdn.com/blogs.auckland.ac.nz/dist/d/75/files/2017/01/modelling-the-august-2021-outbreak.pdf

[xxi] Gilmour et al. ‘Phased Transition’ to Phase Transition: The Network Consequences of Reconnecting. Te Pūnaha Matatini https://cpb-ap-se2.wpmucdn.com/blogs.auckland.ac.nz/dist/d/75/files/2021/10/phased-transition-to-phase-transition.pdf

[xxii] Gilmour et al Preliminary estimates of hospitalisation numbers for the August 2021 outbreak, assuming we stay in Alert Level 4 October 15, 2021. https://cpb-ap-se2.wpmucdn.com/blogs.auckland.ac.nz/dist/d/75/files/2017/01/preliminary-estimates-of-hospitalisation-numbers.pdf

[xxiii] Acharya et al. No Significant Difference in Viral Load Between Vaccinated and Unvaccinated, Asymptomatic and Symptomatic Groups Infected with SARS-CoV-2 Delta Variant. medRxiv Preprint (2021) 10.1101/2021.09.28.21264262

[xxiv] Riemersma et al. Vaccinated and unvaccinated individuals have similar viral loads in communities with a high prevalence of the SARS-CoV-2 delta variant. medRxiv preprint (2021)

[xxv] Pouwels et al. Impact of Delta on viral burden and vaccine effectiveness against new SARS-CoV-2 infections in the UK. medRxiv (2021)

[xxvi] Chau et al. An observational study of breakthrough SARS-CoV-2 Delta variant infections among vaccinated healthcare workers in Vietnam. EClinicalMedicin (2021) 41:101143

[xxvii] Servillita et al. Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases from the San Francisco Bay Area, California. (2021) 10.1101/2021.08.19.21262139

[xxviii] Levine-Tiefenbrun et al. Viral loads of Delta-variant SARS-CoV2 breakthrough infections following vaccination and booster with the BNT162b2 vaccine. medRxiv preprint (2021) 10.1101/2021.08.29.21262798;

[xxix] Tartof et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. October 4 (2021). https://doi.org/10.1016/S0140-6736(21)02183-8

[xxx] Liu et al. Evidence for Community Cloth Face Masking to Limit the Spread of SARS-CoV-2: A Critical Review. Cato Institute. Working Paper No.64. https://www.cato.org/sites/cato.org/files/2021-11/working-paper-64.pdf

[xxxi] Steyn et al. Modelling to support a future COVID-19 strategy for Aotearoa New Zealand. Te Pūnaha Matatini (2021)

[xxxii] Bhopal et al. Children and young people remain at low risk of COVID-19 mortality. Lancet (2021) /10.1016/ S2352-4642(21)00066-3

[xxxiii] Canadian Covid Care Alliance. https://www.canadiancovidcarealliance.org/

[xxxiv] Doctors for COVID Ethics. https://doctors4covidethics.org/

[xxxv] New Zealand Doctors Speaking Out with Science https://nzdsos.com/

[xxxvi] Global Covid Summit. https://globalcovidsummit.org/

[xxxvii] Rome Declaration https://doctorsandscientistsdeclaration.org/

[xxxviii] Great Barrington Declaration www.gbdeclaration.org

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