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

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

Reducing risk of hospitalisation and death is central to management of infectious disease. When Sars-Cov-2 was identified, it was recognised across the public health sector and by medical doctors that vaccination would be incorporated into a greater pandemic response strategy. Measures would be integrated into the response strategy, including managed interventions to slow the spread of the disease to ensure that hospitals would not be overburdened. These would include appropriate hygiene and distancing, early treatment to prevent severe disease and hospitalisation for patients with severe responses. All these measures involve considerable uncertainties. No particular measure prevents transmission of infection.

From an early stage a successful vaccine was considered unlikely, because coronaviruses are shape-shifters, picking up mutations easily. Unlike the smallpox vaccine, COVID-19 vaccines don’t produce sterilising immunity, so vaccinated people can carry viral loads and transmit the virus, resulting in continued circulation in the population. Therefore, because of the recognised difficulty in ‘pinning down’ this virus, vaccines were envisaged by doctors as a tool to protect aged and vulnerable populations, in a similar way as the flu vaccine. This tool would be part of an integrated pandemic response toolkit.

As the data has shifted claims that mandates are required appear contradicted by the scientific literature and evidence from the trials demonstrates that there was no meaningful reduction in death rate in the participants that were exposed to the mRNA treatment. Reduction of transmission was not presented as a key benefit in the approval process and the mRNA treatment appears only to reduce symptoms, while exhibiting a range of risks that appear to place a great majority of the population at more risk of an adverse effect or death from the mRNA treatment, than from hospitalisation and death from infection from Sars-Cov-2.

The clinical trials were not designed to study severe disease – and prevention of death over the longer term remains uncertain:

‘on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).’ [i]

Dr Doshi was referring to the Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine[ii] [iii] trial:

‘During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died. None of these deaths were considered related to BNT162b2 by investigators.’ [iv]

Clinical trial data for mRNA treatments remains incomplete and largely inaccessible – the scientific process is not based on open data. The approval process was swift and resulted in a relatively small group of study participants.[v] The U.S. Food and Drug Administration (FDA) filed (November 2021) to request a 55-year embargo (until 2076) on the documents supporting the FDA vaccine approval.[vi] For many in medicine, the pressure to publish can result in data fraud. There is evidence that research contractors in the trial NCT04368728[vii] may not followed correct protocols.[viii]

The Thomas paper discloses that those who were assigned to receive the placebo were offered BNT162b2. This obscured any chance the placebo group could be followed for the longer term. [ix] A U.K. based initiative has been established to enable global unvaccinated citizens to register as an unvaccinated control group, to help balance the gap in scientific knowledge.[x]

Yet the New Zealand government has continued to enact legislation at a rapid pace. For the state to justify mandates, the infection from a virus must produce a significant and severe disease burden and trust promoting measures must come first. [xi]

Norms of transparency and accountability promote trust that the machinery of government (the executive, judiciary and parliament) are acting in the best interests of citizens.

Citizens unable to contest or deliberate on emergency measures

New Zealand legislation on the management of infectious diseases has historically recognised important principles that must be taken into account by the state – the paramount consideration of which is the protection of public health. The Health Act (S.92) emphasises that paramount considerations include respect for individuals (including known special circumstances or vulnerabilities of the individual) (92C), the role of voluntary compliance (92D); the necessity for the individual to be properly informed and that individuals have a right to appeal against the exercise or performance of the functions, duties or powers and to apply for judicial review (92E). Importantly, the Health Act includes the ‘Principle of proportionality’, stating that ‘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’(92F). In addition to individuals being appropriately informed, ‘Individuals and communities should be encouraged to take responsibility for their own health and, to that end, to participate in decisions about how to protect and promote their own health and the health of their communities’(92D9(3)). [xii]

What has been strange is that the legislation enacted separately from the Health Act and the swift speed of the legislative process :

  • COVID-19 Response (Management Measures) Legislation Bill. 6 days Introduced May 5 2020 received Royal Assent 15 May 2020. Minister in Charge: Hipkins 
  • The COVID-19 Public Health Response Bill. No public consultation 1 day. Introduced May 12, Third reading and Royal Assent May 13 2020.[xiii] Minister in Charge: Parker
  • COVID-19 Public Health Response Amendment Bill. No public consultation. Introduced July 29, received Royal Assent August 6 2020. Minister in Charge: Woods
  • COVID-19 Response (Further Management Measures) Legislation Bill (No 2) No public consultation. Introduced & passed August 4, 2020, Royal Assent August 6 2020. Minister in Charge: Hipkins 
  • COVID-19 Response (Management Measures) Legislation Bill. No public consultation (some private consultation). 4 days. Published October 1, closing date for submissions October 5 2020.[xiv]
  • Inquiry into the operation of the COVID-19 Public Health Response Act 2020. One month. Published May 21, closing date for submissions June 28 2020.[xv]
  • COVID-19 Recovery (Fast-track Consenting) Bill. 5 days. Published 16 June, closing date for submissions 21 June 2020, Royal Assent 8 July 2020. [xvi] Minister in Charge: Parker
  • COVID-19 Public Health Response Amendment Bill. No public consultation. Published and passed 1 December, Royal Assent 7 December 2020. Minister in Charge: Hipkins. [xvii] 
  • COVID-19 Public Health Response (Validation of Managed Isolation and Quarantine Charges) Amendment Bill. No public consultation. Introduced 20 May, Royal Assent 24 May 2021. Minister in Charge: Hipkins. 
  • COVID-19 Public Health Response Amendment Bill (No 2). 11 days. Published 30 Sept closing date for submissions Oct 11 2021.[xviii] Minister in Charge: Hipkins
  • COVID-19 Response (Vaccinations) Legislation Bill. No public consultation. Bill introduced November 23, Royal Assent November 25 2021. Minister in Charge: Hipkins. 

     

Legislation enacted between in November

Recent submissions to the New Zealand COVID-19 Public Health Response Amendment Bill (No 2) revealed widespread agreement across civil society that increasingly strict and coercive measures would produce a disproportionate suffering, particularly to low-income groups.[xix] However the consequent COVID-19 Public Health Response Amendment Act (No 2) 2021 was enacted on 20 November 2021, which strengthened penalties, despite heavy submissions from the public which argued against further controls and more stringent penalties. (Ministry of Health information. Link to Act ).

The following chart reveals legislation was enacted in the period 1-19 November 2021.[xx]

From 15-27 November another raft of legislation was enacted