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It seems that the government did not fully disclose all material facts to the Courts or to mandated workers.

This week the New Zealand Court of Appeal will hear two appeals relating to vaccine mandates. For the vast majority of the country life is now returning back to relative normality with only a few Covid-era rules remaining in place. However, for those affected by the mandates these cases are of critical importance.

More broadly, these vaccination mandates have set a precedent that could be applied by the government in other scenarios in the future.

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This week’s first appeal is brought by teachers (NZTSOS) challenging Justice Cooke’s decision in NZDSOS Inc & NZTSOS Inc v Minister for Covid-19 Response, which was delivered in April of last year. The second appeal is by members of the New Zealand Defense Force who are contesting Justice Churchman’s decision in Four Members of the Armed Forces v Chief of Defense Forces, which was delivered in September.

For those who remember, the Defense Force (along with the Police) won their judicial review of their mandate in the Yardley decision delivered by Justice Cooke in February of last year. However, only weeks after that decision, the Chief of Defense Forces implemented a new internal mandate, which was unsuccessfully challenged in a second judicial review last September. This week, the appeal for this second NZDF decision is also being heard.

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For the purpose of these judicial reviews, the Court assessed whether the decision to mandate vaccination was properly taken, including whether the government took all relevant factors into consideration. In addition, the Court considered whether the vaccine mandate was a justifiable limitation on the rights protected under the New Zealand Bill of Rights Act, including the right to refuse medical treatment.

By their very nature, these appeals are narrow, which usually means that the chances of success are slim. However, having read a fair amount of the publicly available paperwork, it seems clear that the Crown and its experts either overstated or omitted material facts that may have had an effect on the Court’s decision and undoubtedly would have had an impact on the informed consent process that workers undertook when deciding whether to comply with the relevant mandate order or not.

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In NZTSOS, Cooke commented that, “the right in s11 [the right to refuse medical treatment] is well recognised in both legal and medical terms as being fundamental. It is associated not only with the concept of personal autonomy that is at the heart of the relationship between the state and the individual, but also the concept of informed consent that is deeply embedded in the principles of medical ethics and practice.”

Recognising that mandates by their nature reduce “the significance that is otherwise so strongly placed on informed consent”, Cooke concludes that, “What this means is that there is a very significant evidential burden placed on the Crown to demonstrate that the measures implemented by the Order are reasonable, and demonstrably justified in a free and democratic society”.

In this regard, there are questions as to whether the Crown fully disclosed all material facts to the Court in order to satisfy that “very significant evidential burden”. In particular, there are concerns relating to the affidavit of Dr Town who is the Chief Science Advisor at the Ministry of Health and the chair the COVID-19 Technical Advisory Group and the COVID-19 Vaccine Technical Advisory Group (CV-TAG) at the Ministry of Health. These groups, particularly CV TAG, provided technical advice to the government on Covid matters, including vaccine safety.

Issues of concern

1. In paragraph 17 of his affidavit, Dr Town states, “Medsafe will only recommend that a medicine is approved if it meets international and local standards ..”. Town omits to state that Medsafe did not recommend that vaccine be approved.
2. In fact, in its final evaluation, Medsafe concluded, “Due to the unresolved concerns and additional quality, safety and efficacy data to be provided at the time of completion of the evaluation, Medsafe is unable to recommend that this product be granted consent. It is therefore recommended that the application be referred to the Medicines Assessment Advisory Committee (MAAC) under section 22(2) of the Medicines Act 1981 for their consideration.”
3. Indeed on 28 January 2021, the Group Manager of Medsafe, Chris James, wrote to Pfizer Australia and advised it of his decision: “Having reviewed the information supplied in your initial application and in your further responses, I am not satisfied that I should give my consent to the distribution of the product.”
4. On 3 February 2021, MAAC agreed to grant provisional approval for the vaccine and instructed Medsafe to notify Pfizer accordingly, stating that “you are therefore asked to sign the attached letter to the applicant company to advise them of the outcome of the MAAC recommendation.”
5. Again, in paragraph 17 of his affidavit, Town states, “Medsafe will only recommend that a medicine is approved if it meets international and local standards”. In fact, the Pfizer vaccine was non-compliant with local requirements. This was specifically discussed at the pre-submission meeting between Pfizer and Medsafe in September 2020.
6. The minutes of that meeting record Pfizer stating, “Sought comment on the issue of non-compliance with local requirements.” Medsafe responded, “Approval under s23 [provisional approval] does not allow for approval of non-compliant medicines unless an exemption has been granted in relation to non-compliance. We may need to consider requiring “Dear HCP” letters to address various aspects of the vaccine such as vaccine safety.”
7. As a condition of provisional approval, Medsafe therefore required the issuance of a “Dear Healthcare Professional” letter to address the issue of non-compliance.
8. In paragraph 18, Town states, “Medsafe has provisionally approved several COVID-19 vaccines for use in New Zealand. In granting provisional approval, data from clinical trials was considered in a risk-benefit matrix, and it was recommended that the benefits the vaccines provide from COVID-19 outweigh any risks.”
9. In relation to the Pfizer vaccine this is clearly not an accurate statement. Medsafe’s benefit risk assessment was “the benefit risk balance of Comirnaty (COVID-19 mRNA Vaccine) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 16 years of age and older, is not clear.”
10. Chris James, the Director of Medsafe gave a more accurate description in his affidavit in the Four Aviation case when he stated, “The clinical evaluation was that the benefit risk balance was not clear because of the data limitations.”
11. Despite public health officials monitoring emerging real world data and studies relating to the safety profile of the vaccine, Medsafe’s benefit risk assessment has never been clearly articulated to the public.
12. Additionally, neither Town nor Bloomfield clearly set out Medsafe’s formal assessment of the vaccine. Specifically, (a) that the duration of the vaccine protection had not been established beyond two months, (b) that there was limited evidence of protection against severe disease, (c) that there is no long term safety follow-up information and (d) vaccine prevention of asymptomatic infection and disease transmission has not been established..
13. When discussing the myocarditis risk in young people, Dr Town stated in his affidavit that, “Those with a history of myocarditis may be offered the AstraZeneca vaccine which has a very low risk for those with a history of myocarditis.”
14. However, Dr Town failed to advise the Court that he had, in his role as Chair of CV TAG, recommended to the government in a memo dated 21 July 2021 that they extend the dosing interval in the under 30s to at least 8 weeks to reduce the risk of myocarditis.

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Via https://cranmer.substack.com/p/court-of-appeal-to-hear-appeals-on/