Thomas Cranmer: Court of Appeal to hear appeals on vaccine mandates in New Zealand this week

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. In a briefing paper received by then Minister Hipkins in February 2021, it was described in the following manner:

The precedent impacts of a decision to make vaccination mandatory for specific workforces is most likely to have an impact on the health workforces and other frontline public sector workforces in the future. For example, it may result in increased pressure to make influenza vaccination mandatory for these workforces.

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.

As a reminder, the judicial review process is a narrow examination of the facts where evidence is provided in written affidavit form. For instance in the NZTSOS case, affidavit evidence was given by Minister Hipkins and Drs Bloomfield and Town. Importantly, the latter two gave evidence as experts which places a duty on them to provide opinions that are objective and non-partisan.

In addition, there is generally only a limited amount of documentation shared with opposing parties in the discovery process associated with a judicial review. However, because these cases were brought under urgency given that the mandates were being enforced at the time, the court timetable was compressed and there was even less discovery than usual. This is an important point when considering what was, and was not, presented to the Court as discussed in more detail below.

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. In some cases, this is not a question of whether the mandate itself was a justified limitation on rights, but whether the terms of the mandate were appropriately drafted to be no wider than required to achieve its purpose.

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. Drs Town and Bloomfield also failed to set out Medsafe’s assessment of safety of the vaccine in pregnancy as set out in its Non-Clinical Assessment that, “although not directly addressable from the nonclinical data, there may be a basis in the current circumstances for concluding the risk of vaccination during pregnancy is outweighed by the potential benefits of immunity particularly for specific subpopulations at heightened risk.” Ultimately, Medsafe concluded that this should be a clinical evaluation conducted on a case-by-case basis.

14. 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.”

15. 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.

16. The memo notes that “Emerging data from countries such as the United States of America (USA) and Israel, indicate that there is a risk of myocarditis and / or pericarditis following Pfizer and Moderna mRNA COVID-19 vaccination. The risk appears to be higher following the second dose, in males and in younger age groups.” The first recommendation of CV TAG set out in paragraph 24(a) of their 21 July memo was that the interval between the first and second dose should be extended to at least eight weeks for people aged 16 to 29.

17. Dr Town’s affidavit to the Court in the NZTSOS case is dated 16 February 2022. On that same day, Dr Town issued a memo to Dr Bloomfield which considered the appropriate dosing interval for 5-11 years olds. In that memo, Town states: “Research conducted in adults into extending the dosing interval (e.g., to 8 weeks or longer) has shown that longer intervals between the first and second Pfizer dose can lead to higher humoral and cellular immune responses, improved vaccine effectiveness, and potentially a longer duration of protection compared with the standard interval. In addition, data from adults show that an extended dosing interval may also reduce the risk of myocarditis and pericarditis after vaccination.”

18. Neither Town nor Bloomfield advised the Court that a longer dose interval could reduce the myocarditis risk in young people even though they were giving evidence as experts.

19. In fact, the Vaccine Order mandated workers to have the first two doses no more than 35 days apart. This requirement was noted by Cooke in paragraph 106 of his judgment, where he stated that "Schedule 3 of the Order requires the person to have had two doses of the Pfizer vaccine, with the second within 35 days of the first dose." If Town or Bloomfield had disclosed to the Court their knowledge about dosing intervals, it is possible that Cooke would have required the Vaccine Order to be amended to comply with their earlier advice of lengthening the dose interval.

20. In addition, neither Town nor Bloomfield advised the Court of a memo dated 9 December 2021 from Dr Town to Dr Bloomfield on vaccine mandates for the under 18s in which CV TAG recommended only one dose for the under 18s.

21. In that memo, Town wrote, “The individual risk to young people of severe disease is very low. For them to make an informed decision not to get a second dose of the vaccine eg, due to potential myocarditis risk is justified.”

22. Town continued, “The 2 dose schedule, particularly when administered in the shortest possible clinical timeframe, may add unnecessary risk to increasing the likelihood of myocarditis as an outcome in this population.” The memo concludes by recommending, “Those aged <18 years only being required to have received 1 dose of Pfizer vaccine to meet the vaccine requirements for employment.”

23. The government ignored the health advice in that memo and neither the Court, nor the public were advised of it.

24. In addition, Cooke finds the 6 month interval for a booster hard to fathom when the evidence is that vaccine effectiveness wanes quicker. Cooke states, “The requirement to be boosted only within 183 days (that is six months) of being vaccinated is very difficult to understand. The evidence is clear that the benefit that vaccination has in reducing rates of transmission wanes quickly after the first 30 days, but is restored by the booster. To only mandate the booster within six months of being vaccinated is inconsistent with securing the benefits of vaccination imposed through a mandate. Indeed this period of time seems to me to be irrational if the whole purpose of the mandate is to ensure maximum protection against transmission. I am, to say the least, perplexed by this.”

25. Neither Town nor Bloomfield explained to Cooke that one of the primary reasons for the 6 month interval before receiving the booster is the unusually long half-life of one of the lipid nanoparticles which is potentially toxic in high concentrations. This is an issue considered by Medsafe and MAAC, with Medsafe concluding that the long half-life was manageable so long as the interval of any booster is longer than the half life of the lipid.

In the two previous cases, where the Courts have found that the mandates were unlawful - Yardley and Wright - there was no health advice to support the mandate. This seems to be where the Courts have drawn the line on mandate cases.

However, it is now clear that the Vaccine Orders did not comply with health advice in relation to the reduction of myocarditis risk. Nor, it seems, was the approval process or profile of the vaccine accurately described to the public and mandated workers.

More broadly than these two appeals, there is a pressing need for the government to reintegrate the teachers and members of the Defense Force back into the workforce. As Cooke pointed out, workers that decided not to be vaccinated are no less New Zealanders than anyone else. They made a lawful decision in good faith. Now that Covid has moved into a new phase it is important that the government does not act punitively by prolonging their exclusion from their professions.

Teachers who chose not to be vaccinated were excluded from schools during the consultation process and I know of many reports of them receiving atrocious behaviour from principals and former colleagues during this time. Once terminated they were not allowed onsite for any farewells and their dismissals were reported to the Teaching Council. When the mandates were removed, principals had already staffed their schools for 2022, and so many have lost their positions, promotions and careers. To add insult to injury the union has remained largely silent which many find more than disappointing given that it will routinely hire and pay for lawyers to defend teachers facing criminal charges including sex-related charges.

Likewise, within the Defense Forces many personnel left rather than face discharge. The justification that vaccination would be needed for deployment hasn’t eventuated. Other countries, such as the UK do not require the vaccine as part of their baseline vaccinations for their armed services. Currently, our largest mission is Operation Tieke where 120 NZDF staff are in the UK training Ukrainian soldiers. Our service men and women will be serving alongside (some) unvaccinated British service personnel. Likewise, unvaccinated NZDF soldiers that survived the cull are now being deployed domestically and internationally, including in relation to Operation Awhina (Cyclone response).

The NZDF has always emphasized its focus on core values and supporting the welfare and wellbeing of its personnel. However, many members of the Defense Forces believe that these values have been disregarded due to Covid-19, and there have been reports of severe bullying by their chains of command.

Typically, decisions within the NZDF are socialized with commanders on the ground to assess their impact on the troops. However, in this instance, decisions were made directly by HQNZDF in Wellington. The reintroduction and deployment of some unvaccinated staff have led to the perception that the decision and subsequent refusal to back down were politically motivated.

By contrast, when the Ministry of Health announced a workplace mandate in December 2021, Deputy-Director General, Robyn Shearer emailed staff and stated that while there was a high level of support for this policy, “there are some of our colleagues who hold a different view. It is important that we continue to demonstrate our behaviours in line with Our Ministry Values and recognise that while we don’t all have to agree, it is important that we continue to have a respectful and supportive environment.”

Shearer stated that from 17 January only fully vaccinated workers would be allowed in Ministry premises and that those who were not vaccinated or who did not disclose their status would be “asked to work from home”. That arrangement existed until mid-2022 when the mandate was removed and unvaccinated workers returned to Ministry offices.

The stark difference in treatment between our frontline workers and Ministry staff raises questions as to how equitably and fairly the mandates were enforced.

There are many concerns relating to the Vaccine Orders. It seems that the government did not fully disclose all material facts to the Courts or to mandated workers. Maybe the Courts will have something to say about that. In any event, it is not enough that the mandates have been removed. There is an urgent need for a structured programme to rehabilitate unvaccinated workers back into their professions.

Thomas Cranmer, Lawyer with over 25 years experience in some of the world's biggest law firms. This article was first published HERE