In this post by The ‘Hood, the advocacy group that challenged the Government’s decision to roll out the Pfizer product to children, it lays out what it sees were the problems with the way the judicial review was handled.
In June this year, not-for-profit organisation The ‘Hood NZ (The Hood) facilitated a case brought by six families against the New Zealand Government. The case was intended to stop the paediatric roll-out of the Pfizer Covid-19 mRNA vaccine for 5-11 year-olds. Thousands of Kiwis jointly pledged over $250,000 to bring this case to the High Court of New Zealand. The court was presented with a mountain of expert evidence from five doctors, three professors and a statistician.
Six weeks later Justice David Gendall dismissed it all.
The court registry then neglected to notify the decision to the legal team but instead it was posted to the courtsofnz website. This is contrary to normal practice. “We only found out the decision had been delivered through the media,” said The Hood’s director Ms Sereca Friend.
“All six families, The Hood and its community funders believed from the outset that our chances of winning this case against the NZ Government were marginal. However, we were optimistic that even if the court ruled against us, it would at least acknowledge and comment on the stacks of evidence put before it by KC David Jones, Barrister Tom Molloy, The Hood’s Legal Case Manager Katie Ashby-Koppens and Instructing Solicitor Shelley Eden. This would in turn, give the NZ public transparency about the risks involved.”
The parents’ case was clear cut. They believed the Covid-19 virus had near zero risk of mortality for children and that it was too risky to use a new class of drug in such a young population. This was a position clearly shared by Medsafe, given its Group Manager Mr Christopher James initially declined provisional consent of the Pfizer vaccine for 5-11 year-olds because there were “several aspects of data to support the quality, safety and efficacy of the vaccine that are not yet available.”
Also lacking was a logical explanation as to why Pfizer’s Covid-19 product was different to the product used in the trial for this age group.
Rather than delaying consideration of provisional consent because this data was missing from Pfizer’s application, Mr James declined consent and referred the application to the Medicines Assessment Advisory Committee (MAAC) for review. This was done days before an already scheduled meeting of MAAC.
Prior to making a recommendation, MAAC reviewed the same material that Medsafe and Mr James had considered inadequate only four days before. MAAC, as part of its process, met with Pfizer representatives whose input into the meeting was not expressly recorded. But, following this meeting, MAAC recommended Mr James grant provisional consent for the Pfizer vaccine rollout for children, which he did the following day.
A key issue argued at the hearing was that the process adopted by Mr James in light of the Medsafe recommendation notto grant provisional consent, was wrong. However, this issue was not addressed properly in the High Court decision. This was considered a strong appeal ground but given the limitations on the scope of review proceedings and other considerations, an appeal was not advanced. Ms Friend said, “The Hood decided against the appeal given the Crown wanted to award costs of $50,000 for the previous case and would likely do similar in an appeal process – we felt this would be an irresponsible use of stakeholders’ funds”.
Ms Friend noted that another alarming point made during the hearing, was the Crown’s statement that while Medsafe’s approval process may be “lacking”, Mr James had “no legal necessity” to provide evidence to defend his decision.
The respondents – Mr James and Minister of Health Dr Ashley Bloomfield – were respectively responsible for approving the Pfizer vaccine and rolling it out. Pfizer, while not a named defendant in the proceeding, was present throughout and received all the court documents as an ‘interested party’.
“At one stage, Pfizer made submissions that the mRNA inventor Dr Robert Malone did not understand the latest mRNA technology and had not worked on their product. To his credit, Justice Gendall defended Dr Malone’s expertise on this issue,” said Ms Friend.
The parents, with support from The ‘Hood, filed extensive expert reports (now publicly available) from Dr Robert Malone (Scientist, Physician, Inventor of mRNA, esteemed Vaccinologist); Dr Peter McCullough (Cardiologist and Epidemiologist); Dr Byram Bridle (Associate Professor of viral immunology); Dr Geert Van den Gosche (Virologist); Dr Martin Lally (NZ Associate professor in finance); Professor Nikolai Petrovsky (Physical and Vaccine Developer); Lisa Mitchell (Statistician); Professor Simon Brown and pharmaceutical expert Professor Phillip Altman.
The evidence from these global experts was submitted to establish the very real concerns about providing provisional consent for the vaccine to 5 to 11 year old children and to demonstrate how the provisional approval process was flawed. It is difficult to see how a recommendation by Medsafe then Mr James, not to provide provisional consent because of (among other things) the lack of adequate long term data – can be rectified in four days, with the only new information apparently coming from Pfizer representatives.
The Hood’s ability to challenge the provisional consent was limited to an application for review, as opposed to a substantive appeal on the merits.
More recent events have highlighted concerns advanced in The Hood’s evidence in the High Court. Expert testimonials and statistics available on The Hood’s website, show an alarming increase of adverse events being reported across the globe post the mRNA vaccine rollouts. The risks associated with the vaccine are becoming more evident as time goes on. The absence of longer term safety data was one of the principal reasons provisional consent was declined before the reference to MAAC.
“There are clearly numerous failings by the Court to acknowledge and accept expert advice in the case. Perhaps most importantly, it blatantly ignored the experimental status of the Pfizer product, which is still in trials. Instead of considering this status under the Medicines Act, Justice Gendall classified the vaccine as ‘new medicine’ that therefore qualifies for approval under this Act. He said it’s not uncommon for Medsafe to grant provisional approval for medicines before full approval is given, based on therapeutic need. Our argument is that there is no therapeutic need, nor is the risk justifiable. We believe our position is borne out as time goes on and the risks become reality,” concluded Ms Friend.
Ms Friend continues to provide her time cost free alongside Co-Director Nicola Culver, expressing that The ‘Hood community will remain vigilant in defending New Zealand’s children against the Covid vaccines until the NZ Government starts “acting responsibly on this issue”.
The views expressed in this article are the author’s own and do not necessarily represent or reflect those of The Looking Glass.