A legal challenge to the provisional approval for the Pfizer Covid-19 children’s vaccine has failed.
On Friday a judge at the High Court in Wellington issued his decision, dismissing the claim of eight people, whose names were suppressed in the meantime.
They challenged the decision of the Minister of Health to provisionally approve the vaccine for children aged five to 11 years, and Cabinet’s decision on December 20 to roll out the voluntary vaccination process from January 17.
Justice David Gendall said the decisions complied with the law and the court shouldn’t substitute its own views for decisions made on scientific and medical merits.
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The judge also dismissed a claim that Cabinet’s decision was made for an improper purpose or was pre-determined.
The eight applicants had sued the Minister of Health, the group manager of the Medical Devices Safety Authority (Medsafe), the Minister of Covid-19 Response, and drugmaker Pfizer. Medsafe is a business unit of the Ministry of Health.
The applicants were parents of children in the age group that became eligible to have the vaccine, and they thought the decisions put at risk the welfare and wellbeing of children, the judge said.
The health minister delegated the decision-making to Medsafe’s group manager Chris James who assessed the therapeutic benefit and risks.
The paediatric vaccine contains one-third of the amount of the active ingredient of the original dose.
In his evidence for the case James said he reviewed the increasing medical and scientific literature about Covid-19 vaccines before and during the consent process.
He also referred the issue to the Medicines Assessment Advisory Committee, whose members unanimously recommended consent.
James gave consent on conditions that included Pfizer giving further information as it became available, including periodic safety reports.
A separate technical advisory group also considered the vaccine and reported to the director-general of health. The then Director-General, Dr Ashley Bloomfield, accepted the group’s advice to offer the vaccine free of charge to children five to 11.
The applicants had their own evidence weighing the risks and benefits of the vaccine.
The judge said that, as he saw the position, it was not his role when reviewing the process, to decide which experts were right or form his own view on whether the paediatric vaccine should be supplied in New Zealand.
Generally weighing the benefits and risks of the vaccine, and the desirability of it being available in New Zealand, were matters for James as the minister’s delegate.
It was clear from the evidence that James had applied the proper legal test, and that the safety and efficacy of the vaccine was “closely scrutinised” before James made his decision, the judge said.
“Overall, I am satisfied that Mr James’ decision is one which is well-supported by the Crown expert and other evidence provided to the court,” the judge said.
He rejected claims that the vaccine was approved for children to protect older adults, that James’ decision was pre-determined, or he simply “went through the motions”.
It seemed the applicants were also mistaken about the government’s contracts with Pfizer.
