ROBERT KITCHEN/Things
Medsafe group manager Chris James was delegated to decide whether to approve the vaccine for children. (File photo)
A legal challenge to the preliminary approval of Pfizer’s Covid-19 childhood vaccine has failed.
On Friday, a High Court judge in Wellington issued his decision, dismissing the claim of eight people, whose names had been dropped in the meantime.
They challenged the health minister’s decision to provisionally approve the vaccine for children aged five to 11, and the cabinet’s December 20 decision to roll out the voluntary vaccination process from January 17.
Justice David Gendall said the decisions were in accordance with the law and the court should not substitute its own views for decisions on scientific and medical merit.
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The judge also dismissed a claim that the cabinet’s decision was made for an improper purpose or 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 drug manufacturer Pfizer. Medsafe is a business unit of the Ministry of Health.
The applicants were parents of children in the vaccine-eligible age group, and they believed the decisions jeopardized the welfare and well-being of children, the judge said.
The Health Secretary delegated decision-making to Medsafe Group Manager Chris James, who assessed the therapeutic benefits and risks.
Scott Hammond / Stuff
Nina Marfell 9 was vaccinated on January 17, the first day of the rollout for five- to 11-year-olds. (File photo)
The pediatric vaccine contains one third the amount of the active ingredient in the original dose.
In his evidence for the case, James said he had reviewed the growing medical and scientific literature on Covid-19 vaccines before and during the consent process.
He also referred the matter to the Medicines Evaluation Advisory Committee, whose members unanimously recommended approval.
James authorized terms under which Pfizer would provide more information as it became available, including periodic safety reports.
SCOTT HAMMOND/STUFF
A bottle of pediatric doses of the Covid-19 vaccine used in New Zealand in January. (File photo)
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 ages five to 11.
The applicants had their own evidence to weigh the risks and benefits of the vaccine.
The judge said that, as he saw the position, it was not his role in reviewing the trial, deciding which experts were right or forming his own opinion on whether the pediatric vaccine should be used in New Zealand. delivered.
Overall, weighing the benefits and risks of the vaccine, and the desirability of being available in New Zealand, was a matter for James as the minister’s deputy.
The evidence clearly showed that James had applied the appropriate legal test and that the safety and efficacy of the vaccine were “examined carefully” before James made his decision, the judge said.
“Overall, I am pleased that Mr James’s decision 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 predetermined, or that he simply “went through the motions.”
It appeared that the applicants were also mistaken about the government’s contracts with Pfizer.