A group of parents are calling for an urgent review of Medsafe's decision to approve the Pfizer vaccine for children aged five to 11, citing a lack of "robust safety information".
As of Monday, almost half a million Kiwi kids became eligible to receive their first dose of Pfizer's paediatric vaccine - a third of the dose for adults. A course of two shots is recommended, separated by an eight-week interval, for optimum protection.
Although the paediatric dose has been approved for use by New Zealand's regulatory agency and has been given the stamp of approval by leading experts, a group of eight parents say they are concerned about the "new technology" and are questioning Medsafe's consent process.
The group is now claiming in court that the provisional consent process for the paediatric vaccine was based on a lack of "robust" information and "very small trials". In a statement issued on Tuesday morning, The 'Hood - a wider group supporting the applicants and their case - claimed some of the parents have experienced reactions to the vaccine themselves, "have children at risk", or are "simply concerned about the new technology used".
"They draw attention to Pfizer's very small trials for this age group which the New Zealand Government appears to have relied [on] in provisionally approving this vaccine, as well as the lack of robust safety information generally," the group said.
Legal action has now been launched in a bid to have Medsafe's approval rescinded and to immediately halt the roll-out until a judicial review can be held.
According to the New Zealand Herald, the eight-member group includes an electrician, two stay-at-home parents, a service assistant, a quality assurance manager, a company director, a civil engineer and an unemployed woman, all with children aged between five and 11.
Their statement of claim was filed in the Wellington High Court on Saturday, January 15 by lawyer Clinton Light of Shine Lawyers against Health Minister Andrew Little, COVID-19 Response Minister Chris Hipkins and the head of Medsafe.
Speaking to Newstalk ZB on Tuesday morning, Director-General of Health Dr Ashley Bloomfield said he could not comment on the case directly as it is now before the courts. However, he was quick to praise Medsafe's approval process as both "rigorous" and "world-class".
"I am not going to comment on that legal challenge because it will now be before the courts. What I can say is that I am really confident in the approval process that MedSafe [is] undertaking, it's rigorous and it's worldclass and I am confident in the advice we have given to ministers," he said.
At the first court conference on Monday, Justice Rebecca Ellis granted anonymity to the applicants and their families, who argued that they needed to protect themselves and their children from "further bullying" due to their decision not to vaccinate.
The application for a preliminary order to immediately halt the rollout to children aged five to 11 was not granted, however an interim order hearing has been scheduled for January 27. The Crown and Pfizer will have the chance to file evidence beforehand.
Justice Rebecca Ellis has given the group until the end of Tuesday to make their case for why the rollout of the paediatric vaccine should be halted ahead of a judicial review - a date for which has not been set.
The group claims that Medsafe's decision to grant provisional consent was flawed for a number of reasons, including that it considered "irrelevant" information, such as protecting vulnerable whānau or stopping the spread of the virus in schools, the Herald reports. The group argues that children's health should be the only consideration.
The group also argues that despite reassurance that the vaccine will never be made mandatory for children, the jab is effectively "quasi-mandatory" as it will likely be required in order to participate in camps and other school activities.
"Children in this age group and their parents are also likely to be placed under significant governmental and social pressure by others in the community for such children to be vaccinated," the statement of claim says, as reported by the Herald.
Clinical trials have found the Pfizer vaccine is safe for children and highly effective at preventing serious illness.
For children aged five to 11, clinical trials found the vaccine was 90.7 percent effective at preventing COVID-19 symptoms, and no participants fell seriously ill with the virus.
The trials showed the vaccine was safe and side effects were similar to those observed with the full dose in 12 to 15-year-olds. The side effects were generally mild.