The New Zealand Government has changed the law surrounding the distribution of the Pfizer/BioNTech vaccine following a High Court ruling that determined widespread access to the vaccine was unlawful and in violation of the Medicines Act.
In a court case between Nga Kaitiaki Tuku Ihu Medical Action Society (KTI) and the Minister of Health, KTI argued that the Pfizer vaccine has not completed its clinical trial phase and should not be made available to the wider population in accordance with section 23 of the act.
On May 18, the High Court ruled in favour of KTI, stating that it was “reasonably arguable” that the provisional approval for the vaccine in the entire adult population was “problematic.”
Minister for Health Andrew Little subsequently announced the act would be receiving an immediate amendment, and the Medicines Amendment Bill was introduced and passed on May 19, the following day.
Section 23(1) of the Medicines Act originally stated that provisional consent given by the Health Minister to the supply of a new medicine should be used on a restricted basis and only for the treatment of a limited number of patients.
However, the vaccine was approved for use in roughly 3.5 million New Zealanders over the age of 16—more than two-thirds of New Zealand’s population—despite the primary clinical trial for the vaccine yet to be completed, due in April 2023.
Last month, KTI released an open letter signed by 43 New Zealand medical practitioners outlining the case and expressed concern over the promotion of the vaccine despite a lack of evidence demonstrating its safety.
“Nobody currently knows how safe or effective this novel mRNA technology is in the medium to long term,” the letter stated. “Highly credible medical experts around the world, and even some vaccine developers themselves, are predicting problems and raising urgent red-flag concerns.”
The letter went on to say that a health risk could be posed for those who had been given the dose, depending on the outcome of the clinical study.
“If any safety issues are identified in the remaining period of the trials, the effects could be catastrophic for our community or a proportion that have already received the vaccine,” it stated.
The letter also argued that encouraging citizens to have the jab in light of its unproven safety was unethical.
“Compelling patients or workers to receive drug, medicine or vaccine which is still investigational would set a significant medical precedent, which would run counter to all international codes of medical ethics since the Nuremberg Code of 1947 and Declaration of Helsinki in 1952,” the letter said.
Minister for Health Andrew Little announced the amendment to the Medicines Act the day of the ruling, stating the 40-year-old law was in need of modernising.
“The law has, for some time now, lacked clarity over how it can be applied,” Little said in a media release.
“We already knew the Medicines Act was out of date, which is why we were planning to replace it with a new Therapeutic Products Act.”
Little added that the Pfizer vaccine did not need rigorous testing and approval because of the critical need for the vaccine during the pandemic.
“Treatments approved under Section 23 go through a rigorous Medsafe approvals process,” Little said. “There are occasions when the health needs of a population call for urgent access to a medicine, vaccine or treatment, and we need to keep this option available for some circumstances.”
At the time of the ruling, the High Court allowed for the continued rollout of the vaccine based on advice given by the Director-General of Health, Ashley Bloomfield.
The advice suggested that pausing the rollout would pose a risk to public health and would mean that “COVID-19 remains a real threat to the population of New Zealand.”
Consideration towards the waste of vaccine stock was also taken into account, which had a shelf life of about three months upon arrival in New Zealand.
Bloomfield also pointed out that suspension of the vaccine could potentially see public confidence be “significantly undermined,” impacting efforts for national COVID-19 recovery.