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Parents challenge NZ Govt decision to approve Pfizer paed vaccine

Contributor:
Fuseworks Media
Fuseworks Media

Today, 27 June 2022, in the Wellington High Court, legal counsel for eight parents commenced proceedings calling for a judicial review of the New Zealand Government’s decision to give provisional consent and roll out the Pfizer paediatric vaccine to 5-11 year olds.

The parents’ group is the human face of countless New Zealand parents dealing with potentially life-changing decisions in relation to their children. The parents are asserting their right to ask the New Zealand judiciary to scrutinise decisions made by government entities and the Government itself.

They are concerned that the paediatric vaccine approved by Medsafe differs from the original Pfizer product and that Pfizer never conducted clinical trials on this adapted vaccine. Official Information Act requests have forced the Government to confirm that two different ingredients were added to the original paediatric product. Pfizer also used a different manufacturing process with the paediatric product compared to the original adult version.

Legal counsel will also raise questions about the contract Pfizer signed with the New Zealand Government, which remain confidential.

An online search of contracts Pfizer entered into with other governments around the world shows these contracts contain many clauses in common: notably that the government in question: "…acknowledges that the long-term effects and efficacy of the vaccine are not currently known and that there are adverse effects of the vaccine that are not currently known." (emphasis added)[2: https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf ]

Similarly, contracts signed with other governments acknowledge Pfizer’s "…efforts to develop and manufacture the Product are aspirational in nature and subject to significant risks and uncertainties."

How many New Zealand parents would have agreed to their children receiving the Pfizer paediatric vaccine if they had known that even Pfizer acknowledges the long-term effects of the vaccine are "not known" and that adverse events are also "not known"?

Pfizer (in its own Risk Management Plan for COMIRNATY, submitted to the Government) stated that longer term safety data is "missing information" that it does not have.[3: https://www.medsafe.govt.nz/COVID-19/Comirnaty-RMP.pdf ]

Instead, our Government told parents, ad nauseam, that the vaccines are "safe and effective". The Government has even gone so far to say:

"Safety of the Pfizer vaccine: The Pfizer vaccine for 5 to 11-year-olds has been through clinical trials with children in this age group....No clinical trials were skipped and no corners were cut in the testing of its safety."[4: https://www.health.govt.nz/system/files/documents/pages/protecting-your-tamariki-covid-19-23dec2021.pdf ]

Not even Pfizer makes such claims.

The parents’ case notes that at the time the paediatric vaccines were provisionally consented for use on New Zealand children in late December last year, serious adverse side effects such as myocarditis and pericarditis were already well known to the Government.

It was also well known then that Pfizer’s vaccines did not prevent a person contracting COVID-19 or transmitting it. Despite this, Pfizer’s application for provisional consent stated that its paediatric vaccine provided "active immunisation to prevent" COVID-19.

Lawyers for the group of concerned parents will argue there was no justification for claims children are at serious risk from COVID-19 and will argue that the Government has not provided any substantive evidence in support of its claim to the contrary. The lawyers will argue the science shows that healthy children have robust innate immune systems that can readily fight both infection and symptoms. The risk of severe consequences from COVID-19 for children - hospitalisation or ICU admission - is negligible.

The minutes of Medsafe’s Medicines Assessment Advisory Committee (MAAC) meeting held on 14 December 2021 that considered Pfizer’s paediatric product state: "The application has been submitted via an expedited priority review process and has been assessed under urgency due to the significant clinical need for a COVID-19 vaccine that can be administered to children." However, MAAC did not provide any information supporting for the need for urgency, such as deaths or infection rates specific to 5-11 year olds.[5: https://fyi.org.nz/request/17981/response/70758/attach/5/H202117877%20Binder%20Redacted.pdf ]

Considering the potential vaccine recipients were children, Pfizer’s application was considered and evaluated in a breathtakingly brief five-week period. The very premise of provisional approval is that a drug is temporarily approved and subject to conditions, given not all safety trials are able to be conducted or concluded. It has therefore never been open to our Government to assert its safety message to New Zealand parents in such a comprehensively emphatic manner, particularly in light of the fact that Pfizer never conducted clinical trials of its adapted paediatric vaccine.

For children, COVID-19 was never an emergency. In further support of there being no health emergency impacting healthy New Zealand children, it is notable that the truncated provisional consent process occurred at the same time (in December last year) that the Government was recommending to relax the country’s border requirements. [6: https://www.health.govt.nz/system/files/documents/information-release/h202117272-response.pdf ]

Another key point that will be made by lawyers for the parents’ is that the risk/benefit analysis between children being unvaccinated and contracting COVID-19, versus them having the vaccine, with its known and unknown consequences, did not support the provisional consent granted by the New Zealand Government.

Traditionally, vaccines have taken 15-20 years to develop, starting with animal testing, then proceeding through Phase 1, Phase 2 and then Phase 3 trials, before proceeding to a regulatory review and approval phase. However, Pfizer’s mRNA vaccine trials involved extremely limited animal testing before entering accelerated clinical trials and regulatory approval - all within less than 12 months. The median follow up of trial subjects was just two months.

The Pfizer vaccine skipped altogether the usual testing for genotoxicity, mutagenicity, teratogenicity and oncogenicity. Accordingly, it is not possible for the New Zealand Government to assert the paediatric vaccine was "safe and effective", as it could not possibly know whether or not the vaccine will change human genetic material, cause birth defects, reduce fertility or cause cancer.

The parents’ case asserts the roll out decision was simply part of a longstanding vaccination strategy that ignored vaccine risks to children. Expert evidence will be presented to the court that mRNA vaccines can trigger fundamental changes to children’s immune systems and that a genetically reset immune system cannot be repaired. The harms and risks from new medicines are often only revealed many years later.

Safety for vaccines is far more important than for therapeutic drugs, as vaccines are given in large numbers to perfectly healthy people. Therefore, vaccines must be extremely safe.

The parents’ case highlights serious concerns about our Government’s comprehensive reliance on Pfizer and the material Pfizer provided. The standing of Pfizer in the pharmaceutical world is substantial, but hardly unblemished. Breaches by Pfizer of various legal requirements amounting to dishonesty are a matter of public record internationally and Pfizer has paid out more than $15 billion dollars in related fines.

The parents group asks the critical questions that countless New Zealand parents want the answers to, the same questions our Government ought to have also been asking.

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