An independent blog in New Zealand called The Looking Glass reports on a lawsuit involving a nonprofit group called The ‘Hood, led by their director, Sereca Friend, challenging the New Zealand regular Medsafe’s decision to authorize the Pfizer mRNA vaccine for 5- to 11-year-old in that nation’s High Court. The nonprofit group is concerned about the lack of transparency and the risk of bias in the approval process. Regulatory capture during the pandemic has emerged as a real concern among activists across the developed world. While the group attempted to secure in court an interim injunction against the mass vaccinations of young persons in New Zealand, this effort failed to halt or even pause the vaccination campaign targeting children. Yet, according to Sereca Friend, she believes that the nonprofit’s legal moves may have stopped a vaccine mandate for the youngest Kiwis.
The Kiwi regulatory agency approved the COVID-19 vaccine produced by Pfizer at the end of 2021, as reported by Reuters. But challenges to the roll-out plan ensued, based on the fact that the actual vaccine formulation is different than the one tested during the safety studies according to the claim by The ‘Hood’s Sereca Friend, a collective of parents, doctors, scientists, as well as concerned citizens now working to sue the New Zealand government over the approval. The legal argument? How can Pfizer use one formulation for safety studies then use another formula for production? Doesn’t that violate the principles of good clinical and manufacturing practices?
The Defense
According to The Looking Glass article, Pfizer and the regulator argue that all that was changed were two ingredients of minimal risk. The Looking Glass reported:
“They created an updated pediatric version of the product that they then supplied us with, but they didn’t supply updated safety studies because they argued the two ingredients they changed were just buffers. OIAs sent by The ‘Hood were replied to by Medsafe, expressing that, as these were only stabilizers, and in trace amounts, Pfizer has replied this was ok.”
Regulators are not arms of Pharma!
What? Pfizer dictates what is and what is not risky? That isn’t the way regulation is supposed to work. Independent government agencies with impartial regulators must make that determination---not the company that stands to continue to generate windfall revenues and profits.
The nonprofit argued, “Any changes to an experimental formulation for children must be rigorously researched; emergency status is not an excuse to skip safety trials!”
The nonprofit’s director continued:
“The whole thing with Medsafe is in the name, they have a responsibility to keep our medicines safe and to demand more from Pfizer and companies supplying medications for children and healthy individuals. It’s not good enough. They have a duty to protect all of us, but especially children.”
What are the extra ingredients?
According to the New Zealand-based independent media outlet, this ingredient is known as Tromethamine, which actually comprises two ingredients. See a definition by the Cleveland Clinic.
The Argument
Importantly, a difference in philosophy has emerged as, on the one side are, medical establishments that seem to unilaterally align with the approach of universal vaccination against COVID-19, even for the youngest children that overwhelmingly do not get very ill due to SARS-CoV-2.
However, this started to change with the Delta variant, and with Omicron, record numbers of children ended up in the hospital due to SARS-CoV-2 infections. However, in a majority of cases, the children have comorbidities from obesity to type 2 diabetes, for example.
So, the argument for mass vaccination centers on the fact that it represents the most efficient and convenient way to protect the most possible people in society.
On the other side is the argument for more precision and personalization. What about natural immunity—most kids in America have now been exposed to COVID-19, for example. According to Sereca Friend, parents should question why jab in children is needed in the first place when the risk for COVID-19 is essentially zero. This, however, is not entirely true as there actually is some risk from COVID-19 for children.
Ms. Friend stated her concerns are associated with mass media campaigns and what she refers to as “the despicable use of children to protect others. That goes against the Care of Children Act.” She continued, “It is unethical to give a child a treatment to protect another person. The fact that the media and the Government have openly promoted that you should go and get your children jabbed to protect your whanu (Maori for family) and that it’s a responsible thing for a child to do. It’s completely against their human rights, and yet it is openly and utterly abused in this situation.”
Friend expressed concern as well as to how the government is abusing the vaccination campaign to discriminate against kids that aren’t vaccinated.
Safety Risks?
The nonprofit director reminds all that adverse reactions do exist with these vaccines, such as myocarditis with the Pfizer product.
According to Ms. Friend, the Kiwi adverse event database called CARM evidence “a 5000% increase in adverse event reporting in the last year alone. An alarming increase that should be raising serious red flags.”
TrialSite verifies that reports in various national adverse event databases have skyrocketed across America, the UK, Europe, Australia, and New Zealand. Of course, one explanation is the unprecedented number of inoculations over the last year-and-a-half. These vaccines, and for that matter, no vaccines, are perfect. While rare adverse events do occur, and when hundreds of millions of persons in the aggregate are vaccinated, the various open reporting systems will be active. Health authorities are quick to report that just because incidents are reported doesn’t mean they are actual cases.
Modeling not Enough
Ms. Friend also went on the record that during the pandemic, the way regulatory agencies such as Medsafe went about ensuring safety for adults must change for children, society’s most vulnerable population, along with the elderly.
She noted:
“With adults, everything was done on guesstimates and modeling because it was new. But once we got to the kids, we had alarming evidence based on actual data, and actual real-life problems, with massive red flags. We know. We don’t use any modeling in our case. We use real-world data. We can reference things that the Government knew prior to approving the product; that was solid evidence.”
The legal Review
The Looking Glass now prepares for a forthcoming judicial review in the High Court deemed “The Crown vs. The Hood with expert evidence to commence June 27 and June 28 at the High Court in Wellington, New Zealand.
Expert witnesses include Dr. Robert Malone, Dr. Peter McCullough, Gert Vanden Bossche, Dr. Philip Altman, and others. See the link.
The Hood needs donations. The judicial review is $250,000, and they are still $106,500 short. See the donation link.
About The ‘Hood
The ‘Hood is a Kiwi nonprofit organization representing people from all walks of life seeking unbiased answers. Composed of parents, doctors, nurses, academic scientists, lawyers, and others, the group seeks to ensure children are protected during the pandemic, from COVID-19, and from the government.
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