Last week Medsafe gave provisional consent to the new, experimental COVID vaccine from Pfizer for New Zealand. The rollout is set to begin in late March, with frontline staff being first in the queue. Many Kiwis, along with our PM and the usual cohort of "experts" and media personalities, celebrated the announcement. However, it appears that few, if any, have taken the time to look into exactly what the terms of the provisional consent are. We hope they do, and soon, because the 58 conditions raise some serious alarm bells for all New Zealanders.
Safe and effective?
The phrase "safe and effective" has been trotted out at every opportunity with much exuberance. On constant loop are the reassurances that we could expect the side effects to be minor - a sore arm or a bit of a temperature. Signs your immune system is doing its job. Nothing to worry about. Appeal to authority. Trust the experts.
Those of us who've cared to keep across the science surrounding these new mRNA vaccines have been less enthusiastic. We've listened to the concerns from those within the system over the past year - "experts" like Dr. Paul Offit and Dr. Peter Hotez in the US, who've described the potential issues from early on in the piece. Ears have been continuously poised to pick up the slightest whisper of a problem.
We've known to watch out for signs of Antibody Dependent Enhancement (ADE) and molecular mimicry alongside the usual suspects of neurological disorders - seizures, paralysis, encephalitis; ITP, cardiac concerns etc., oh, and let's not forget death too.
Dr. Michael Yeadon (Pfizer's ex-Chief Scientific Officer, Allergy & Respiratory Research) and Dr. Wolfgang Wodarg (physician and epidemiologist) have felt the heat over their petition to the EMA to halt the Pfizer trials . Their action was taken over a serious concern about the potential for the mRNA vaccine to stimulate the creation of antibodies that could confuse the SARS-CoV-2 spike proteins with Syncytin-1, a protein responsible for placental development.
The official term for this is 'molecular mimicry', which is important and you'll see why shortly. Yeadon and Wodarg are deeply worried that if this mimicry is found to be occurring, many women might be rendered infertile as a result. What happened as a result of their petition? Well, what happens to so many who ask questions about the Covid vaccines: they were laughed out of town. Fact-checked, de-platformed, cancelled and humiliated. All for wanting to ensure the i's were dotted and the t's crossed for the sake of humanity.
What about our checks and balances?
Dr. Bloomfield, our PM and the other usual suspects assured us that Medsafe were being extremely thorough in its approval process. Much was made about the secret committee members beavering away right through the holidays and Christmas - working overtime to make sure they had identified all the potential problems.
And problems they did indeed find.
The committee has constructed a list of 58 conditions , which Pfizer is expected to address. None of these conditions have been specifically reported on in the media. Or to the extent that the conditions have been referenced, they've been overly simplified, reduced to passing references to what random journalists see as the key - something to satisfy Joe Public that yes there was a process being gone though, but that it's all just matter of procedure.
"Conditional consent" may be what the actual form says, but "conditional approval" is what our Prime Minister announced and that was translated and abbreviated in media reports to straight out "approved" - Tick, Tick, Tick... 'Medsafe have our best interests in mind and this issue is safe in their hands', so goes the thinking of this Team of Five Million.
What are these 58 conditions and why should you care?
To be fair, the document outlining the 58 conditions isn't exactly bedtime reading - not unless you want to be put to sleep. It's technical and complex and most people's eyes would glaze over after the first sentence. But those that take the time to read deeply will appreciate immediately that Medsafe has identified some seriously hefty issues - the summertime slog was not in vain.
Alas, we are not to hear much in the way of detail from the Information Keepers. Here's what the Ministry of Health (MoH) published on its website by way of explanation of the conditions:
“Medsafe has placed 58 conditions on the approval for the Pfizer and BioNTech vaccine.
Of these, 52 relate to requiring additional manufacturing data from the company, for instance as it upscales its manufacturing. Six of the conditions relate to additional clinical information such as regular updates from clinical trials, and ensuring we receive any information on safety concerns from around the world." 
Not a peep about the stuff we saw - the stuff that sent us into a spin. Specifically: a) Medsafe actually shares some of our personal concerns, including those outlined above; b) Medsafe printing these concerns; and c) the document being accessible to the public (if you know where to dig).
It's important to note here that Medsafe has given Pfizer timeframes to respond on the conditions, and is apparently "keeping an open dialogue with the company". Remember, the vaccine is due to land in NZ at the end of March.
This morning I sat at the breakfast table with my toast, cuppa, highlighter and printed document. My mission? To colour all the conditions that caused me to lose sleep last night.
A list of conditions raising serious concerns:
Provisional consent is to be granted for nine months to address an urgent clinical need.
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the dates of which may be altered by mutual agreement with Medsafe.
Prepare a "Dear Healthcare Professional" letter or comparable instructive material... Due date: February 2021.
- ...Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim report: March 2021.
DNA, lipid and elemental impurities. Due dates: July 2021; July 2021, Interim: March 2021; July 2021.
- The in-house controls applied to the raw materials and solvents used should also be detailed, as should the control of any potentially genotoxic contaminants. Due date: July 2021, Interim: February 2021.
- Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
Now, just so we're clear, I am pleased to see that Medsafe has identified this list of 58 conditions. What I'm not impressed about is premature rollout date and the complete glossing over of some pretty WHOPPING issues by Bloomfield and co. and media.
Critical questions for Medsafe:
- What level of detail is required to be covered in an Interim report? Will the content of these reports provide enough evidence and data to sufficiently address the concerns raised? If they are sufficient, why not just have the due date at this earlier point?
- Many of the due dates are well beyond the rollout date of the vaccine. How can we claim safety and effectiveness when we presumably don't hold all the information?
- What will Medsafe and the MoH do with the response to their conditions should they be unfavourable? Will they be published or treated as commercially sensitive and remain hidden? Will the report be heavily redacted like some of the other Risk Management Plans in the past (flu vaccine)? Is this whole palaver too big to fail?
- Will the frontline staff and their families be informed of these concerns as part of the informed consent process?
- Is there really an urgent clinical need for these vaccines? We know there are safe treatments available with good supporting evidence behind them - why are we not hearing about these other options (Vitamin D, zinc, Ivermectin etc.)?
- Condition 5 validates the concerns of Dr Yeadon and Dr Wodarg. Will these men be vindicated?
- Why hasn't this information been requested by the other international agencies (EMA, FDA, etc.)? And if it was, why was Medsafe unable to access it (if the concerns had already been addressed)?
- Are the people in countries with Emergency Use Authorisation such as the UK and US, essentially being used as guinea pigs? Have their medicines agencies asked these questions on their behalf?
- How will these signals (autoimmunity, infertility, genotoxicity) be identified and measured once the rollout has begun in NZ to ensure that the future assurances given are accurate?
- What is considered to be acceptable and safe when it comes to the level of impurities present?
- In terms of targeted medical response and compensation packages, what is being planned for those who suffer the worst of these adverse effects? Will they be abandoned by the system like the majority of vaccine injury cases in NZ?
As you can see, there are plenty of questions to be answered.
What can you do?
Here are some ideas I have on how we can advance the exposure of these issues and to encourage open and honest discourse.
Write to your local MPs. Send them this blog post and ask them what they plan to do with this information. Now is their time to stand up for the people they represent.
Write to the Ministry of Health. Ask them to provide you with the answers to the questions above and, if need be, request the Pfizer reports via the Official Information Act.
Write to journalists and the media. Implore them to investigate this issue and remind them of their duty to the public to report the facts and to dig deeper in search of the truth.
SHARE this post. Email it to those in your address book who you think might be receptive. Share it to social media - your own pages/accounts AND in the comments sections of relevant news articles.
Ask questions whenever you can. Respectfully stimulate discussion by requiring those you interact with to THINK deeply and beyond the contrived media soundbites we have become accustomed to.
Sign our petition! Say NO to:
- Rushed, experimental COVID-19 vaccines.
- No jab, No job & No jab, No fly.
- Wasting NZ taxpayer money to pay All Blacks and Shorty Street celebs to convince us to take a rushed, experimental jab.
In the spirit of Voices for Freedom: Stand up, Speak out - Together we are mighty!
 Medsafe's 58 Conditions: Comirnaty-Gazette (PDF download) OR https://www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette.pdf
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