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By now, most people will be aware of the growing problems with the vaccine registration trials for acute respiratory infection (ARI). We documented several of them in our series on the COVID-19 Comirnaty.
The regulatory trial C4591001 was a large multicenter randomized controlled trial with a single-blind design. It allowed administrators to distinguish the vaccine from a placebo, but it under-reported potential harms, had no completed trials in pregnant women, and used unclear definitions for Covid case effectiveness outcomes.
Since the 1990s, we have conducted a series of Cochrane reviews both on vaccines and antivirals. Our findings indicate that there is minimal or no data available to guide practice for significant outcomes. Additionally, we found low-certainty evidence regarding influenza and 'influenza-like illness' (ILI), highlighting the weaknesses in the methods employed by those who design and undertake such trials.
The recent overhaul and reorganisation of the US Vaccine Committee emphasised the problems of conflicts of interest in vaccine research. “The new members will prioritise public health and evidence-based medicine,” said Secretary Kennedy.
The hoard of vaccine evangelists, who serve at the pharma altar, were quick to dismiss this new approach. Supported by news organisations like the BBC, they appear to want the status quo: relying on poor-quality research and making inadequate decisions regarding vaccine research and policy.
With the recent US announcement winding down mRNA vaccine development and the CDC’s vaccine advisory committee's Covid-19 vaccine review, the tide may be turning on the decades of shoddy research and practice.
“We reviewed the science, listened to the experts, and acted,” said Robert F. Kennedy, Jr. “...Because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
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Thirty years of distortion of the evidence base for vaccines is under review. The TTE Office has often been distressed by the quality of regulatory trials that sow the seeds of doubt on the real performance of the various vaccines. Because these initial trials are so badly done, they are replaced by even more shoddy observational data that draw erroneous conclusions.
In our upcoming posts, we will provide a comprehensive overview of the rationale behind a new approach to Vaccine Registration Trials. We aim to address the current challenges in these trials and propose recommendations that could enhance their effectiveness and reliability. To conclude our discussions, we will present a detailed checklist, which we plan to share with our colleagues in the United States to facilitate a new framework. In doing so, we’ll rely on the TTE community to input to this important work.
For those readers who do not believe any of this is possible or enforceable, we remind you that secrecy is the acid that corrodes trust, and with no trust, vaccine coverage will plummet.
Remember that if the right work is not done at the beginning, enablers and scare agencies will then rely on observational studies, which are much easier to manipulate.
To give our readers a refresher on the issues highlighted by the emergency registration of Comirnaty, we will be re-publishing parts of our series on this topic. This series currently consists of 64 posts, along with documents from the MHRA and several other relevant TTE publications that demonstrate the disregard with which regulators and governments treat the public.
We’d welcome your comments as we go.
This post was written by two old geezers who have kept a few tricks up their sleeves to avoid giving too many people costly ideas.
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