Of Course Vaccines Still in Phase 3 Clinical Trials Are ‘Experimental’

‘Fact check’ website Lead Stories (which Facebook and others rely on to guide censorship) has published an article by journalist Ed Payne claiming to ‘fact-check’ a recent Daily Sceptic article by retired Pharmaceutical Researcher Dr. John D. Flack. The ‘fact check’ is headlined: “Covid Vaccines are NOT Experimental Gene Technology – they ARE Fully Authorised.” Here Dr. Flack responds.

I think Mr. Payne and I are jousting around semantics – none of which addresses my fundamental concerns as to whether appropriate preclinical regulatory test protocols were conducted prior to MHRA/FDA/EMA approval of these novel gene-based ‘vaccines’. In his own admission, “they’re still under trial for about three years after being given the OK”. Under the emergency powers these gene-based ‘vaccines’ were authorised by the Government health regulatory bodies during the clinical trial phase of medicine development. Many products that have yielded promising results in early clinical trials with limited patient numbers have failed in the ‘field’ when larger patient numbers are involved. Therefore, to those practised in the art of pharmaceutical development, an experiment is still being conducted until the trials are fully completed and reported. To date, only interim analysis of the Phase 3 study results has been published, meaning the Phase 3 studies are ongoing (and are now unblinded so the quality of any final results is questionable). Will the product meet or fail to meet the agreed clinical end points? These are very large clinical trials of products however one wants to describe them.

I did make a mistake in saying: “Under the emergency laws surrounding the pandemic, these new injections were not approved but licensed as experimental medicines so there is no transparency as to the regulatory toxicology studies conducted.” Mea culpa. I should have said: “Under the emergency laws surrounding the pandemic, these new injections were approved as experimental medicines and not as licensed medicines.” (This has now been amended.) The MHRA in its statement says its authorisation was given “following a review of safety, quality and efficacy information from the clinical trials”. This begs the question – which is the main thesis of my article – of what preclinical studies were conducted to identify the toxicological profile of the both the gene sequence in the injection and the spike protein that it induces? I think we should know. Frankly, a ‘trust me’ statement that “there is sufficient evidence to demonstrate the safety, quality and effectiveness of the vaccine” is not good enough.

Mr. Payne says that I am “promoting the idea that mRNA-based vaccines… are a form of gene therapy, but this is inaccurate”. He is incorrect. Nowhere in my article do I use the term “gene therapy”. In fact, I was diligent in not doing so for the very reasons he quotes. I don’t need to be lectured by a journalist on what gene therapy is. How to define this new class of medicine is worthy of debate. Given that I was attempting to cover both mRNA and DNA based products, I chose to use the term gene-based ‘vaccines’. I think this is as accurate as one can get and stand by it. Gene technology is of course an umbrella term for a very wide range of research applications. This means the claim on the front of the Lead Stories article (depicted below) is false – indeed, the article itself does not dispute that the ‘vaccines’ are gene technology.

Finally, Mr. Payne plays the old trick of playing the man and not the ball: “Some vaccine-hesitant people like Flack…”. I am not vaccine hesitant, not by any stretch. I shouldn’t have to declare my health status, but needs must in these circumstances. In the last year alone I willingly had shots for shingles, pneumococcal, flu and Covid. As R&D Chief of a biotech company in Australia I was responsible for developing a rotavirus vaccine – which sadly failed in clinical trials through lack of sufficient efficacy (immunogenicity). I was proud to be a volunteer at my local vaccination centre in the early months of 2021 in helping to roll out these gene-based ‘vaccines’ to the vulnerable, and I have a certificate signed by Mr. Javid to prove it! As someone who has spent his whole career in discovering and developing new medicines, I am only interested in one thing – that the highest standards are met in ensuring the safety and efficacy of all medicines.

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November 2022
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