UK Covid-19 Vaccine Regulatory Response - Gamekeeper turned Poacher?

By John Flack, B Pharm, PhD, retired Pharmaceutical Research and Development Scientist and a member of HART

In 2022 I published a paper in the Daily Sceptic (at that time called the Lockdown Sceptic) concerning the safety testing of the Covid-19 vaccines that had miraculously been developed and approved in a matter of months rather than years. In this paper I was highly critical of the way these products had been developed and expressed great concern about their potential short and long-term safety. I went as far as suggesting a preclinical programme of testing for these novel products that would have been able to identify areas of potential safety concern. Now some three and a half years later it seems appropriate to review my 2022 paper against the empirical outcomes from the mass vaccination programmes that were conducted worldwide. The bottom line of this review is that the official government narrative of these novel vaccines as being “safe and effective” was at best misleading and at worst a complete fabrication. At the time of their introduction there was no solid data that provided evidence from the clinical trials of their clinical effectiveness. Subsequent worldwide clinical experience has confirmed these products are not preventing infection or stopping transmission. But worse still the early trials also showed clear evidence of adverse side effects, and these have unfortunately been confirmed in the roll out to millions of people all around the globe. The early signals of significant and serious adverse events were ignored. Political hubris and expediency trumped patient safety. The very opposite of the precautionary principle. Thousands of people have died or suffered serious disability directly because of these products.

Governments bragged about the “warp speed” development of these “vaccines” and the various regulatory agencies previously charged with ensuring that tragedies such as thalidomide never occurred again told us, and the UK MHRA in particular, that they were now “enabling” pharmaceutical companies with rapid authorisations of new medicines. In effect, regulatory gamekeeper turned poacher. I quote directly from my 2022 paper- “but it (the warp speed development) must be recognised as being a huge gamble. Unfortunately, we will never know whether it is a gamble that has paid off”.

My statement was predicated on the fact the pharmaceutical companies together with the national regulatory authorities had decided to “unblind” the clinical trials so it would not be possible to ascribe either efficacy or safety unequivocally to the vaccines. An absolute mantra in science and not least in the testing of medicines for safety and efficacy, is the danger of conflating cause and effect when this could have occurred purely by chance. However cognisant of this perennial problem in science a paradigm has been established, known as the Bradford Hill paradigm, that takes account of all the observational empirical data associated between two events. There is no doubting from such an analysis that serious side effects are directly caused by the administration of these novel vaccines.

No amount of grandstanding by the likes of Hugo Keith QC at the Hallett Inquiry - who at the opening of the session on the vaccine’s module said, “we all know the vaccines have saved millions of lives and are safe and effective” - will hide the truth of the matter. I quote from Professor Angus Dalgleish, Emeritus Professor of Oncology at St Georges Hospital, “It is clear to everyone who has not been anaesthetised by government dogma that the vaccines were anything but safe with millions suffering from heart conditions and strokes as well as every manifestation of autoimmune disease ever described”.

And then came the very recent announcement from the US government that all further government support for vaccine mRNA development – that’s the technology platform used for the Covid-19 injections – is to be banned and the contracts that have been already issued are to be overturned. So, at last recognition by a major government that the mRNA Covid-19 vaccines are not fit for purpose in fighting viral respiratory infections. A momentous decision indeed but hardly worth a mention in the UK media. The delusion of the miracle of British technology saving the world will one day be exposed if not by the Hallett Inquiry, then by international and national science. We can only live in hope that in the short term the gene technology platform in general and modified messenger RNA in particular, at least as applied to vaccines, will be quietly phased out in the UK too, and that in the long term the folly of the coercion of millions of people into vaccination will be exposed.

How did it come to this?

Perhaps because I am a born sceptic, I smelt a rat from very early on. There was talk in early 2020 of a novel deadly virus which was so virulent it was going to kill millions of people. The pseudo-science of predictive computer modelling told us so. We were exposed on our TV screens to pictures in China and Italy showing people falling over in the street and ambulances queuing to take body bags from hospitals. All subsequently shown to be grossly exaggerated. And yet it was known as early February 2020 that the virus was causing harm to only the old and fragile of the population. Children were mercifully spared altogether and the middle aged barely affected. How could this virus possibly be called highly virulent whilst having this highly selective demographic profile? It just didn’t make any sense. Then as 2020 progressed and the symptoms of infection became better defined, I realised that I had seen these “flu- like” symptoms in two friends in November/December 2019, way before the SARS-2 virus had even been mentioned. The doctors and laboratory investigators at that time were mystified as they couldn’t identify the causative organism, but my friends were successfully treated symptomatically with corticosteroids and antibiotics for secondary bacterial infections. The hacking dry and painful cough, high temperatures and loss of taste and smell which came to characterise the Covid symptoms were very evident. But even these were not unique to this respiratory virus. Slightly different in overall profile maybe but hardly unique. So, the virus had clearly been around in the Autumn of 2019 and most probably earlier than that. If it was so contagious and virulent why weren’t people dying in their thousands then? How and why did ‘flu suddenly disappear overnight? Again, it didn’t make any sense.

In addition, we were told that this was a novel and dangerous coronavirus. I am not a virologist, but I was aware that the common cold is also caused by a coronavirus. Scientists had been studying this class of viruses for decades. Yes, indeed they are very contagious but by contrast weakly virulent. They were also known to mutate with great rapidity, indeed at such a rate that despite decades of trying no vaccine had been developed to mitigate prevention and transmission of the common cold virus. Now this new mutant was apparently not only highly contagious but extremely virulent. Except that it wasn’t, as the selective demographics had clearly shown. Once again it didn’t make any sense. In fact I was inclined to the view that this was not a highly lethal virus that came from a wet fish market in China or indeed that was made by some rogue scientist that had than escaped from a laboratory but simply another coronavirus strain that had evolved in the normal course of the virus lifecycle and was novel only to the extent scientists hadn’t yet identified it.

And then there were the historical facts about all the preplanning that had been done over a decade or more in anticipation of a respiratory virus epidemic. All this analysis pointed to doing what had previously been done and in accordance with conventional wisdom and practical experience. This being to simply protect the vulnerable and isolate those showing symptoms of infection. That was indeed the plan proposed to deal with future respiratory epidemics. Scientists and healthcare experts were all agreed. That is until mid- March 2020 when Boris Johnson told us we all had to stay at home. So began the farce of the unprecedented lockdown strategy until the miracle of a vaccine became available.

Scientists, academia and the medical and scientific institutions fell silent. Empirical based science of speaking the truth was suspended. Science instead became politicised. Boris Johnson, who I had respected as a true libertarian and a student of history and literacy, turned out to be the clownish fool his detractors had labelled him. He coined the meme “We will follow THE science” when there is no such thing as THE science. Boris ushered in, perhaps unwittingly, the age of scientific dictatorship which Dwight Eisenhower had foreshadowed and warned the world about in 1961. Before our very eyes Technocracy was displacing Democracy.

Overnight it seemed governments world-wide were told to forget any previously well considered and thought through pandemic planning and instead put in place a previously untried plan – an experiment in effect of population control. Simultaneous decisions made by governments all over the world were surely not coincidence but rather orchestrated on high. But who was the conductor?

In effect it seemed that the situation had been taken out of the hands of experienced scientists and public health authorities and put into the hands of a more military style operation. How else to explain all the “U-turns” from previous policy. Whoever it was pulling the levers, they enlisted the support of a compliant World Health Organisation who had in turn been captured by the communist Chinese government. They were originators of the previously unused “lockdown strategy”. Why on earth would democracies follow Communist doctrine? But all Western governments bar one followed them. Perhaps it’s best, rather than to conjecture and invoke criticisms of conspiracy, to suggest simply that “blind panic” was the reasoning. The State mantra, previously used only in a situation of war with other nations, of “the first duty of any government is protecting its people from harm” was now being invoked as the excuse for “fighting a deadly novel virus”. Indeed, we were told that we were fighting a war with a virus. And so began three years of fascist rule in which all freedoms were withdrawn and impositions applied upon populations under the guise of “emergency powers”.

We will all have our personal experiences of these extraordinary times. Experiences, if my own are anything to go by, we can barely believe happened let alone complied with. What a surprise when there suddenly appeared a whole industry that had just been lying dormant for a decade or more waiting for the opportunity to exploit the situation. The sharks moved in. Government propaganda and the control of the mainstream media went into top gear – the population had to be terrified into compliance. And it was. This was an experiment of mass psychosis, and the experiment was seen to be a complete success. Censorship of any dissent was legitimised. And the rest, as they say, is history.

Limited space precludes discussion of the plethora of impositions applied, all without any evidence ever being presented of their effectiveness. So, let’s just gloss over the mandatory mask fiasco, the test and trace debacle, the abandonment of decades of basic immunology knowledge particularly innate immunity, the social distancing nonsense, the scientific fallacy of asymptomatic transmission, the exaggeration of mortality caused by the virus by wilful distortion of data, the disgraceful abandonment of medical bioethics as witnessed in the lack of obtaining informed consent, mandatory vaccination and vaccine passport policies and all the rest designed to frighten the population into compliance.

Yet the reality was we were not dealing with a deadly novel virus that was going to kill millions of people.

Instead, a fabricated illusion of a pandemic had to be created and perpetuated. How the politicians loved it.

Except not every country did fall for the new plan. Sweden saw through it and by way of its constitution the scientists there were able to resist the political pressures and continue down the conventional path of epidemic planning. They did not “lock down”. But nor did they get everything right – they didn’t protect care homes as they should have- but nevertheless the evidence is now clear. The Swedish outcomes in terms of human mortality and morbidity not to mention matters of education and the economy are far better than any country that chose to lockdown. If we now need to be assured that that lockdowns were a disaster for our society, then the Swedes are the control arm of the experiment showing definitively that the lock down experiment failed. Let it never be repeated.

Of course, part of the government propaganda encouraging us all to behave like compliant sheep during this lockdown period was to tell us we will be saved by the brilliance of our innovative scientists who were busy working on a vaccine. Just wait, be patient, all will be well. So went the patronising political hubris. And so it was in December of 2020 that the first person was vaccinated and from about February 2021the big national vaccine rollout began. I volunteered and helped at our local temporarily set up vaccine centre in the logistics of making it happen. All very impressive.

To be very clear I am not an “antivaxxer”. I had, sad to say in retrospect, two Pfizer injections. But no boosters! Initially we were told that the vaccines were only for the very vulnerable – namely the over seventies and immunocompromised. But then the whole population – including children – was coerced into the rollout programme. This didn’t tally with what we knew about the demographics of the disease, and in protest I immediately resigned my position at the vaccination centre. Once again it didn’t make any scientific or clinical sense. I have spent my whole professional career in trying to discover and develop new medicines, including vaccines (for the rotavirus) that have an appropriate benefit to risk ratio in the disease being targeted. If nothing else I know what good and bad medicines look like.

I was very interested in learning much more about these new vaccines, especially since heretofore scientists had been unable to develop effective vaccines against coronaviruses. Although there have been a few very unfortunate examples of vaccines causing serious harm and being withdrawn, in general, vaccines directed at respiratory viruses such as flu are considered very safe if not as effective as we might like. Bearing in mind I knew it takes up to a decade to discover and develop new medicines, I had thought that these new vaccines had been developed on traditional vaccine platform technologies and require minimal safety testing. Just like annual flu jabs which get modified year on year depending on the strains circulating that year and can be rapidly developed and manufactured using well tried and safe conventional technologies. Isn’t this what most of us thought? Were we told otherwise? Safe and effective was all that we were told and why, bearing in mind our general positive experience with influenza vaccines, would we think otherwise?

But NO, we had been misled again. I discovered that these are not vaccines based on traditional methods of development and manufacture but rather a completely novel and unproven technology in respect of vaccine products. The technology called messenger RNA (mRNA) had been around for a while and attempts to use it in curing diseases of genetic origin had sadly failed.

But it got worse. These products that had been called vaccines were NOT vaccines as defined by historical conventional medicine terminology. But nevertheless, they had been developed under the guidelines of standard procedures of traditional vaccines. Sleight of hand in other words. To overcome this sleight of hand the WHO and regulatory authorities were complicit in quietly changing the definition of a vaccine to cover for this completely novel class. So, the official narrative went, “nothing to see here. We have complied with standard procedures for the safety testing of vaccines”

The bottom line is that these are completely novel products and should have been subject to the same rigorous testing methodologies as any other completely novel pharmaceutical product. I was shocked. Neither short term nor long term safety testing had been conducted on products intended for mass administration to millions of healthy people. Hence the title of my February 2022 paper “Why weren’t these vaccines put through the proper safety trials for gene technology “.

Governments and its regulatory institution, the MHRA, together with the pharmaceutical industry, who never forget had been indemnified from any commercial risk by governments, took a huge gamble. It is now clear the vaccine gamble has failed, as did the lockdown strategy, both with devasting health consequences for society today and tomorrow.

The tragedy is that this was all self-inflicted through nothing less than a carefully crafted and fabricated illusion of a deadly pandemic that never was. Is it any wonder that no one in authority now wants to talk about, least of all assume any accountability for, the disaster of the management of the Covid Event?

The fight for truth is far from over, but it seems to be slowly emerging in the USA through President Trump and Health Secretary Robert Kennedy. Be assured that some of us in the UK will seek to reestablish the trust and integrity of science and medicine, accountability for government failings and most importantly justice for those whose lives have been devastated by the lockdown policies and the morbidity and mortality of a novel medical technology that had not been subjected to the scrutiny of the appropriate tests for safety.