by Iain Davis
In November 2020 Pfizer and BioNTech announced they had concluded their phase three trial [3] of BNT162b2. This wasn't true, they had barely completed phase 1 of the trial. Pfizer's phase III NCT04368728 trial won't be completed until January 2023 and is still in the recruitment phase [4] (at the time of writing.) None of the COVID 19 vaccines have completed clinical trials. For example, AstraZeneca’s will be complete in February 2023 [5].
The British Medical Journal were among those who recognised that the vaccine trials were, in any invent, incapable of assessing either efficacy or safety [6]. All the pharmaceutical corporations provided were some interim trial results, but these too had numerous problems.
The Lancet reported that the selective use of data was just one among many issues undermining the interim vaccine reports [7]. There was a lack of consistency with definition of disease, reporting bias was evident, study protocols differed between vaccines and even changed mid trial in some instances. Endpoints were mixed, meaning it wasn't clear from the interim analysis who would be the primary beneficiaries, if any, from the claimed efficacy.
These full clinical trials were designed to be blind, randomised control trials (RCT's). The vaccine's efficacy and safety would supposedly be measured by comparing the outcomes of a placebo group, who did not receive the vaccine, with the vaccinated group. According to all of the various vaccine trial protocols this would generally be measured over approximately a two to three year period.
However, the pharmaceutical corporations decided to ignore their own trial protocols. Long before they were due for completion they unblinded their studies. They gave the vaccine to their placebo control group. This meant that none of the current COVID 19 vaccines were studied in randomised control trials. The British Medical Journal stated [8]:
"The BMJ asked Moderna, Pfizer, and Janssen (Johnson and Johnson) what proportion of trial participants were now formally unblinded, and how many originally allocated to placebo have now received a vaccine. Pfizer declined to say, but Moderna announced that 'as of April 13, all placebo participants have been offered the Moderna covid-19 vaccine and 98% of those have received the vaccine.' In other words, the trial is unblinded, and the placebo group no longer exists."
Without completed clinical trials of any kind, the COVID 19 vaccines were only approved for "emergency use." The interim trial results for the Pfizer BioNTech trial C4591001 (NCT04368728) were cited throughout the Medicines and Healthcare Products Regulatory Agency (MHRA's) Authorisation for Temporary Supply [9]. However, when independent researchers used freedom of information request (FOIR) to ask about why the trials didn't assess the vaccine's impact upon pregnant women the MHRA stated [10]:
"The above trial was not conducted in the UK, the MHRA did not assess its content and are therefore not in a position to answer specific questions relating to it."
This indicates that the MHRA hadn't read the interim trial data they cited prior to granting emergency approval of the vaccine. Further, given how frequently it was referenced in the authorisation report, it is not unreasonable to question if the MHRA wrote it.
The MHRA weren't the only regulator who seemingly didn't bother reading the pharmaceutical corporations interim trial results before approving their COVID 19 vaccines. A FOI by Doctors for Covid Ethics (DFCE) to the Australian regulator (TGA) found that they hadn't looked at any of the data [11] from the Pfizer trials and had simply accepted the corporation's claims.
In the UK and Australia at least, this indicated that there was no regulatory oversight of the COVID 19 vaccines prior to their emergency approval. The pharmaceutical corporations could claim anything they liked about their product as the regulators made no effort to verify the data or even assess the contents of their study reports.
Tony Blair was absolutely clear that the vaccines reduced the risk of hospitalisation and death but without any completed clinical trials he had absolutely no basis for anything he said. Once the vaccines were being used on the public the evidence certainly didn't support Blair's absolutism.
For the period between February 1st to June 7th Public Health England [12] reported that, of the 19,573 unvaccinated Delta VoC "cases" they monitored, 23 died. This meant the unvaccinated Delta case fatality rate (CFR) was 0.117%. Of the 9,344 vaccinated Delta "cases" they monitored, 19 died. The CFR for the vaccinated was 0.203%, nearly double the rate among the unvaccinated group. The following week, for the period up to the 14th June 2021 [13] the unvaccinated CFR had dropped to 0.095% while the vaccinated CFR had risen slightly to 0.209%.
The numbers of "cases" were virtually meaningless, so we can't draw any reliable conclusions from the PHE figures. We can, however, conclude that Blair had no reason to be certain, and the questionable evidence that does exist suggests he was wrong.
There is no current evidence that the two most common COVID 19 vaccines (nor any of the others) are any better at reducing infection or transmission rates than natural infection and subsequent natural immunity. A casual glance at the mortality figures over the late spring of 2020, when there were no vaccines, contrasted with the same period in 2021 shows no difference in mortality trends. They are practically identical. There is no observable vaccine effect.
On April 30th 2021 the UK State franchise launched a committee review of the evidence surrounding the proposed vaccine passports (certificates.) In the corresponding press release [14] they stated:
"Vaccine certificates' would provide proof of vaccination to confirm an individual is at lower risk of suffering severe covid symptoms. However it is not yet known what effect the vaccine has on transmission."
They claimed they didn't know what the effect on transmission or infection rates were five months into their mass vaccination program. This probably wasn't true. It seems they did have a reasonable idea they just preferred not to mention it. The truth was that the vaccines didn't appear to make any difference to our SARS-CoV-2 immunity.
The UK COVID 19 Infection Survey [15] (CIS) attempts to measure the prevalence of SARS-CoV-2 antibody responses in the population. Two comparative studies [16] used CIS data to compare the antibody response elicited by the Pfizer and Astrazeneca vaccines to those following infection without the vaccines. The findings revealed:
"21 days after a single dose of either the AstraZeneca or the Pfizer vaccine the rates of all new SARS-CoV-2 infections had fallen by 65%...Among people who had a second dose of the Pfizer vaccine, infections were 70% lower and symptomatic infections 90%, similar to the effects in people who had previously been infected naturally (70% and 87% reductions, respectively)."
The lack of confidence in the vaccines appears to be underlined in the SAGE Spi-M-O March 2021 report [17] looking at the possible impact of easing restrictions. Predicting, using computer models, a return of infections, they stated:
"The resurgence in both hospitalisations and deaths is dominated by those that have received two doses of the vaccine, comprising around 60% and 70% of the wave.... accounting for more serious illness than unvaccinated individuals..... most deaths and admissions.... are in people who have received two vaccine doses... This is because vaccine uptake has been so high in the oldest age groups.... 95% over 50-year olds."
While 95% of those most at risk from SARS-CoV-2 will have been vaccinated they will still, according to Spi-M-O's model, comprise up to 70% of all future claimed COVID 19 deaths. While models aren't evidence they are the basis for policy and so we will refer to them here. It is far from clear from these models how the marginal claimed benefits of vaccines outweigh the alleged risk.
Currently the UK State franchise claim that 24 million people [18] have been fully vaccinated (two doses) in the UK. However their statistics for vaccine adverse reactions [19], reported via the MHRA's Yellow Card system, suggest the health risk of vaccination may be worse than they are for COVID 19.
By late May 2021 there were 822,845 adverse drug reactions, many of them serious, and 1,180 deaths reported for all COVID 19 vaccines in the UK. However, in 201
8 the MHRA, who are responsible for monitoring and supposedly investigating adverse events, stated:
"It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported."
This suggested the possibility of approximately 11,000 UK vaccine related deaths by the end of May 2021. With another 30 million adults to be vaccinated and plans to vaccinate children, given that genuine COVID 19 mortality is a low percentage [20] of the claimed figure, the direct harm caused by the vaccine could certainly exceed the harm caused by COVID 19.
The constant refrain from regulators and vaccine manufacturers is that there is no proof determining how many deaths are caused by the COVID 19 vaccines. This is true to the extent that postmortem examinations and investigations by the regulators would be needed to clearly establish vaccine mortality. To date they have not shown any willingness to carry out those investigations. However they do at least concede that the COVID 19 vaccines can be lethal.
The UK State franchise information for recipients of the Astrazeneca COVID 19 vaccine stated [21]:
"Extremely rare cases of blood clots with low levels of platelets have been observed following vaccination with COVID-19 Vaccine AstraZeneca... Some cases were life-threatening or had a fatal outcome. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks."
In order to know that the COVID 19 vaccine benefits outweigh the risks there would need to be a thorough risk assessment which compared an accurate analysis of the vaccine risks with an accurate analysis of the COVID 19 risks. The UK regulators are among those who have not undertaken any such assessment. Their claims of beneficial COVID 19 vaccine are based upon nothing.
The Norwegian Health Authorities [22] did undertake a risk assessment. Their data showed that the risks from the Astrazeneca vaccine outweighed the risk of COVID 19 for Norwegian people under 65. They halted the use of the Vaxzevria vaccine.
The situation was no better anywhere else. All vaccine adverse drug reaction reporting systems under-report incidents and the official figures present a small percentage of the actual total. Nonetheless, in the US [23] there were 12,625 hospitalisations and 4,201 apparent deaths by mid May 2021. In the EU the vaccines had seemingly accounted for 9,306 deaths [24] by the beginning of May 2021.
These numbers must be seen in context of millions of administered vaccines but these appear to be exceptionally dangerous drugs with risk profiles that would usually warrant immediate withdrawal. Without any meaningful trial data we have no any way of knowing what the long term health impacts will be. Irrespective of the numerous reasons for concern about relative health harm, the rationale for vaccinating the entire population was as lacking as it was for lockdowns.
In particular there is no possible justification for vaccinating the young. The COVID 19 health risk for all healthy young people, under the age of 18, is zero. There is no evidence that they present a SARS-CoV-2 infection risk to anyone and the scientific evidence which does exist clearly indicates that they do not infect others. Therefore any suggestion that COVID 19 vaccines could harm children only adds to the obvious conclusion that there is no public health rationale to vaccinate children and young people.
Researchers for the US Center For Disease Control (CDC) found that the two doses of the mRNA COVID 19 vaccine significantly increased heart inflammation (myocarditis and pericarditis) among those under the age of 24 [25]. The risk for those aged 18 - 24 increased by 136%, for those aged 15 - 18 it rose by 316% and, for those aged 12 - 15, by more than 100%.
Among the many doctors, scientists and other concerned professionals who recognised the clear evidence of unacceptable COVID 19 vaccine risks, in early June 2021 Dr Tess Lawrie (MBBCh, DFSRH, PhD) was concerned enough to write to the MHRA [26] urging a halt to the vaccine roll out. Dr Lawrie is a medical researcher, public health policy advisor and contributing research author to the prestigious Cochrane Review. She and her team analysed the adverse reaction reporting in the UK. Writing to the Chief Executive of the MHRA, June Raine, she stated:
"The MHRA now has more than enough evidence on the Yellow Card system to declare the COVID-19 vaccines unsafe for use in humans.. the mechanism for harms from the vaccines appears to be similar to COVID-19 itself."
On June 4th 2021 the MHRA extended the emergency COVID 19 vaccine authorisation to allow the injection of children [27] aged between 12 - 15 years. Perhaps the MHRA don't communicate with the CDC or weren't aware of their findings. Having received the analysis from Dr Lawrie, the high risk vaccination of children remained on schedule and the MHRA gave no indication of their intention to rescind the authorisation. Announcing the authorisation, June Raine said:
"We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk."
As the risk to children from COVID 19 was zero there were no potential benefits to vaccinating them. There were clearly risks associated with the vaccines and Raine's claim that the vaccine benefit outweighed the risk was wrong. Given previous statements from the MHRA, nor was there any reason to believe that they had carefully reviewed the interim clinical trial data. There was good reason to suspect that they hadn't even read it.
In the UK, as elsewhere, the COVID 19 vaccines do not have market approval and are black triangle medications [29] because the MHRA only has "relatively limited information about their safety from clinical trials." Given that they didn't apparently read it, presumably this is extremely limited. Regardless, the vaccine were approved under Regulation 174 of the Human Medicine Regulations 2012 (as amended) which permits the emergency approval of unlicensed medications.
The MSM made fantastic claims [29] that the vaccine reduced the risk of developing COVID 19 by 90%, 95% or even 99%. As usual this was profoundly misleading. All claims about vaccine efficacy have been calculated based upon their relative not absolute risk reduction. This made a huge difference in the way the data was presented to the public.
In the initial phase I of the NCT04368728 (C4591001) trial, which was blinded, following infection with SARS-CoV-2, 8 of the 18310 vaccinated participants went on to develop COVID 19 symptoms compared to 162 of the 18319 unvaccinated participants. The vaccinated had a 0.044% of contracting COVID 19 post infection and the unvaccinated 0.88% risk.
Pfizer claimed a 95% risk reduction by using relative risk, expressed as 100(1 – (0.044/0.88)). Yet we can see that the risk was tiny for both vaccinated and unvaccinated participants. The absolute risk reduction was 0.84% (0.88-0.044). This ruse of relying upon relative risk reduction has been consistently used by all the vaccine manufacturers and is the only way the Trusted News cartel have reported the alleged benefits. In reality the interim trials suggest a negligible benefit from vaccination.
Public Health England (PHE) published estimates of just how successful vaccines were [30]. These were utterly ridiculous. For the 3 month period ending in March 2021 they claimed that the vaccines had saved 10,400 lives in England. They defined a COVID 19 death in the usual way as mortality within 28 days of a positive test. Consequently, their initial starting figure was wrong.
In an underwhelming display of mathematical folly they proceeded to make an estimate of vaccine effectiveness based upon their own previous estimates which were constructed from a number of unwarranted assumptions for which they presented no evidence. Next they applied the assumed estimate they made up to the original incorrect mortality figure to make a modelled prediction, based on another set assumptions, of the estimated number of lives saved.
This was neither science nor statistical analysis. It wasn't even a badly constructed computer model. It was just gobbledegook.
When we combine study findings, post vaccine roll out mortality spikes among the most vulnerable, official adverse reaction data and MHRA statements, with what little trial data there
is, the public health rationale for using these vaccines to combat COVID 19 does not exist. However this didn't stop the UK Health Secretary Matt Hancock from citing PHE's laughable claims as proof of vaccine effectiveness.
As far as anyone knows the vaccine neither lowers the risk of infection nor transmission. If someone has not been infected they are just as likely to contract SARS-CoV-2 from a vaccinated individual as they are from someone who hasn't been vaccinated. Currently the most vaccinated country in the world is the Seychelles. With a population of just under 100,000, approximately 62% have been fully vaccinated. Currently (June 2021) They are experiencing a surge in cases [31].
Fact checkers were dispatched to claim that there was some evidence that vaccines reduce transmission (the risk of infecting others). In their effort to concoct this justification Full Fact [32] not only cited the CIS studies we have just discussed but also the comical number salad churned out by Public Health England, presumably without reading any of it. They probably just "Googled it."
Their primary "proof" that the COVID 19 vaccines really did reduce the transmission rate, was a pre-print non peer reviewed paper written by State franchise scientists base upon the SIREN study [33]. This said nothing at all about transmission of the virus but claimed more than a 70% reduction in infection rates following two doses of the Pfizer mRNA gene therapy.
SIREN allegedly evaluated infections among 20,641 vaccinated and 2683 unvaccinated health workers. They monitored each group at two week intervals for a number of months. They then calculated the total accumulated number of days each cohort had been monitored, divided that by the number of positive RT-PCR results per cohort, to derive a figure of incidents per 10,000 days cumulative monitoring.
For the unvaccinated this was said to be 14 incidents per 10,000 days and for the vaccinated this dropped to 4 incidents per 10,000 days, following the second dose. Subsequently, the SIREN scientists reported:
