)Vaccine salvation, in the form of Pfizer and BioNTech's mRNA-based BNT162b2 (BNT) vaccine, promises to set us free from the COVID 19 horror, according to official sources. The UK government are among those who have already ordered millions of doses of this "highly effective" vaccine. Leading "experts" say it could see lockdown restrictions lifted in the summer of 2021, as COVID is defeated. Thanks to the vaccine.
There is no evidence to back up anything said in the previous paragraph. There are currently no clinical trial results for BNT162b2 and trials aren't due to complete until June 2021. It is simply the latest COVID vaccine story you are being asked to swallow without question or complaint.
Not only is there no evidence the new vaccine is safe for anyone, there isn't any that it does anything useful. All anyone has is a press release from the manufacturers claiming their vaccine is fantastic. Off the back of this, the MSM and governments around the world are reporting its great success and the manufacturers' share price is soaring.
That the proposed solution, to a questionable problem, is an mRNA vaccine is very concerning. MessengerRNA vaccines, with their reliance upon lipid nanoparticle (LNP) carrier systems, have the potential for severe long term side effects. They could be used to modify our DNA.
If approved, which is practically guaranteed due to the deliberate removal of nearly all licensing restrictions, BNT will be the first mRNA vaccine ever to be administered to the human population. A vaccine which has apparently been developed in a matter of months. Despite decades of previous attempts, to develop a SARS vaccine, not only failing but occasionally leading to disastrous results.
Over this article, and the next, we are going to explore these important issues. We may as well because, if nothing else is clear, it is certain that the mainstream media aren't going to bother.
What's In A Statement?
In his statement, Albert Bourla (Pfizer CEO) said:
[the] Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection....Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate - required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.
Phase 1 trial results (NCT04368728) are available. However, the full trial protocols for BNT162b2 state that evaluation of Serious Adverse Events (SAE's), following completion of Phase 3 trials, should monitor test subjects health for no less than 6 months. So either the protocols aren't worth the paper they are written on, or everyone who is reporting this remarkable success just don't care what they are.
FDA’s guidance for potential Emergency Use Authorization allows unlicensed medicines to be distributed in times of claimed emergency. Similarly, in the UK, proposed changes to Human Medicine Regulations, will enable the same. In both cases, pharmaceutical corporations have no liability for any harm their vaccines may cause. Rendering safety concerns practically a moot point for them.
In Pfizer's case this is probably just as well for their shareholders. Their record is appalling.
In the late 80's, after hundreds of people died following the implant of their artificial heart valves, they were forced to pay up; the drugs they have withdrawn due to safety concerns include Rezulin (after another settlement), Bextra, Celebrex, Prempro and Effexor and they are currently fighting thousands of claims for the damage their products have reportedly caused.
In 1996 they were accused of conducting unauthorised clinical trials on children in Nigeria, killing 11 and disabling many more, before again settling out of court. In 2009, they paid a huge settlement for large scale healthcare fraud to the U.S. Department of Justice.
However, on both sides of the Atlantic, they are now free to roll out emergency, unlicensed vaccines, without completed clinical trials, while enjoying absolute immunity from prosecution. Thankfully, the UK Health secretary is keen to stress that the UK will be ready to distribute Pfizers latest product. So there is no need to worry.
Instead of reliable licensing framework and legal protections, we have a kind of pharmaceutical Wild West, where everyone is chasing their pot of gold. Pfizer and BioNTech have announced their intention to use this new system to sell their unlicensed vaccine without finishing their trials.
This may explain why the UK Medicines and Healthcare products Regulatory Agency (MHRA) have applied for an emergency tender for AI software from the EU to deal with the slew of vaccine adverse reaction they presumably anticipate. They state:
The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs)....it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine.
Just like every other alleged COVID 19 safety measure, the resultant policy and regulation changes appear to increase the health risk. They reduce the necessity for testing, allowing governments and pharmaceutical corporations further opportunities to make baseless claims about how great their policies and products are.
It is one such claim from Pfizer that both governments and the MSM are celebrating. In response, the UK government's released statement, is remarkable. They say the results are promising, although they haven't seen any yet and all they reference in their statement is Bourla's press release.
Regardless, we learn from the Prime Minister Boris Johnson that the UK government have gone ahead and ordered 40 million doses. Bringing instant profits to shareholders, based upon nothing more than an evidence free claims from their own company CEO.
Albert Bourla certainly did well out of it. Having made his announcement, sending the share price through the roof, he sold more than 60% of his stock, netting a tidy profit. This was part of a trading commitment created in August and it is not evidence of insider trading because reasons.
What Does 90% Effective Mean?
Frankly, we don't really have any way of knowing what 90% effective means. There are no trial results.
The BBC say it is based upon the first 94 people in the trial who contracted COVID 19. The Guardian report that 90% of infections were prevented. Which seems to be in keeping with Bourla's statement. So the claim appears to be that, after contracting SARS-CoV-2, it reduced the chances of you becoming ill with COVID 19 by 90%.
As the plan is to give this vaccine to everyone, to pick this apart, we need to understand what our COVID 19 risks are. These need to be evaluated against any known risks presented by the vaccine.
In total, across all three trial phases, approximately 43,500 people (aged between 12 and 85) who did not have SARS-CoV-2 were studied. In Phase 2/3 about 22,000 people received BNT162b2 (BNT) and the others were given a saline placebo.
If there were 94 cases of COVID 19, but the vaccine was found to be 90% effective, it suggests there were about 85 COVID 19 incidents in the placebo control group and 9 in the BNT cohort.
This presumably suggests a COVID 19 case rate of 0.39% (from the placebo group of approximately 21,500) and 0.041% in the BNT group. It doesn't seems likely that Bourla was referring to lower rates of SARS-CoV-2 infections. It he was, it infers the population risk of COVID 19 is statistically zero.
Initially, it would seem that a vaccine potentially reducing this risk to something closer to 0.04% would be most welcome. However, the vast majority of people who develop COVID 19 experience it as little more than a cold. So that risk needs to be seen in context.
Using the UK government statistics they claim that 184,000 people have been admitted to hospital in the UK with COVID 19. Although it is not clear if they were admitted due to COVID 19. Further, they claim approximately 50,000 people have died from COVID 19. There are many reasons why we might question this figure but for now, let's proceed on that basis.
This means, on a population wide basis, the chances of you becoming seriously ill with COVID 19 is 0.27% and of death 0.073%. These risks increase appreciably with age, as nearly all mortality risks do. Population based risk is valid here, because the plan is to give this vaccine to the entire population.
According to the Office of National Statistics the chances of COVID 19 mortality among the working age population (an Age Standardised Mortality Rate of 16.6 per 100,000 in England and Wales) is approximately 0.017%.
Deaths below 18 are statistically zero, but the ASMR rise sharply with age. For the 65-69 age group the COVID 19 ASMR is 134 per 100,000 (0.13%) and for the over 85's it is more than 2068 (2%). While these risks are in keeping with the normal pattern of mortality distribution, its is clear who the vulnerable COVID 19 group are.
Phase 1 BNT trials found the following:
Vaccines elicited generally lower antigen-binding IgG and virus-neutralizing responses in participants 65 to 85 years of age than in those 18 to 55 years of age.
The COVID 19 risk to those under 65 is negligible. In this age range it is a risk only to those with quite serious comorbidities. As all viral respiratory illnesses are.
Reduced effectiveness for the at risk older population is disappointing. However, as the full trial results haven't been published, we don't know if this situation has changed.
What we can say is that a vaccine that protects the health of the under 65's but is less effective for older people, while doing nothing to stop the spread of COVID 19, is of questionable value.
This is a vaccine which, if we accept government figures, allegedly reduces the overall population risk of serious COVID 19 illness from 0.27% to 0.03% and death from 0.073% to 0.006%. However, it appears to be less effective for the most vulnerable and doesn't reduce anyone's risk of infection with the SARS-CoV-2 virus.
As the trials have not been completed, in accordance with the trial protocol (NCT04368728), investigation of Serious Adverse Events (SAE) has barely begun, let alone been completed. The countless claims that this vaccine is "safe" are literally based upon nothing. Yet the UK and other governments are planning to allow the pharmaceutical corporations to use their "emergency regulations" to fast track this untested vaccine for distribution to the entire population.
When we look at who is involved in this process, their stated objectives, the current technological possibilities of mRNA vaccines and resultant policy decisions, an uncomfortable reality emerges. We are going to explore that reality in Part 2.
Take it easy you hoopy froods.
