THIS is a summary of my two TCW articles, which you can find here and here, with a small amount of new information added.
My contentions and conclusions are backed up by reference to freely available MHRA/NHS/Government documents and the articles contain direct quotations from these documents. This does not, incidentally, require a medical or scientific research qualification, simply the ability to read, absorb and logically analyse information, with a close attention to detail.
Lack of peer review
Pfizer and Moderna announced their trial results in press releases and there have been no scientific papers published about their trials. This is unheard of with a vaccine which is approved for mass usage.
Licensing and ‘approval’ are not the same
If the MHRA (Medicines and Healthcare products Regulatory Agency) are satisfied that a medicine is safe and efficacious, it is licensed. However, the Pfizer vaccine has been ‘approved’, not licensed, a new classification which suggests that the vaccine has not gone through rigorous clinical trials and safety checks. MHRA information to the public appears to be designed to conflate the two terms, which looks deliberately deceptive.
The vaccine is being rolled out too late
Pfizer made it very clear to the US Food and Drug Administration (FDA) that the vaccine ‘must be introduced before the peak of reported cases to have a significant impact on the pandemic course’.
This suits the situation in the USA, where the graphs suggest that the peak of ‘cases’ has not yet been reached and thus would encourage the USA to roll out the vaccine as quickly as possible.
However, in the UK, whether or not the figures on ‘cases’ are actually correct, Government data tells us that the peak of initial ‘cases’ in the UK was on April 10 and the later peak was on November 17. However, since I wrote that, there was a new peak of ‘cases’ on December 17. Even if we take the view that the UK Government was correct, with hindsight, to introduce the vaccine on December 2, this would still be based on trusting that PCR tests with an abnormally high cycle count (see ‘PCR testing and its use in the Pfizer trials’ below) are providing accurate figures of real-world infections.
However, there still appears to be less than robust medical or epidemiological justification for introducing any vaccine in the UK at this point which, according to Pfizer themselves, is unlikely to have a ‘significant impact’ on the course of the pandemic.
An investigational vaccine
The Pfizer briefing document for the FDA, prior to their approval of it, refers to the vaccine being an ‘investigational vaccine’.
The ‘contraindications’ section of the UK ‘Information for Healthcare Professionals’ document was updated on December 10(only eight days after vaccination started) to include a section on anaphylactic shock, after some cases of this severe allergic reaction occurred following vaccination.
This was not present in the original document, even though that exclusion conflicts with Pfizer excluding people with a ‘history of severe adverse reaction associated with a vaccine’ from their original trial.
We are also told that no data is available about concomitant use of immunosuppressant drugs. However, immunosuppressed people are in the long list of ‘at risk’ groups who will be vaccinated as a priority. Are this group of people being put at risk in order to provide the missing data?
What other contraindications and precautions will appear as more people are vaccinated?
It is difficult not to conclude that the UK and US public appear to be involved in trials for an investigational vaccine, masquerading as a rollout of a vaccine which has already been thoroughly tested for safety and effectiveness.
We now learn that the virus appears to have mutated, which is not at all surprising, since this is in the nature of viruses. If, as we are told, the mutated virus is more transmissible, again this is not surprising, since the only thing a virus ‘wants’ to do is infect as many people as possible.
Ill-informed journalists (an increasing proportion these days, it seems) have been saying that all we have to do is ‘tweak’ the vaccine, as if this is akin to changing your cake recipe because the cake didn’t rise as well as expected. A ‘tweaked’ vaccine would need to be trialled again, approved again and rolled out instead of the original one. Perhaps, therefore, we should stop injecting people with the vaccine stocks we have, chuck them all away, and buy new stocks when the new one is approved?
This seems to be yet another reason to conclude that the vaccine was rolled out much too precipitously.
mRNA vaccines
The development and production of mRNA vaccines is a new technology and no such vaccine has ever been used on a population. Therefore, we have no idea what medium to long-term effects the vaccine might have. Such effects would not be expected to be found for some time after vaccination – perhaps years or decades – so the complete lack of any medium or long-term safety trial is extremely worrying.
In addition, the mRNA is coated with ‘lipid nanoparticles’, which studies have shown can induce allergies and autoimmune diseases, trigger their own immune reactions, and cause damage to the liver.
It is not known whether the vaccine actually prevents severe symptoms, death, or viral transmission
The trials (as well as those for the Moderna and Astra Zeneca vaccines) were not designed to test for reductions in severe COVID-19 symptoms or if the vaccine can interrupt transmission. These are the very things which the public thinks the vaccine is protecting them from, so the Government appears to be foisting the vaccine on us under completely false pretences.
Pfizer’s briefing document for the FDA states that they do not know whether their vaccine can have an impact on either symptoms or transmission. Reduction in deaths is simply ‘likely’ and the vaccine ‘may be able to’ have an effect on controlling the pandemic.
Safety of the vaccine
1. Adverse effects from the injection which the trials identified as ‘very common’ are extremely high and might require time off work for potentially several days;
2. No drug interaction studies have been undertaken;
3. No animal reproductive or development toxicity tests been carried out;
4. Safety of the vaccine during pregnancy has not been determined;
5. It is not known whether the vaccine is excreted in human milk;
6. It is unknown whether the vaccine might have an impact on female fertility.
This looks, therefore, like a vaccine which has been rolled out before adequate safety testing.
Possible effects on female fertility
Dr Michael Yeadon, a former head of Pfizer’s respiratory research, and Dr Wolfgang Wodarg, a health policy adviser, raised the possibility that, since the vaccine (by design) causes the body to produce antibodies against the ‘spike proteins’ in the virus, it might also cause the production of antibodies against similar proteins which are required for formation of the placenta in pregnancy.
If this were the case, itwould result in vaccinated women essentially becoming infertile, an effect which might be permanent. No research studies have been undertaken on this issue, so it is this writer’s view that the vaccine has been rolled out much too early and with no knowledge of whether the hypothesis of Drs Yeadon and Wodarg is correct or incorrect.
The Moderna vaccine is also an RNA vaccine, so the same applies to that. The Oxford/AstraZeneca vaccine is designed to create the same result – the formation of antibodies against the Covid-19 virus – so they all have the inherent potential risk of causing infertility.
PCR testing and its use in the Pfizer trials
A positive PCR test result does not indicate infection, simply the presence of viral RNA, which might indeed indicate a current infection, but is more likely to indicate exposure to the virus some time ago, possibly many months. Every magnification cycle doubles the viral RNA so, after ten cycles it has been increased by 1024 times, after 20 cycles by over a million and after 40 cycles by over a trillion.
Therefore, the greater the number of cycles, the more likely one is to find what was originally only a tiny amount of viral RNA, and vice-versa. We do not know what PCR cycle counts Pfizer used in their trials, so we have no idea whether they might have manipulated the cycle counts to create their desired result and ‘prove’ that the vaccine was extraordinarily effective.
UK Government testing uses an extremely high cycle count of 45. Expert opinion (including from Anthony Fauci) is that, if a cycle count of ‘37, 38, even 36’ does not indicate the presence of a current infection, increasing the cycle count further is just finding ‘dead nucleotides’ and does not ‘represent infectious virus, only pieces of viral RNA’.
Safety in pregnancy
NHS and Public Health England (PHE) leaflets suggest that they are very worried about women of childbearing age having the vaccine. The leaflet warns that you should not be vaccinated whilst pregnant or if you are ‘planning to get pregnant in the next three months’. In addition, it warns that you can start the course of vaccines now, but ‘should avoid getting pregnant until at least two months after the second dose’ and that, if you do get pregnant, ‘you should delay the second dose until after the pregnancy is over’
The vast majority of couples who are trying to have a baby are ‘planning’ for that, hoping she will get pregnant quite soon. But they can be trying (or ‘planning’) for that joyful outcome for many months, even years, which would preclude all of these women from vaccination for the foreseeable future.
Except that care home staff, social workers and NHS staff are already being vaccinated. These are very likely to be women of childbearing age, but it appears that they are not being given the leaflet to read before being persuaded (which can often mean bullied) into having the vaccine.
It also warns that you shouldn’t be vaccinated if you are breastfeeding and that, if you were breastfeeding when you had the first dose, you should not have the second dose until you stop.
Since pregnant women, women trying to get pregnant and women who are breastfeeding are specifically excluded from the vaccine rollout, how will the Government obtain the ‘additional evidence’ which they tell us they need before allowing it to be used in the wider population?
Placebos
Almost everybody assumes that the placebo in a drugs trial is either a ‘sugar pill’ for an oral drug, or a saline solution for an injected medicine. This is very far from the truth.
In the Oxford AstraZeneca Covid-19 vaccine, the placebo was the meningitis vaccine, Nimenrix, which often causes a number of adverse reactions similar to those caused by the Covid-19 vaccine. It seems to me that a simple saline solution would have been a more sensible choice of placebo for such an important vaccine, but the UK Government has already ordered 100million doses.
Finally, however, we have some information on the placebo in the Pfizer trial: according to page 16 of the recently-released US FDA ‘Emergency Use Authorization’ document, it appears to have been saline. We are being required to accept that Pfizer didn’t misinform the FDA.
Non-medical staff administering the vaccine
The NHS list of people who will be allowed to administer the vaccine includes dental hygienists, dieticians, opticians, speech therapists, etc – i.e. anyone with anything even remotely resembling a ‘medical’ qualification. Normally only doctors, nurses and paramedics would be listed.
Everyone has to be trained but, given the very complicated instructions and warnings about how to administer the vaccine, it is alarming that people with essentially no medical experience will be do this and that they will apparently be expected ‘to assess individuals for suitability for vaccination, identify any contraindications or precautions, obtain informed consent and to discuss issues related to vaccination’ and be ‘competent in the recognition and management of anaphylaxis’.
That seems a tall order for many of those people and there seems to be far too much scope for error at just about every stage.
Political expediency might be driving early approval of the vaccine
The vaccine appears to have been ‘approved’ (not licensed) with unseemly haste. One might wonder, therefore, if the precipitous rollout was primarily (or solely) designed to recoup Mr Johnson’s support in the country and in particular stave off any challenge to his leadership?
