‘ . . . the whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, most of them imaginary’ – H L Mencken
THIS article follows on from my original piece in The Conservative Woman last week which discussed a large number of concerns which I have with the precipitous UK rollout of the Pfizer vaccine. This follow-up stands on its own, but is best read after the first article.
Pfizer have no idea if the vaccine can prevent symptoms or transmission
I wrote in my original article that ‘the trials for this vaccine . . . were not designed to test if the vaccine can reduce severe COVID-19 symptoms, ie hospital admissions ICU admission or death. The trials were also not designed to test if the vaccine can interrupt transmission.’
Detailed examination of the very long Pfizer briefing document for the US Food and Drug Administration (FDA) prior to their approval of the vaccine confirms that Pfizer have no idea whether their vaccine can have an impact on either symptoms or transmission.
Reduction in deaths is simply ‘likely’ (how likely?) and the vaccine ‘may be able to’ (or may not, presumably) have an effect on controlling the pandemic:
‘A COVID-19 vaccination program implemented soon can likely prevent many deaths. A highly effective vaccine, with sufficient uptake as supplies become available, may be able to induce population herd immunity to bring the pandemic under control’ (page 74) [my emphasis in bold].
As I have already pointed out: ‘These are the very things which the public thinks the vaccine is protecting them from – severe symptoms, death and/or transmission of the virus – so it is clear that the Government is foisting a substantially untested vaccine on us under completely false pretences.’
The vaccine is being rolled out too late
In the FDA document, Pfizer make it very clear that the ‘vaccine must be introduced before the peak of reported cases to have a significant impact on the pandemic course’ (page 74 again) [my emphasis in bold].
Whether or not the figures on ‘cases’ are 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 12. The peak of UK deaths (again, subject to uncertainty as to whether these are deaths directly from Covid-19 infections) was on April 21.
So, based on the Government’s own data and Pfizer’s opinion, there is no medical or epidemiological justification for introducing any vaccine at this point. We have to assume that Pfizer also gave that opinion to our own Government, so why are we spending a vast amount of taxpayers’ money on a vaccine that will have no impact on the course of the pandemic?
The answer simply appears to echo the point in my original article that vaccines are being introduced solely for political purposes.
More on mRNA vaccines
A December 12 article by Dr Frank Shallenberger echoes my concerns about the RNA vaccines from Pfizer and Moderna:
‘The mRNA molecule is vulnerable to destruction. So, in order to protect the fragile mRNA strands while they are being inserted into our DNA they are coated with PEGylated lipid nanoparticles. This coating hides the mRNA from our immune system which ordinarily would kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Because of their effect on immune system balance, several studies have shown them to induce allergies and autoimmune diseases. Additionally, PEGylated lipid nanoparticles have been shown to trigger their own immune reactions, and to cause damage to the liver.
‘In November 2020, Dr Peter Jay Hotez said of the new mRNA vaccines, ‘I worry about innovation at the expense of practicality because they [the mRNA vaccines] are weighted toward technology platforms that have never made it to licensure before.’ Dr Hotez is Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine, where he is also Director of the Texas Children’s Hospital Center for Vaccine Development.’
An investigational vaccine
The Pfizer briefing document for the US FDA refers in the Executive Summary (page 8) to its being an ‘investigational vaccine’:
‘Pfizer and BioNTech submitted an Emergency Use Authorization (EUA) application for an investigational vaccine intended to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2’.
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:
‘Any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the COVID-19 mRNA Vaccine BNT162b2. A second dose of the COVID-19 mRNA Vaccine BNT162b2 should not be given to those who have experienced anaphylaxis to the first dose of COVID-19 mRNA Vaccine BNT162b2.’
This warning was not 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.
Why did our government not mention this and 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.
Safety in pregnancy
The NHS and PHE information leaflet for women of childbearing age suggests they are very worried about women taking the vaccine:
‘A guide to COVID-19 vaccination
‘All women of childbearing age, those currently pregnant, planning a pregnancy or breastfeeding
‘You must read this before you go for vaccination’
This is in contrast to their attitude – whether it be mendacity or a cavalier disregard for the truth – regarding the flu vaccine, where the manufacturers state that the vaccine has not been tested in pregnancy, but the NHS/PHE breezily assert that it ‘can be used in all stages of pregnancy’.
So NHS warnings about taking the Pfizer vaccine in pregnancy have to be treated very seriously.
These are the warnings in that leaflet:
· if you are pregnant you should not be vaccinated – you can be vaccinated after your pregnancy is over;
· if you think you may be pregnant you should delay vaccination until you are sure you are not;
· if you are planning to get pregnant in the next three months, you should delay your vaccination;
· if you know you are not pregnant you can start the two-dose course now and you should avoid getting pregnant until at least two months after the second dose;
· if you have had the first dose and then become pregnant you should delay the second dose until after the pregnancy is over;
· If you are breastfeeding you should wait until you have finished breastfeeding and then have the vaccine. If you were breastfeeding when you had the first dose you are advised not to have the second dose until you have finished breastfeeding.
That third point applies to the vast majority of couples who are trying to have a baby – they are ‘planning’ to have a baby, in that they are hoping she will get pregnant quite soon. That will be a rolling three months, which might turn into a year and then might turn into IVF treatment for the increasing number of women who are having trouble with fertility.
The NHS Patient Group Direction (PGD) for administration of the vaccine has a list of nine prioritised ‘risk groups’; the lowest (therefore last to be vaccinated) group is ‘All those 50 years or over’, which means that there are actually no plans to vaccinate women of childbearing age. So the only women for whom that leaflet is relevant are those who are defined as ‘clinically extremely vulnerable’ (priority 3) and ‘with underlying health conditions which put them at higher risk of serious disease and mortality’ (priority 6).
Except that priority 1 includes care home staff and priority 2 incudes ‘front-line’ health and social care workers. These are very likely to be women of childbearing age, so I fervently hope that all female care workers, social workers, nurses, doctors and paramedics are being given that leaflet before being persuaded (which can often mean bullied) into having this vaccine which is completely untested in pregnancy.
This seems unlikely in this febrile atmosphere of fear and panic: young women will be vaccinated (because they want to ‘do the right thing’) and then get pregnant. And we have absolutely no idea of the consequences for their health, nor for the health (or survival) of their babies.
The PGD document is also full of warnings about pregnancy, including, on page 17:
‘ . . . routine questioning about last menstrual period and/or pregnancy testing is not required before offering the vaccine. Those being invited for vaccination should be able to access the advice in the leaflet COVID-19 vaccination: a guide for women of childbearing age, pregnant, planning a pregnancy or breastfeeding and their understanding checked as part of the consent process.’
So how do these untrained ‘vaccinators’ work out whether a woman is of childbearing age? Should they just create enormous bottlenecks at the vaccine centres, whilst they hand out the pregnancy leaflet to any woman who looks remotely like she might be of childbearing age and then wait whilst she reads it?
The government has unintentionally manoeuvred itself into a tight spot here:
‘This advice is precautionary until additional evidence is available to support the use of this vaccine in pregnancy and breastfeeding. It may then be possible to have the Pfizer-BioNTech vaccine. Until that advice is changed you may be able to have one of the other COVID-19 vaccines that are expected.’
But since pregnant women, women trying to get pregnant and women who are breastfeeding are specifically excluded from the vaccine rollout, how will they obtain this ‘additional evidence’? All eyes are on the drug firms, so they are unlikely to be able to pay women in Bangladesh or Kenya to take part in a trial without this neo-colonial exploitation of the Third World getting out. In any case, this would have to be a complex multi-cohort study: pregnant; not pregnant; pregnant within two months; pregnant within three months; breastfeeding; not breastfeeding; all of these cohorts after one dose and after two doses, etc.
So regarding the concern in my original article that compulsion might creep in through the back door, it looks like pregnant women might be the people who can save the world from vaccine compulsion. My Christian friends might note, with Christmas approaching, that this is not the first time a pregnant woman has saved the world!
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.
Every published drugs trial discloses the placebo used and will normally leave health researchers like this writer wondering what on earth they had in mind when they chose it. Often the placebo is another unrelated vaccine, a previous version of the vaccine being tested, or an ingredient in the vaccine which is known to create its own adverse effects (aluminium being the most glaring example of this). But these supposedly rigorous, supposedly scientifically-based vaccine trials are classified as the foundational ‘evidence’ on which the jerry-built edifice of so-called ‘evidence-based medicine’ has been constructed.
Fundamentally, it is incorrect – and naïve – to assume that pharmaceutical companies can be trusted to provide us with valid data on which to make decisions about safety or efficacy of their drugs/vaccinations and, in particular their, at best, strange choice of placebo.
The general reader sees only ‘as safe as placebo’ and has in their mind that it is as safe as something inert and that the drug has no adverse effects (which we might view as the desired deception). When the placebo is another drug, or a potentially harmful ingredient in a vaccine, ‘as safe as placebo’ means just that, and no more.
In the Oxford AstraZeneca Covid-19 vaccine, the placebo (often, incidentally, now called the ‘comparator’) was the meningitis vaccine Nimenrix (source: September 25, 2020, Parliamentary Question from French MEP Michèle Rivasi to the EU Commission).
Ms Rivasi’s question was as follows: ‘The Commission has pledged to purchase 300million doses of the ChAdOx1 vaccine produced by AstraZeneca (AZN). However, it appears that the clinical trials conducted by AZN to ascertain the side-effects of the vaccine do not comply with the standard protocol followed by pharmaceutical companies to verify the efficacy and safety of medicinal products. Instead of using a control group of test subjects injected with a saline solution as a placebo, the AZN clinical trials use injections of the meningitis vaccine Nimenrix (Pfizer).
‘Any vaccine may have undesirable side-effects. On what grounds does AZN operate differently from other laboratories and why does it use a meningitis vaccine for its control group? How could the Commission pay AZN while the latter’s clinical trial protocol does not comply with established standards?’ [my emphasis in bold].
It would be useful for us to have comments on those points from the MHRA, NHS and/or the UK Government, since they have already ordered 100million of doses of this inadequately tested vaccine.
Nimenrix certainly seems a very odd choice for a placebo, given that the possible ‘very common’ (defined as 10 per cent and upwards) adverse reactions include: drowsiness, headache, fever and fatigue, whilst ‘common’ (defined as between 1 per cent and 10 per cent) adverse effects include diarrhoea, vomiting and nausea.
So the use of this vaccine as a placebo will conveniently produce an ‘as safe as placebo’ conclusion for a wide range of adverse effects from their Covid-19 vaccine. It seems to me that, for a vaccine which the whole world has been anxiously awaiting for many months, prudence should have dictated the use of a placebo which has been demonstrated to have no such reactions, preferably a simple saline solution?
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.
I suppose we just have to hope that Pfizer didn’t misinform the FDA.
PCR cycle counts – a smoking gun for the Pfizer vaccine?
Information has come to light (via my correspondent Derek Reynolds) about a discussion in the July 16 episode of a podcast called ‘This Week in Virology’, in which Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, directly responded to a question about COVID-19 testing, specifically how patients with positive tests might determine whether or not they are actually infectious and need to quarantine:
‘What is now sort of evolving into a bit of a standard’ is that ‘if you get a cycle threshold of 35 or more . . . the chances of it being replication-confident are minuscule.’
‘It’s very frustrating for the patients as well as for the physicians’ when ‘somebody comes in, and they repeat their PCR, and it’s like [a] 37 cycle threshold, but you almost never can culture virus from a 37 threshold cycle.’
‘So, I think if somebody does come in with 37, 38, even 36, you got to say, you know, it’s just dead nucleotides, period.’
Vincent Racaniello, the Higgins Professor at Columbia University’s Department of Microbiology and Immunology and the host of ‘This Week in Virology’, echoed Dr Fauci’s remarks: ‘I agree that in general, Ct values over 36 do not represent infectious virus, only pieces of viral RNA.’
Page 22 of the NHS document ‘Guidance and standard operating procedure – COVID-19 virus testing in NHS laboratories’ shows us that the required PCR test cycle count in the UK is 45, which is massively high.
As Professor Racaniello put it, a cycle count above 36 does not ‘represent infectious virus, only pieces of viral RNA’, or ‘dead nucleotides’, to quote Dr Fauci. (Credit again to Derek Reynolds for uncovering this information).
So much for the ‘second wave’ of infections, then.
It might be this which is the smoking gun for the Pfizer vaccine – not the six deaths in the trial, four of which were in the placebo group, nor the placebo, which appears to be saline. If they used a cycle count of 45 (and why would they not, since the UK and presumably other governments are using this), those infections which they noted might well have not been Covid-19 cases at all. And there would have been ample opportunity to adjust cycle counts at will (as I discussed in my original article), in order to achieve that massive success rate of 90-95 per cent.
Immunosuppressed people
The ‘Information for Health Professionals’ document (see above) specifically notes: ‘No data are available about concomitant use of immunosuppressants’. However, immunosuppressed people are in their long list of ‘at risk’ groups (see Patient Group Direction, page 23), where they specifically refer to drugs they might be taking. So are this group of people being put at risk in order to provide this data?
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 completely unheard of with a vaccine which is approved for mass usage. This looks like peer review by social media.
Non-medical staff administering the vaccine
The PGD (see above) raises concerns in my mind, primarily that the people who they will be allowing to administer it includes dental hygienists, dieticians, opticians, speech therapists, etc, etc – i.e. anyone with anything remotely resembling a ‘medical’ qualification:
· nurses and midwives registered with the Nursing and Midwifery Council (NMC);
· pharmacists registered with the General Pharmaceutical Council (GPhC);
· chiropodists/podiatrists, dieticians, occupational therapists, orthoptists, orthotists/prosthetists, paramedics, physiotherapists, radiographers and speech and language therapists registered with the Health and Care Professions Council (HCPC);
· dental hygienists and dental therapists registered with the General Dental Council;
· optometrists registered with the General Optical Council.
Obviously, they have to do the e-learning programme or ‘locally provided training’ but, given the very precise (and very complicated) instructions and warnings about how to administer the vaccine (contained in the ‘Information for Healthcare Professionals‘ document, it is alarming that people with essentially no medical experience will be allowed to administer it.
Amongst other requirements, ‘practitioners’:
· must be competent to assess individuals for suitability for vaccination, identify any contraindications or precautions, obtain informed consent and to discuss issues related to vaccination;
· must be competent in the correct handling and storage of vaccines, and management of the cold chain;
· must be competent in the recognition and management of anaphylaxis.
That seems a tall order for many of those people who, essentially, have no medical training at all, and note that they must be competent in ‘management’ of the very complicated cold chain for this vaccine (see ‘Storage’ on page 14), not just be handed thawed and correctly diluted vaccine doses by a doctor or nurse.
There is too much scope for error at just about every stage and no indication of what danger there is if, for example, the saline-diluted vaccine is not ‘an off-white suspension’, is ‘discoloured’ or if it ‘contains particulate matter’. How ‘off-white’ does it have to be? What do they mean by ‘discoloured’? ‘What type of ‘particles’ are we looking for? What might happen if you mistakenly shake the diluted dose, instead of ‘gently inverting it 10 times to mix’.
Does an error in following these instructions (or the complicated storage temperature requirements) make the vaccine ineffective or unsafe, or both? This looks like a multitude of accidents waiting to happen.
Contrast this with, for example, the PGD for administration of a wide range of childhood vaccinations: diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b and hepatitis B vaccine (DTaP/IPV/Hib/HepB) which only has nurses and paramedics listed, with a similar list of requirements, including:
· must be competent to undertake immunisation and to discuss issues related to immunisation;
· must be competent in the handling and storage of vaccines, and management of the cold chain;
· must be competent in the recognition and management of anaphylaxis.
Note that the first of those is much less stringent than what these hastily enrolled non-medical staff will be required to undertake for the Pfizer Covid-19 vaccine, whilst the ‘cold chain’ pretty much amounts to taking the vaccine out of a fridge and making sure it hasn’t been at room temperature for more than eight hours.
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The reply to all our criticisms of rolling out an untested vaccine with unknown health consequences or enabling dental hygienists, speech therapists and dieticians to administer the vaccine would probably be: ‘We are in the middle of a health emergency.’ So what? So we have to cut corners?
The trouble with introducing any measures when we are in panic mode is that decisions will be ill-conceived, badly thought out and generally fraught with peril.
And it is us – the unsuspecting, docile and trusting general public – who will suffer if any of those decisions turns out to have been wrong.
What sort of a world are we creating here, with all the compulsions and rules we have had to put up with since March and now being expected to flock to the vaccination centre temples to take part in a covert trial of a substantially untested vaccine?
I am reminded so often these days of this quote by Gabrielle Palmer, from her ground-breaking book, ‘The Politics of Breastfeeding’:
‘They will end up destroying our planet and making us believe their wasteland is what we want.’
