With the roll-out of the Pfizer/BioNTech vaccine set to begin early next week, after it received temporary authorisation from the Medicines and Healthcare Products Regulatory Agency, Kit Knightly has some burning questions to ask over at Off-Guardian. I quote from the piece and add some other sources:
Does it work?
The claim is that they are “95% effective”, but where did this come from:
The Pfizer vaccine trial included nearly 44,000 people. Half getting their vaccine, half getting a placebo. In total, from the 44,000 people, 170 were later recorded as having become ‘infected with COVID-19’. 162 of them were in the placebo group, eight of them in the vaccine group. The vaccine is therefore credited with preventing 154 cases of COVID-19… or 95%. This implies that the entire trial of 44,000 people is deemed a success based on the potentially multi-variant outcome from less than 4% of those involved. The details of the trial are hard to come by, so we have yet to find out how these 170 people were even diagnosed with COVID-19. Was it a clinical diagnosis based on symptoms? Or PCR test? Either method would raise serious questions about accuracy… Does it work? We have no idea.
The article Kit Knightly links to, by Peter Doshi in the BMJ, is worth reading on this. He writes that:
First, a relative risk reduction is being reported, not an absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of COVID-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly).
Peter Doshi recommends full, open and independent scrutiny of the underlying trial data in order to build confidence in its results and in the vaccine’s efficacy. It is hard to disagree. It is also worth remembering that Matt Hancock, one of the vaccine’s foremost advocates, conceded yesterday that it is not known how long immunity derived from the Pfizer/BioNTech vaccine will last.
Is it safe?
The potential for complications down the line certainly exists. Further, the vaccine is based on new technology – an mRNA vaccine, which injects viral genetic material to generate an immune response. The technology has been in development for years, but this would be the first mRNA vaccine actually put to use. So, “is it safe?” is “we don’t know”.
However, the vaccine pushers and manufacturers clearly have doubts about its safety, since they have gone out of their way to guarantee they have total legal indemnity from prosecution or civil suits should something go wrong. Not a confidence booster that.
Yesterday, a number of readers flagged up a newly-released Government document – “Reg 174: Information for Healthcare Professionals on Pfizer BioNTech COVID-19 vaccine“(pdf) – which contains some indications of how much about the vaccine is still unknown.
Summary of safety profile: “The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination.”
Paediatric population: “The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age have not yet been established”.
Incompatibilities: “In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.”
Pregnancy: “Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162v2 is not recommended during pregnancy. For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least two months after their second dose.”
Fertility: “It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.”
Not a confidence-booster that, either. Do read the full document.
Who will get it?
First on the docket are the elderly and NHS workers. We don’t know who will be excluded. Immunocompromised people were excluded from the efficacy study, so presumably they’ll also be excluded from taking the vaccine. If not, that’s a potential disaster waiting to happen (although they have legal protection, so I guess that doesn’t matter).
The question of the hour is: Who will take it first on live TV? Boris Johnson or Matt Hancock? Both are game, apparently, though of course neither wants to “jump the queue”. According to the Telegraph, care home residents will get the vaccine first. The Guardian reports that the staff of the NHS are no longer first in the queue.
Will it become mandatory?
It’s certainly a possibility here in the UK. A few months ago a group of scholars submitted written evidence to the UK Parliament that mandatory vaccinations would be defensible on a human rights basis, and that there was already legal precedent for this action in UK legislation (specifically, treating mental health patients who may be a danger to themselves).
In the end, and this is purely my speculation, I doubt the vaccine will ever be literally legally mandatory. Parliament will reject the “expert advice” suggesting COVID-19 vaccines be forced on people. This will accomplish two goals at once: a) It will give the Government a veneer of “libertarianism”, a thin façade to cover its tyrannical nature. And b) It will allow a potential “third wave” of COVID-19 to be blamed on “vaccine hesitancy”.
Mandatory vaccination and its ugly twin sister, the vaccine passport, are being talked up by a number of ‘think tanks’, most recently by the Tony Blair Institute for Global Change, which yesterday released a report – “How the Government Should Call the Shots: Getting the UK Vaccine-Ready“. Among other things, it recommended :
Urgently approve a digital platform for a health passport that can draw on vaccine and testing data to enable individuals to live freely and safely alongside COVID-19. This platform should also have a paper-based version.
No Tony. Just no.
A reader has been in touch about the ethics of the vaccination drive and the “warped behavioural logic” that underlies it. I’ll leave you with a few snippets from this correspondent’s remarks:
I feel that the Government is deliberately ramping up lockdowns and the fear factor, and will continue doing so probably at least until June, to worry as many people as possible so that they will rush for a vaccine and not ask too many questions. Whereas minor behavioural modification (“nudging”) might occasionally be desirable, inducing mass panic/hysteria (basically terrorising the public, as they have been doing since March) is unethical in the extreme and people should be called to account for it.
Whitty recently said don’t hug a relative at Christmas “if you want them to survive to be hugged again”, i.e., touch a relative and they will die. This for a virus that is as dangerous as a bad flu? SAGE gave the advice that people should not play board games at Christmas. This for a virus that is as dangerous as a bad flu? People are being told to wear masks because, if you walk past someone, you will kill them (remember the policeman on TV earlier in the pandemic screaming at a man walking down the road “You are killing people! You are killing people!”). How can you really make an informed choice after being bombarded in this way?
Is it ethical to push people into having an experimental COVID-19 vaccine that will not provide them with any benefit, for an illness which is no more dangerous than a bad flu? I’m sure that the Government will say that vaccination is necessary, to protect the older and more vulnerable. However, many in this group would die of something else if not COVID-19. You can’t stop people dying. You cannot justify mass mass vaccination on the grounds that it will save people who will die shortly anyway.
I will not have the vaccine if offered. My view may change in the future. Unlike the Government, I am open to other viewpoints. But I can see nothing in the current situation that justifies the mass vaccination of people, with an experimental vaccine, who are at little or no risk whatsoever – for a virus that is no more dangerous than a bad flu.
Stop Press: The MHRA has released the list of ingredients of the Pfizer/BioNTech vaccine. Along with the guidance for health care professionals referenced above, it is available here (scroll down for links and references).