We Needed a Covid Inquiry – but this isn’t it.

Part 2

In November 2023, Carl asked in the Spectator, “What is the point of the Covid Inquiry? It should be to establish which parts of the government’s pandemic response worked, which parts didn’t, and what to do next time. Instead, it is a farce – a spectacle of hysteria, name-calling and trivialities.”

The tone of the inquiry has shifted away from a King's Counsel, seemingly preoccupied with reading inappropriate words in others' private messages. However, the latest module on vaccines reveals that the King's Counsel remains indifferent to substance, trust, and uncovering the truth.

Hugo Keith KC laid down the Inquiry’s position in his opening statement. 

“My Lady, the public health benefit of vaccination generally is beyond argument.  But the issue which arose, and it's the issue which lies at the heart of this module, was whether the MHRA properly assessed whether the benefit of a particular product -- of course the vaccines -- outweighed the risk.”

However, if public health vaccination's importance is indisputable, questioning whether the benefits truly outweigh the risks is inherently contradictory.

Mr Keith asserted that ‘the question was whether being vaccinated carried fewer risks than being unvaccinated, where there was a high chance of acquiring Covid, and where Covid was a life-threatening disease for many.” 

Yet, Mr Keith and his inquiry team have predetermined the answers to these questions —they are so sure you cannot disagree; they are “beyond argument.”

With his new-found authority, Mr Keith goes on to state that,  “During the Covid-19 pandemic, to increase efficiency and to progress the regulatory review in a shorter time, evidence in support of these authorisation applications was considered in an expedited and flexible rolling review procedure by the MHRA.”

Something that we would agree on. However, our MHRA papers series shows just how much secrecy, denial, and lack of proper analysis went on. 

The MHRA papers - comparison of the two sets of minutes

However, Mr Keith considers, “The expert evidence commissioned by this Inquiry is to the effect that there was no reduction in the efficacy or safety of any of the vaccines, or the trials, as a result of this process.”

We do not fully understand this statement. Mr Keith appears to be saying that after 50 years of developing robust methods to assess new drugs and vaccines, tried and trusted processes can be assigned to the bin. Mr Keith is a godsend for the global pharmaceutical trade—in months, we can develop and trial new vaccines without reducing their safety. So why bother with research evidence in the first place?

Yet, who gets to question Mr Keith? No one. 

Suppose they were able to question Mr Keith. In that case, they might ask him about the Japanese regulator's assessment, which found vaccine metabolites (in order of frequency) in the liver, spleen, and rat ovaries and smaller concentrations in most rat organs. The Japanese regulator considered Comirnaty to be a powerful drug, not a biologic, and that no carcinogenicity studies were conducted when the product was registered.

Exploring regulatory data sets of the Comirnaty vaccine - 9a

Mr Keith might ask about the role of two lipid nanoparticles, why the trial on pregnant women was so substandard, or the Kansas City Attorney General’s legal report that showed Pfizer used confidentiality agreements to conceal critical data relating to the safety and effectiveness of its COVID-19 vaccine.

Mr Keith's assertions are even more troubling when it comes to harms:

“My Lady, because clinical trials can only study a finite number of patients over a defined period, rare or very rare adverse reactions are unlikely to be identified by those trials.  The serious conditions for which there now exists published evidence suggesting an association with a Covid-19 vaccine were all either very rare, that is to say between 1 in 10,000 and 1 in 100,000, doses; or even rarer, described in places as extremely rare, that is to say less than 1 in 100,000 doses, and a reaction or a condition that only occurs in less than 1 in 100,000 people will simply not be apparent in a clinical trial involving only 30,000 people.  It will only become apparent when much higher numbers of people, for example, at a population level, are being vaccinated.”

Without cross-examination, Mr Keith can enter misinformation into the record without checks.  Someone might ask Mr Keith why two public bodies are at odds on the frequency of harm and about issues such as Bell's Palsy, which aren’t ‘very rare,’ occuring in 1 in 1000 individuals.

Who is afraid of Helen McArdle and James Jones?

Mr Keith says, "a reaction or a condition that only occurs in less than 1 in 100,000 people will simply not be apparent in a clinical trial involving only 30,000 people.” 

So, Mr Keith, what size of trial should have been done then?

If a new medication caused adverse reactions in 1 in 1000 cases, you need to study 3000 subjects (the rule of three) to have a 95% chance of detecting even one case.

The rule of three states that you need three times as many subjects to observe an event when you assume the adverse event of interest does not usually occur without the medication. So, Mr Keith, a trial of 300,000 subjects should detect an expected adverse event at a rate of 1 in 100,000 unless you biased the results by omitting to report the adverse events. 

Finally, Mr Keith turns to the indisputable effects of the vaccine.

“My Lady, by June 2021, Public Health England estimated that over 44,500 hospitalisations and over 14,000 deaths had been averted in older adults.” 

“The United Kingdom Health Security Agency further estimated in September 2022 that by September 2021, a year earlier, nine months after the rollout had begun, the Covid-19 vaccines had prevented more than 23 million infections and 123,000 deaths in the United Kingdom.”

But on TTE and in the Spectator, we reported, ‘In 2021, there were 667,479 deaths in the UK, 22,150 fewer than the 689,629 deaths in 2020. By our reckoning, the modellers want us to believe that in the absence of vaccination, there would have been 1,174,679 deaths in the UK in 2021.’ How do we think Mr Keith would answer this in a cross-examination? 

The Inquiry expert helped Mr Keith form his opinions. “The absolutely clear expert opinion of the leading pharmacoepidemiologist instructed by the Inquiry, Professor Prieto-Alhambra, from whom of course we will hear in due course, is that the vaccines, those three Covid-19 vaccines, were entirely effective.”

The expert's report (which discloses his conflict of interest with an Astra Zanca consultancy) states that ‘Early UK-based studies consistently showed that COVID-19 vaccines reduced the risk of transmission by nearly 50% among household members from index cases when the Alpha variant was dominant (Harris et al., 2021; Shah et al., 2021).’

The Harris et al. study is a letter published in the NEJM for a retrospective data linkage thing with so many holes in it that it cannot call itself a study, and its conclusion cannot stand. The case definition is absent, there is a lack of history (the letter reports that there were no ‘data on symptoms or cycle-threshold values’), follow-up of participants and absence of details on testing and viral load. 

Apart from that, Mr Keith, all is well. Unless he looked at the package inserts and what they hold about transmission? The MHRA, EMA, FDA, and Health Canada say nothing about transmission or post-exposure prophylaxis in the package inserts or the Summary of Product Characteristics. It was tested, but it wasn't approved for this indication, and the only evidence that suggests it prevented transmission was very low quality and, therefore, unreliable.

More on Crossed Harms

Based on unreliable evidence, Mr Keith  states, “That is to say that a person who is vaccinated is less likely to catch the virus, as well as infectiousness, ie the likelihood of passing it on.” Yet, if  Mr Keith had done his homework and found an expert who systematically reviewed the evidence (the Inquiry expert reports he didn't do any systematic reviews), he would have come across further actual studies that report ‘peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts.’

The inquiry is not set up to ask the critical questions. It could ask why the government spends more time reviewing cases than on vaccine damage claims; it could ask why the MHRA obfuscated when the signal for harm was clear; it could ask some of the questions the Kansas Attorney General posed on how Pfizer misled the public. TTE could go on -  the list of questions is long.

The Inquiry has shut down those giving evidence mentioning troubling truths and prevented cross-examination of witnesses, allowing the cherry-picking of evidence and misinformation. 

The projected costs exceed £200 million, making it the most expensive statutory inquiry to date. Yet, the inquiry is failing to learn the lessons of Covid: It is time to shut it down. Instead, we need an inquiry that asks difficult questions and reveals inconvenient truths. 

This post was written by two old geezers with few certainties, unlike Hugo Keith KC.