Module 4 Vaccines and Therapeutics, HART report Chapter 3

Days 5-8, 20th-23rd January

From HART member Dr Ros Jones

Day 5: Professor, now Sir, Chris Whitty, Chief Medical Officer

Chris Whitty’s statement was prefaced by the usual remarks from Hugo Keith KC: “So on, I think, a fairly sensible view, there was very considerable success in both programmes [Vaccines and Therapeutics] that the product of a vast and mount of work dedication and attention on the part of a very substantial number of government bodies entities, advisory committees, and scientists, epidemiologists, researchers, academics and the like, is that a fair summary?” to which the predictable reply, “it's a very fair summary and I think we should all pay huge tribute to the fact that not only the scientists in the UK and internationally and fry to the pandemic who worked on this many people as you say who came in to advise government from academia, from industry and elsewhere, but I think above all to the people who volunteered over a million people in the UK volunteered for clinical trials and other studies and that was what really drove this and it's that volunteer spirit which I think underlies many of the successes that you outline…It was an extraordinary logistical effort by the NHS and many others.”

During his time on the witness stand, Professor Whitty was asked about the process for advising on the vaccination rollout to healthy 12-15s. It was depressing to see no questioning about the calculations for their suggestion that a vaccine rollout could reduce school disruption and hence improve children’s mental health. This was covered in detail in the witness statement from the Children’s Covid Vaccines Advisory Council which was submitted to the Inquiry team months ago. As highlighted in our report, the CMOs’ calculations of 15 minutes school loss avoided per pupil, took no account of the time taken out of class to get vaccinated and more importantly no account of any time off school for vaccine side effects. It took Sajid Javid’s statement later in the week to reveal where the political pressure was coming from but surely it was up to Chris Whitty as Chief Medical Officer to highlight to the Prime Minister the low risk to children from covid-19 and the real potential for serious adverse events such as myocarditis, let alone any as yet unknown long term effects of mRNA technology vaccines.

As for vaccine mandates he said “My view is it was always one hundred per cent a political decision, but there was some clinical information that needed to precede it. But ultimately, it's about essentially balancing two risks and rights against one another: the risk to an individual who is highly vulnerable being cared for by someone who, because they haven't had a vaccine, then has an infection and then passes it on. So that's the risk to the person who is being cared for versus the risk to the individual that their right to essentially not have a medical procedure, or lose their job, is protected.” Fair enough, put like that it is an ethical and therefore a political decision, but the clinical input from the CMO should surely have included the high rate of natural immunity especially amongst health care workers, the poor efficacy of the vaccines especially as new variants came long, the lack of any RCT evidence regarding transmission, and the high rate of adverse events especially in younger people who make up a large part of the health and social care workforce. At least he could have provided some calculation of any plausible reduction in hospital acquired infections which might have arisen from a mandate offset against any poorer hospital outcomes resulting from low staffing levels arising from staff leaving their jobs. It was notable that Jenny Harris interviewed later in the day, also said she disagreed with mandatory vaccination.

Under questioning from UK Covid Bereaved Families for Justice, regarding therapeutics for children, Mr Whitty deplored that “the default has for many years been for many people who do trials, to exclude both pregnant women and children”. It seems that no-one at these hearings has ever read the Nuremberg Code or the Helsinki Declaration. One thing he did explain was one aspect of why children were different was in their risk benefit balance “I think this is a really important question, children were much less likely to have severe outcomes than adults. So for the same side effects …the risk-benefit for children in this particular infection is much less clear. So if you have a drug that had, let us say, a side effect rate of 1 in 100,000, the risk-benefit is less good for a child because actually the benefit is going to be smaller than it would be for an adult.”

Day 6:

Kate Bingham, the Vaccine Tsar

Kate Bingham is clearly a force to be reckoned with - someone who is very capable of knocking heads together and getting things done. Of course this leads to the groupthink assumption that what the Task Force achieved, which they undoubtedly did including being first in the world, was without question of overall benefit to the citizens of the UK. This is at the heart of the problem with the whole of Module 4. If a population-wide vaccine was really needed urgently because SARS-CoV-2 infection really was as lethal as suggested, and if indeed the vaccines produced had really been SAFE and, yes you’ve guessed it, really EFFECTIVE, then I might be joining in the applause. But this is where it all falls down.

Just as an example, Kate Bingham praised the size and duration of the trials, but neither she nor Hugo Keith, were aware that the removal of the control group was in contravention of advice from the International Coalition of Medicines Regulatory Authorities of which the MHRA is a member.

She did say something interesting about Valneva, the traditionally made vaccine which was due to be delivered in late 2021. She was critical of the "view was that, if the clinical advice is that the vaccine doesn't work, then we should terminate with immediately effect in line with the advice". She commented on the groupthink which was that once we had got Pfizer we didn’t need anything else. Perhaps she had an uneasy feeling about mRNA safety!

Charlet Crichton from UKCVFamily

At the end of the day, Charlet Crichton took the witness stand. Like Ruth Rafferty and Kate Scott, she showed great composure and clearly had put together a huge witness statement, which Mr Keith endeavoured to say he had read repeatedly.

Mr Keith was willing to discuss criticism of the MHRA, if not of the vaccines themselves. “Your members are concerned about the process by which vaccines were authorised for younger people. You're concerned about the state of public messaging, about the risks of adverse reactions, and as with a number of other similarly bereaved and injured groups, you want to know much more about how the MHRA responded to the emerging reports of the most serious conditions, like TTS, myocarditis, pericarditis, you've mentioned Guillain-Barré syndrome, and ME, myalgic encephalomyelitis” to which Charlet replied, “Yes, and in particular why the MHRA took such a long time in actually announcing the vaccine induced thrombocytopenia, thrombosis and thrombocytopenia situation to the public.” As she explained, a letter was sent to hospitals from Public Health England on 22nd March regarding management of VITT. Mr Keith: “And you're concerned that -- either that the MHRA knew about the condition a long time before that letter went out or that when the letter went out, it wasn't enough, there should have been more data given and more information given at that same time? A. Our concern is that we have members whose loved ones died in that period, and they feel that their loved one's death may have been prevented if the MHRA had been more public sooner.”

These concerns are similar to those expressed by Ruth Rafferty from Scottish Vaccine Injured Group, regarding one of their members who was “in hospital paralysed for months, and we discovered that she had the same diagnosis as a condition that appeared in the AstraZeneca trial. Had her doctors known that that had happened during the AstraZeneca trial, the trial was actually paused.” And Kate Scott from VIBUK who commented that her husband was only alive today because the doctor he first saw had received an information leaflet about VITT.

And of course, all three women were absolutely right that the information given out was too little, too late. The MHRA response was widely different from Denmark, who not only suspended AZ within 24 hours of their first death, but also notified health professionals and recent vaccinees of what symptoms to look for and what action to take.

Biologyphenom has gone into many questions from Charlet’s detailed written statement but whether Mr Keith has really read it seems unlikely, judging by his lacklustre questioning of June Raine the following day.

Day 7:

Dame June Raine

Dame June’s appearance was perhaps most notable for her failure to acknowledge the different manufacturing processes involved in the covid-19 vaccines.

HART’s Clare Carig has already written in detail about Process 1 and Process 2 in TCW Untested – the mass-produced covid vaccines that skipped clinical trials and this was followed by another critique by Nick Hunt from the Perseus group writing in the Daily Sceptic: Covid Inquiry Fails to Hold MHRA to Account (Again) so please read these. Nick Hunt’s article includes a letter he has written to Baroness Hallett to point out the inconsistencies in Dame June’s evidence. Of course it is the concerns regarding residual DNA contamination in Process 2, which have led to now over 22 countries in the NORTHGroup calling for a complete moratorium on mRNA-based vaccines. That she would not be aware that even with the vaccines rolled out to the public, the batch-testing does not include looking for DNA, seems implausible. Not looking is the easiest way to ensure not finding.

The experts: Professor Evans & Professor Prieto-Alhambra

Earlier on day 7 was a double act between Professor Stephen Evans, professor of medical statistics, and Professor Prieto-Alhambra, professor of pharmacoepidemiology. These were the two experts who were commissioned to undertake a review of the safety data. Between them and Mr Keith, they glossed over many of the inadequacies of the preclinical (no animal carcinogenicity or genotoxicity studies) and phase 1 studies (no human distribution or pharmacokinetic studies to check where the mRNA went, how much spike protein was produced and for how long, ie the standard measurements for most drug trials) and even for phase 3 trials, we were told follow-up was continued for 2 years, but not really explained that by then almost all the controls had received the vaccines too, so comparison was impossible.

Indeed Professor Evans said it would be unethical to enrol more patients into trials once a vaccine had been shown to be 'EFFECTIVE', but he seemed to have no problem with the ethics of effectively closing down the control arm before a vaccine had been shown to be 'SAFE'.

Professor Evans was asked about batch testing but no mention of how Process 2 for the mass rollout differed from Process one used in the trials. He also made a great play of the independence of the MHRA from government, but no mention of its dependence on pharmaceutical industry funding.

They were both asked about the overall impact of the vaccines in terms of lives saved, and Professor Prieto-Alhambra said among other things, “global analysis of mathematical models that take the estimate of how effective the vaccine is, and then compute how many lives were saved by the vaccines. There's many, many studies in that regard, and the most recent one says that the vaccines saved over 14 million lives globally”.

Their witness statements were not up on the website at the end of the day, so it was not possible to see which papers he was quoting. I did notice that Mr Keith repeated a frequent misleading quotation from an Oxford study on myocarditis, saying “that whilst there is a risk of myocarditis after vaccination, the risk was much lower compared to that seen following Covid infection in the unvaccinated. And, I should say, that's the conclusion of one particular study to which you refer.”

Prof Professor Prieto-Alhambra confirmed “That is correct. And I would say this study, in particular, by Patone et al, is probably one of the best quality studies on this topic.” What the study actually showed was: “In men younger than 40 years old, the number of excess myocarditis events per million people was higher after a second dose of mRNA-1273 than after a positive SARS-CoV-2 test (97 [95% CI, 91–99] versus 16 [95% CI, 12–18]).” I wrote to Dr Patone asking if she had a breakdown for younger age groups, since other studies had reported much higher risk in adolescence, but she was unable to provide me with this data, rather fundamental for “probably one of the best quality studies on this topic.”

More on this double act to follow!

Day 8:

Sajid Javid

One staggering admission by Mr Javid was that he had never heard of the Yellow Card scheme. This came from his written witness statement and was brought out by Anna Morris, KC for the Vaccine injured and bereaved groups. "You said in your statement when you were Secretary of State for Health that the Yellow Card Scheme was something that didn't come to your attention and therefore you couldn't answer the inquiry's questions about whether it was effective, and you couldn't make any observations about the scheme and how it could be improved.

My question is, then, how, then, was the government effectively monitoring adverse reactions if the Health Secretary, yourself, the individual responsible for overseeing the nation's health, was unaware of the primary tool designed for this purpose?”

Mr Javid looked visibly uncomfortable when he replied, “Yeah, thank you. It's a very reasonable question, of course, and what I would say -- so I wasn't aware of the Yellow Card, sort of, scheme, which I, you know, I understand is -- the scheme has been there for many years, in terms of if there is -- if someone suspects an adverse effect, they can report it especially to the MHRA and make sure obviously it is taken account of, but I think, just because a Secretary of State is not aware of a particular sort of system or process within the wider department, whether it's in the NHS or to do with the MHRA or the various other multiple bodies that fall under the department, doesn't mean to say it's not taken seriously or it's not happening”.

Ms Morris pushed the point and he rather lamely said that he assumed the system was working well, which is why no-one at the DHSC brought it to his attention. It was made very clear, however, that he was having daily briefings on vaccine uptake but receiving no daily or even monthly updates on adverse reactions.

It also highlights that if the Secretary of State (who given his enthusiasm for the public to be vaccinated, one might think had also received a dose or two himself) doesn’t know how to report an adverse reaction to their immunisation, then nor do the vast majority of citizens.

I think Amazon could have done a better job of delivering vaccines and then emailing the recipients within hours to request satisfaction ratings!

With a vaccine involving a totally new technology and with as yet no long-term safety data, rolled out on this scale, it would have been easy to give every patient a leaflet explaining the Yellow Card system or every 10th vaccinee could even have had a pre-addressed card to return at 28 days. But of course, information not sought is information not found.

More of Mr Javid’s and Professor Lim’s roles in children’s vaccinations to follow….