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Our series on Pfizer’s Comirnaty vaccine was sparked off by a remark from one of our readers.
He is an eye doctor who saw an abnormally high number of cases of Bell’s Palsy during the months of the vaccine's rollout—perhaps we should say vaccines. Bell’s Palsy is a frightening progressive weakness of facial muscles, usually one-sided. Most cases recover, but some do not. At the time, we asked, “How would you like to go around with half your face hanging down and unable to see properly?”
We have summarised our series of posts on Comirnaty and ask you to refresh your memory before reading further. At the bottom of this post is a series of relevant pieces we have produced since TTE began.
The third of our summary posts wraps up how far we got:
We promised to keep tabs on any major step towards understanding the properties of Comirnaty, having identified some very large gaps in the evidence base.
One of the most contentious parts of the whole saga (apart from the mode of action) is the potential harms of the Covid vaccines. The Oxford AstraZeneca vaccine’s demise is a case in point.
In the post
we reported that in response to a 2022 FOI request on the number of Yellow Card reports for Bell’s Palsy over the previous three years (FOI 21-750), the MHRA responded:
After the table, the responders wrote:
All is well then, thanks to the “evaluation of electronic healthcare record data.” Please remember that.
However, the underreporting rate in the Yellow Card system can be as high as 98%. Anthony Haywood, a member of the public, asked a simple question:
“Dear Medicines and Healthcare Products Regulatory Agency, would you please supply your estimate of the degree of underreporting to your ‘Yellow Card’ scheme, and subsequently your estimate of the actual number of deaths and adverse events, likely to be related to the covid 19 vaccine, at least in the view of the injured party.”
The MHRA’s answer was interesting:
“The MHRA do not hold an estimate of the degree of underreporting to the Yellow Card scheme, nor an estimate of the actual number of deaths and adverse events, likely to be related to the COVID-19 vaccines.”
This is a contradictory statement given that the MHRA reported following up 54% of deaths possibly linked to this or the other Covid vaccines in answering an FOI request.
In the twilight of our neuronal function, we ask: If you do not have an estimate of possible linked vaccine-related deaths, how can you possibly know you are following 54%? Percentage of what we ask?
Of course, they do not have an estimate. They only licensed the stuff, so why on earth would they be interested in its effects?
Nah, you naughty old geezers, they are, they are. One of our subscribers (active lot, are they not?) drew our attention to this newly published preprint:
Oh wow! We thought: this is active surveillance of 30 thousand people who had at least one exposure to one of the Covid vaccines and were prepared to give feedback to MHRA. So we started reading.
First, the authors are employees of MHRA and declare no conflicts and no funding, so it’s intramural work by the “enabler” policing itself for the consequences of its actions. This is straight from the Berlusconi School for studying conflicts: everyone has them, so they balance each other out.
Second, surveillance ended at the end of 2022, so why so long for a pre-print?
Third, YCVM picked up two cases of Bell’s Palsy: one after the first exposure to the AstraZeneca vaccine and the other after a second exposure to Comirnaty. So that’s 2/30,000 over 18 months (0.0067%), which is not quite the same as 783/5 million over six months (0.016%). Standardising annually gives percentages of 0.0045% and 0.031%, respectively.
The difference in these small percentages might seem insignificant, but the MHRA appears to forget—or ignore—what happens when exposures are scaled up to a larger population. Applying to 1 million exposures would result in 45 versus 310 cases of Bell’s Palsy, respectively. Which is it to be?
It gets even more interesting as we move further along to Table 5. This table shows the self-reported seriousness of events after any dose or first dose. It took us some time to wade through this table and consider its implications.
We focussed on the life-threatening events and assumed the nonresponders who enrolled in the surveillance did not answer the MHRA because they were busy watching soccer, following Matt Hancock eating lizards, or were just bored. I.e., let’s just assume they were alive and did not fail to respond because they were six feet under.
Table 5 reports 22 life-threatening events in 15,764 exposures (0.14%). Again, this might not seem much, but it's worth considering what happens when you scale this up to the numbers that had the vaccines. We took the figure of 50 million as reported by the BBC to estimate that roughly 69,500 life-threatening events would occur, and in 50 million exposures, we would expect about 350K hospitalisations.
If the MHRA stands by its figures, they might help explain winter pressure and excess mortality.
A further noteworthy statement in the MHRA preprint is, “The YCVM is currently not automatically linked to other sources of health data; therefore, it is impossible to medically confirm self-reported ADRs reported through the YCVM.”
This was particularly important when adverse events of special interest such as GBS and Bell’s palsy were reported”. Does that mean MHRA cannot verify the report’s accuracy? If so, why such sweeping conclusions? And what has happened to the 4 billion IT contract the MHRA stipulated early on to facilitate the exchange of information?
We were also perplexed that the COVID-19 Vaccine Surveillance Strategy, published by Public Health England on 11 Jan 2021, stated: “We supplement this form of safety monitoring with other epidemiology studies, including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety.”
Which is it to be: we can’t link, or can we?
Finally, a pearl for all our Riddlers: on Table 7, ILI, or Influenza-like illness, is listed as a harm of the AstraZeneca vaccine, but it’s in good company. All the preceding signs and symptoms listed in the table are present in the ILI syndrome, so here’s a further non-infectious cause of ILI. Wham!
This post was written by two old geezers who need the figures checked please.
Readings
Covid-19 Vaccine Damage Payments Bill Volume 738: debated on Friday 20 October 2023, look at Columns 508-509.
Please also have a look at the frequency of diagnoses of Parkinson’s disease since the vaccine rollout. Is it just my impression, or are my vaccinated friends and relations developing it at an alarming rate at a younger age than expected?
It has taken so long for them to write this up that I had started to wonder if the MHRA had shelved their active surveillance project. So it is good to see it at long last and thanks so much for sharing.
In 2021 after the VITT issue I was so unimpressed by the quality/timing of early official communication on adverse events following immunisation (AEFI), that in my own practice I started to monitor AEFIs and yellow card reports. So not active surveillance as only looking at people who presented with symptoms (or died suddenly). Obviously this method also has limitations, not least that the cohort of unvaccinated people is too small to allow for statistical comparison, and there is the confounder of infection.
In our practice in the first year of vaccination we too had 2 patients develop Bell's palsy - one 2d after AZ2 (resolved), the other 9d after first Pfizer booster (3rd vaccine) - also resolved. The denominator by November 2021 for our vaccinated practice population was 16427 (4194 people receiving 1, 2 or 3 vaccines). So rate of Bell's Palsy per vaccine was about 2/16427 = 0.012%. One also had an unusual severe brachial neuritis/plexopathy 9d after AZ1, and other cardiovascular events, all quite unusual.
I note with interest the authors comments on tinnitus ('The number of patients reporting a tinnitus-related ADR in the YCVM was small, which emphasised the use of YCVM data in a supportive role in signal assessment and not in isolation as well as providing reassurance on the potential incidence rate.').
We yellow-carded one case of bilateral tinnitus 14d after a Pfizer booster which could be classed as clinically severe/potentially life changing (high pitched noise in head like a continual shrieking). So it might be small numbers but that doesn't detract from the potential seriousness of the issue for the individual. Another developed tinnitus after the 2nd AZ vaccine which lasted at least 6m and also had Covid pneumonia 'in the waning' of (5m after) the 4th vaccine as well as flu-like illness 24h after the 5th and 6th vaccines. It is testament to the success of the vaccination marketing strategy that people continue to risk a couple of days in bed for a vaccine that has manifestly failed to provide enduring protection against severe infection (of course, it would have been worse...).
For completeness, it is worth noting that two others developed tinnitus associated with fatigue +/- vertigo post Covid INFECTION, but both had been vaccinated multiple times already (one had at least 3 symptomatic covid infections and a temporally unrelated unprovoked thromboembolism - incidentally any suggestion of such a VTE being vaccine-related would instantly be dismissed because no temporal link, but to suggest a relationship to Covid infection would be considered an acceptable hypothesis, such is the nature of long covid).
If we look at vertigo separately we see one person having acute severe vertigo 8d after AZ1 (investigated for TIA). Another severe vertigo and vomiting 5d after AZ1 (resolved) then myocardial infarction within 3m of AZ2. Another vertigo and an odd gaze palsy 2m after AZ1 (resolved) with angina and later other haematological health issues. Another unstable angina with associated vertigo 7d after Pfizer booster Another Giant Cell Arteritis with flu like symptoms starting 3d after 2nd AZ and later vertigo after the 6th vax (Pfizer).
Some of these presentations stand out as being quite odd little clusters of similar illnesses. Given what we now know, it would seem hasty to exclude causality where overlapping health themes emerge in a short time frame (tinnitus, vertigo, neuropathies, fatigue, vascular phenomenon/vasculitides/thromboembolisms, immune suppression/infections, haematological malignancies etc), especially given some of the unexpected properties of the new technology.
I do accept that with this approach/perspective there is a significant risk of seeing patterns where none exist (https://en.wikipedia.org/wiki/Apophenia) and active surveillance is superior if comprehensively followed up. In my defence it was deemed perfectly acceptable for us to see patterns in 2020, with an explosion of case reports/case series linking Covid infection with a wide range of autoimmune, haematological, neurological and cardiovascular issues (some quite similar to a range of reported AEFIs). I find it remarkable that the bar for causality is set so much higher for a drug than for a virus, and that it continues to be taboo/feel risky to discuss these issues openly.
I do also wonder about those non-responders in the MHRA active surveillance study, especially given that 'only 4,134 (13.7%) reported an event considered medically serious'. Surely in this day and age we could link the MHRA active surveillance system with a few selected GP practices so that the non-responders can be followed up to ensure they didn't for example all die or have debilitating strokes?