TCW | 5 July 2022
EASILY missed in the latest Medicines and Regulatory Healthcare products Agency (MHRA) Yellow Card Report is its plan to reduce its updates from weekly to just once a month from August. Either chief executive Dr June Raine and her team have grown accustomed to being paid to have time off as the country’s toll of vaccine victims mounts, or they have no taste for this particular task.
It is moot whether this fast-developing ‘drugs regulator for hire’ is fit to carry out this monitoring job at all. Seventeen years ago it stood accused of losing sight of ‘the need to protect and promote public health above all else’ as it sought to win ‘fee income’ from the drugs companies. Today, those fees dominate its income. But there is worse. The appalling quality of its Covid vaccine Yellow Card reporting, plus its consistent failure to respond to the urgent concerns of top doctors and scientists, betray not just a low prioritisation, not just a ‘standard’ conflict of interests but, given its advocacy of crony capitalist mRNA biotech minimally tested novel vaccines, an unauthorised change of role in direct conflict with its regulatory purpose.
Speaking at her Oxford alma mater six weeks ago, June Raine openly boasted of her transformation of the MHRA from a watchdog to an ‘enabler’, wonderfully catalysed by the Covid pandemic. An enabler of what? Experimental gene therapies that bypass traditional testing protocols? Her speech which I will comment on in detail tomorrow in these pages is deeply concerning. It exposes her as a fully signed-up Covid cultist or fanatic who believes that Oxford University’s research has saved millions of lives – presented as a given, requiring no proof for which there is none. In it, without conscience, let alone second thoughts, she boasts explicitly of her unilateral decision to ditch the MHRA’s watchdog role and the opportunity Covid presented to tear up the rulebook on efficacy standards. Seemingly oblivious to the AstraZeneca vaccine’s withdrawal by several countries following thousands of reported adverse events and fatalities, she recounts its rollout as a triumph for science. Just weeks later, as if to underline this newly self-appointed ‘enabling role’, we find the once watchdog cheering on another experimental gene therapy, this time for polio.
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Perhaps we should not be surprised therefore that its latest Yellow Card report is most notable for denying that its own vaccine fatality data has any meaning, though by MHRA admission these statistics are massively under-reported. That perhaps is why, although reported fatalities had reached 2,191 by June 15, the update tells us so little about them. It was for this reason I commissioned an analysis of the data that can be gleaned from the published regulatory agency adverse event tables.
This shows that fatalities reported by vaccine type are 794 (Pfizer) + 1,287 (AZ) + 62 (Moderna) + 48 (Unknown) = 2,191 (including six suicides). But what of the vaccines’ relative risk? Is one more to blame than others? To answer that requires a fatality reporting rate. The MHRA is, conveniently, not interested. It states ‘that Yellow Card data cannot be used to derive side-effect rates or compare the safety profile of Covid-19 vaccines as many factors can influence ADR reporting’.
Don’t the public have the right to know which factors exactly are so different between brands?
It is not so much the inadequacy of the MHRA’s data collection that is the problem, it is the lack of investigation of the data and hence the lack od meaningful reporting that is the issue. They do not reveal, for example, whether or not the child and booster related figures are included in or excluded from certain totals, or whether there have been any child or booster related fatalities. It could insist on this information breakdown. Instead they provide very little from which to draw conclusions that would enable healthcare professionals and the public to make an informed consent decision of risk.
All that can be calculated from the data provided is fatality per dose:
· Pfizer – 81.9m doses – 794 fatalities = 1 in 103,149
· AZ – 49.06m doses – 1,287 fatalities = 1 in 38,120
· Moderna – 12.5m doses – 62 fatalities = 1 in 201,613
· Brand Unknown = unknown
This doesn’t account for some people having one dose and some having four doses, or the booster being a different brand and so on. The overall fatality rate may well be higher per person injected.
What is strikingly clear however is that fatalities associated with AstraZeneca are markedly higher than for the other vaccines, a trajectory that surely could have been spotted prior to the administration of all 49million doses. Yet not only has this vaccine not been withdrawn (it is simply not advised for younger age groups), astonishingly 100 AZ boosters were reported to have been administered since the previous week’s reporting. Could this blindspot be anything to do with Dr June Raine’s enthusiasm for Oxford’s role in fighting the Covid plague?
The MHRA is also less than transparent about the adverse event ‘categories’ most associated with the fatalities. Again, we had to dig into the regulatory adverse event data tables to find this. Most fall into a conveniently designated ‘General’ category – a lucky dip of multiple organ dysfunction and failure, sudden death, sudden cardiac death and more. The top categories for each vaccine are listed below:
Pfizer
250 ‘general’ disorders
164 cardiac disorders
120 infections
95 nervous system disorder (which includes Guillain-Barré syndrome, paralysis, seizure, brain injury, brain stem haemorrhage, transient ischaemic attack)
67 respiratory disorders
AstraZeneca
405 general disorders
237 nervous system disorders
209 cardiac disorders
149 respiratory disorders
116 infections
79 vascular disorders
Moderna
30 general disorders
12 cardiac disorders
5 nervous system disorders
Unknown Brand
16 general disorders
8 cardiac disorders
7 respiratory disorders
A complete set of tables for all categories relating to each brand can be found in this associated PDF.
What the MHRA does do is denial. In fact it presents a masterclass in this art in its section ‘Comments on safety in specific populations’. Under the sub heading ‘Safety of Covid-19 vaccines in pregnancy’ it says: ‘Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant. Reports of miscarriage and stillbirth are also low in comparison to how commonly these events occurred in the UK outside of the pandemic.’ This rather brutally implies that since women commonly have miscarriages anyway it doesn’t matter if the vaccines cause a few more.
‘A few reports of commonly occurring congenital anomalies and obstetric events have also been received’. So nothing to worry about here either: ‘There is no pattern from the reports to suggest that any of the Covid-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage, stillbirths, congenital anomalies or birth complications.’
Really?
How about that in addition to the 20 stillbirths and foetal deaths recorded among the fatalities for all brands, to the week ending June 15, there’s an overall total of 495 spontaneous abortions (Pfizer) + 236 (AZ) + 71 (Moderna) + 7 (Unknown) reported – a hardly insignificant 809 miscarriages recorded in total. All to be discounted, apparently, though this number has grown significantly in the six months since Sally Beck investigated vaccine related reproductive problems for TCW in January.
And what evidence is given of these very sad cases being thoroughly investigated and definitively found to be unrelated to the vaccines? None. And why is no age data provided for example, greater than 24 weeks gestation up to neonate? (MHRA do define stillbirth as greater than 24 weeks, and a miscarriage is less than 24 weeks’ gestation.)
Apart from just one identified fatality ‘disorder category’, shockingly no specific or across the board age breakdown data is provided at all. This exception is 81 fatalities ‘from thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts)’ noted in the section ‘Comments on specific safety topics’, and quoted as accepted fatalities, not ‘suspected’, received for the Covid-19 vaccine AstraZeneca. They are set out by age in Table 6, the large majority under 70 years old and 32 of them between 18 and 49. 32 (Pfizer) Yellow Card reports of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) are also identified for 13 females, and 18 males between the ages of 18 to 91 years, (no age breakdown provided) with an overall case fatality rate of 13 per cent and four deaths reported.
There is no mention in the summary text of the three other categories that have related fatalities recorded in the vaccine brand pdfs under these headings:
· Anaphylactoid reactions recorded with related fatalities – 2 (Pfizer) + 2 (AZ)
· Immune thrombocytopenia recorded with related fatalities – 1 (AZ) + 3 (Brand Unknown)
· Guillain-Barré syndrome recorded with related fatalities – 2 (Pfizer) + 5 (AZ)
Shockingly despite more than 4,000 Yellow Card Reports now filed for children (under 18s) – 3,857 for Pfizer and 264 for AstraZeneca – no details are disclosed as to their nature. Are we supposed to take the MHRA’s word when it says they mirror those in the general population? Yet this is put into serious doubt by the discussion text under ‘Suspected side effects reported in individuals under 18 years old’ section, in which myocarditis and pericarditis are the only and key child related conditions that the MHRA specifically highlights.
Even more culpably the MHRA provides no age-related data for these adverse events, nor for the six separately and untabulated but identified ‘fatal suspected’ myocarditis or pericarditis events associated with the Pfizer/BioNTech vaccines or for the five fatal events associated with the AZ vaccine, both reported in a later section. Yet a special warning to alert healthcare professionals of the risk of myocarditis and pericarditis in children is given in the drug formulation documents for Pfizer for 12 years and over dose – and 5-11 years dose which raises the question of whether any or all of these 11 deaths have, in fact, been in the under-18 age group.
The MHRA in response to questions on these specific cases has said it has no more information to relay. Yet it is notable that some worrying cases of sudden unexplained death in teens have been reported in the media this year. Also of concern is an ONS identified spike in male teen deaths in 2021 which the MHRA insists was ‘administrative’ and due to delayed death reporting.
In conclusion their discussion of the 2191 fatalities can be summed up as an exercise in discounting evidence. They assert that the majority of these reports are in ‘elderly people or people with underlying illness’ yet nowhere have they provided any supporting data for this assertion.
They also suggest these deaths are inevitable: ‘Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within seven days of the many millions of doses of vaccines administered so far, mostly in the elderly.’
Surely, though, if an elderly individual was expected to die within seven days it would generally be obvious, and a vaccination would likely be clinically inappropriate. Hence, common sense would suggest that an unexpected death of any cause within seven days of a vaccine warrants very careful investigation for indications of linked accelerated exacerbation of a condition or direct side-effect causation from the vaccine administration.
Not on Planet MHRA.
Then, finally, they essentially denounce the whole Yellow Card reporting of fatal events, saying that ‘a temporal association with vaccination’ does not mean that there is a link between vaccination and the fatalities reported, and that ‘the pattern of reporting for all other fatal reports does not suggest the vaccines played a role in these deaths’.
Such denial is surely the most incredible extrapolation from the facts ever. It makes no clinical sense and is at odds with the mounting evidence globally of vaccine fatalities, elevated risks in younger age groups (most notably the highly significant myocarditis risk), and of suppressed immune system response.
Our full MHRA yellow card reporting summary breakdown to June 15, 2022 (data published 24th June 2022):
Adult – Primary & Booster/Third Dose, Child Administration
Primary doses
Pfizer – 27million people – Yellow Card reporting rate – 1 in 157 people impacted
Astrazeneca – 24.9m people – reporting rate – 1 in 101 people impacted
Moderna – 1.7m people – reporting rate – 1 in 43 people impacted
Overall 1 in 117 people injected experiences a Yellow Card Adverse Event, which may be less than 10 per cent of actual figures according to MHRA.
Total doses including boosters administered – 81.9m (Pfizer) + 49.06m (AZ) + 12.5m (Moderna)
1st doses = 53,547,255 (all brands)
2nd doses = 50,081,461
Boosters = 39,874,186 (30.5m Pfizer, 57,700 AZ & 9.3m Moderna)
TOTAL = 143,502,902 doses
Booster Yellow Card Reports – 31,646 (Pfizer) + 576 (AZ) + 17,970 (Moderna) + 201 (Unknown) = 50,393
Reactions – 494,329 (Pfizer) + 870,093 (AZ) + 130,851 (Moderna) + 5,378 (Unknown) = 1,500,651
Reports – 171,590 (Pfizer) + 245,614 (AZ) + 39,514 (Moderna) + 1,745 (Unknown) = 458,463 people impacted
Fatal – 794 (Pfizer) + 1287 (AZ) + 62 (Moderna) + 48 (Unknown) = 2,191
Blood Disorders – 17,163 (Pfizer) + 7,870 (AZ) + 2,559 (Moderna) + 65 (Unknown) = 27,657
Anaphylaxis – 666 (Pfizer) + 885 (AZ) + 93 (Moderna) + 3 (Unknown) = 1,647
Acute Cardiac – 13,508 (Pfizer) + 11,554 (AZ) + 3,479 (Moderna) + 117 (Unknown) = 28,658
Eye Disorders – 8,169 (Pfizer) + 15,020 (AZ) + 1,626 (Moderna) + 94 (Unknown) = 24,909
Blindness – 169 (Pfizer) + 329 (AZ) + 42 (Moderna) + 4 (Unknown) = 544
Deafness – 308 (Pfizer) + 433 (AZ) + 55 (Moderna) + 5 (Unknown) = 801
Infections – 12,702 (Pfizer) + 20,550 (AZ) + 2,538 (Moderna) + 193 (Unknown) = 35,983
Herpes – 2,256 (Pfizer) + 2,708 (AZ) + 269 (Moderna) + 27 (Unknown) = 5,260
Gastrointestinal Disorders – 42,844 (Pfizer) + 81,151 (AZ) + 11,506 (Moderna) + 420 (Unknown) = 135,921
Spontaneous Abortions – 495 + 14 stillbirth/foetal deaths (Pfizer) + 236 + 5 stillbirth (AZ) + 71 + 1 stillbirth (Moderna) + 7 (Unknown) = 809 miscarriages
Nervous System Disorders – 82,068 (Pfizer) + 183,398 (AZ) + 21,278 (Moderna) + 933 (Unknown) = 287,677
Bell’s Palsy – 652 (Pfizer) + 644 (AZ) + 105 (Moderna) + 3 (Unknown) = 1,404
Guillain-Barré Syndrome – 106 (Pfizer) + 500 (AZ) + 20 (Moderna) + 7 (Unknown) = 633
Paralysis – 527 (Pfizer) + 903 (AZ) + 121 (Moderna) + 11 (Unknown) = 1,562
Seizures – 1,151 (Pfizer) + 2,091 (AZ) + 300 (Moderna) + 23 (Unknown) = 3,565
Psychiatric Disorders – 10,387 (Pfizer) + 18,540 (AZ) + 2,637 (Moderna) + 130 (Unknown) = 31,694
Respiratory Disorders – 22,138 (Pfizer) + 29,990 (AZ) + 4,552 (Moderna) + 233 (Unknown) = 56,913
Epistaxis (nosebleeds) – 1,118 (Pfizer) + 2,302 (AZ) + 208 (Moderna) + 12 (Unknown) = 3,640
Renal & Urinary Disorders – 1,454 (Pfizer) + 2,792 (AZ) + 347 (Moderna) + 39 (Unknown) = 4,632
Skin Disorders – 34,672 (Pfizer) + 53,548 (AZ) + 13,572 (Moderna) + 380 (Unknown) = 102,172
Reproductive/Breast Disorders – 31,492 (Pfizer) + 20,910 (AZ) + 5,267 (Moderna) + 237 (Unknown) = 57,906
Vascular Disorders – 7,680 (Pfizer) + 14,017 (AZ) + 1,385 (Moderna) + 114 (Unknown) = 23,196
CHILDREN & YOUNG PEOPLE SPECIAL REPORT
Suspected side effects reported in individuals under 18 years old
Pfizer – 4,000,000 children (1st doses) plus 2,300,000 second doses & 200,000 boosters resulting in 3,857 Yellow Cards
AZ – 11,600 children (1st doses) plus 8,700 second doses & ‘extremely limited boosters’ resulting in 264 Yellow Cards
Moderna – 2,100 children (1st doses) and 1,900 second doses & 2,400 boosters resulting in 30 Yellow cards
Brand Unspecified – 31 Yellow Cards
Total = 4,013,700 children injected
Total doses (1st, 2nd & boosters) = 6,526,700
Total Yellow Cards Under 18s = 4,182
For full reports including 361 pages of specific reaction listings, see here.
