OUR medicines watchdog has blamed ‘missing information’ for its failure to act on early reports of potentially fatal side effects to AstraZeneca’s covid vaccine. It did not mention that it rarely followed up victims, or contacted their GPs, to ask for the missing information it needed.
The Medicines and Healthcare products Regulatory Agency (MHRA), run by Dame June Raine during covid, has been criticised by Conservative former minister Esther McVey, who said the agency should be reformed. It is too late for many who struggled to get any meaningful response after reporting their injuries to the MHRA’s not-fit-for-purpose early warning Yellow Card Scheme.
Former BBC radio presenter Jules Serkin, 66, suffered a life-changing adverse reaction to her one and only AstraZeneca jab received on March 5, 2021. Had our health chiefs taken vaccine injury seriously, her injury may have been prevented, and she may have been able to get help.
Last week she updated the MHRA telling them: ‘Nearly four years on, I am still suffering the neurological effects caused by batch number PV46671. This one jab has ruined my life and health. Since my initial report to you in 2021, I have thought I would die many times.
‘I suffer extreme pains in my head, lightning strikes in my head and eyes. My left eye is especially scary. The brow is drooped and the NHS had to lift my eyelids as I could not see properly. The symptoms mimic a stroke, but A&E in my local hospital in Ashford, Kent, is so inundated I waited 21 hours in a chair as they wanted to admit me. They had no beds and no access to an MRI scan so now I stay at home during a vax attack and pray I won’t die.’
I first reported on the MHRA’s shambolic system for TCW in May 2021, highlighting that they received reports of no more than 10 per cent of injuries and that the public and many health professionals were unaware of the Yellow Card Scheme. Doctors and nurses were already voicing concerns.
A senior NHS board member said: ‘I know that the Yellow Card reporting system is not reflective of the amount of adverse events that are actually happening. I know of a patient who reported their extreme adverse event side effect to a nurse, and that nurse did not report it to the Yellow Card reporting system. People are told that their adverse events are normal. It is not normal to have to stay in bed for two days after a vaccine.’
In August 2021, I interviewed five women, Ms Serkin was one, and two men whose AstraZeneca jab had the prefix PV466, a series of batches that Freedom of Information (FoI) requests show are AstraZeneca’s deadliest. Six of the ten most injurious batches have that prefix, recording 75 fatalities and 29,935 adverse events by September 2, 2024.
Back in 2021, I contacted the MHRA about these batches and they said they were not aware of multiple reports made about them. I provided them with the reporters’ names and full batch numbers but they did not respond.
Ms Serkin, who describes herself as a ‘regret vaxxer’, was the first I spoke to who suffered catastrophic injury. She was unable to work for five months and has never returned to full-time work. She said: ‘Shivers were the first symptom, I felt like I had full-blown flu. I was in bed for two days. Then blood clots came out of my nose for three weeks, I developed sinusitis. I began sleeping a lot, couldn’t look at a screen because my eyes were so sensitive. Developed a pain in my calf and headaches, which I’ve never had, with pains in my temples, numbness in my cheek and pins and needles in my feet.’
She reported her reaction to the Yellow Card and her GP filled out AstraZeneca’s ‘laborious’ reporting form. Ms Serkin received no response from the MHRA, and her GP received an auto reply but no request for further information. To date Ms Serkin has spent almost £10,000 on private scans, alternative health practitioners and supplements to try to regain her health as well as regular visits to hospitals and consultants.
She said: ‘I have seen two neurologists, one in 2021, and one more recently. I have been diagnosed with inflammation of my pituitary gland, my balance is affected, so is my speech, the left side of my face, my eyes and limbs.’
Blood tests confirmed she has never had covid, but her symptoms have been labelled long covid. Her consultant’s comments were telling: ‘We are seeing it in the vaccinated.’
Ms Serkin added: ‘There is no help, there is no cure for vaccine injuries. Just more Pharma with more side effects.’
Events broadcaster Howard Griffiths, 55, worked for the BBC, ITV and Channel 5. He used to run marathons but can no longer. Within three minutes of his first AstraZeneca vaccine received on April 4, 2021, he suffered anaphylaxis. He said: ‘My lips and mouth became swollen, and I thought I was having a heart attack. I had a throbbing headache for ten days, which changed to mild headaches that have now gone. I began suffering insomnia, which I never had before, dizziness, disorientation and fatigue. I developed tinnitus in my left ear, throbbing in the back of my neck and brain fog. I’m left with tingling and numbness in the hands, face, mouth and beneath the nose.
‘I called the Yellow Card Scheme and had a long telephone consultation, and they recorded all details. As my side effects and injuries became more distressing, I called again, had a telephone conversation and completed another report to update my first.
‘The MHRA team have never called back or reached out since.’
At the inquest for trainee lawyer Oli Hoque, 26, who died of vaccine-induced cerebral venous sinus thrombosis (CVST), (when a blood clot develops in the brain’s sinuses), after receiving the jab in 2021, senior medical assessor at the MHRA, Gary Peters, mentioned a 32-year-old man who died within 48 hours of admission.
Mr Peters said the information they received about him was ‘incomplete’ and they took no action. Instead, they decided they ‘should keep a close eye on the signal’, which in this case was blood clots and low platelets.
In January 2021, psychologist Dr Stephen Wright, 32, was one of the first to die after suffering a stroke and blood clots with low platelets – vaccine-induced thrombosis and thrombocytopenia (VITT) – caused by the AstraZeneca vaccine. His family and the hospital where he died reported his death to the MHRA.
Dr Wright’s widow, Charlotte, told the Telegraph: ‘If the MHRA had missing information, I have no idea why they didn’t just ask us for it. If the MHRA had acted sooner, lives might have been saved.’
The MHRA told the Telegraph that it ‘followed up’, contacting ‘healthcare professionals who provided additional information’. It did not say why it did nothing until 18 other countries had suspended the AstraZeneca vaccine and Denmark had axed it from its covid vaccine schedule altogether.
Senior coroner Nadia Persaud warned health secretary Therese Coffey in October 2022 that it was ‘a matter of concern that the MHRA are unable to compel the timely production of relevant clinical data’.
She added in a letter to the Department of Health and Social Care: ‘In my opinion, there is a risk that future deaths could occur unless action is taken.’
No action was taken. So far, the Yellow Card Scheme has received 2,707 fatal reports – 1 in 180 reports and potentially just 10 per cent of the real total. The last data set issued by the MHRA detailing injuries and deaths was May 20, 2024 and reported on TCW here and reproduced below. I asked the MHRA why they had stopped updating and publishing this data.Their reply, when it finally came, was this:
‘Enhanced versions of iDAPs (cloud storage) are being tested with a view to improving transparency and accessibility of the data held by the Agency. We are intending to deploy these new capabilities in the near future. Up to date data is available on request.
‘The MHRA found no batch-related issues in relation to the AstraZeneca Covid-19 PV466 batch. When assessing for any batch-specific issues, numbers of Yellow Card reports were considered alongside information about the size and source of the batch; the MHRA’s analysis of Yellow Card reports did not result in any safety concerns.’
Really? The grim reading below – for adults and children – contradicts their confidence. How many lives could have been saved had health chiefs and the MHRA acted on the information given them?
MHRA Yellow Card reporting summary up to May 20, 2024
Government data (archived) up to September 2022 showed 53.8million people had received a 1st dose UK-wide.
By week ending June 2, 2024, 55.6 per cent (3,227,657 out of 5,806,636) of all people aged 75 years and over, living in England, had received a vaccine dose in the spring 2024 campaign.
TOTAL Yellow Card adverse event reports = 486,634 people impacted (increase of 384 reports in just under four weeks)
178,565 (Pfizer-mono) +
6,227 (Pfizer-bivalent) +
249,496 (AZ) +
43,306 (Moderna-mono) +
5,802 (Moderna-bivalent) +
193 (Novavax) +
3,045 (Unknown brand)
Reports classified as SERIOUS* by MHRA = 74.5 per cent of all reports = 362,662
126,535 (Pfizer-mono) +
4,820 (Pfizer-bivalent) +
193,388 (AZ) +
31,339 (Moderna-mono) +
4,262 (Moderna-bivalent) +
125 (Novavax) +
2,193 (Unknown)
More than 46,915 of the above serious reports are of ‘Unknown Age’ = 12.9 per cent of all serious reports.
Overall, 1 in 111 people injected experiences a Yellow Card adverse event (assuming one person submits only one report)
1 in 148 people injected experiences an adverse event classified as SERIOUS*
Reports classified as Non-SERIOUS by MHRA = 25.0 per cent = 121,265
51,110 (Pfizer-mono) +
1,339 (Pfizer-bivalent) +
54,640 (AZ) +
11,865 (Moderna-mono) +
1,485 (Moderna-bivalent) +
68 (Novavax) +
758 (Unknown)
TOTAL Reactions = 1,586,411
516,187 (Pfizer-mono) +
16,851 (Pfizer-bivalent) +
885,374 (AZ) +
142,342 (Moderna-mono) +
15,927 (Moderna-bivalent) +
527 (Novavax) +
9,208 (Unknown)
Note: Some people may have reported more than one type of reaction.
1 in 180 reports are associated with a fatality, which may be less than 10 per cent of actual figures, according to MHRA.
TOTAL FATAL REPORTS = 2,707 = 0.5 per cent of all reports (increase of 19 reports with fatal outcome in just under four weeks)
920 (Pfizer-mono) +
68 (Pfizer-bivalent) +
1,468 (AZ) +
102 (Moderna-mono) +
55 (Moderna-bivalent) +
94 (Unknown)
451 of the above fatalities are of ‘Unknown Age’ = 16.7 per cent of all fatalities, and at least 184 are of ‘Unknown Sex’ = 6.8 per cent of all fatalities.
* MHRA definition of ‘serious’ – patient died, life threatening, hospitalisation, congenital abnormality, persistent or significant disability or capacity, deemed medically significant by MHRA medical dictionary or reporter.
Full reports are here.
