Postmarketing surveillance in name only
Dr Ros Jones
On 7th March 2021, a nurse in Austria died of a massive stroke. Her platelet function was seriously deranged and she was diagnosed with ‘thrombotic thrombocytopenia’. In the same week, another nurse was seriously ill with blood clotting in her lungs. So what did the Austrian health ministry do? Did they ignore the case? No, they suspended the entire batch of AstraZeneca immediately. A death in Denmark was reported 4 days later and they, along with other Nordic countries, suspended all AstraZeneca vaccines the same day. The Danish Health Authority notified doctors and everyone who had been vaccinated in the previous 2 weeks of the relevant symptoms to look out for and the need for urgent investigation. Within days 24 countries across 4 continents had suspended the DNA-based vaccine.
Meanwhile in the UK, where the drug was originally developed and where the first doses world-wide were given, the Medicines and Healthcare products Regulatory Agency (MHRA), stated that there was no evidence of causation and the number of cases reported via the Yellow Cards system was no higher than expected. They even authorised a trial of AZ in children, after the first UK death. It was a month later before another body, the Joint Committee on Vaccination and Immunisation (JCVI) recommended avoiding AstraZeneca in patients under 30 years and in May 2021 this restriction was extended to under 40s. During summer 2021, AstraZeneca quietly disappeared from vaccination centres in the UK as stocks were used up. Vaccine-Induced Thrombotic Thrombocytopaenia (VITT) was only added to the Patient Information Leaflet (PIL) in November 2023, more than two and a half years after the first reports of this catastrophic adverse event was first reported to the regulators. It is the only condition for which payments have been made under the infamous Vaccine Damage Payments scheme. By March 2024, AstraZeneca eventually made its own request to cancel the drug’s authorisation, quoting commercial reasons. Much has been written by Hedley Rees, pharmaceutical supply chain expert, on the failure to undertake a proper recall of unused supplies.
Safety concerns around the AstraZeneca DNA-viral-vector injections did nothing to diminish the government’s enthusiasm for the mRNA products of Pfizer BioNTech and Moderna, which both continued to wear the ‘SAFE & EFFECTIVE ©’ label.
So turning to the mRNA products, their only acknowledged adverse event is myo- and peri-carditis, added to their PILs much more promptly on 21st June 2021, within just over 6 months since the rollout began. Notably, this update occurred only 2 weeks after the MHRA had approved these vaccines for adolescents. The first reports came from Israel, where a press release on 1st June noted that myocarditis occurred most frequently in 16- to 24-year-old males especially after their 2nd dose. This data was shared with the JCVI and was one of the reasons behind their reluctance to follow the MHRA authorisation with their own recommendation. Indeed, they held conference calls with cardiologist from Israel and also from the US on 1st September 2021 and requested a further 6 months’ delay while they waited for follow-up data on the cases reported. Meanwhile, the UK Health Security Agency (UKHSA), continued to downplay the potential seriousness of myocarditis, prompting an open letter to Dr Jenny Harries. The US group, in particular, had noted significant scarring on cardiac MRI scans, which suggests it may be far from mild and self-limiting.
This has all come back into the headlines again this week with the publication of an article entitled Real-time pharmacovigilance and cardiac risk communication during the COVID-19 vaccination campaign in Israel. Published on 3rd September, Yaakov Ophir and Yaffa Shir-Raz disclose an internal pharmacovigilance dataset obtained from the Israeli Ministry of Health.
“The anonymized dataset, provided as Supplementary Data File 1, includes 531 hospitalization records and 67 unique deaths reported to Pfizer between March 2021 and May 2022.” “Reported events spanned cardiac, neurological, inflammatory, and other serious clinical categories and involved a substantial proportion of younger individuals .. 39.8% were under 30 years old”. 71.6% of the admissions in under 30s were related to myo-pericarditis. This is of course an age range at much lower risk from SARS-CoV-2, yet the group for whom vaccines were being pushed as a pro-social act to protect their elderly relatives (remember ‘Don’t Kill Your Granny’) and to enable society to reopen from the self-inflicted restrictions which governments had introduced while waiting for a rushed novel-technology vaccine.
The aspect of the report which they highlight, is that despite sharing this information with international health authorities, the safety signal was only communicated to clinicians and the public approximately three to four months later, by which time of course most eligible young people had already received not one, but two doses of Pfizer.
As in the UK, they played down the findings as generally mild and self-limiting and also highlighted the risk of myocarditis after infection. This was also emphasised in the UK with a paper from Oxford. This paper was constantly being misquoted by the press and so-called ‘experts’ as showing a higher risk with infection than immunisation. In fact the Oxford paper showed that for under 40s there was an 8-fold risk in the week following a second dose of Pfizer and 44-fold risk within a week of a second Moderna shot. These findings are not spelled out in the abstract but are in table 3B in the appendix. They did not give a breakdown by age and sex only by one or the other. So there is a declared 8x increased risk for under 40s and also 2x for males, but nowhere do they give the risk for males under 40. Despite this study being nationwide, the authors were unable to provide a breakdown for under 30s let alone under 20s.
It fell to Hong Kong, noting the post-vaccination myocarditis cases from Israel, to ask all their paediatricians, cardiologists and emergency medicine specialists to look out for cardiac symptoms and report them. They found a risk of 1 in 3000 for adolescent boys after their second dose, so they changed their policy to emulate the initial single dose in England and Wales. A follow-up paper from Hong Kong noted a reduction in myocarditis cases after discontinuing the second dose, by which time the JCVI here were switching to two doses. In late 2021, researchers in Thailand went a step further and organised a prospective study in which teenagers at two large secondary schools had ECG and blood troponin levels (a marker for cardiac damage) carried out before their second Pfizer dose; vaccinees then kept a symptom diary card and returned for repeat troponins and ECG on days 3 and 7. The authors found a shocking 29% with symptoms or signs of heart disturbance and 1 in 43 children with evidence of clinical or subclinical peri-myocarditis.
The facts are that the Israeli group first noticed cases of myocarditis in January 2021 in the first month after rollout. They notified the CDC, the EMA and presumably the MHRA in February 2021. The CDC appears to have alerted doctors of the requirement to report to VAERS in late May and the patient information leaflets were updated in June, five months after the first cases were noted. The contrast between this and the letter about VITT sent out by the Danish Health Ministry to all patients in receipt of a recent AstraZeneca vaccine could not be more stark.
How many young lives would have been saved if this information had been shared with the public at the time?
Rodney Palmer, a long-standing journalist with the Canadian Broadcasting Company (CBC) giving evidence to the Allison Inquiry, asked the same question. He recounted that senior reporter Marianne Klowak wrote an article in May 2021 about deaths from myocarditis (watch his testimony here from 10 minutes) but for the first time in her 35 years, her report was censored. Earlier in the Inquiry was testimony from a father whose 18-year-old son had died of Vaccine-induced Myocarditis. Rodney Palmer’s question is unanswerable, “Imagine if young Sean Hartmann had known that. Imagine if Marianne Klowak’s story had been broadcast like every other one of her stories.. and had gone across the country in June 2021? If he had known that people were dying, even if it was only a tiny minority, would he have taken it?”
This is Dame June Raine’s Brave New World of drugs in 100 days, of the MHRA transformed from watchdog to enabler, or of Sir Patrick Vallence’s 2014 prophesy, “In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”
This is postmarketing pharmacovigilance in operation. It is not pretty.
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