Response to FOIs expose how UK’s drug regulator hid covid injection safety signals using “absurd calculations”

Response to FOIs expose how UK’s drug regulator hid covid injection safety signals using “absurd calculations”

The Exposé | | Rhoda Wilson

While much of the attention has been on the Pfizer and Moderna covid injections, back in the spring of 2021 attention turned briefly to the Oxford/AstraZeneca “vaccine” when numerous countries halted its use due to concerns about blood clots.

ICAN has obtained confidential Periodic Safety Update Reports (“PSURs”) from the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) which has shed light on numerous safety concerns.

ICAN Obtains UK Safety Update Reports for the AstraZeneca Covid-19 Vaccine

The Informant | Informed Consent Action Network (“ICAN”) |

To date, approximately 2.4 billion doses of the AstraZeneca covid-19 injection have been administered worldwide, including, infamously, in Europe. As the vaccine was rolled out, the UK’s version of the FDA, the Medicines and Healthcare Regulatory Agency, was receiving confidential safety reports from AstraZeneca twice per year. While later PSURs have been released, the earliest ones were withheld from public view. Through FOIA requests, ICAN’s attorneys have obtained these reports for December 2020–June 2021 and June 2021–December 2021.

Lead Counsel, Aaron Siri, Esq. details below:

ICAN lead Counsel Aaron Siri details the new information from MHRA, 12 February 2024 (2 mins)

One thing that stands out is how often AstraZeneca used “observed versus expected” calculations which appeared to function as a means to dismiss concerns that a particular type of adverse events was caused by the vaccine. AstraZeneca’s investigators used cryptic calculations to determine the “expected” incidence rate – i.e., how many people in a given population would spontaneously develop a particular health issue.

Then, AstraZeneca compared the expected rate to the “observed” incidence rate – i.e., the number of people who reported that issue in the safety database. In these reports, the expected rate was dramatically higher than the observed rate in most cases.

For example, in AstraZeneca’s analysis of the tinnitus safety signal, it states that 3,142 cases of tinnitus within 14 days of the vaccine were reported, 38% of which occurred within one day of vaccination. But it calculated the “expected” number of tinnitus cases to be 10,597. Therefore, it blithely concluded that there was no “pattern or cluster suggesting a causal association” nor any “potential safety concern.” These kinds of absurd calculations allowed health agencies to hold off recognising tinnitus for another full year until August 2022 when the European Medicines Agency finally listed it as a side effect of the AstraZeneca vaccine.

A rare exception was the analysis for Cerebral Venous Sinus Thrombosis (“CVST”) with Thrombocytopenia (“TCP”). This is a type of stroke where a blood clot forms in the brain, combined with a low blood platelet count. Background rates for this condition were so low that no mathematical gymnastics could hide this signal. For subjects ages 18-49, the observed-to-expected ratio was 107.69 within 14 days of vaccination (anything greater than 1 is concerning). Yet, the MHRA continues to describe this side effect as “extremely rare,” providing no context for the significantly increased risk.

Additional points of interest, including the analysis of fatal events, Guillain-Barré Syndrome, ongoing clinical trials, as well as reviews of myocarditis/pericarditis are included in the full legal update, linked HERE.

Throughout the reports, there is a pattern of denial and delay. And while AstraZeneca delayed, thousands of additional adverse event reports poured in.

ICAN is now demanding access to some information that appears to be referenced by – but not included with – the PSURs and will promptly make it available to the public as well.

Original Article:

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