While much of the US’s attention has been on the Pfizer and Moderna vaccines, back in the spring of 2021, attention turned briefly to the Oxford/AstraZeneca COVID-19 vaccine when numerous countries halted its use due to concerns about blood clots. Now, ICAN has obtained exclusive confidential Periodic Safety Update Reports (PSURs) from the UK’s FDA equivalent that shed light on numerous safety concerns.
Lead Counsel, Aaron Siri, Esq. details the new information here:
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.
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 event 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 recognizing 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.
Some additional points of interest include:
- The first PSUR includes an analysis of fatal events involving the term “Sudden Death.” Of the 2,748 fatal cases received during the reporting period, 152 were reported as sudden. Unsurprisingly, it stated that a review “did not indicate any pattern or cluster suggesting a potential safety concern.”
- The first PSUR also profiles two fatalities that were “associated with vaccination error.” In one, the patient was given the vaccine subcutaneously and experienced “allergic reaction, severe vomiting, severe stopping blood circulation,” as well as “breathing problems, severe increasing shortness of breath, severe loss of consciousness.” The review lists the individual’s cause of death as “central cyanosis, breathing problems, allergic reaction, increasing shortness of breath, vomiting, loss of consciousness, stopping blood circulation and blue face and neck.” In the other case, the patient died “due to blood clotting in the brain, intravenous route of administration, Vein rupture in brain, severe headache for 5 days and mild COVID-19 in the lungs X-ray.”
- The first PSUR additionally provides an extensive analysis of 833 reports of Guillain-Barré Syndrome (GBS) after which it concludes “it is the continued opinion of AstraZeneca that a reasonable possibility of a causal relationship between COVID-19 VACCINE ASTRAZENECA and GBS has not been established at this time.” However, the second PSUR reports that the signal for GBS was re-opened based on “new information from retrospective analysis…as well as well-documented case reports of GBS with COVID-19 VACCINE ASTRAZENECA from the published literature.”
- The second PSUR also discusses 11 ongoing clinical trials. Of those that specified what the placebo or control was, 4 trials used a meningococcal vaccine (Meningococcal B vaccine or MenACWY), 1 used the rabies vaccine, and only 2 indicated that a saline placebo was used.
- The second PSUR provides an exhaustive review of 593 myocarditis cases and 603 pericarditis cases, but still somehow concludes: “There were [sic] too limited information in many case reports for myocarditis and pericarditis to make an informed assessment of causality or conclude on the presence of confounding factors.”
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.
In the meantime, see the links below to catch up on some of ICAN’s other COVID-19 vaccine document updates:
