While many may not be familiar with Post-Authorization Safety Studies PASS studies, they play a crucial role in monitoring the safety of medicines. These studies are typically required for any new medicine introduced by pharmaceutical companies.
In the case of Covid vaccines, PASS studies utilize real-world data from healthcare systems like the NHS to anonymously compare vaccinated and unvaccinated individuals based on factors like age, gender, and Covid infection status. This allows for a thorough examination of the occurrence of side effects in both groups.
Unlike the Yellow Card system, which relies on passive reporting of side effects, and the ONS Covid vaccine safety analysis, which faces challenges in determining the number of unvaccinated individuals (the ‘denominator problem'), Covid vaccine PASS studies promise to provide more comprehensive insights into the safety of these vaccines.
The protocols for conducting these PASS studies were approved by the European Medicines Agency (EMA) in 2021, with Pfizer, AstraZeneca, Moderna, as well as the MHRA, endorsing the use of NHS data in these studies.
As of now, interim progress reports were expected to have been submitted according to the set timetables outlined by each company. Surprisingly, out of the 13 reports anticipated, only two have been found: AstraZeneca's ‘Interim Report 1‘ and one Pfizer ‘Progress Report,' which did not contain any results.
Taking a closer look at AstraZeneca's ‘Interim Report 1' dated April 21st, 2022, spanning 292 pages, it's worth noting that the rate of Adverse Effects of Special Interest (AESI) per 10,000 people tends to be higher in the vaccinated group, sometimes significantly so. However, the report's core conclusion emphasized the largest numerical differences were observed in specific conditions.
To be fair, the report came with necessary caveats, acknowledging that the differences weren't consistent across all data sources, and the results should be interpreted with caution due to the short study period and lack of standardization. This prompts the question: where are AstraZeneca's subsequent reports?
Similarly, there's no trace of PASS studies for Pfizer and Moderna's Covid vaccines. This raises concerns about transparency and the ability for individuals to give informed consent.
An FOI request has been submitted to the MHRA to obtain the missing PASS reports and to receive updated delivery dates for those still pending. It's worth noting that it's not just the MHRA; the EMA and FDA have also not made these reports available.
One can't help but wonder, if the missing reports confirmed the safety of the Covid vaccines, wouldn't they be proudly shared with the public? While it's possible these reports may be out there, if they are, they're well hidden. If you come across them, please share. Until then, the question remains.
