EU safety report on Pfizer-BioNTech mRNA vaccine reveals damning data
It is high time to hold the EMA and the EU Commission and their complicit partners – starting with WHO and FDA, CDC – accountable for their dereliction of duty in failing to protect public health by ignoring the glaring safety signals and standing by the obviously erroneous statement that the Pfizer-BioNTech COVID-19 vaccine’s ‘benefit-risk profile remains favourable.’ This long existing safety report, published in August, 2021 serves as solid evidence that parties involved in evaluation and decision to allow COVID-19 ‘vaccinations’ to market were aware of the devastating impact they brought about. They did not only fail in their duty to properly evaluate mRNA ‘vaccinations’ before application on humans but they continue ignoring safety indicators at hand causing unmeasurable harm and destruction.
Their repeated refusal to respect their lawful mandates calls for an investigation of potential civil and criminal violations and the process to hold all involved accountable.
Orsolya Gyorffy, Children’s Health Defense Europe
The first ever 286-page EU Periodic Safety Update Report, covering the 6 month period from 19 December 2020 through 18 June 2021 reveals damning safety signals for the Pfizer-BioNTech Covid-19 vaccine (COMIRNATY). It was released via FOIA request from an anonymous reader and provided to the Austrian science and political blog, TKP.
Source: Periodic Safety Update Report #1 (PSUR #1)
According to the European Medicines Agency definition: ‘PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits.’
It is the MAH (Marketing Authorisation Holder) in this case, BioNTech SE, who are legally required to submit PSURs to the EMA, along with an application fee. The EMA then assesses the information found in the report to determine if any new risks are identified or if the risk-benefit balance has changed.
I, Sonia Elijah from Children’s Health Defense Europe, have extensively gone through voluminous Pfizer-BioNTech vaccine-related documents, this report was one of the most eyebrow-raising, not just in relation to the damning data but its conclusion that the ‘benefit-risk profile of BNT162b2 remains favourable.’
The damning data
The following is an overview of the total number of cases (post-marketing and clinical trial data) of the 6-month reporting period:
Click here to read more about the side effects of the COVID vax on Children’s Health Defense Europe