An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Quasi-vaccine based on the European Medicines Agency’s Public Assessment Report (EPAR)

“This article summarizes the main findings of a more detailed technical assessment concerning the development and manufacturing of the BioNTech/Pfizer’s COVID-19 quasi-vaccine BNT162b. A number of deficiencies in the product’s development were identified by regulatory agencies and appear to have either been ignored or glossed over. Vaccine approval for the declared COVID-19 pandemic was given ‘fast-track ’conditional approval to address ‘a seriously debilitating, rare or life-threatening disease devoid of a viable treatment’ and approval was granted on the condition that additional information would be forthcoming after the vaccine was rolled out. This data has not been fully provided to date.

Data for this review was primarily obtained from the European Medicines Agency European Public Assessment Report (EPAR) for the BioNTech/Pfizer vaccine. Additional information was obtained through email leaks from December, 2020 that were released to journalists and to the British Medical Journal…

The quasi-vaccine quality is questionable and variable. There may be substantial differences in the mRNA vaccines between batches and even between vials. This may be due to variations in handling, freezing/thawing/dilution requirements, the short half-life of the mRNA, and manufacturing variability…
 
It appears that there is insufficient evidence that this vaccine product meets the quality required of a pharmaceutical product, raising concerns about its safety and efficacy… Real-world data falsifies the original claim that mRNA based COVID-19 biologics function as an authentic vaccine for preventing viral infection and transmission rather than as a short-term gene-based therapeutic agent that might alleviate at best symptom severity. With this in mind, the authorization for these products should be suspended until the concerns in this review have been resolved and publicly verified by the regulatory authorities.”