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)

L. Maria Gutschi et al.

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.

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