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.