Pfizer vaccine batch integrity issues known to regulators

From leaked emails and reports to Trial Site News in June 2022, it indicates that as early as November 10, 2020, the European regulatory agency (EMA) staff, who oversees the evaluation of medicinal products for the European Union, had reason to be concerned about the rushed speed of the regulatory process with respect to robustness of assessment, plus they were aware of potential issues with Pfizer-BioNTech’s vaccine batch integrity.

The emails reveal that regulatory bodies like the FDA, MHRA, EMA and Health Canada knew of the differences in batches, regarding % mRNA integrity and the presence of uncharacterised fragments of RNA in batches (“impurities”), making the ‘safety and efficacy’ of the COVID-19 vaccine an unknown and could account for the variation in adverse reactions to batch/lot numbers.

Knowing these issues the regulators granted various designations of emergency use authorisation a few weeks to months later – which would not pass normal regulation.