On December 21, 2020 the European Medicines Agency (EMA) granted Conditional Marketing Authorization (CMA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) following European Medicines Agency (EMA) “positive opinion, to BNT162b2 for active immunisation of individuals aged 16 years and older to prevent COVID-19, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” in people from 16 years of age. [1, 2]
They stating that “EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty” concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation.”
In 2022, leaked emails would reveal that there was “concern over accelerated timelines to ensure they would meet the ‘deadline’ for vaccine authorization at the expense of a robust assessment”, and there was great pressure placed on the EMA staff by the European Commissioner, Ursula von der Leyen, who had known close ties with Pfizer CEO. [1]