www.fdanews.com/articles/199412-eu-evaluating-pfizer-biontech-covid-19-vaccine-using-rolling-review
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EU Evaluating Pfizer-BioNTech COVID-19 Vaccine Using Rolling Review
October 7, 2020
The European Medicines Agency said it is reviewing Pfizer’s and BioNTech’s investigational COVID-19 vaccine using a “rolling” review process that will assess the latest study data without waiting for the companies to file a completed application.
The messenger RNA-based vaccine candidate, BNT162b2, prompts cells to make proteins mimicking the coronavirus’ outer surface, spurring the immune system to repel the virus.
BNT162b2 is currently being assessed in phase 3 studies in the U.S., Brazil, South Africa and Argentina.