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10/6/2020, 11:25 AM (Source: TeleTrader)
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EMA to start rolling review of Pfizer, BioNTech vaccine

BioNTech SE and Pfizer Inc. announced on Tuesday that the European Medicines Agency (EMA) will start a rolling review of the companies' coronavirus vaccine candidate BNT162b2.

EMA decided to commence the rolling review based on the "encouraging preliminary results from pre-clinical and early clinical studies in adults," which means that it will analyze further trial data as it becomes available, unlike the regular process in which all the information needs to be gathered before the evaluation starts.

"It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process," BioNTech CEO Ugur Sahin asserted in a statement.

BioNTech's stocks soared more than 9% in the premarket, selling for $88.0, while Pfizer's shares gained 0.54%, to go for $36.95.

Breaking the News / BU