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EMA launches rolling regulatory review of Pfizer and BioNTech's COVID-19 vaccine

Published on 07/10/20 at 12:19pm

European Medicines Agency has launched a “rolling review” of the promising COVID-19 vaccine candidate BNT162b2 currently in development from BioNTech and Pfizer, following a similar protocol to the one it has adopted to evaluate a rival vaccine from AstraZeneca and the University of Oxford.

Promising data from early and preclinical studies support the potential of the therapy to generate neutralising antibodies and TH-1 dominant CD4+ and CD8+ T cells to target the SARS-CoV-2 virus, indicating possible immunity in dosed patients.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has already launched a “rolling review” of these findings, with BioNTech and Pfizer working closely with the committee to help speed along a final approval.

“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,” remarked Dr Ugur Sahin, CEO and Co-founder of BioNTech. “We will continue to have regular and open dialogue with the EMA throughout the rolling review process.”

The EMA was keen to stress that the launch of the review “does not mean that a conclusion can be reached yet on the vaccine's safety and effectiveness, as much of the evidence is still to be submitted”.

The vaccine is currently being tested in over 37,000 participants across the US, Brazil, Argentina and South Africa, 28,000 of whom have received a second dose. Should it prove successful and safe, BioNTech plans to deliver 100 million doses by the end of the year, ramping up to 1.3 billion by the end of 2021.

Matt Fellows

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