UK medicines regulator grants approval for first COVID-19 vaccine

2 December 2020

The first COVID-19 vaccine for the UK, developed by Pfizer (NYSE: PFE) and Germany’s BioNTech (Nasdaq: BNTX), has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). As a result, the UK has become the first western country to license a vaccine against COVID-19.

MHRA chief executive, Dr June Raine said: “We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword…..We are globally recognized for requiring high standards of safety, quality and effectiveness for any vaccine.”

This constitutes the first Emergency Use Authorization following a worldwide Phase III trial of BNT162b2, a vaccine to help fight the pandemic, noted Pfizer and BioNTech, which are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.

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