Policy & Regulation
UK Regulator Issues Temporary Approval for Pfizer-BioNTech COVID-19 Vaccine
3 December 2020 - - The Medicines and Healthcare Products Regulatory Agency in the UK has granted a temporary authorization for emergency use for US-based pharmaceutical company Pfizer Inc's (NYSE: PFE) and Germany-based BioNTech SE's (NASDAQ: BNTX) COVID-19 mRNA vaccine (BNT162b2), against COVID-19, the companies said.

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic.

Pfizer and BioNTech 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.

The distribution of the vaccine in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation.

The MHRA's decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p