Pfizer and BioNTech have secured temporary authorisation for emergency use from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for the duo’s COVID-19 mRNA vaccine (BNT162b2).
This constitutes the first Emergency Use Authorisation 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 prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
“Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19,” said Albert Bourla, Chairman and CEO of Pfizer.
“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK.
“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
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% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%.
In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. The decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2.