Pfizer and BioNTech received the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) authorisation for emergency use of their mRNA-based Covid-19 vaccine BNT162b2.
The vaccine makers expect global regulatory decisions in few days and weeks, and are ready to deliver vaccine doses after receiving potential regulatory approvals.
Also, the companies are prioritising the distribution of vaccine in the UK, based on guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
Pfizer chairman and chief executive officer Albert Bourla said: “Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against Covid-19.
“This authorisation 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 has granted the authorisation based on a rolling submission, including data from the Phase 3 clinical study of the vaccine.
In the study, BNT162b2 showed 95% efficacy rate, reaching the first primary objective in people without prior SARS-CoV-2 infection and the second primary objective of people with and without prior SARS-CoV-2 infection, after seven days from the second dose.
The first primary objective analysis is based on 170 Covid-19 cases, Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%.
According to the individual Data Monitoring Committee report, BNT162b2 was well tolerated with no serious safety concerns till date.
In July 2020, Pfizer and BioNTech have entered into an agreement with the UK to supply 30 million doses of their mRNA-based vaccine BNT162b2, after achieving authorisation. The agreement was later increased to 40 million doses in early October.
The companies intend to deliver 40 million doses through 2020 and 2021, in different stages. First doses to the UK are expected in few days, with complete delivery expected in 2021.
Furthermore, Pfizer and BioNTech have filed applications with the US Food and Drug Administration (FDA) for Emergency Use Authorization, and the final Conditional Marketing Authorization Application (CA) with the European Medicines Agency (EMA).
BioNTech CEO and co-founder Ugur Sahin said: “The Emergency Use Authorization in the U.K. will mark the first-time citizens outside of the trials will have the opportunity to be immunized against Covid-19. We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalised.
“Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”
