The UK Government has authorised the Pfizer-BioNTech COVID-19 vaccine which will be made available from next week.
The UK Government has granted a temporary authorisation for emergency use of the Pfizer-BioNTech COVID-19 mRNA vaccine (BNT162b2), against COVID-19, based on the recommendation of the independent Medicines and Healthcare products Regulatory Agency (MHRA).
The authorisation is the first Emergency Use Authorisation following a worldwide Phase III trial. The vaccine will be made available from next week, and distribution of the vaccine will be prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
First approval for a vaccine
The authorisation opens the door to mass vaccination of UK citizens and the vaccine is one of seven that the Government has signed contracts for. One of the other vaccines the Government has purchased is the ChAdOx1 nCoV-19 vaccine, which is currently in Phase III trials to confirm the results and how effective the vaccine is in protecting against COVID-19 infections.
A Department of Health and Social Care spokesperson said: “The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality, and effectiveness.
“The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.”
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said: “Today’s Emergency Use Authorisation in the UK 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 authorisations 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 Emergency Use Authorisation in the UK will mark the first-time citizens outside of the trials will have the opportunity to be immunised against COVID-19,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe that the roll-out of the vaccination programme in the UK 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 programme.”
The UK Government has bought 40 million doses of the vaccine and distribution will take place throughout the remainder of 2020 and through 2021, with the first doses expected to arrive in the next few days.