The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech.

The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial.

Pfizer and BioNTech expect further regulatory decisions across the world in the coming days and weeks. The companies are said to be ready to supply vaccine doses after securing potential regulatory authorizations or approvals.

The decision from MHRA has been driven by a rolling submission. This includes data from the phase 3 clinical study, which showed a vaccine efficacy rate of 95% in participants without prior Covid-19 infection and also in participants with and without prior Covid-19 infection, thereby meeting both the primary and second objectives of the trial. In each case, the efficacy rate was measured from seven days following the second dose.

Albert Bourla – Chairman and CEO of Pfizer said: “Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. 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 U.K.

“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.”

According to Pfizer, the distribution of the BNT162b2 Covid-19 vaccine in the UK will be prioritized as per the populations marked in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).

In July 2020, Pfizer and BioNTech signed an agreement with the UK government to deliver 30 million doses of the BNT162b2 Covid-19 vaccine candida, after it gets authorization for emergency use. In early October, that agreement was increased to cover 40 million doses with delivery to occur throughout 2020 and 2021, in stages.

Following the emergency use authorization, Pfizer expects to deliver the first doses of the BNT162b2 Covid-19 vaccine candidate in the UK in the coming days, with complete delivery fulfillment anticipated in 2021.

Pfizer and BioNTech have filed a request for emergency use authorization for BNT162b2 with the US Food and Drug Administration (FDA) and have submitted the final conditional marketing authorization application (CA) following rolling submissions with the European Medicines Agency (EMA) and various other regulatory agencies across the world.

Ugur Sahin – CEO and Co-founder of BioNTech 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 hospitalized. 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.”

  Albert Bourla, BioNTech, BNT162, BNT162b2, COVID-19, Novel Coronavirus, Pfizer, Ugur Sahin, UK Medicines & Healthcare Products Regulatory Agency, UK MHRA, United Kingdom