Pfizer and BioNTech have secured temporary emergency use authorisation (EUA) from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) for their Covid-19 mRNA vaccine called BNT162b2.
The BNT162b2 mRNA vaccine is said to be the first in the world to secure EUA status to fight against Covid-19.
The status was provided by the UK regulator based on a rolling submission, including data from the phase 3 clinical study that showed 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).
BioNTech CEO and co-founder Dr Ugur Sahin said: “The emergency use authorisation in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against Covid-19.”
In July this year, Pfizer and BioNTech entered into an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, upon securing EUA status. In early October, the agreement was increased to 40 million doses.
Both firms will deliver 40 million doses in stages throughout 2020 and 2021 to equally allocate vaccines across the geographies under executed contracts.
Pfizer and BioNTech have filed an application to secure EUA for the vaccine from the US Food and Drug Administration (FDA).
The companies have also filed the final conditional marketing authorisation application (CA) following rolling submissions with the European Medicines Agency (EMA) and various other regulatory agencies across the world.
Pfizer chairman and CEO 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.”