Pfizer/BioNTech mRNA vaccine to prevent COVID-19 wins approval in UKDecember 2, 2020 0 By FM
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for COVID-19 mRNA vaccine (BNT162b2) developed by Pfizer and BioNTech.
With this approval, the UK became the first Western nation to grant emergency-use authorization for a COVID-19 vaccine.
“The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
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% (p<0.0001) in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection, 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.
In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and
2021. The two-shot vaccine is also being reviewed by the US FDA.