UK authorises emergency use of Pfizer-BioNTech Covid-19 vaccine
08 Dec 2020
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The UK’s drug regulator, the Medicines & Healthcare Products Regulatory Agency (MHRA) has granted temporary authorisation for emergency use for the Covid-19 mRNA vaccine developed by Pfizer Inc and BioNTech SE, the two companies announced today.
This is the first emergency use authorisation for a Covid-19 vaccine thst has completed worldwide Phase 3 trial. Pfizer and BioNTech said they expect further regulatory approvals across the globe in the coming days and weeks and are ready to deliver vaccine doses.
MHRA authorised supply of Covid-19 mRNA vaccine for emergency supply under Regulation 174 and the companies said they are ready to deliver the first doses to the UK immediately.
The companies previously signed an agreement to supply a total of 40 million doses to the UK with delivery in 2020 and 2021.
US FDA and EU EMA decisions on authorisation are expected in December
The distribution of the vaccine in the UK will be prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI), the joint release added.
“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.” said Albert Bourla, chairman and chief executive officer of Pfizer.
“The Emergency Use Authorisation in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against Covid19,” 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 per cent 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.
In July 2020, Pfizer and BioNTech announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorised 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, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts, Pfizer stated.
Now that the vaccine is authorised in the UK, the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfilment expected in 2021.
The companies said they have filed a request for Emergency Use Authorization with the US Food and Drug Administration (FDA) and have submitted the final conditional marketing authorisation application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.
Pfizer and BioNTech said the twp companies are working in collaboration with governments and ministries of health around the world that will distribute the vaccine, subject to country authorisation or approval.
