The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has authorised Pfizer/BioNTech’s COVID-19 vaccine BNT162b2 for emergency supply, with the first doses set to be delivered ‘immediately’.
The UK emergency approval is the first in the world to come following the positive results announcement from Pfizer/BioNTech’s phase III trial of BNT162b2.
The MHRA’s decision is based on a rolling submission which included data from the phase III trial. In this trial, BNT162b2 demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection.
The first primary objective analysis is based on 170 cases of COVID-19 within the trial and efficacy was consistent across age, gender, race and ethnicity demographics.
Pfizer/BioNTech signed an agreement with the UK back in July to supply 30 million doses of BNT162b2 upon its approval, which was further increased to 40 million in October.
Pfizer added in a statement that the first doses are expected to arrive in the UK in the ‘coming days’ with full delivery expected to be completed in 2021.
In a statement released regarding the vaccine authorisation, a Department of Health and Social Care spokesperson said: “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.
“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.”
Pfizer/BioNTech added that they expect further regulatory decisions from additional global health regulators over the coming days and weeks.