The Pfizer/BioNTech COVID-19 vaccine has been authorised for emergency use by the Medicines and Healthcare Products Regulatory Authority (MHRA).
Pfizer and BioNTech recently announced final efficacy analysis in their Phase III study for their mRNA-based COVID-19 vaccine candidate BNT162b2, which showed an efficacy rate of 95% in participants without prior SARS-CoV-2 infection.
The vaccine will be made available in the UK in the next week. This approval comes ahead of US and EU decisions.
A Department of Health and Social Care spokesperson said: “The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.
“The Joint Committee on Vaccination and Immunisation (JCVI) will shortly also publish its latest 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.
“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.
“Further details will be set out shortly.”