MHRA scientists and clinicians carried out a meticulous ‘rolling review’ of all the data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
A final decision to approve the Pfizer/BioNTech vaccine for public use was made with advice from the Commission on Human Medicines (CHM) and will be rolled out across the UK next week.
The National Institute for Biological Standards and Control, part of the MHRA, will continue to do independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.
MHRA Chief Executive, Dr June Raine said:
“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.
“I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way – and in helping to save lives.
“We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.
“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.”
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 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.
“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.”