The UK has become the first country to approve a vaccine against COVID-19. The vaccine developed by Pfizer/BioNTech has been given approval for use after a comprehensive review by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA carried out a ‘rolling review’ of the vaccine. This is a complete assessment of a promising drug or vaccine, conducted in the shortest possible time. In this process, data is assessed as it becomes available from ongoing studies.
MHRA scientists and clinicians completed the assessment rigorously and thoroughly in only two months. They reviewed data from pre-clinical studies, clinical trials, manufacturing and quality control, product sampling and and testing of the final vaccine. The conditions for its safe supply and distribution were also taken into account.
Dr June Raine, Chief Executive of MHRA, 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.”
Read the MHRA press release for further information.