UK medicines regulator gives approval for first UK Covid-19 vaccine

The first Covid-19 vaccine for the UK, developed by Pfizer/BioNTech, has been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body and was announced on Wednesday 2 December.

A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.

This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.

The MHRA expert scientists and clinicians reviewed 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.

The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, 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.”

 

 

Responding to the announcement of the Pfizer-BioNTech COVID-19 vaccine receiving regulatory approval, Councillor Ian Hudspeth, Chairman of the Local Government Association’s Community Wellbeing Board, said: “This great news will come as a huge relief to so many people, including our residents who are vulnerable, alongside those who work on the frontline to support and protect them. It has provided a sense of renewed optimism about the future and the prospect of our normal way of life returning next year, but will take some time to implement.

“Councils are ready to stand shoulder to shoulder with the NHS and are working closely with their health service colleagues in preparing for this unprecedented rollout, to ensure everybody receives this life-saving vaccine as soon as possible.

“Local knowledge and expertise will be crucial in encouraging everyone from all parts of the community to get vaccinated. Councils’ unique relationship with the people they represent mean they are best placed to reach out to those in the priority groups and beyond.

“Care home residents and their carers are at the top of the priority list and it is absolutely vital that they receive this vaccine as soon as possible, as part of our collective efforts to finally defeat this disease.”