The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today 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. 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.
The vaccine, which has 95% protection against the virus, will be rolled out from next week with the first 800,000 doses becoming available.
Elderly people, care homes residents and staff and some NHS staff are to receive priority.
The MHRA expert scientists and clinicians reviewed the data and considered the conditions for its safe supply and distribution.
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.”
Wilf Williams, strategic command for the Kent and Medway NHS pandemic response, said: “A vaccine being approved is great news and gives hope that we can get on top of the pandemic. But in Kent and Medway we have high infection rates and we cannot be complacent.
“We all need to keep working hard to break the chain of infection. Hands, face, space and all the requirements of being in Tier 3. Crucially, if you or someone in your household show symptoms of the virus, or are contacted by the Test and Trace services self-isolate straight away.
“The NHS across Kent and Medway has been working hard to prepare the vaccine programme. Everyone aged 18 and over will be offered the vaccine. In Kent and Medway that is around one million people.
“There will be lots more news coming in the weeks and months ahead. People will be invited for a vaccine based on a national priority list. Please be patient and avoid contacting GP surgeries or other services with general questions about the vaccine and when it will be available to you.”
Vaccine priority list
Residents in a care home for older adults and their carers
All those 80 years of age and over
Frontline health and social care workers
All those 75 years of age and over
All those 70 years of age and over
Clinically extremely vulnerable individuals*
All those 65 years of age and over
All individuals aged 16 years to 64 years with underlying health
conditions which put them at higher risk of serious disease and
All those 60 years of age and over
All those 55 years of age and over
All those 50 years of age and over