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. 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.”
Please note:
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The decision to approve the supply of this vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic.
- The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD) The MHRA is an executive agency of the Department of Health and Social Care.
- The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care
A Department of Health and Social Care spokesperson said in a press release issued this afternoon:
'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.'
Further details will be set out shortly."
The full details of the vaccine risk assessment, possible side-effects and those found during the human trials, have not been released. Until they have been, and the documentation supporting the vaccine, it's trial, and subsequent findings have been peer reviewed across the scientific community; the public has only the word of Pfizer and of Matt Hancock, Sec of State For Health and Social Care, as to its efficacy and safety.
In the meantime, the MHRA have urgently sourced a computer AI programme to process the numerous Yellow Card system for reporting adverse drug responses from patients recieving the vaccine(s).
See Unionsafety November news item: Government Prepares For Mass Adversory Drug Reaction To Covid Vaccine
See Information for Healthcare Professionals, and Information for UK recipients available now from the E-Library here and here
See also: Dr June Raine discusses how COVID-19 vaccines are approved by the MHRA on YouTube.
Source: MHRA
