The first COVID-19 vaccine for the united kingdom , developed by Pfizer/BioNTech, has been given approval to be used following a radical review administered by the Medicines and Healthcare products regulatory authority (MHRA).
The decision by the united kingdom regulatory agency was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. a fanatical team of MHRA scientists and clinicians administered a rigorous, scientific and detailed review of all the available data, starting in October 2020.
This was done employing a regulatory process referred to as a ‘rolling review’. A ‘rolling review’ are often wont to complete the assessment of a promising medicine or vaccine during a public health emergency within the shortest time possible. this is often done because the packages of knowledge 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 control , product sampling and testing of the ultimate vaccine and also considered the conditions for its safe supply and distribution.
The National Institute for Biological Standards and Control, a part of the agency, has been and can continue doing, independent laboratory testing in order that every batch of the vaccine meets the expected standards of safety and quality.
The decision to approve the availability of this vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid temporary regulatory approvals to deal with significant public health issues like an epidemic .
The MHRA may be a centre of the Medicines and Healthcare products regulatory authority which also includes the National Institute for Biological Standards and Control (NIBSC) and therefore the Clinical Practice Research Datalink (CPRD). The MHRA is an agency of the Department of Health and Social Care.
The Commission on Human Medicines (CHM) advises ministers on the security , efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.