| MHRA give more details of the approval process on their site[1]: > 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. The information sheet for doctors gives a long list of "we don't know yet" about safety and efficacy for certain populations[2]. [1] https://www.gov.uk/government/news/uk-medicines-regulator-gi... [2] https://assets.publishing.service.gov.uk/government/uploads/... |