The MHRA reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling, and testing of the final vaccine,. The agency also considered the conditions for its safe supply and distribution.
Until January 1, 2021, the UK still has to follow EU rules, so vaccines in the UK would usually have to be approved by the Amsterdam-based European Medicines Agency . In the past, the agency has worked closely with UK regulator the Medicines and Healthcare Products Regulatory Agency . The EMA has said it hopes to authorize at least one vaccine by the end of the year. Pfizer said Tuesday it had asked the EU to approve its vaccine, and the EMA said its scientific committee will decide whether Pfizer's vaccine is safe and effective enough on or before December 29.
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