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18 November 2020

MHRA responds to results from Phase 3 studies of Pfizer/BioNTech’s potential COVID-19 vaccine and sets out potential approvals process


The Medicines and Healthcare products Regulatory Agency (MHRA) says that the results reported by Pfizer are 'very encouraging' and that 'we look forward to receiving the full results of the trials as soon as possible, after which we will rigorously assess the evidence of safety and effectiveness of the vaccine'.

The statement sets out that until the end of December 2020, COVID-19 vaccine candidates can be licensed and authorised via the European Medicines Agency (EMA), and that this authorisation will automatically be valid in the UK. 'However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.' Any COVID-19 vaccine submitted after the UK's transition period with the EU ends in 2021 will be assessed directly by the MHRA.


Gov.uk news story