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Coronavirus: Vaccination

Question for Department of Health and Social Care

UIN 109471, tabled on 30 October 2020

To ask the Secretary of State for Health and Social Care, if he will make it his policy to publish salient trial data for covid-19 vaccine candidates and any risk-based or other analyses of them that might be used toward any marketing authorisation, with sufficient time for review prior to any authorisation being given for a candidate’s marketing in the UK.

Answered on

27 January 2021

Data or clinical study reports from clinical trials of new medicines are not published before authorisation or prior to trial completion due to commercial confidentiality and concern that publication may influence or bias the on-going trial. The Medicines and Healthcare products Regulatory Agency (MHRA) performs a thorough and robust assessment of clinical trial data together with non-clinical data and manufacturing and control data submitted as part of a Marketing Authorisation Application.