Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what processes the Medicines and Healthcare products Regulatory Agency uses to determine whether a covid-19 vaccine may have caused (a) fatal outcomes and (b) adverse reactions in patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) does not assign causality at the level of individual reports, as this is not the responsibility of the MHRA, and as such a process is not held. The MHRA holds processes for cumulative analysis of Yellow Card data, as well as assessment of data from other sources, for patterns or evidence which might suggest a causal link between the vaccination and the reported reaction, alongside other relevant data. In relation to fatal reports, it is the role of a Coroner to determine the likely cause of death for an individual. The MHRA’s approach to post authorisation surveillance of COVID-19 vaccines is outlined in the published Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance.