Research and analysis

Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance

The MHRA has developed, and now has in place, a four-stranded approach to vigilance, which is summarised in this report.

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In May 2020, the Commission on Human Medicines established an Expert Working Group (EWG) to advise the Medicines and Healthcare products Regulatory Agency (MHRA) on its safety monitoring strategy for COVID-19 vaccine(s).

The EWG held four meetings from May to October 2020, during which it considered proposals and methodologies for MHRA-led vigilance activities.

Based on this advice, the MHRA has developed, and now has in place, a four-stranded approach to vigilance, which is summarised in this report.

View the weekly report on Coronavirus (COVID-19) vaccine adverse reactions.

Published 5 February 2021