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.
Documents
Details
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.