To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 15 March 2022 to Question 121676 on Yellow Card Scheme: Coronavirus, what the average time taken is to analyse each yellow card; whether yellow cards reporting serious injury or death are subject to more detailed analysis; and if he will ask the MHRA to share the assessment of an individual report when the patient who is the subject of that report so requests.
This answer is the replacement for a previous holding answer.
11 April 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) have not made a specific assessment of the average time taken to analyse a Yellow Card reports. However, reports received are promptly recorded on the MHRA’s adverse drug reaction (ADR) database to accurately reflect the specific Yellow Card report which supports effective action on emerging information on harms. Those reports with fatal or serious ADRs are prioritised for review, with events of particular interest given the highest priority.
For the COVID-19 vaccines, the MHRA’s assessors perform signal assessment on the Yellow Card data several days a week and events of interest are discussed at twice weekly meetings. Serious Yellow Card reports, particularly those with a fatal outcome, are followed up to enable assessment of the report. There are no plans to request the MHRA to share the assessment of individual reports with the patient.