Medicines and Healthcare Products Regulatory Agency
Dear Dr. Raine,
RE: Urgent preliminary report of Yellow Card data up to 26th May 2021
As the Director of the Evidence-based Medicine Consultancy Ltd and EbMC Squared CiC, I am writing to share with you this urgent preliminary report on the Yellow Card data up to 26th May 2021. Please note that EbMC Squared CiC is a Community Interest Company that conducts research mandated by the public and funded by public donations. We have no conflicts of interest and do not engage in industry-funded work.
The MHRA describes the purpose of its Yellow Card system as providing "an early warning that the safety of a medicine or a medical device may require further investigation. It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about."[1] Furthermore, the MHRA recognises that the conditions under which medicines are studied in clinical trials do not reflect how the medicines will be used in hospitals or clinical practice once they are rolled out. This means that some adverse drug reactions "may not be seen until a very large number of people have received the medicine."
The Covid-19 vaccines were rolled out in the UK on the 8th of December 2020. As of the 6th May 2021 nearly 39 million people have received their first dose of the Covid-19 vaccine, and 24 million both doses. Sufficient data have now accumulated to get a good overview of adverse drug reactions (ADRs). I would, therefore, like to draw your attention to the high number of covid-19 vaccine-attributed deaths and ADRs that have been reported via the Yellow Card system between the 4th January 2021 and the 26th May 2021. In total, 1,253 deaths and 888,196 ADRs (256,224 individual reports) were reported during this period.
