Medicines Healthcare Products Regulatory Agency
Summaries of Yellow Card reporting
On 8 March 2023 we published the summary report of Yellow Card reporting for the COVID-19 vaccines. This report covers the period up to and including 22 February for COVID-19 vaccines used from the beginning of Autumn 2022.
The Commission on Human Medicines (CHM) has advised that given the end of the Autumn 2022 booster campaign and the stable safety profile of the COVID-19 vaccines, the MHRA should transition to routine data publication and communication of safety concerns for COVID-19 vaccines. The report published 8 March 2023 is therefore the last regular publication of the Summary of Yellow Card reporting for COVID-19 vaccines.
This will also be the last regularly scheduled article in Drug Safety Update of recent COVID-19 vaccines and medicines advice.
Robust safety monitoring and surveillance of any COVID-19 vaccines used in the UK will continue, along with timely communication on any updated safety advice when needed. Additionally, monthly updates of Adverse Drug Reaction (ADR) data will continue with the new interactive?COVID-19 vaccine reports.
We would ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine or medicine to report via the?Yellow Card website.
Other recent MHRA updates on COVID-19 vaccines and medicines:
We have also recently:
- authorised a new version of the Moderna bivalent COVID-19 vaccine (Spikevax) that targets both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants
- updated the Summary of Product Characteristics and Patient Information Leaflet to reflect the COVID-19 Janssen vaccine was converted to a full marketing authorisation. Please see the Decision page?on our website which has more details about the COVID-19 Vaccine Janssen.
See?guidance on COVID-19 for all our latest information, including after publication of this article.
We have included summaries of the latest COVID-19 information being issued by the MHRA since January 2021, including in the?December 2022,?January 2023?and February 2023 issues of Drug Safety Update.
Article citation: Drug Safety Update volume 16, issue 8: March 2023: 3.