Medicines Healthcare Products Regulatory Agency
Summaries of Yellow Card reporting
We continue to publish the summaries of the Yellow Card reporting for the COVID-19 vaccines being used in the UK. The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the?COVID-19 Vaccine Surveillance Strategy.
The MHRA has revised the format of the Summary of Yellow Card reporting to focus on the COVID-19 vaccines administered from the beginning of the Autumn 2022 booster campaign. Any new assessments or safety issues regarding vaccines used in the primary and initial booster campaigns will also be included in this record, however previous and known information on these vaccines will remain available as a record only and can be viewed in an archived form on our website. Yellow Card reports received via the scheme across all vaccines will be updated and reflected in the COVID-19 vaccine reports.
The MHRA has begun implementing a new enhanced format of data visualisations. This enables us to provide improvements in format, accessibility and data protection, while also providing more data than has been published previously. Since December 2022, COVID-19 vaccine reports have replaced the previous Vaccine Analysis Prints (VAPs).
Other recent MHRA updates on COVID-19 vaccines and medicines:
We have also recently:
- published our Public Assessment Report on the Pfizer/BioNTech bivalent vaccine - Comirnaty Original/Omicron BA.4-5
- updated the Pfizer Omicron BA.1 and BA.4-5 SmPC and PIL documents
- authorised VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, after finding it meets the MHRAs acceptable standards of safety, quality and effectiveness
See guidance on COVID-19 for all our latest information, including after publication of this article.
We previously included summaries of latest COVID-19 information, including in the October 2022, November 2022 and December 2022 issues of Drug Safety Update.
The public consultation on how the MHRA communicates medicines and medical devices safety information to healthcare professionals is now open. The consultation is a unique opportunity to influence future MHRA safety communications and safety reporting systems so please encourage all healthcare professionals to complete the survey. The deadline for responses has been extended to 11.45pm on Tuesday 31 January.
Article citation: Drug Safety Update volume 16, issue 6: January 2023: 4.