COVID-19 vaccines and medicines: updates for December 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2022 issue of Drug Safety Update, up to 8 December 2022.
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 includes other data such as usage of COVID-19 vaccines and relevant epidemiological data. The report is updated regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
The MHRA will be updating the format of the summary of Yellow Card reporting in future publications to focus on the coronavirus vaccines being administered as part of the autumn booster campaign. Information on monovalent vaccines used in the previous primary and initial booster campaign will remain available as a record on the government website.
Other recent MHRA updates on Coronavirus vaccines and medicines:
We have also recently:
- authorised the Pfizer/BioNTech COVID-19 vaccine for use in infants and children aged 6 months to 4 years after finding it meets the MHRA’s 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 September 2022, October 2022 and November 2022 issues of Drug Safety Update.
Reporting Yellow Cards
Report suspected side effects to medicines, vaccines and medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using:
- the dedicated Coronavirus Yellow Card reporting site
- the Yellow Card app (download from the Apple App store or Google Play store)
For products under additional monitoring (▼) such as the COVID-19 vaccines, you should report all suspected side effects. This will allow the MHRA to identify new safety information for these products.
When reporting please provide as much information as possible, including information about medical history, any concomitant medications, onset timing, and treatment dates, and for vaccines, the product brand name and batch number.
You may be contacted following submission of a Yellow Card report so that we can gather additional relevant information for the assessment of the report. These contributions form an important part of our understanding of suspected side effects.
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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.
Article citation: Drug Safety Update volume 16, issue 5: December 2022: 2.