COVID-19 vaccines and medicines: updates for July 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the June 2022 issue of Drug Safety Update, up to 20 July 2022.
Product information updates for Vaxzevria
We have also recently updated the product information for Vaxzevria (COVID-19 Vaccine AstraZeneca). These changes included updating preclinical data for breastfeeding and updating the efficacy, safety. and immunogenicity data. Wording has also been updated to state that in clinical trials, transient mild thrombocytopenia was commonly reported.
For more information about Vaxzevria, please see the Decision page with the Summary of Product Characteristics and Patient Information Leaflet.
Summaries of Yellow Card reporting – update on publication frequency
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.
In line with the wider government’s Living with COVID-19 agenda strategy, the frequency of publication of the updated summary has changed to every other week, before transitioning to once per month from August. Our robust safety monitoring and surveillance will continue in the normal way between publications and we will continue to communicate promptly on any updated safety information.
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 April 2022, May 2022 and June 2022 issues of Drug Safety Update.
Reporting Yellow Cards
Report suspected side effects to medicines, vaccines, medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using the dedicated Coronavirus Yellow Card reporting site or via the Yellow Card app.
For products under additional monitoring such as the COVID-19 vaccines, this includes all suspected adverse reactions. This will allow quick identification of new safety information.
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 adverse events.
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Article citation: Drug Safety Update volume 15, issue 12: July 2022: 2.