COVID-19 vaccines: updates for October 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the September 2021 issue of Drug Safety Update, up to 1 October 2021.
Summaries of Yellow Card reporting and other recent MHRA publications
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.
We have also recently:
- published regulatory updates on the COVID-19 booster vaccine programme for winter 2021 to 2022
- updated the Summary of Product Characteristics and Sections 5 and 6 of the Patient Information Leaflet for COVID-19 Vaccine Janssen. For more information on COVID-19 Vaccine Janssen, see the Decision page
- approved the extension of the shelf life of the COVID-19 Vaccine Pfizer/BioNTech from the current 6 months to 9 months
We previously included summaries of latest COVID-19 information, including in the July 2021, August 2021 and September 2021 issues of Drug Safety Update.
See guidance on COVID-19 for all our latest information, including after publication of this article.
Reporting Yellow Cards
Suspected adverse reactions associated with COVID-19 vaccines should be reported to the MHRA through the MHRA’s Coronavirus Yellow Card reporting site or via the Yellow Card app.
As these products are under additional monitoring, this includes all suspected adverse reactions associated with these vaccines. 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, treatment dates, and vaccine 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.
Article citation: Drug Safety Update volume 15, issue 3: October 2021: 4.