COVID-19 vaccines and medicines: updates for September 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 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 a statement on booster doses of Pfizer/BioNTech and AstraZeneca COVID-19 vaccines
- given approval to Ronapreve▼ (casirivimab/imdevimab), a monoclonal antibody treatment for the prevention and treatment of COVID-19. For more information about this medicine see the Decision page which includes the Summary of Product Characteristics and Patient Information Leaflet
- updated the shelf life, special precautions for storage and special precautions for disposal in the Summary of Product Characteristics and Patient Information Leaflet for Spikevax (formerly COVID-19 Vaccine Moderna)
- added a precautionary warning about Guillain-Barré Syndrome to the Summary of Product Characteristics and Patient Information Leaflet for Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) following a review of the available data
- authorised an extension to the current UK approval of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) that allows its use in 12 to 17 year olds
We previously included summaries of latest COVID-19 information, including in the June 2021, July 2021 and August 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 2: September 2021: 2.