COVID-19 vaccines and medicines: updates for June 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the May 2022 issue of Drug Safety Update, up to 17 June 2022.
Product information update for Spikevax COVID-19 vaccine
We have updated the Summary of Product Characteristics for Spikevax (formerly COVID-19 Vaccine Moderna) to allow for third dose heterologous boosting (that is, for someone having a different vaccine to their primary course as a booster). We have also shortened the interval between the primary course and booster dose from at least 6 months to at least 3 months.
Please see the Decision page on our website, which has more details about the Spikevax vaccine for COVID-19.
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 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.
We have also recently:
- updated the shelf life for Comirnaty 10 micrograms/dose mRNA Vaccine (orange cap) from 9 months to 12 months. Please see the Decision page which has more details about the Pfizer/BioNTech vaccine for COVID-19 (Comirnaty)
- updated the product information for Spikevax to include a warning on the risk of flare-ups of capillary leak syndrome (CLS) in individuals who already have CLS. The batch site address and Marketing Authorisation Holder address has also been updated.
We previously included summaries of latest COVID-19 information, including in the March 2022, April 2022 and May 2022 issues of Drug Safety Update.
See guidance on COVID-19 for all our latest information, including after publication of this article.
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.
If you have been forwarded this article, subscribe directly to Drug Safety Update via our website.
Article citation: Drug Safety Update volume 15, issue 11: June 2022: 3.