COVID-19 vaccines and medicines: updates for November 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2022 issue of Drug Safety Update, up to 24 November 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.
Other recent MHRA updates on Coronavirus vaccines and medicines:
We have also recently:
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issued updated information to reflect the fact that the shelf life of Paxlovid has been extended from 18 to 24 months from initial manufacture
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granted approval for a second updated Pfizer/BioNTech ‘bivalent’ booster vaccine after it was found to meet acceptable standards of safety, quality and effectiveness
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granted approval for Comirnaty 10 micrograms concentrate for dispersion for injection (one of the licensed Comirnaty vaccines produced by Pfizer/BioNTech) for use as a booster for 5- to 11-year-olds
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updated the product information for the Comirnaty vaccines on myocarditis and pericarditis after a third dose and in the age group 5-11 years to reflect the most up-to-date information about these known side effects
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granted approval for Nuvaxovid to be used as an adult booster for those aged 18 and above. The product information has also been updated to add information on additional side effects
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updated the Summary of Product Characteristics (SmPC) and Patient Information Leaflet to reflect the approval of Evusheld for the treatment of COVID-19 in adults who are at risk of progressing to severe disease
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 July 2022, August 2022, September 2022 and October 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:
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the dedicated Coronavirus Yellow Card reporting site
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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 adverse 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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Article citation: Drug Safety Update volume 16, issue 4: November 2022: 3.