COVID-19 vaccines and medicines: updates for March 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11 March 2022
COVID-19 antivirals: reminder on reporting
We remind of advice in the February 2022 Drug Safety Update on COVID-19 antivirals and reporting to the UK COVID-19 Antivirals Pregnancy Registry.
As the safety of COVID-19 antivirals in pregnancy has not been established, please report any pregnancies which occur during use of a COVID-19 antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This advice is relevant for molnupiravir (Lagevrio▼), the combination of PF-07321332 (nirmatrelvir) plus ritonavir (Paxlovid▼), and remdesivir (Veklury▼).
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:
- updated the product information for COVID-19 Vaccine Janssen to include dizziness and rare coagulation disorders such as thrombosis with thrombocytopenia syndrome, venous thromboembolism, and immune thrombocytopenia. The storage and transportation instructions have also been updated.
We previously included summaries of latest COVID-19 information, including in the December 2021, January 2022 and February 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.
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 8: March 2022: 4.