COVID-19 vaccines and medicines: updates for February 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2022 issue of Drug Safety Update, up to 11 February 2022.
See article in February 2022 Drug Safety Update on COVID-19 antivirals: reporting to the UK COVID-19 Antivirals Pregnancy Registry
Approval of Novavax COVID-19 vaccine: Nuvaxovid
We have approved Nuvaxovid, the COVID-19 Vaccine developed by Novavax. This follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines (CHM).
For more information, please see the Decision page on our website which includes the Summary of Product Characteristics and Product Information Leaflet.
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:
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updated the product information for Vaxzevria (previously COVID-19 Vaccine AstraZeneca) to include extremely rare cases of transverse myelitis. A further dose of Vaxzevria should not be given to those who have experienced symptoms of transverse myelitis after a previous dose of this vaccine
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published the Public Assessment Report and a summary of the Public Assessment Report for Paxlovid antiviral treatment for COVID-19
We previously included summaries of latest COVID-19 information, including in the November 2021, December 2021 and January 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 7: February 2022: 4.