COVID-19 vaccines and medicines: updates for August 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the July 2022 issue of Drug Safety Update, up to 19 August 2022.
Approval of Spikevax bivalent COVID-19 booster vaccine
We have approved Spikevax bivalent Original/Omicron COVID-19 Vaccine after it was found to meet our standards of safety, quality and effectiveness. The decision to grant approval for this booster vaccine in the UK was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.
Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified.
Please see the Press Release and the Decision page for more information about Spikevax bivalent Original/Omicron booster vaccine for COVID-19.
Summaries of Yellow Card reporting – update on publication frequency
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.
In line with the wider government’s Living with COVID-19 agenda strategy, the frequency of publication of the updated summary has transitioned to once per month from August. Our robust safety monitoring and surveillance will continue in the normal way between publications and we will continue to communicate promptly on any updated safety information.
We have also recently:
- published the Public Assessment Report for Valneva COVID-19 vaccine
- extended the shelf life of Paxlovid from 12 months to 18 months following a review of stability data
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 May 2022, June 2022 and July 2022 issues of Drug Safety Update.
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.
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Article citation: Drug Safety Update volume 16, issue 1: August 2022: 2.