COVID-19 vaccines and medicines: updates for February 2023
Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2023 issue of Drug Safety Update, up to 21 February 2023.
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.
The MHRA has updated the format of the summary of Yellow Card reporting to focus on the bivalent coronavirus vaccines being administered as part of the autumn booster campaign. Information on monovalent vaccines used in the previous primary and initial booster campaign will remain available as a record on the government website. Yellow Card reports received via the scheme across all COVID-19 vaccines will be updated and reflected in the COVID-19 vaccine reports.
Other recent MHRA updates on Coronavirus vaccines and medicines:
We have also recently:
- updated the SmPC and PIL documents for the COVID-19 Vaccine AstraZeneca to add tinnitus as an uncommon side effect
- added a new, age-appropriate presentation of product information for the bivalent version of the vaccine Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose
- authorised a new version of the Moderna ‘bivalent’ Covid vaccine (Spikevax) that targets both the original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants after finding it meets the MHRA’s acceptable standards of safety, quality and effectiveness
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 November 2022, December 2022 and January 2023 issues of Drug Safety Update.
Article citation: Drug Safety Update volume 16, issue 7: February 2023: 1.