COVID-19 vaccines and medicines: updates for May 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the April 2022 issue of Drug Safety Update, up to 13 May 2022.
Removal of 15-minute observation period following vaccination with COVID-19 Vaccine Pfizer/BioNTech or Moderna
The 15-minute observation period following vaccination with COVID-19 Vaccine Pfizer/BioNTech or Moderna has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Green Book advice).
This follows careful review of the safety data by us and advice from the government’s independent Commission on Human Medicines. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis.
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:
- published the Public Assessment Report for Nuvaxovid COVID-19 vaccine. Please see the Decision page on our website which has more details about the Nuvaxovid COVID-19 vaccine.
- Updated the Summary of Product Characteristics and Patient Information Leaflet of COVID-19 Vaccine Janssen to include transverse myelitis as a possible side effect
We previously included summaries of latest COVID-19 information, including in the February 2022, March 2022 and April 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 10: May 2022: 2.