COVID-19 vaccines: updates for June 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 11 June 2021.
Here we include a summary of key MHRA advice issued up to 11 June 2021 and since the publication of the May 2021 edition of Drug Safety Update.
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.
Information about our review of reports of menstrual disorders and unexpected vaginal bleeding with the three COVID-19 vaccines currently being used in the UK has been included in the weekly summary. The current evidence does not suggest an increased risk of either menstrual disorders or unexpected vaginal bleeding following vaccination with the vaccines reviewed (Pfizer/BioNTech, COVID-19 Vaccine AstraZeneca or COVID-19 Vaccine Moderna). Our advice remains that the benefits of the vaccine outweigh the risks for most people. We will continue to closely monitor reports of suspected menstrual disorders and vaginal bleeding with COVID-19 vaccines.
We take every report of a suspected adverse reaction seriously and encourage everyone to report through the Coronavirus Yellow Card reporting site.
We have also recently:
- authorised an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12 to 15 year-olds
- given regulatory approval to the COVID-19 vaccine developed by Janssen after it met the required safety, quality and effectiveness standards
See guidance on COVID-19 for all our latest information, including after publication of this article.
We previously included a summary of latest advice in the January 2021, February 2021, March 2021, April 2021 and May 2021 issues of Drug Safety Update.
Article citation: Drug Safety Update volume 14, issue 11: June 2021: 3.