COVID-19 vaccines and medicines: updates for November 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
Approval of Lagevrio (molnupiravir)
We have approved Lagevrio (molnupiravir), following a rigorous review of its safety, quality and effectiveness by us and the government’s independent expert scientific advisory body, the Commission on Human Medicines (CHM), making it the first oral antiviral for the treatment of COVID-19 to be approved.
Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease.
Lagevrio works by interfering with the virus’ replication. Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so we recommend its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset.
Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.
For more information about Lagevrio (molnupiravir), see our Press release and Decision page which includes the Summary of Product Characteristics and Patient 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:
- added Guillain-Barré syndrome (GBS) as a very rare side effect for Vaxzevria (previously COVID-19 Vaccine AstraZeneca) and updated the Information for Healthcare Professionals and Information for UK recipients
- updated the Summary of Product Characteristics sections 4.8 and 5.1 of the Pfizer/BioNTech vaccine for COVID-19 with additional information on potential side effects and vaccine efficacy, and updated section 4 of the Patient Information Leaflet with possible side effects
- updated the Summary of Product Characteristics (sections 4.3, 4.4 and 4.8) and Patient Information Leaflet (section 2 and 4) for COVID-19 Vaccine Janssen
We previously included summaries of latest COVID-19 information, including in the August 2021, September 2021 and October 2021 issues of Drug Safety Update.
See guidance on COVID-19 for all our latest information, including after publication of this article.
Reporting Yellow Cards
Suspected adverse reactions associated with COVID-19 vaccines should be reported to the MHRA through the MHRA’s 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 4: November 2021: 3.