COVID-19 vaccines and medicines: updates for December 2021

Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.

Approval of Xevudy (sotrovimab), a monoclonal antibody treatment for COVID-19

We have approved Xevudy (sotrovimab) 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). This is the second monoclonal antibody therapeutic to be approved following Ronapreve.

Xevudy (sotrovimab) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.

Xevudy works by interfering with the replication of the virus, binding to the COVID-19 spike protein and preventing the virus from attaching to and entering human cells. Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.

Like the antiviral molnupiravir, Xevudy has been authorised for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (over 55 years), diabetes mellitus, or heart disease. Unlike molnupiravir, sotrovimab is administered by intravenous infusion over 30 minutes. It is approved for individuals aged 12 and above who weigh more than 40kg.

For more information about Xevudy (sotrovimab), 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:

  • updated sections of the Summary of Product Characteristics and Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech to include information about receiving a third/booster dose, added the official international non-proprietary name ‘tozinameran’ and included two new reagents, sodium hydroxide and hydrochloric acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process
  • published the Public Assessment Report (PAR) for Ronapreve, an antibody treatment for COVID-19. Please see the Decision page on our website which has more details about Ronapreve
  • published a statement on the expansion of the COVID-19 vaccination booster programme

We previously included summaries of latest COVID-19 information, including in the September 2021, October 2021 and November 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

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 5: December 2021: 4.

Published 10 December 2021