COVID-19 vaccines and medicines: updates for April 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
Updates to the pregnancy and breastfeeding information for Spikevax COVID-19 vaccine and Comirnaty COVID-19 Vaccine
We have made changes to the product information for the Spikevax (Moderna) COVID-19 Vaccine and the Comirnaty (Pfizer/BioNTech) COVID-19 Vaccine to reflect the large amount of real-world data on pregnancy and breastfeeding that has now been collected. The available data are reassuring on safety and that the vaccines can be used during pregnancy and breastfeeding – see recent Yellow Card reporting for the COVID-19 vaccines.
A large amount of information from pregnant women vaccinated with Spikevax and Comirnaty during the second and third trimester has not shown negative effects on the pregnancy or the newborn baby.
Published studies from the USA and Norway have compared miscarriage rates for vaccinated and unvaccinated women who were pregnant over the same time periods. The studies included data from a large number of women (more than 15,000) who received Spikevax or Comirnaty COVID-19 vaccines. Both studies found that the occurrence of miscarriage was equally likely amongst unvaccinated women as amongst women at the same stage of pregnancy who were vaccinated in the previous 3 to 5 weeks. These studies provide strong evidence for no increased risk of miscarriage in association with the mRNA vaccines in current use.
The numbers of Yellow Card reports for pregnant women are low in relation to the number of pregnant women who have received COVID-19 vaccines to date. There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage, stillbirths, congenital anomalies or birth complications.
There is no current evidence that COVID-19 vaccination while breastfeeding causes any harm to breastfed children or affects the ability to breastfeed. Spikevax and Comirnaty can be given during breastfeeding.
For more information, see the Summary of Product Characteristics section 4.6 for Spikevax and Comirnaty, and Patient Information Leaflet section 2 for Spikevax and Comirnaty.
Approval of Valneva COVID-19 Vaccine
We have approved the COVID-19 Vaccine developed by Valneva after a rigorous review, and we found it met the required safety, quality and effectiveness standards.
For more information about the Valneva COVID-19 Vaccine, please see our Press release and Decision page, which includes the Summary of Product Characteristics and Patient Information Leaflet.
Approval of Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention
We have authorised Evusheld (tixagevimab/cilgavimab), a new medicine for COVID-19 prevention after it met our regulatory standards of safety, quality and effectiveness.
For more information, please 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 the product information for Comirnaty 10 mg/dose concentrate to reference the products orange cap and extended the shelf life from 6 months to 9 months. Also updated the product information for Comirnaty 30 mg/dose concentrate to reference the products purple cap, amended the frequencies for myocarditis and pericarditis from not known to very rare, added erythema multiforme as a potential side effect, updated the wording around the shelf life and included a reference to the new paediatric formulation for children aged 5 to 11 years.
- added paraesthesia as a rare side effect to the product information of Spikevax COVID-19 Vaccine
- published the Public Assessment Report for Xevudy (sotrovimab)
- approved an update to the current UK approval of the Spikevax COVID-19 Vaccine that allows its use in Great Britain in 6 to 11 year-olds
We previously included summaries of latest COVID-19 information, including in the January 2022, February 2022 and March 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 9: April 2022: 2.