COVID-19 vaccines and medicines: updates for September 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2022 issue of Drug Safety Update, up to 23 September 2022.
Approval of Pfizer/BioNTech bivalent COVID-19 booster vaccine
We have approved the Pfizer/BioNTech bivalent COVID-19 vaccine as a booster after it was found to meet our standards of safety, quality and effectiveness. The brand name for the bivalent vaccine is Comirnaty Original/Omicron BA.1.
The updated booster vaccine targeting the original coronavirus strain and the Omicron BA.1 variant, has been approved for use in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.
Safety monitoring in clinical trials showed that the types of side effects observed were the same as those seen for the original Pfizer/BioNTech monovalent vaccine (brand name Comirnaty) booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified.
Please see the Press Release and the Decision page for more information about Pfizer/BioNTech bivalent Original/Omicron booster vaccine.
MHRA statement: COVID-19 vaccines are safe and effective during pregnancy and breastfeeding
We would like to reassure the public that our advice has not changed. Our advice remains that the COVID-19 vaccines are safe and effective during pregnancy and breastfeeding and there is substantial evidence to support this advice.
For our latest advice, please see our Summary of Coronavirus Yellow Card Reporting or the relevant Summary of Product Characteristics.
Summaries of Yellow Card reporting
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 includes other data such as usage of COVID-19 vaccines and relevant epidemiological data. The report is updated regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
Other recent MHRA updates on Coronavirus vaccines and medicines:
We have also recently:
- granted an extension to the Nuvaxovid COVID-19 Vaccine manufactured by the company Novavax to allow use in 12 to 17 year olds
- updated the Summary of Product Characteristics and Patient Information Leaflet for Comirnaty monovalent COVID-19 Vaccine (Pfizer/BioNTech) to include information about receiving a heterologous booster dose in individuals aged 18 years and over, and to update information on shelf life and transportation storage time
See guidance on COVID-19 for all our latest information, including after publication of this article.
We previously included summaries of latest COVID-19 information, including in the June 2022, July 2022 and August 2022 issues of Drug Safety Update.
Reporting Yellow Cards
Report suspected side effects to medicines, vaccines and medical device and test kit incidents used in coronavirus (COVID-19) testing and treatment using:
- the dedicated Coronavirus Yellow Card reporting site
- the Yellow Card app (download from the Apple App store or Google Play store)
For products under additional monitoring such as the COVID-19 vaccines, you should report all suspected adverse side effects. This will allow the MHRA to identify new safety information for these products.
When reporting please provide as much information as possible, including information about medical history, any concomitant medications, onset timing, and treatment dates, and for vaccines, the 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 side effects.
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Article citation: Drug Safety Update volume 16, issue 2: September 2022: 3.