The updates affect the Comirnaty Original 10 microgram/dose and 3 microgram/dose products. The updates affect all the Comirnaty Original Products. A variation to reflect new posology for primary immunisation. Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) updated to reflect: 1. Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) of the Comirnaty Omicron XBB.1.5 vaccines have been published. The MHRA regularly publishes reports of the safety of the COVID-19 vaccines. Please regularly check this information as it is often updated. The information for healthcare professionals and UK recipients on using the vaccine safely has been updated as new data have become available and this will continue under the MA. The GB CMA was converted to a full MA on 9 November 2022. The CMA issued by the EMA has continued to have effect in Northern Ireland since 21 December 2020 and was converted to a full Marketing Authorisation (MA) on 10 October 2022. The original conditional Marketing Authorisation (CMA) was issued by the European Medicines Agency (EMA) on 21 December 2020 and was automatically converted to a GB CMA on 1 January 2021. The archived product information for the COVID-19 Vaccine Pfizer/BioNTech authorised under Regulation 174 can also be found on this page. Supply of the vaccine is now in accordance with the Marketing Authorisation with all remaining Regulation 174 stocks expiring at the end of February 2022. Initially, the COVID-19 Vaccine Pfizer/BioNTech was supplied in the UK on a temporary basis under Regulation 174 of the Human Medicine Regulations 2012, but this was always intended to be a temporary arrangement. There is currently no GB supply of the fourth presentation and the product information for this will only be published once this supply becomes available.Īll four presentations use the same drug substance but have specific administration requirements and are differentiated by use of different coloured caps on the vials. The product information for the above three presentations can be found on this page. The 3 microgram/dose paediatric presentation currently for infants and children aged 6 months to 4 years (maroon cap).The 10 microgram/dose paediatric presentation currently for 5-11 year-olds (orange cap).The 30 microgram/dose presentation (purple cap).There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all require dilution: A temporary suspension will also apply for infants and children aged 6 months to 4 years, should this age group be included in the vaccination programme. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. The 15-minute observation period following vaccination with COVID-19 Vaccine Pfizer/BioNTech or Moderna has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice.) This follows careful review of the safety data by the MHRA and advice from the government’s independent Commission on Human Medicines.
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