Northern Ireland | COMIRNATYEDUCATION.co.uk | Pfizer UK

Therapeutic indications:

COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.
COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.
COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.

The use of these vaccines should be in accordance with official recommendations.^1-3

This website contains information and resources to support the usage of presentations of COMIRNATY Omicron XBB.1.5 used in the National Immunisation Programme.
You can access the full content which is aligned to the Summary of Product Characteristics for Great Britain via the links in the table below:

Click here

GB Quick Reference Guide Click here	COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion (ready for use^†) Click here	COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion (ready for use^†) Click here	COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion (dilute before use) Click here

^†It is expected that the majority of vaccinating sites will receive this vaccine thawed and stored at 2 °C to 8 °C, ready for use.

^{There are differences between the Summary of Product Characteristics (SmPC) in Northern Ireland and Great Britain. Some of these differences affect the information on the website pages and animations on this site. These differences are:}

^{Administration:}^{On the Northern Ireland SmPC, the administration section also includes the wording 'Do not inject the vaccine intravascularly, subcutaneously or intradermally.}

^{There may be other differences between the SmPC for Northern Ireland and Great Britain. Before administering the vaccine, refer to the relevant Northern Ireland Summary of Product Characteristics for full information:}

Information about COMIRNATY Omicron XBB.1.5▼ (raxtozinameran) COVID-19 mRNA Vaccine 30 mcg / dose dispersion for injection can be found here.
Information about COMIRNATY Omicron XBB.1.5▼(raxtozinameran) COVID-19 mRNA Vaccine 10 mcg / dose dispersion for injection can be found here.
Information about COMIRNATY Omicron XBB.1.5▼(raxtozinameran) COVID-19 mRNA Vaccine 3 mcg / dose concentrate dispersion for injection can be found here.
Information about COMIRNATY® Original/Omicron BA.4-5▼ (tozinameran / famtozinameran) COVID-19 mRNA Vaccine can be found here.
Information about COMIRNATY®▼ (tozinameran) COVID-19 mRNA Vaccine 10 mcg / dose concentrate for dispersion for injection can be found here.
Information about COMIRNATY®▼ (tozinameran) COVID-19 mRNA Vaccine 3 mcg / dose concentrate for dispersion for injection can be found here.

Adverse Event Reporting

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via a Yellow card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the batch/Lot number if available.

Alternatively, adverse events of concern in association with COMIRNATY can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.

Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates.

References:

Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection 12+ years COVID-19 mRNA Vaccine Summary of Product Characteristics, Northern Ireland. Available at https://www.emcmedicines.com/en-gb/northernireland/medicine?id=fb7b0598-d163-43b6-973b-284adbebbee6 (accessed: Junel 2024)
Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection children 5-11 years COVID-19 mRNA Vaccine Summary of Product Characteristics, Northern Ireland. Available at https://www.emcmedicines.com/en-gb/northernireland/medicine?id=9273204e-35c7-47c6-9ded-8f97fb6746ba (accessed: June 2024)
Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection children 6 months - 4 years COVID-19 mRNA Vaccine Summary of Product Characteristics, Northern Ireland. Available at https://www.emcmedicines.com/en-gb/northernireland/medicine?id=5cb2e978-3166-4ef5-b8cc-2c0e27c45f22 (accessed: June 2024)

PP-CMR-GBR-0587. June 2024

*Healthcare Professionals ** Other Relevant Decision Makers

The product information provided in this site is intended only for Healthcare Professionals and Other Relevant Decision Makers resident in the United Kingdom.

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The products discussed may have different product labelling in other countries.