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Great BritainCOMIRNATY Omicron XBB.1.5 30mcgCOMIRNATY Omicron XBB.1.5 10mcgCOMIRNATY Omicron XBB.1.5 3mcgNorthern Ireland

The information on this website relates to storage, preparation and administration of COMIRNATY vaccines used as part of the UK National Immunisation Programme.
For information regarding private provisions of COMIRNATY vaccines please visit PfizerPro:

www.Pfizerpro.co.uk/medicine/comirnaty

For more information relating to Pfizer’s vaccines and related therapy areas, including clinical publications and resources, as well as assets relating to particular at-risk groups, please visit:
  https://pfizermedical.pfizerpro.co.uk/vaccines


There are several formulations of COMIRNATY vaccine used as part of the current programme. These are summarised in the table below, with more information on the product pages. To verify that you have selected the correct vaccine, observe the key aspects of the pack and vial lable for the formulation before administation.


COMIRNATY Vaccine Formulation Quick Reference Guide for use on the National Immunisation Programme.
 

COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion (ready for use)​

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COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion (ready for use)​

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COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion (dilute before use)​

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Name

COMIRNATY Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine1

COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine 2

COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine3

Licensed age of use

12 years and older 1

5 to 11 years old 2

6 months to 4 years old3

One Dose Contains

30 micrograms raxtozinameran 1

10 micrograms raxtozinameran 2

3 micrograms raxtozinameran 3

Pack image

Dilution Status

Ready for use.Do not dilute 1

Ready for use.Do not dilute  2

Dilute before use3

Doses per vial

6 doses of 0.3mL 1

6 doses of 0.3mL 2

10 doses of 0.2mL after dilution 3

Dilution Volume

Do not dilute prior to use.

Do not dilute prior to use.

Dilute in its original vial with 2.2 mL sodium chloride 9 mg/mL (0.9%) solution.

Link to product resources

Click here
Click here
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.
  • Information about COMIRNATY® Original/Omicron BA.4-5▼ (tozinameran / famtozinameran) COVID-19 mRNA Vaccine can be found here
  • Information about  COMIRNATY® Original/Omicron BA.1▼ (tozinameran / riltozinameran) COVID-19 mRNA Vaccine can be found here
  • Information about COMIRNATY®▼ (tozinameran) COVID-19 mRNA Vaccine  30 mcg / dose concentrate for dispersion for injection 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
Mechanism of Action and Composition:
  • Raxtozinameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (Omicron XBB.1.5).

  • The nucleoside-modified mRNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen.1-3
  • The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19. 1-3
References:
  1. Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection 12+ years COVID-19 mRNA Vaccine Summary of Product Characteristics, Great Britain. Available at https://www.medicines.org.uk/emc/product/15042 (accessed: April 2024)
  2. Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection children 5-11 years COVID-19 mRNA Vaccine Summary of Product Characteristics, Great Britain. Available at https://www.medicines.org.uk/emc/product/15043 (accessed: April 2024)
  3. 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, Great Britain. Available at https://www.medicines.org.uk/emc/product/15044 (accessed: April 2024)
       PP-CMR-GBR-0544. April 2024

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH

COMIRNATY, COMIRNATY Omicron XBB.1.5, COMIRNATY Original/Omicron BA.4-5 and COMIRNATY Original/Omicron BA.1 COVID-19 mRNA Vaccines, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.


©2024 Pfizer Inc. All rights reserved. PP-CMR-GBR-0522  February 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. 

This website is brought to you by Pfizer Limited, a company registered in England and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent CT13 9NJ, VAT registration number GB201048427.

The products discussed may have different product labelling in other countries.​​​​​​​
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For Healthcare Professionals* and Other Relevant Decision Makers** only

This website is not intended for patients or for members of the general public. The website contains promotional content.

I confirm that I am a Healthcare Professional* or Other Relevant Decision Maker** resident in the United Kingdom.

If you select Yes – Great Britain: you will be directed to the Great Britain*** homepage. Information on this page is aligned to the Summary of Product Characteristics (SmPC) for Great Britain.

If you select Yes – Northern Ireland: you will be directed to the Northern Ireland homepage. Information on this page is aligned to the SmPC for Northern Ireland.


If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition of Healthcare Professional is members of the medical, dental, pharmacy and nursing professions and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

**The ABPI Code definition of ‘Other Relevant Decision Makers’ particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.

*** Great Britain includes England, Scotland and Wales.

PP-CMR-GBR-0400 June 2023