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

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

Full name: COMIRNATY Omicron XBB.1.5 10 micrograms /dose dispersion for injection COVID-19 mRNA vaccine1

Indication: indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years1
The use of this vaccine should be in accordance with official recommendations.1

How does the Pfizer/BioNTech Vaccine COMIRNATY Omicron XBB.1.5 differ from Pfizer/BioNTech's pre-existing COMIRNATY Vaccines?

COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion (ready for use) is a monovalent vaccine adapted to target the Omicron XBB.1.5 COVID-19 variant.

COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion is ready to use, do not dilute before use


The dose of COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection is 0.3 mL given intramuscularly.

There should be an interval of at least 3 months between administration of COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion for injection and the last prior dose of a COVID-19 vaccine.

Please refer to 4.2 of the Summary of Product Characteristics for more information.

Administration: administered intramuscularly Do not dilute prior to use. The preferred site is the deltoid muscle of the upper arm.1 ​ 

Pack size: 10 multidose vials1

Dilution status:  Ready for use. Do not dilute before use1

Refrigerated storage (2°C to 8°C) once thawed: 10 weeks storage and transportation at 2 °C to 8 °C within the 18-month shelf life. Once thawed the vaccine should not be re-frozen.1

Vial: 6 multidose vial1

Dose:  10 micrograms (0.3mL)1

Room temperature stability before use: the unopened vials can be stored for up to 12 hours at temperatures between 8oC and 30oC.1

Stability of diluted vials: Chemical and physical in-use stability has been demonstrated for 12 hours at 2oC to 30oC, which includes up to 6 hours transportation time. From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user. Discard any unused vaccine 12 hours after first puncture.1

Click here for Summary of Product Characteristics

Verification, handling & preparation of COMIRNATY Omicron XBB.1.5 10 micrograms/dose dispersion (ready for use)

Undesirable Effects :
The safety of COMIRNATY Omicron XBB.1.5 is inferred from safety data of the prior COMIRNATY vaccine, given as first, second or subsequent doses. 

The most common adverse reactions from COMIRNATY and COMIRNATY Original/Omicron BA.4-5 clinical trials and COMIRNATY post-authorisation experience in individuals 5 years of age and older were:

Injection site pain/swelling

* a higher frequency of pyrexia was observed after a second dose compared to a first dose

Before administering the vaccine, refer to the Summary of Product Characteristics for further details.

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.


  1. 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 (accessed: February 2024)

PP-CMR-GBR-0490 February 2024

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH

COMIRNATY, COMIRNATY Omicron XBB.1.5, COMIRNATY Original/Omicron BA.4-5 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-0588  June 2024

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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.​​​​​​​

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

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PP-CMR-GBR-0400 June 2023