This site is intended for UK HCPs* and ORDMs** and is brought to you by Pfizer Ltd.
Full name: COMIRNATY Omicron XBB.1.5 10 micrograms /dose dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)
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 12-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
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.
PP-CMR-GBR-0433 September 2023
COMIRNATY, COMIRNATY Omicron XBB.1.5, COMIRNATY Original/Omicron BA.4-5 and COMIRNATY Original/Omicron BA.1 COVID-19 mRNA Vaccines (nucleoside modified), which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.
©2023 Pfizer Inc. All rights reserved. PP-CMR-GBR-0422 September 2023
*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.
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