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This page is for HCPs* and ORDMs** in Northern Ireland. Information on this page is aligned to the Northern Ireland Summary of Product Characteristics for each formulation.
Prescribing Information can be found in the top right corner of the website. Information about adverse event reporting can be found towards the bottom of the page.
Full name: COMIRNATY Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine1
Indication: indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 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 3 micrograms/dose concentrate for dispersion (dilute before use) is a monovalent vaccine adapted to target the Omicron XBB.1.5 COVID-19 variant.
Posology:
Please refer to 4.2 of the Summary of Product Characteristics for more information.
Administration: administered intramuscularly after dilution. In infants from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.1
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
Pack size: 10 multidose vials1
Dilution status: Dilute with 2.2mL of sodium chloride 9mg/mL (0.9%) solution for injection.1
Refrigerated storage (2°C to 8°C) once thawed: 10 weeks storage and transportation within the 18-month shelf life. Once thawed the vaccine should not be re-frozen.1
Vial: 10 multidose vial1
Dose: 3 micrograms (0.2mL)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 opened vials: Chemical and physical in-use stability has been demonstrated for 12 hours at 2oC to 30oC, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, which includes up to 6 hours transportation time. From a microbiological point of view, unless the method of dilution precludes the risk 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 within 12 hours after dilution.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 6 months of age and older were:
Irritability ⱡ
Diarrhoea
Headache
Drowsinessⱡ
Arthralgia/Myalgia
Injection site pain/tendernessⱡ/swelling
Pyrexia*
Chills
Fatigue
ⱡ Irritability, injection site tenderness, and drowsiness pertain to participants 6 to 23 months of age
* 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.
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.
COMIRNATY is a Prescription Only Medicine which has been centrally procured by the UK government.
References:
PP-CMR-GBR-0473 December 2023
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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This website is not intended for patients or for members of the general public. The website contains promotional content.
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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.
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*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