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Information about adverse event reporting can be found towards the bottom of the page

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AboutmRNA TechnologyMechanism of ActionDosing & AdministrationComirnaty Omicron XBB.1.5Dosing & Administration StorageComirnaty Omicron XBB.1.5 30mcg 12 years + (Grey cap)How to OrderComirnaty Omicron XBB.1.5 Supply for Great BritainResourcesMaterialsVideosEN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Information on how to access prescribing information and adverse event reporting can be found at the bottom of the page.

mRNA TechnologymRNA vaccines can be updated in response to new SARS-CoV-2 variants1The nonreplicating mRNA in COMIRNATY Omicron XBB.1.5 stimulates immune responses to SARS-CoV-22

Made entirely in vitro2,3

COMIRNATY Omicron XBB.1.5 is made entirely by a cell-free in vitro transcription process.

Cannot cause COVID-194,5

COMIRNATY Omicron XBB.1.5 does not contain a live virus and cannot cause COVID-19.

Does not enter nucleus2,3,5

COMIRNATY Omicron XBB.1.5 does not integrate into the cell’s genome and cannot cause mutation of the DNA.

Transiently active5,6

The mRNA in COMIRNATY Omicron XBB.1.5 is transiently active and degraded by normal metabolic pathways. After the piece of the spike protein is made, the cell breaks down the mRNA strand and removes it, leaving the body as waste.
COMIRNATY Omicron XBB.1.5 elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-192
Explore moreCOMIRNATY Omicron XBB.1.5 in a private healthcare setting

Learn more about how to order COMIRNATY Omicron XBB.1.5 single dose vials

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References:

Pather S, Muik A, Rizzi R, Mensa F. Clinical development of variant-adapted BNT162b2 COVID-19 vaccines: the early Omicron era. Expert Review of Vaccines. 2023;22(1):650-661. DOI: 10.1080/14760584.2023.2232851COMIRNATY Omicron XBB.1.5 Single Dose Vial Summary of Product Characteristics. Background document on the mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19. 14 January 2021. World Health Organization. Accessed February 2024. https://www.who.int/publications/i/item/background-document-on-mrna-vaccine-bnt162b2-(pfizer-biontech)-against-covid-19Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines - a new era in vaccinology. Nat Rev Drug Discov. 2018;17(4):261-279. doi: 10.1038/nrd.2017.243Centers for Disease Control and Prevention. Understanding how COVID-19 vaccines work.  Accessed February 2024. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.htmlSchlake T, Thess A, Fotin-Mleczek M, Kallen KJ. Developing mRNA-vaccine technologies. RNA Biol. 2012;9(11):1319-30. doi: 10.4161/rna.22269
PP-CMR-GBR-0517. February 2024

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.

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Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH

COMIRNATY, COMIRNATY Omicron XBB.1.5, are based on BioNTech proprietary mRNA technology, developed by both BioNTech and Pfizer.


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.

 

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PP-CMR-GBR-0512. January 2024
 

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These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

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