COMIRNATY®▼ (tozinameran) COVID-19 mRNA Vaccine (nucleoside modified) Prescribing Information can be found in the top right corner of the website. Information about adverse event reporting can be found below.
This page is for HCPs* and ORDMs** in Great Britain. Information on this page is aligned to the Great Britain Summary of Product Characteristics.
Several formulations of COMIRNATY are now available in the UK that have different handling and preparation requirements. Quick access information is displayed below.
COMIRNATY has been granted a conditional Marketing Authorisation in the UK for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older, and in individuals 5 to 11 years old.1,2
Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and the product information will be updated as necessary.1, 2
Therapeutic indications:
COMIRNATY 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified) is indicated for the active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1
COMIRNATY 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.2
The use of this vaccine should be in accordance with official recommendations.1, 2
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.
A guide to product handling, preparation and administration of COMIRNATY at your vaccination site.
Training for Healthcare Professionals and Other Relevant Decision Makers in Great Britain.
Refer to the information outlined below to understand the differences across age groups and formulations.
Formulation |
Formulation |
Formulation |
30mcg/dose concentrate - |
Ready to Use, |
10mcg/dose concentrate - |
Name |
Name |
Name |
COMIRNATY 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)1 |
COMIRNATY 30 micrograms/dose dispersion for injection COVID-19 mRNA vaccine (nucleoside modified) |
COMIRNATY 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)2 |
Indication |
Indication |
Indication |
Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1 |
Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older. |
Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.2 |
Licensed age of use |
Licensed age of use |
Licensed age of use |
12 years of age and older1 |
12 years of age and older |
Children 5 to 11 years old2 |
Vial Cap Colour |
Vial Cap Colour |
Vial Cap Colour |
Handling & Administration Poster |
Handling & Administration Poster |
Handling & Administration Poster |
Pack Size |
Package Size |
Pack Size |
195 multidose vials1 |
10 multidose vials |
10 multidose vials2 |
Vial |
Vial |
Vial |
Multi-dose vial1 |
Multi-dose vial |
Multi-dose vial2 |
Requires Dilution before use? |
Requires Dilution before use? |
Requires Dilution before use? |
YES1 |
NO |
YES2 |
Doses per Vial |
Doses per Vial |
Doses per Vial |
6 doses after dilution1 |
6 doses |
10 doses after dilution2 |
Dose |
Dosage |
Dose |
30 micrograms1 |
30 micrograms |
10 micrograms2 |
Amount of diluent required per vial |
Amount of diluent needed per vial |
Amount of diluent required per vial |
1.8 mL of sodium chloride 9 mg/mL (0.9%) solution for injection1 |
DO NOT DILUTE |
1.3 mL of sodium chloride 9 mg/mL (0.9%) solution for injection2 |
Injection volume per dose |
Injection volume per dose |
Injection volume per dose |
0.3mL1 |
0.3mL |
0.2mL2 |
Storage
This is an overview of the storage requirements for COMIRNATY – for full information on handling and preparation of this vaccine please refer to the relevant Summary of Product Characteristics.
Formulation |
Formulation |
Formulation |
30mcg/dose concentrate - 12 years and older1 |
12 years and older, Ready to Use |
10mcg/dose concentrate - 5 to 11 years old2 |
Storage of frozen unopened vials | ||
Shelf life when stored at -90 °C to -60 °C |
Shelf Life when stored at -90 °C to -60 °C |
Shelf life when stored at -90 °C to -60 °C |
|
6 months |
12 months2 |
Shelf life when stored at -25 °C to -15 °C |
||
DO NOT STORE |
||
Storage of thawing or thawed unopened vials | ||
Conditions required to thaw frozen vials |
Conditions required to thaw frozen vials |
Conditions required to thaw frozen vials |
195 vials: 3 hours at 2-8 °C, or individual vials: 30 mins at temperatures up to |
10 vials: 6 hours at 2-8 °C or individual vials: 30 mins at 30 °C |
10 vials: 4 hours at 2-8 °C or individual vials: 30 mins at temperatures up to |
Shelf life of thawed unopened vials at 2 °C to 8 °C |
Shelf life of thawed vials at 2 °C to 8 °C |
Shelf life of thawed unopened vials at 2 °C to 8 °C |
1 month1 |
10 weeks |
10 weeks2 |
Stability of thawed unopened vials prior to use |
Shelf life of thawed vials prior to use |
Stability of thawed unopened vials prior to use |
Up to 2 hours at temperatures up to 30 °C1 |
Up to 12 hours between 8 °C-30 °C |
Up to 12 hours between 8 °C-30 °C2 |
Transportation |
||
10 weeks storage and transportation at 2 °C to 8 °C within the 6-month shelf life. |
||
Storage of diluted vials | ||
Stability of diluted vials |
Shelf life of opened vials |
Stability of diluted vials |
After dilution, store at 2 °C to 30 °C and use within 6 hours, including any transportation time.1 |
DO NOT DILUTE |
After dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 2 °C to 30 °C, which includes up to 6 hours transportation time2 |
Discard times of unused vaccine |
Discard times of unused vaccine |
Discard times of unused vaccine |
Discard within 6 hours after dilution1 |
Discard within 12 hours post first puncture |
Discard any unused vaccine within 12 hours after dilution2 |
Transportation | ||
30mcg/dose concentrate - 12 years and older |
12 years and older, ready to use formulation |
10mcg/dose concentrate - 5 to 11 years old |
|
Frozen vials must be transported at -90 °C to -60 °C. Thawed vials can be stored or transported for up to 10 weeks at 2 °C to 8 °C within the 6-month shelf life. |
|
COMIRNATY is a Prescription Only Medicine which has been centrally procured by the UK government.
Injection site pain (>90%),
Fatigue (>70%),
Headache (>70%),
Myalgia (>40%),
Chills (>40%),
Arthralgia (>20%),
Pyrexia (>20%)
Injection site pain (>80%),
Fatigue (>50%),
Headache (>30%),
Injection site redness and swelling (>20%)
Myalgia (>10%),
Chills (>10%)
†If this material is shared with patients it must be downloaded and NOT shown directly to patients from this website which is intended for Healthcare Professionals and Other Relevant Decision Makers
References:
COMIRNATY (tozinameran) 30 micrograms/dose 12+ years COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available at: www.medicines.org.uk/emc/product/12740/smpc (accessed: May 2022)
COMIRNATY (tozinameran) 10 micrograms/dose Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available at: www.medicines.org.uk/emc/product/13134/smpc (accessed: May 2022)
Pfizer Data on File. May 2022.
PP-CMR-GBR-0263 May 2022
Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
©2022 Pfizer Inc. All rights reserved. PP-CMR-GBR-0251 April 2022
*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 product 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-0265 June 2022