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HomeShelf Life & StoragePosology & Administration12 years and older5 to 11 years old Undesirable Effects12 years and older5 to 11 years old Efficacy12 years and older5 to 11 years oldResources
Global information about A Conditional Marketing Authorisation (CMA) has been granted in the EU for the product COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) (Pfizer-BioNTech COVID-19 Vaccine in several countries) for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years and individuals 12 years of age and older.12 years and older
Posology & Administration
Undesirable Effects  Efficacy
5 to 11 years old
Posology & Administration
Undesirable Effects  Efficacy
SmPC Update: Variation II/102, effective 04/02/2022 and variation II/101, effective 04/02/2022.

For formulation Dilute to use, 12 years and older, the sections listed below have been updated. Please view each section of the SmPC for Dilute to use, 12 years and older for full details.
4.8 Undesirable Effects
5.1 Pharmacodynamic properties

For formulation 12 years and older, Ready to use, the sections listed below have been updated. Please view each section of the SmPC for 12 years and older, Ready to use for full details.
4.8 Undesirable Effects
5.1 Pharmacodynamic properties
6.3 Shelf life

For formulation 5 to 11 years old, Dilute to use, the sections listed below have been updated. Please view each section of the SmPC for 5 to 11 years old, Dilute to use for full details.
4.8 Undesirable Effects
5.1 Pharmacodynamic properties
6.3 Shelf life

View the SmPC for Dilute to use, 12 years and older Formulation, Purple Cap View the SmPC for 5 to 11 years old, Dilute to use Formulation, Orange Cap
Vaccine Formulations GuideRefer to the information outlined below to understand the differences across age groups and formulations

Formulation

Dilute to use,
12 years and older

12 years and older,
​​​​​​​Ready to use

5 to 11 years old, 
Dilute to use

Vial

Multi-dose vial

Multi-dose vial

Multi-dose vial

Vial Cap Color

Purple

Grey

Orange

Summary of Product Characteristics

Summary of Product Characteristics

Summary of Product Characteristics
[countries to program the hyperlink based on website URL]

Summary of Product Characteristics
 

Dosage

30 mcg

30 mcg

10 mcg

Dilution

Dilution required

Dilution NOT required

Dilution required

Amount of Diluent
Needed per Vial

1.8 mL

No dilution

1.3 mL

Vial Size

2 mL

2 mL

2 mL

Doses per Vial

6 doses per vial
(after dilution)

6 doses per vial

10 doses per vial
(after dilution)

Injection Volume per Dose

0.3 mL

0.3 mL

0.2 mL

Fill Volume per Vial

0.45 mL

2.25 mL

1.3 mL

Refrigeration Storage Time
​​​​​​​(2°C to 8°C)

1 month

10 weeks

10 weeks

Freezer Storage Time
​​​​​​​(-25°C to -15°C)

2 weeks within the 9-month shelf life

DO NOT STORE

DO NOT STORE

ULT Freezer Storage Time
(-90°C to -60°C)

9 months (shelf life)

9 months (shelf life)

9 months (shelf life)

Room Temperature
​​​​​​​(8 °C to 30 °C)

2 hours prior to dilution
(including any thaw time)

12 hours prior to first puncture

12 hours prior to dilution

After First Puncture or Dilution
​​​​​​​(2 °C to 30 °C)

Discard 6 hours after dilution

Discard 12 hours after first puncture

Discard 12 hours
​​​​​​​after dilution

Package Size

195 vials

10 vials

10 vials

DOWNLOAD THIS GUIDE Indication

COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years (10 micrograms/dose) and individuals 12 years of age and older (30 micrograms/dose).​​​​​​​
The use of this vaccine should be in accordance with official recommendations.​​​​

Mechanism of action

The nucleoside-modified messenger RNA in COMIRNATY (tozinameran) is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19. 

Ensuring the Authenticity of COMIRNATY 
  • Pfizer is committed to patient safety and ensuring that people have accurate information about COMIRNATY, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate COMIRNATY to protect patients from products that might be dangerous and lead to serious and life-threatening harm

    • COMIRNATY is only administered intramuscularly by government-authorized healthcare professionals

    • COMIRNATY is not taken orally and is not available in a capsule or tablet form

  • Authentic COMIRNATY, manufactured by Pfizer or BioNTech, will include the COMIRNATY name on the label and is dispensed in a vial as follows: 

    • with a purple cap and border for Dilute to use, 12 years and older

    • with an orange cap and border for 5 to 11 years old, Dilute to use

  • COMIRNATY is not available for private purchase. COMIRNATY is NOT sold online. Any sales of COMIRNATY over the internet, including from online pharmacies, are not legitimate

    • The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer

If you suspect COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) you have purchased may be counterfeit, contact Customer Service at [email protected]  

For more information ​​​​​​​

Submit a Medical Inquiry 

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
​​​​​​​

​​​​​​​Imported in Bhutan by Ministry of Health, Royal Government of Bhutan, Thimphu, Bhutan. 

The product information provided in this site is intended only for Bhutan healthcare professionals. The product discussed herein may have different labeling in different countries. 

 ​​​​​​​​​​©2022 Pfizer Inc. All rights reserved. 
​​​​​​​February 2022. PP-CMR-IND-0026. 31.01.2022

​​​

SmPC Updates

Updates to Undesirable Effects, Pharmacodynamic Properties, and Shelf Life. Please see sections 4.8, 5.1, and 6.3 of Summary of Product Characteristics for details. This update concerns all available formulations of COMIRNATY.

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