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Summary of Product Characteristics
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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.
4.4 Special warnings and precautions for use
4.8 Undesirable Effects
Table 1: Adverse reactions from COMIRNATY clinical trials and post‑authorisation experience in individuals 12 years of age and older
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.
4.4 Special warnings and precautions for use
4.8 Undesirable Effects
Table 1: Adverse reactions from COMIRNATY clinical trials and post‑authorisation experience in individuals 12 years of age and older
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.
4.4 Special warnings and precautions for use
4.8 Undesirable Effects
Table 1: Adverse reactions from COMIRNATY clinical trials and post‑authorisation experience in individuals 5 years of age and older
Formulation |
Dilute to use, |
12 years and older, |
5 to 11 years old, |
|---|---|---|---|
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 |
Summary of Product Characteristics |
Dosage |
30 mcg |
30 mcg |
10 mcg |
Dilution |
Dilution required |
Dilution NOT required |
Dilution required |
Amount of Diluent |
1.8 mL |
No dilution |
1.3 mL |
Vial Size |
2 mL |
2 mL |
2 mL |
Doses per Vial |
6 doses per vial |
6 doses per vial |
10 doses per vial |
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 |
1 month |
10 weeks |
10 weeks |
Freezer Storage Time |
2 weeks within the 9-month shelf life |
DO NOT STORE |
DO NOT STORE |
ULT Freezer Storage Time |
9 months (shelf life) |
9 months (shelf life) |
9 months (shelf life) |
Room Temperature |
2 hours prior to dilution |
12 hours prior to first puncture |
12 hours prior to dilution |
After First Puncture or Dilution |
Discard 6 hours after dilution |
Discard 12 hours after first puncture |
Discard 12 hours |
Package Size |
195 vials |
10 vials |
10 vials |
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.
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.
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 a grey cap and border for 12 years and older, Ready to use
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 (INSERT LOCAL COUNTRY INFORMATION)
[Country to insert: customer service contact information]
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.
©2021 Pfizer Inc. All rights reserved. December 2021. PP-CMR-GLB-0080
SmPC Updates
Updates to General Recommendations and Undesirable Effects regarding Myocarditis and Pericarditis. Please see sections 4.4 and 4.8 of Summary of Product Characteristics for details. This update concerns all available formulations of COMIRNATY.
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