This site is intended for Healthcare Professionals.
Expiry Date Information
Report an Adverse Event
Summary of Product Characteristics
Package Leaflet
English
Menu
Close
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
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 |
||
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 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]
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.
For healthcare professionals only
The information contained on this site is reserved exclusively for Healthcare Professionals in Bhutan.
I confirm that I am a Healthcare Professional in Bhutan*
I accept and agree to the Terms of Use*
1. TERMS OF USE – COMIRNATY
Use and content of this Web site. The information provided on this site is for general informational and educational purposes and has been approved by relevant regulatory authorities.
Certain sections of this Web site are intended for Healthcare Professionals only and we ask you to not access these sections if you are not a Healthcare Professional. Specific appropriate sections have been developed and are accessible for the general public. Your access to and use of the information contained in the Web site is subject to this Terms of Use Agreement. By accessing and using this Web site, you accept, without limitation or qualification, this Terms of Use Agreement.
Neither Pfizer nor any party involved in creating, producing or delivering this Web site shall be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of or inability to use this Web site, or any errors or omissions in the content thereof. This limitation includes damages to, or for any viruses that infect, your computer equipment.
2. Privacy. Pfizer respects the privacy of its Web site users. Please refer to https://privacycenter.pfizer.com/ that explains users' rights and responsibilities with respect to information that is disclosed on this Web site.
3. Third Party Web sites and Links. This Web site may contain links or references to other Web sites maintained by third parties over whom Pfizer has no control. Such links are provided merely as a convenience. Similarly, this Web site may be accessed from third party links over whom Pfizer has no control. Pfizer makes no warranties or representations of any kind as to the accuracy, currency, or completeness of any information contained in such Web sites and shall have no liability for any damages or injuries of any kind arising from such content or information. Inclusion of any third party link does not imply an endorsement or recommendation by Pfizer.
4. Medical Information. Patients should not use the information contained in this website for diagnosing a health or fitness problem or disease. Patients should always consult with a doctor or other health care professional for medical advice or information about diagnosis and treatment.
5. Non-Confidential Information. Subject to any applicable terms and conditions set forth in our Privacy Policy, any communication or other material that you send to us through the Internet or post on a Pfizer Web site by electronic mail or otherwise, such as any questions, comments, suggestions or the like, is and will be deemed to be non-confidential and Pfizer shall have no obligation of any kind with respect to such information. Pfizer shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing products.
6. Trademarks. All product names, whether or not appearing in large print or with the trademark symbol, are trademarks of Pfizer, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. The use or misuse of these trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, the law of slander and libel, the law of privacy and publicity, and communications regulations and statutes. Please be advised that Pfizer actively and aggressively enforces its intellectual property rights to the fullest extent of the law.
7. Copyrights. The entire contents of this Web site are subject to copyright protection. Copyright © 2020 Pfizer Inc. The contents of Pfizer Web sites may not be copied other than for non commercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed. Except as expressly provided in the website or above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents contained in this Web site or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of Pfizer. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Pfizer, or any third party.
8. Void Where Prohibited. This Web site and its contents are intended to comply with the laws and regulations in the E.U. Although the information on this Web site is accessible to users outside of the E.U., the information contained on this website is intended for use only by residents of the E.U and/ or residents of such other countries as may be specifically permitted under law. Other countries may have laws, regulatory requirements and medical practices that differ from those in the E.U. Pfizer reserves the right to limit provision of its products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any products or services we provide. Any offer for any product or service made on this Web site is void where prohibited.
9. Governing Laws. This Terms of Use Agreement and your use of the Web site shall be governed by the laws of Belgium without regard to its conflicts of laws principles. Any legal action or proceeding related to this Web site shall be brought exclusively in a federal or state court of competent jurisdiction sitting in Belgium.
10. Miscellaneous. If any provision of this Agreement is held to be unlawful, void or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions. Pfizer reserves the right to alter or delete materials from this Web site at any time at its discretion.
Not a Healthcare Professional in Bhutan? This website is not intended for patients or for members of the general public.