A new formulation of the COMIRNATY booster "12 years of age and older, Ready
to use (Original/Omicron BA.1 Cap and Package, Multi-dose vial)" was approved
on DD/MM/YY with procedure X/0000.Additional website content relevant to this
new formulation will be available on DD/MM/YY.

COMIRNATY Original/Omicron BA.1 15/15 micrograms/per dose for dispersion
for injection, for 12 years of age and older, Ready to use (Original/Omicron BA.1
Cap and Package, Multi-dose vial)
PP-CMR-GLB-0188

This site is intended for Healthcare Professionals within the scope of COVAX facility.

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Important Expiry Date Information for the Dilute to use, 12 years and older formulation

 

The storage and handling conditions printed on the vial or carton labels may differ from those in approved WHO product information. In these circumstances, the conditions in the product information should be followed

WHO Product Information for Dilute to use, 12 years and older, Purple Cap and Package, Multi-dose vial


The shelf life for COMIRNATY is 24 months when stored at -90 °C to -60 °C. In order to determine appropriate expiry date, please first check the date printed on vials and cartons.

If the date printed on the vials and cartons reflects the date of manufacture (MFG)
In this case vaccine vials should not be used after 24 months from the date of manufacture (MFG) printed on the vials and cartons. Please refer to the table below to determine the appropriate expiry date based on the printed date of manufacture (MFG):  

Printed  Date of Manufacture (MFG)
on Vial and Carton
EXPIRY Date (24-months)
October 2021  September 2023a, b
October 2021 August 2023c
November 2021 October 2023
December 2021 November 2023
January 2022 December 2023
February 2022 January 2024
March 2022 February 2024
April 2022 March 2024


a - Expiry date update combining 9, 12- and 15-,18-months and 24 months shelf-life extension.
b - Due to implementation of the change in shelf-life from 6 to 9 months in October 2021, three different printed expiry dates could be extended to September 2023.
- Applicable to batch with printed expiry date May 2022 corresponding to 9-months shelf-life; two different printed expiry dates could be extended to August 2023.

If you observe a vial and carton label that says expiry date (EXP) on it, the guidance above does NOT apply. Please review the guidance regarding EXP dates below.


If the date printed on the vials and cartons reflects the date of expiry (EXP) and if that date is February 2022 or earlier
In this case the expiry date is in the past and before WHO's authorisation of 18- to 24-month extension, therefore the vials should not be used. Please note that per standard regulatory principles, WHO does not recommend use of vaccines beyond their labelled expiry date.

If the date printed on the vials and cartons reflects the date of expiry (EXP) and if that date is March 2022 or later
In this case please refer to your local regulatory authority to determine whether your local regulatory authority has allowed the acceptance of vaccine batches impacted by retroactive shelf-life extension from 18 months to 24 months. Please note that per standard regulatory principles, WHO does not recommend use of vaccines beyond their labelled expiry date. If there is express permission of the local regulatory authority, please refer to the table below to determine the appropriate expiry date based on the printed date of expiry (EXP): 

Printed Expiry Date (EXP) on Vial and Carton Updated Expiry Date - if your local regulatory authority has allowed the acceptance of vaccine batches impacted by retroactive shelf-life extension from 18 months to 24 months
March 2022 September 2023a,b 
May 2022 August 2023
June 2022 September 2023b
July 2022 October 2023
August 2022 November 2023
September 2022 December 2023
October 2022 January 2024
November 2022 February 2024
December 2022 March 2024


a - Expiry date update combining 9, 12- and 15-,18-months and 24 months shelf-life extension.
b - Due to implementation of the change in shelf-life from 6 to 9 months in October 2021, three different printed expiry dates could be extended to September 2023.
- Applicable to batch with printed expiry date May 2022 corresponding to 9-months shelf-life; two different printed expiry dates could be extended to August 2023.
 

Important Expiry Date Information for the 12 years and older, Ready to use, the 12 years and older, Ready to use, Original/Omicron BA.1, the 12 years and older, Ready to use, Original/Omicron BA.4-5, and the 5 to 11 years old, Dilute to use formulations

 

The storage and handling conditions printed on the vial or carton labels may differ from those in approved WHO product information. In these circumstances, the conditions in the product information should be followed

WHO Product Information for 12 years and older, Ready to use Grey Cap and Package
WHO Product Information for 12 years and older, Ready to use Grey Cap and Package, Original/Omicron BA.1
WHO Product Information for 12 years and older, Ready to use Grey Cap and Package, Original/Omicron BA.4-5
WHO Product Information for 5 to 11 years of age, Dilute to use, Orange Cap and Package, Multi-dose vial
WHO Product Information for 5 to 11 years of age, Dilute to use, Orange Cap and Package, Multi-dose vial, Original/Omicron BA.4-5

The shelf life for COMIRNATY is 24 months when stored at -90 °C to -60 °C. In order to determine appropriate expiry date, please first check the date printed on vials and cartons.

If the date printed on the vials and cartons reflects the date of manufacture (MFG)
In this case vaccine vials should not be used after 24 months from the date of manufacture (MFG) printed on the vials and cartons. Please refer to the table below to determine the appropriate expiry date based on the printed date of manufacture (MFG):  

Printed  Date of Manufacture (MFG)
on Vial and Carton
EXPIRY Date (24-months)
October 2021 September 2023a
November 2021 October 2023a
December 2021 November 2023a
January 2022 December 2023b
February 2022 January 2024b
March 2022 February 2024b
April 2022 March 2024b
May 2022 April 2024
June 2022 May 2024
July 2022 June 2024
August 2022 July 2024
September 2022 August 2024
October 2022 September 2024
November 2022 October 2024
December 2022 November 2024
February 2023 January 2025 
March 2023 February 2025 


aExpiry date update combining 9,12- and 18-and 24-months shelf-life extension
b - Expiry date update combining 12- and 18- and 24-months shelf-life extension

If you observe a vial and carton label that says expiry date (EXP) on it, the guidance above does NOT apply. Please review the guidance regarding EXP dates below.


If the date printed on the vials and cartons reflects the date of expiry (EXP) and if that date is February 2022 or earlier
In this case the expiry date is in the past and the vials should not be used. Please note that per standard regulatory principles, WHO does not recommend use of vaccines beyond their labelled expiry date.

If the date printed on the vials and cartons reflects the date of expiry (EXP) and if that date is March 2022 or later
In this case please refer to your local regulatory authority to determine whether your local regulatory authority has allowed the acceptance of vaccine batches impacted by retroactive shelf-life extension from 18 months to 24 months. Please note that per standard regulatory principles, WHO does not recommend use of vaccines beyond their labelled expiry date. If there is express permission of the local regulatory authority, please refer to the table below to determine the appropriate expiry date based on the printed date of expiry (EXP): 

Printed Expiry Date (EXP) on Vial and Carton Updated Expiry Date - if your local regulatory authority has allowed the acceptance of vaccine batches impacted by retroactive shelf-life extension from 18 months to 24 months
March 2022 September 2023a
April 2022 October 2023a
April 2022 November 2023e (for batch FP1979 only) 
May 2022 November 2023a, b  (for all batches except batch FT2639)
August 2022 November 2023b,c 
September 2022 December 2023c
October 2022 January 2024c
November 2022 February 2024c
November 2022 March 2024c,d (for batch GC6964 only)
December 2022 March 2024c
March 2023 March 2024
April 2023 April 2024
May 2023 May 2024
June 2023 June 2024
July 2023 July 2024
August 2023 August 2024
September 2023 September 2024
October 2023 October 2024
November 2023 November 2024
July 2024 January 2025 
August 2024 February 2025 


a - Expiry date update combining 9, 12- and 18- and 24-months shelf-life extension
b - Due to implementation of the change in shelf-life from 6 to 9 months in December 2021, three different printed expiry dates could be extended to November 2023.
c - Expiry date update combining 12- and 18- and 24-months shelf-life extension
e - Printed expiry date assigned automatically by SAP system based on system calculation algorithm


All vials with an expiry date of March 2025 and beyond will already reflect the 24 months shelflife.

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.

Privacy: The terms available at pfizer.com/privacy shall apply. These terms may differ from those applicable in your country. Please check your local Pfizer website for the privacy terms specific to your country.​​​

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