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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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.
c - 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 2023c |
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.
c - 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.
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 |
a – Expiry 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.
©2023 Pfizer Inc. All rights reserved. September 2023. PP-CMR-GLB-0524
FOR HEALTHCARE PROFESSIONALS ONLY
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