The shelf life for deep-freeze vials of the following vaccines was prolonged from 12 to 18 months on 2 December 2022: Comirnaty 30 micrograms/dose dispersion for injection, Comirnaty 10 micrograms/dose concentrate for dispersion for injection, Comirnaty 3 micrograms/dose concentrate for dispersion for injection, Comirnaty Original/Omicron BA.1 15/15 micrograms/dose dispersion for injection, Comirnaty Original/Omicron BA.4-5 15/15 micrograms/dose dispersion for injection, and Comirnaty Original/Omicron BA.4-5 5/5 micrograms/dose concentrate for dispersion for injection. This six-month extension applies to vaccine batch vials manufactured after the extension authorisation was granted. The extension of 6, 9 or 12 months may also be applied retroactively to vials manufactured prior to the granting of the authorisation, provided that the required storage conditions between -90°C and -60°C have been complied with.
The updated expiry dates for each of the Comirnaty products are listed below:
EU/1/20/1528/002 and EU/1/20/1528/003
GTIN: 04260703260088, GTIN 4260703260071
For persons 12 years and older, ready to use, vial with grey plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| February 2022 | February 2023 (only for batch FK5132) |
| April 2022 | April 2023a |
| April 2022 | May 2023e (only for batch FP1979) |
| May 2022 | May 2023a,b (for all batches except FT2639) |
| May 2022 | February 2023c (only for batch FT2639) |
| August 2022 | May 2023b,d |
| September 2022 | June 2023d |
| October 2022 | July 2023d |
| November 2022 | August 2023d |
| December 2022 | September 2023d |
| March 2023 | September 2023 |
| April 2023 | October 2023 |
| May 2023 | November 2023 |
| Juni 2023 | December 2023 |
| July 2023 | Januar 2024 |
| August 2023 | February 2024 |
| September 2023 | March 2024 |
| October 2023 | April 2024 |
| November 2023 | May 2024 |
a according to the combined shelf life extension of 9, 12 and 18 months
b due to the implementation of the shelf life adjustment from 6 to 9 months in December 2021, two different printed expiry dates can be updated to November 2022.
c applies only to batch FT2639 with a printed expiration date that corresponds to the nine-month shelf life.
d according to the combined shelf life extension of 12 and 18 months
e the printed expiration date is automatically assigned by the SAP system based on its calculation algorithm.
EU/1/20/1528/004 and EU/1/20/1528/005
GTIN: 04260703260118
For children aged 5 to 11 years, dilution required, vial with orange plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| March 2022 | March 2023a |
| April 2022 | April 2023a |
| May 2022 | May 2023a |
| July 2022 | April 2023b,c |
| August 2022 | May 2023b,c |
| September 2022 | June 2023c |
| October 2022 | July 2023c |
| November 2022 | August 2023c |
| November 2022 | September 2023c,d (only for batch GC6964) |
| December 2022 | September 2023c |
| April 2023 | October 2023 |
| June 2023 | December 2023 |
| July 2023 | January 2024 |
| August 2023 | February 2024 |
| September 2023 | March 2024 |
| October 2023 | April 2024 |
| November 2023 | May 2024 |
a according to the combined shelf life extension of 9, 12 and 18 months
b Applies to batches with a printed expiration date corresponding to the nine-month shelf life.
c according to the combined shelf life extension of 12 and 18 months
d the printed expiration date is automatically assigned by the SAP system based on its calculation algorithm.
All vials with an expiry date of June 2024 or later already comply with the approved shelf life of 18 months.
EU/1/20/1528/010
GTIN: 04260703260132
For infants and children aged 6 months to 4 years, dilution required, vial with reddish-brown plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| October 2022 | July 2023a |
| November 2022 | August 2023a |
| April 2023 | October 2023 |
| June 2023 | December 2023 |
| September 2023 | March 2024 |
| October 2023 | April 2024 |
| November 203 | May 2024 |
a according to the combined shelf life extension of 12 and 18 months
EU/1/20/1528/006, EU/1/20/1528/007
GTIN: 04260703260286, GTIN: 04260703260293
For persons 12 years and older, ready to use, vial with grey plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| November 2022 | August 2023a |
| December 2022 | September 2023a |
| February 2023 | August 2023 |
| April 2023 | October 2023 |
| May 2023 | November 2023 |
| June 2023 | December 2023 |
| July 2023 | January 2024 |
a according to the combined shelf life extension of 12 and 18 months
EU/1/20/1528/008, EU/1/20/1528/009
GTIN: 04260703260354, GTIN: 04260703260361
For persons 12 years and older, ready to use, vial with grey plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| June 2023 | December 2023 |
| July 2023 | January 2024 |
| August 2023 | February 2024 |
| September 2023 | March 2024 |
| October 2023 | April 2024 |
| November 2023 | May 2024 |
EU/1/20/1528/011, EU/1/20/1528/012
GTIN: 04260703260408, GTIN: 04260703260514
For children aged 5 to 11 years, dilution required, vial with orange plastic cap
| Printed expiration date | Updated expiration date |
|---|---|
| August 2023 | February 2024 |
| October 2023 | April 2024 |
| November 2023 | May 2024 |
All vials with an expiry date of June 2024 or later already comply with the approved shelf life of 18 months.
The different expiration intervals are due to multiple shelf life extensions of 6, 9 or 12 months.
The required storage conditions of -90°C to -60°C remain unchanged and must be complied with.
All additional information affected by this change will be updated accordingly by the manufacturer of Comirnaty.
Updated: 30.12.2022
