The shelf life extension from 12 to 15 months for ultra frozen vials of the vaccine 'Comirnaty 30 micrograms/dose concentrate' from BioNTech/Pfizer for dispersion for injection (purple cap) was approved in the EU on 1 August 2022 and 5 August 2022, respectively. This three-month extension applies to vaccine batch vials manufactured after the extension approval was granted. An extension of three, six, or nine months may also be applied retroactively to batch vials manufactured prior to the extension. This is due to previously granted shelf life extensions. The required storage conditions of -90°C to -60°C remain unchanged and must be complied with.
Vials with an expiry date between December 2021 and March 2022 may be used for 9 months after the date printed (according to the combined shelf-life extension of 9, 12 and 15 months) provided that the authorised storage conditions between -90°C and -60°C have been complied with.
Vials with an expiry date between April 2022 and December 2022 may be used for 6 months after the date printed, provided that the authorised storage conditions between -90°C and -60°C have been complied with.
The expiration dates of Comirnaty 30 micrograms/dose concentrate for dispersion for injection (violet cap) are as follows:
| Printed date | Updated expiration date |
|---|---|
| December 2021 | September 2022 |
| January 2022 | October 2022 |
| February 2022 | November 2022 |
| March 2022 | December 2022 |
| April 2022 | October 2022 |
| May 2022 | November 2022 |
| June 2022 | December 2022 |
| July 2022 | January 2023 |
| August 2022 | February 2023 |
| September 2022 | March 2023 |
| October 2022 | April 2023 |
| November 2022 | May 2023 |
| Dezember 2022 | June 2023 |
The different expiration intervals are due to the shelf life being extended by 9, 12 or 15 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: 09.09.2022
