The EU Commission approved a new shelf life of 15 months on 25 July 2022 for the COVID-19 vaccine Valneva (inactivated, adjuvanted) from Valneva Austria GmbH. As a prerequisite, the vaccine product must have been stored correctly in an unopened container in the refrigerator (2°C to 8°C). The three-month extension of the shelf life applies to vaccine batches manufactured after the 25 July 2022 approval date. In addition, this three-month shelf life extension may be applied retroactively to batches of vaccines manufactured prior to the approval.
Cartons of vaccine, multi-dose vials and peel-off traceability labels that have an expiry date of 09/2022 printed on them may be used three months beyond the printed expiry date, provided that the storage conditions at 2 °C to 8 °C as set out in the marketing authorisation have been complied with.
Updated expiration dates of affected product batches are listed here:
| Batch number | Printed expiration date | Updated expiration date |
|---|---|---|
| CV00001 | 09/2022 (September 2022) | December 2022 |
| CV00002 | 09/2022 (September 2022) | December 2022 |
| CV00003 | 09/2022 (September 2022) | December 2022 |
The 15-month shelf-life has already been taken into account in the information on cartons, multi-dose vials and peel-off traceability labels with an expiry date printed after September 2022.
Any additional information on the COVID-19 vaccine Valneva (inactivated, adjuvanted) affected by the above change should be updated accordingly.
The COVID-19 vaccine Valneva (inactivated, adjuvanted) is stable in unopened containers at 25 °C for a total of 6 hours. This is not a recommended temperature for storage or shipment, but the information may be used as a decision-making aid regarding vaccine use in the event of temporarily high temperatures during storage at 2°C to 8°C.
Updated: 26.08.2022
