For BioNTech/Pfizer's Comirnaty vaccine, the shelf life for frozen vials was extended from six to nine months in the European Union on 10 September 2021. This three-month extension applies to vials of vaccine batches manufactured after the approval was granted. In addition, this three-month extension may also be applied retroactively to vials of batches manufactured before the approval was granted. The storage conditions of -90 °C to -60 °C remain unchanged.
Extension of the shelf life by three months applies to all vials manufactured after 10.09.2021. In future, all vials with an expiry date after March 2022 will already have a nine-month shelf life and will be labelled accordingly.
For vials manufactured before 10 September 2021, it is possible to apply the shelf life extension of three months retroactively if the carton shows an expiry date printed on the label between June 2021 and March 2022 and the approved storage conditions between -90 °C and -60 °C have been observed.
For such batches of Comirnaty vaccine currently already in circulation, the following expiry dates will then apply:
| Imprinted date | Updated expiration date |
|---|---|
| June 2021 | September 2021 |
| July 2021 | October 2021 |
| August 2021 | November 2021 |
| September 2021 | December 2021 |
| October 2021 | January 2022 |
| November 2021 | February 2022 |
| December 2021 | March 2022 |
| January 2022 | April 2022 |
| February 2022 | May 2022 |
| March 2022 | June 2022 |
The requirements for storage conditions from -90 °C to -60 °C remain unchanged. Within the nine-month shelf life, unopened vials can be stored and transported at 25 °C to 15 °C for a total of two weeks. Thereafter, storage at -90 °C to -60 °C is possible.
This COVID-19 vaccine is being marketed on the basis of the Regulation on the Provision of Medical Supplies to the Population in the Event of a Pandemic caused by the SARS-CoV-2 Coronavirus (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV).
The product information of Comirnaty has already been updated. All additional information from the manufacturer on Comirnaty affected by this change will be updated accordingly.
Product Information: Comirnaty
Updated: 01.10.2021
