A new shelf life for ultra-low temperature storage at -75°C (±15°C) was approved on 9 December 2021 for two formulations of BioNTech/Pfizer's Comirnaty COVID-19 vaccine. The shelf life has been extended from six to nine months for frozen vials of COMIRNATY® 10 micrograms/dose concentrate for dispersion for injection and the ready-to-inject formulation COMIRNATY® 30 micrograms/dose dispersion for injection. The new shelf life has been updated accordingly in the product information. The storage conditions remain unchanged.
The three-month shelf life extension applies to all vials manufactured after 9 December 2021.
Going forward, all vials with an expiry date after April 2022 will have a nine-month shelf life.
The three-month extension can also be applied retroactively to vials manufactured before the approval was granted. Cartons with a printed expiry date between October 2021 and May 2022 (COMIRNATY® 30 micrograms/dose dispersion for injection) or March/April 2022 (COMIRNATY® 10 micrograms/dose concentrate for dispersion for injection) may be used three months beyond the printed date provided the permitted storage conditions of -75 °C (±15 °C) have been observed.
The following expiry dates apply to the vaccine batches that are already in circulation:
COMIRNATY® 30 micrograms/dose
Dispersion for injection
EU/1/20/1528/002, EU/1/20/1528/003
For those aged 12+, ready-to-use solution, grey cap
| Printed date | Updated expiration date |
|---|---|
| October 2021 | January 2022 |
| November 2021 | February 2022 |
| April 2022 | July 2022 |
| May 2022 | August 2022 |
COMIRNATY® 10 micrograms/dose
Concentrate for dispersion for injection
EU/1/20/1528/004, EU/1/20/1528/00
For children 5 to 11 years, dilute before use, orange cap
| Printed date | Updated expiration date |
|---|---|
| March 2022 | June 2022 |
| April 2022 | July 2022 |
The placement of this COVID-19 vaccine on the market is based on the ordinance assuring the supply of products for medical needs for the population in the context of the SARS-CoV-2 pandemic (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV).
Comirnaty's product information has already been updated. All additional Comirnaty information from the manufacturer that is affected by this change will be updated accordingly.
Updated: 02.02.2022
