COVID-19 Vaccine Comirnaty – Shelf Life Extended to 12 Months
An extension of the shelf life from nine to twelve months for deep-freeze vials of both doses and all formulations of the BioNTech/Pfizer Comirnaty vaccine was approved in the EU on 24 March 2022 and 4 April 2022. The three-month extension applies to vaccine batch vials manufactured after each of the extension authorisations were granted, but the extension may also be applied retroactively to batch vials that were manufactured prior to the extension being granted. The storage conditions of -90°C to -60°C must be maintained.
The shelf life extension applies to all Comirnaty formulations:
- Tris/Sucrose 10 micrograms/dose (children aged 5 to 11 years, concentrate for dispersion for injection, vial with orange plastic cap)
- Tris/Sucrose 30 micrograms/dose (adults aged 12 years and over, dispersion for injection, vial with grey plastic cap)
- PBS/Sucrose 30 micrograms/dose (adults aged 12 years and over, concentrate for dispersion for injection, vial with purple cap)
Due to the shelf life extension from six to nine months approved in September 2021, and the new extension just approved from nine to twelve months, the shelf life of vaccine batches bottled prior to the latest shelf life extension are extended by three or six months, depending on the date they were bottled.
For PBS/Sucrose 30 micrograms/dose (adults aged 12 years and over, concentrate for dispersion for injection, vial with purple cap):
- Vials with an expiry date between December 2021 and March 2022 may be used for six months after the printed expiry date (according to the combined shelf-life extension of nine and twelve months), provided that the authorised storage conditions between -90°C and -60°C have been maintained.
- Vials with an expiry date between June 2022 and December 2022 may be used for three months after that date provided that the authorised storage conditions between -90°C and -60°C have been maintained.
For Tris/Sucrose 10 micrograms/dose (children 5 to 11 years of age, concentrate for dispersion for injection, vial with orange plastic cap) and Tris/Sucrose 30 micrograms/dose (adults 12 years of age and older, dispersion for injection, vial with grey plastic cap):
- Vials with an expiry date between March 2022 and May 2022 may be used for six months after the date printed (according to the combined shelf-life extension of nine and twelve months) provided that the authorised storage conditions between -90 °C and -60°C have been maintained.
- Vials with an expiry date between August 2022 and December 2022 may be used for three months after that date provided that the authorised storage conditions between -90°C and -60°C have been maintained.
The new expiry dates for Comirnaty are listed below:
Printed date | Updated expiration date |
---|
December 2021 | June 2022 |
January 2022 | July 2022 |
Februar 2022 | August 2022 |
March 2022 | September 2022 |
April 2022 | October 2022 |
May 2022 | November 2022 |
June 2022 | September 2022 |
July 2022 | October 2022 |
August 2022 | November 2022 |
September 2022 | Dezember 2022 |
October 2022 | January 2023 |
November 2022 | February 2023 |
Dezember 2022 | March 2023 |
The different expiry intervals are due to the shelf life being extended by nine or twelve months.
All vials with an expiry date of April 2023 or later are already labelled with the newly approved 12-month shelf life.
The requirements for the storage conditions of -90°C to -60°C must be maintained.
For PBS/Sucrose 30 micrograms/dose (adults aged 12 years and over, concentrate for dispersion for injection, vial with purple cap):
- Unopened vials can be stored and transported between -25°C to -15°C for up to two weeks within the 12-month shelf life. Afterwards, it can be stored again at -90°C to -60°C
For Tris/Sucrose 10 micrograms/dose (children 5 to 11 years of age, concentrate for dispersion for injection, vial with orange plastic cap) and Tris/Sucrose 30 micrograms/dose (adults 12 years of age and older, dispersion for injection, vial with grey plastic cap):
- The vaccine is obtained in a frozen state at -90°C to -60°C. Once received, the frozen vaccine can be stored at -90°C to -60°C or at 2°C to 8°C. Unopened vials can be stored and transported at 2°C to 8°C for a total of 10 weeks within the 12-month shelf life.
All additional information concerning Comirnaty affected by this change will be updated accordingly.