COVID-19 Vaccine Spikevax – Shelf Life Extended
A new shelf life for frozen vials of the Moderna mRNA vaccine Spikevax was approved in the EU on 8 December 2021. The shelf life of vials stored between -25 ºC and -15 ºC was extended from seven to nine months. This two-month extension can be applied retroactively to all vials containing batches that were manufactured before the amendment to the marketing authorisation. The storage conditions remain unchanged.
The approved two-month extension to shelf life of Spikevax applies to all vials with an expiry date of 9 December or later printed on the label, as long as the approved storage conditions of -25 ºC to -15 ºC have been maintained and a shelf life of seven months was indicated on the vial.
While the shelf life extension is being implemented, Spikevax batches that were already distributed in EU countries and those that will be manufactured and distributed in the EU in December 2021 and January 2022 will continue to be labelled with a shelf life of seven months. The shelf life extension will also apply retroactively to those Spikevax vaccine batches currently in circulation. The following expiry dates will therefore apply as detailed below:
Printed Expiry Date | Updated Expiry Date |
---|
December 2021 | February 2022 |
January 2022 | March 2022 |
February 2022 | April 2022 |
March 2022 | May 2022 |
April 2022 | June 2022 |
May 2022 | July 2022 |
June 2022 | August 2022 |
July 2022 | September 2022 |
August 2022 | October 2022 |
The new printed label indicating a shelf life of nine months will be implemented for all new vials manufactured as of February 2022. Therefore, the vials with a printed expiry date of August 2022 (manufactured in January 2022) will be the last vials subject to the retroactive shelf life extension. All vials with an expiry date of November 2022 or later (manufactured in February 2022) will already have a nine-month shelf life printed on the label.
The storage conditions remain unchanged (-25 ºC to -15 ºC). Within the nine-month shelf life, unopened vials may be refrigerated at 2 °C to 8 °C, protected from light, for a maximum of 30 days. Up to 12 hours may be used for transportation within this period. The vaccine should not be re-frozen once thawed.
The Spikevax product information has already been updated. All of the Spikevax supplementary information that is impacted by this change is being updated accordingly by the manufacturer.