Spikevax▼ bivalent Original/Omicron BA.1 (elasomeran / imelasomeran) – Important shelf-life update when stored at ultra-low-temperature conditions – Marketing Authorisation number PLGB 53720/0004 (3April2023)
• On 31st March 2023, a new shelf-life at ultra-low-temperature storage conditions (–50ºC to –15ºC) was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for ‘Spikevax bivalent Original / Omicron BA.1’ • Alternative storage conditions have been added to the Summary of Product Characteristics (SmPC), allowing extension of the shelf-life from 9 months to 12 months in certain circumstances • Extension of the labelled 9-month shelf-life by a further 3 months (to 12 months) is possible when the product has been stored at –50ºC to –15ºC without interruption for 9 months. However, this change results in a reduction of the time allowed for use under the short-term storage conditions (i.e., from 2°C to 8°C) from 30 days to 14 days • As such, settings in possession of product stored within these ultra-low-temperature conditions can use it for up to 3 additional months beyond the printed expiry date (for a total of 12 months), provided that once thawed and placed at 2°C to 8°C, the unopened v