In May 2021, the pharmaceutical company Pfizer submitted new stability data on its COVID-19 vaccine (Comirnaty®) to Swissmedic, the Swiss Agency for Therapeutic Products. These data show that the coronavirus vaccine can be stored at refrigerator temperature for a considerably longer period than previously recommended. Having scrutinised the data from the stability studies, on 1 June 2021 Swissmedic approved the modified storage conditions. This makes it easier to handle the vaccine – which is already approved for use in Switzerland – during the current vaccination campaign.
Comirnaty®: Swissmedic approves storage at 2–8 °C for up to one month
Swissmedic has examined the stability data submitted by the authorisation holder along with the modified product information, and has approved the application for this quality amendment. Thus from now on the unopened, thawed vials of the COVID-19 vaccine Comirnaty® can be stored at 2–8 °C in a temperature-controlled refrigerator for up to a month. Extension of the permissible storage duration after thawing from five days to one month makes it easier for healthcare facilities to handle the vaccine, which can then also be administered more flexibly.
Swissmedic gives top priority to all applications relating to the COVID-19 pandemic and is in constant contact with authorisation holders and partner authorities. Thus any new findings with regard to the safety, efficacy and quality of the COVID-19 vaccines can be taken into account on a rolling basis.
Information for healthcare professionals
Within this extended storage period at refrigerator temperatures, up to 12 hours can be used for transportation of the vaccination. Prior to use, the unopened vial can be stored for up to two hours at temperatures of up to 30° C; diluted vaccine remains stable for a maximum of six hours at 2–30 °C. Once thawed, the vaccine must not be frozen again.