Swissmedic approves new storage conditions for the COVID-19 vaccine from Pfizer/BioNTech

With immediate effect, the COVID-19 vaccine from Pfizer/BioNTech (Comirnaty®) no longer needs to be stored permanently in special freezers. Newly submitted stability data reviewed by Swissmedic demonstrate that its quality can still be guaranteed for up to two weeks when stored at freezer temperatures between -25 and -15 degrees Celsius. This a key factor in enabling the vaccine to be used in Switzerland in health centres, medical practices or pharmacies. The greater flexibility in the distribution, storage and administration of the vaccine may help increase the vaccination rate in Switzerland.

Following the approval of the application for the quality amendment and the modification of the product information, the vials can now be transported and stored for up to two weeks at - 25 to -15 degrees Celsius and not just – as was previously the case – at ultra-low temperatures between -90 and -60 degrees Celsius.

During long-term storage (up to six months), the vaccine still needs to be kept at ultra-low temperatures, but storage for two weeks in a freezer is now permitted. This will take the strain off vaccination centres, since the vials will be easier to distribute and, henceforth, easier to use in health centres, medical practices or pharmacies with standard pharmaceutical freezers.

According to Swissmedic’s Deputy Executive Director, Philippe Girard, this extension of the authorisation comes at an important point in enabling more people to be vaccinated: “The new storage conditions mean that the vaccine is easier to distribute. We also now have the option of using new vaccination sites because freezing the product at ultra-low temperatures is no longer required.”

The recommendation to date has been to avoid transporting any pre-diluted vaccine between facilities. With immediate effect, vaccine doses could now be prepared for shipment in the vaccination centres and transported carefully to the administration site, provided they are securely packaged. Before use, the unopened, thawed vaccine can continue to be stored for up to five days at 2 to 8 degrees Celsius. Diluted vaccine remains stable for a maximum of six hours at 2 to 30 degrees Celsius.