Pfizer/BioNTech submitted an application for variation of the shelf life for mRNA vaccine «Comirnaty» of 12 months rather than 9 months. The Agency for Therapeutic Products has reviewed the application and approved the extension.
Swissmedic has examined the stability data submitted by the marketing authorisation holder along with the modified product information, and has approved the application to extend the shelf life. The three-month increase in shelf life can be applied retrospectively: it applies with immediate effect for all currently available and future batches. The formulation and storage conditions of the vaccine remain unchanged. The application for variation was submitted as there was a lack of comprehensive or sufficient empirical data on shelf life when the vaccine was authorised on 19 December 2020.
Pfizer/BioNTech submitted two applications for new storage conditions to Swissmedic last year. The Agency for Therapeutic Products approved storage at temperatures between minus 25 and minus 15 degrees Celsius on 30 March 2021 and storage of unopened, thawed vials for up to one month at between 2 and 8 degrees Celsius in a temperature-controlled refrigerator on 2 June 2021.