EMA’s human medicines committee (CHMP) has recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU).
This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder. Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of vaccine roll-out in EU Member States.