The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use
has extended the approved storage period of the thawed and unopened vial of Pfizer / BioNtech vaccine to 2-8 ° C (i.e. in a regular refrigerator) from five days to a month (31 days).
This was announced by the EMA.
The extension of the retention period, communicates Ema, has been approved following the evaluation of further data on the stability studies presented by the manufacturer. "It is expected that greater flexibility in the storage and handling of the vaccine will have a significant impact on planning and logistics" of its use in EU member states, reads the note from the European regulatory agency. The changes described will be included in the publicly available information on the vaccine and the product labeling will be updated accordingly. The Ema, we read again in the note,is in constant dialogue with the pharmaceutical companies producing Covid-19 vaccines on the improvements that the companies are developing for the production and distribution of these drugs in Europe.