BRUSSELS - The European Medicines Agency (EMA) has allowed the storage of the Pfizer/BioNTech vaccine against the coronavirus in normal fridge conditions, at 35 to 46 degrees Fahrenheit, for up to 31 days.
According to initial demands from manufacturers, the Pfizer/BioNTech vaccine had to be stored at ultra-cold temperatures between -80 to -60 degrees Celsius (-112 to -76 degrees Fahrenheit).
EMA’s human medicines committee (CHMP) has recommended a change to the approved storage conditions.
"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," the EMA said on Monday.
According to the EU regulator, the increased flexibility in the storage and handling of the Pfizer/BioNTech vaccine is expected to have a significant impact on planning and logistics of vaccine rollout across the European Union and will facilitate the handling of the vaccine at medical centers.
In February, US authorities approved the storage and transport of the Pfizer/BioNTech vaccine at standard freezer temperatures of -15 to -25 degrees Celsius (5 to -13 degrees Fahrenheit) for up to two weeks.
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