The South African Health Products Regulatory Authority (SAHPRA) has approved relaxed cold storage rules for the Pfizer-BioNTech COVID-19 Vaccine.
The new storage conditions are expected to help the government and health sector administer the vaccines faster, and reportedly also avoid vaccines going to waste.
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This comes two months after the Federal U.S. Food and Drug Administration announced its more flexible storage and transportation conditions for the same drug.
The Pfizer vaccine has posed a major challenge in distribution because of its extreme cold storage requirements, which calls for it being stored at -70 degrees celsius.
But in February, Pfizer Inc. and and BioNTech submitted new data to the U.S. FDA showing that their their vaccine remained stable when stored at -25°C to -15°C (-13°F to 5°F), which are temperatures more commonly found in pharmaceutical freezers and refrigerators.
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This data allowed for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative, or complement to storage in an ultra-low temperature freezer.
Sahpra’s approved changes extends the approved storage period of the unopened thawed vaccine vial at -2 to -8 degrees from five days to a month (31 days). This means that one can store the vials in a vaccine fridge thawing for up to a month.
These changes take immediate effect and are applicable to all unopened vials, including vials from those batches which have already been distributed.
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