Cold storage rules for Pfizer vaccine relaxed – will speed up rollout

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.

The following rules now apply:

• The Pfizer vaccine must be stored at – 80 to – 60 degrees Celsius for the full period up until the expiry date of the product.
• It can be stored at – 25 to – 15 degrees Celsius for 14 days not exceeding the original expiry date of the product.
• It can be stored at 2-8 degrees Celsius for 31 days not exceeding the original expiry date of the product.
• Note once thawed the vaccine is never to be frozen again.
• All of these rules are conditional on the expiry date on the outer tray or the vaccine vial being updated when the vaccine tray or vial is moved to the next temperature range.
• The storage conditions for opened reconstituted Pfizer Covid-19 vaccines have not changed and the vaccine vial should be discarded after six hours or at the end of an Immunisation session, whichever comes first.