CAPE TOWN – The South African Health Products Regulatory Authority (Sahpra) has approved a change in the storage conditions of the Pfizer vaccine.
The change will allow the Pfizer vaccine to be stored at normal fridge temperatures for up to 31 days, this change does not apply to the storage of thawed vials (diluted or undiluted). Up until now, the vaccine had to be administered within five days of being removed from ultra-low temperature freezers.
The request to update the vaccine’s storage conditions was received by Sahpra on May 19.The amendment was approved by the regulatory authority and adopted by the Department of Health on May 21.
This comes days after the health department announced that the Pfizer jab will be administered six weeks apart compared to the approved schedule of two doses three weeks apart.
Department of Health Director-General Dr Sandile Buthelezi says this will be implemented with immediate effect, and applies °to all unopened vials including vials from those batches which have already been distributed.
The following storage conditions will apply:
- Storage at -80°C to -60°C for the full period up until the expiry date of the product.
- Storage at -25°C to -15°C for 14 days, not exceeding the original expiry date of the product.
- Storage at 2°C to 8°C for 31 days, not exceeding the original expiry date of the product.
“The storage conditions for opened reconstituted Pfizer vaccines have not changed and the vaccine has not changed and the vaccine vial should be discarded after 6 hours or at the end of the immunisation session, whichever occurs first,” Buthelezi said.
The two-dose Pfizer vaccine is being used in the country’s Phase 2 vaccine roll-out. More than 30 million doses of Pfizer vaccine have been ordered.
The regulator said the updated advice was expected to make storage easier and possible for a wider range of health facilities.
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