UPDATE | SA approves Pfizer update, extending vaccine storage times in normal fridges to 31 days
- Vials of the Pfizer-BioNTech vaccine can be kept in a normal fridge, at between 2°C and 8°C, for up to one month.
- This was confirmed by South Africa’s health department, following suit on approvals granted by the United States’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Previously, the vaccine was only permitted to be stored in normal fridge conditions for five days.
- The latest update will benefit South Africa’s vaccine rollout, particularly in rural communities which were initially meant to rely on Johnson & Johnson jabs.
- For more articles, go to www.BusinessInsider.co.za.
* This article has been updated below.
Unopened, thawed vials containing the Pfizer-BioNTech Covid-19 vaccine – sold under the brand name Comirnaty – can be stored in normal refrigerators, at between 2°C and 8°C, for up to month. These updated conditions have been accepted by South Africa’s department of health.
Following approvals by the United States’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA), South Africa’s Health Products Regulatory Authority (Sahpra) revealed that it, too, had accepted Pfizer’s updated conditions.
Pfizer’s request to update its vaccine’s storage conditions was received by Sahpra on Wednesday 19 May. The amendment was approved by the regulatory authority and adopted by the department of health on Friday.
“This change extends the approved storage period of the unopened, thawed vaccine vial at 2°C to 8°C [i.e. in a vaccine fridge after taking out of deep-freeze conditions] from five days to one month [31 days],” noted the health department’s director general Sandile Buthelezi.
The health department summarised the varying storage conditions applicable to the Pfizer vaccine as follows:
- 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. – Note, once thawed the vaccine may never be frozen again.
Unthawed vials still need to be stored and transported in the ultra-cold conditions at temperatures between -60°C and -80°C that present significant logistical challenges.
The update to the Pfizer vaccine, which remains one of the most efficacious jabs in combatting severe illness stemming from both the original and mutated strains of Covid-19, is expected to have a "significant impact on planning and logistics of vaccine rollout” according to the EMA.
South Africa has ordered more than 30 million doses of the Pfizer vaccine, which will be used to achieve 38% of government's herd immunity target. The two-dose vaccine is currently being used to vaccinate senior citizens as part of Phase 2 of the rollout which launched on Monday 17 May, while the Johnson & Johnson jabs await approval from both local and international regulators.
South Africa's three-phase vaccination rollout initially earmarked Pfizer jabs for use in predominantly urban settings while the one-dose Johnson & Johnson shots were to be rolled out in rural areas. This geographic spread was determined according to each vaccine's temperature sensitivity ratings and storage capabilities. The health department had highlighted three reasons as to why the Pfizer vaccine is preferred for use in cities:
- Easier to access the population.
- Large pack size requires high throughput to be administered within five days or site requires -20°C storage to be administered within 19 days.
- Can also be used at work-based or mass vaccination sites.
Transporting and storing the Pfizer vaccine, which needs to be kept in ultra-cold freezers, is easier to manage within metropolitan environments, explained the department of health in April.
(Compiled by Luke Daniel)
* This article was updated after publication to include subsequent approval of extended storage by the FDA.
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