SA’s medicines regulator has extended the length of time the thawed Pfizer/BioNTech Covid-19 vaccine can be stored in a normal refrigerator from five days to a month, a development expected to enable the government to offer the shot at a wider range of health facilities, including those in rural areas.
After a series of delays and unexpected setbacks, SA began its national coronavirus vaccine rollout last week with the Pfizer shot, which because of its ultra-cold freezer requirements and short refrigerator storage time has been largely limited to urban health-care facilities. SA is still waiting for US regulators to give Johnson & Johnson the green light to release its Covid-19 vaccine, which has been held back due to safety concerns at a Baltimore plant that makes vaccine ingredients used throughout its supply chain. The J&J shot does not require ultra-cold storage, and was expected to be the backbone of SA’s vaccination programme.
The SA Health Products Regulatory Authority approved the change to the storage requirements for the Pfizer shot last week after similar moves by the European Medicines Agency, the US Food and Drug Administration and the UK Medicines and Health Products Regulatory Agency. The changes were approved by regulators after Pfizer submitted new stability data.
The government was adjusting the planning for rural sites in light of the new storage requirements for the double-shot Pfizer-vaccine, but there were still “substantive” benefits to providing the J&J vaccine in hard-to-reach populations, since it required only a single shot, said Ian Sanne, director of Reach to Care, a non-profit supporting the health department’s vaccine rollout.
The new storage requirements simplified the logistics for vaccine sites, and would enable deliveries to be scheduled at longer intervals, he said.
Health director-general Sandile Buthelezi sent a circular to vaccination sites on Friday announcing the change with immediate effect. The new storage requirements allow the vaccine to be stored at -80°C to -60°C until its expiry date; at -25°C to -15°C for 14 days, and at 2°C to 8°C for 31 days, according to the circular. Opened vials must be discarded if they are not used within six hours.
“This change makes distribution of the vaccine significantly easier, and also reduces risk of the vaccine expiring once thawed. Our depot can reduce deliveries per site from twice a week to once every two weeks,” said Western Cape head of pharmacy Helen Hayes.
Eastern Cape provincial health department spokesperson Sizwe Kupelo said the new storage requirements would make storage and transport of the vaccine more manageable for rural settings, and allow the province to increase the number of vaccination sites. The longer period for safe storage in an ordinary refrigerator would also reduce pressure on health-care workers, he said.
Dis-Chem national clinic manager Lizeth Kruger previously told Business Day a longer refrigerator storage time for the Pfizer shot would enable the retail pharmacy chain to offer it at more sites, including its in-store clinics. Until now it was only planning to provide the shot at its mass vaccination sites.
“It will make a substantial difference,” she said.
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