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The South African Health Products Regulatory Authority (Sahpra) has extended the expiry date for millions of Pfizer Covid-19 vaccines by three months.
The vaccines that were going to expire at the end of October have now been given a longer shelf-life, subject to storage conditions.
“The previous circulars related to this topic refer, indicating that the latest storage stability data reviewed by Sahpra and the storage conditions of all batches of Comirnaty Vaccine were previously extended from 9 to 12 months when stores at ultra-cold chain storage temperatures of between -90C and -60C,” reads a statement from Sahpra.
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“The manufacturer submitted new stability data to Sahpra for review and approval. Based on the data available, Sahpra has approved a further 3-month extension of the shelf life for all vaccines when stored between -90C and -60C, resulting in a total shelf life of 15 months from the date of manufacture. This shelf life extension applies to all Pfizer batches listed. The extension does not apply if the vaccine doses have already been moved to -20C and 2-8C storage.”
This comes just days after two fatal cases of the rare Guillain-Barre syndrome in people who had received a Johnson & Johnson Covid jab were recorded.
Sahpra reported its first case in August and the second last Monday.
“Sahpra has been informed of a second fatal case of Guillain-Barre syndrome (GBS) following vaccination with the Covid-19 vaccine Janssen,” it said in a statement.
In a response to AFP on Tuesday, Johnson & Johnson said “very rare cases of the neurological disorder, Guillain-Barre Syndrome (GBS) have been reported following vaccination with the Janssen Covid-19 vaccine with most occurring during the first 42 days following vaccination”.
“GBS is a very rare but severe adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by infections such as SARS-CoV-2,” it said, but made no direct reference to the South African cases.
Pressed for details, Sahpra on Tuesday refused to disclose further information, citing “patient confidentiality” rules.
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Additional reporting by AFP