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The Health Department says there is a real possibility that the Johnson and Johnson vaccines awaiting distribution from Aspen’s Gqeberha plant, “may not be” suitable for use in South Africa.
The Department’s statement on Friday followed news from the US Food and Drug Administration in relation to the doses of the Johnson and Johnson vaccines produced at the Emergent BioSolutions Plant in Baltimore, USA.
The FDA had been investigating the plant following revelations that some of the batches may have been contaminated.
“We confirm that the FDA announced that two batches of these doses are safe and have been cleared for emergency use,” the Health Department said.
However, it said the vaccines awaiting distribution from Aspen’s Gqebherha plant need further assessment by the South African Health Products Regulatory Authority, which will advise soon if they are suitable for use in South Africa.
“There is now a real possibility that they may not be, however, this is for the regulator to rule on,” the Health Department said.
“In total, 300 000 doses are cleared to be shipped to South Africa as a matter of extreme urgency.”
“Furthermore, the FDA announced that, after careful evaluation of these doses, they approved an extension of the expiry date after determining that the vaccine can be stored in 2-8 degrees Celsius (normal bar fridge) for 4,5 months instead of 3 months.”
The Department of Health said work was also being undertaken to identify more safe doses for the rest of the mass vaccination programme.
“We further note that the FDA is still evaluating some batches and we will await those outcomes, in the hopes that this will make more doses of Johnson and Johnson available to the international community, including South Africa.”
“Further announcements will follow in due course,” the Department said.
“We remain committed to the success of the South African mass vaccination campaign and are doing everything in our power to source safe and effective vaccines for all people residing in South Africa.”
