The South African Health Products Regulatory Authority (SAHPRA) has decided not to release the long-awaited Johnson & Johnson (J&J) vaccines for use in the country.
However, SAHPRA said about 300 000 doses from batches that have been cleared by the US Food & Drug Administration (FDA) meet the requirements and will subsequently be released and shipped to South Africa.
This comes after the FDA authorised two batches of the drug substance produced by Emergent BioSolutions in Baltimore, United States, and determined that several others are not suitable for use.
“SAHPRA reviewed the data provided by the FDA and has made a decision not to release the vaccine produced using the drug substance batches that were not suitable,” the drug watchdog said.
The FDA has been investigating potential contamination problems at a COVID-19 vaccine plant in Baltimore, which has had a knock-on effect locally.
Concerns were identified by the FDA, relating to non-compliance to good manufacturing practices during the manufacturing of some active pharmaceutical ingredient used in the vaccine.
“SAHPRA focuses on the quality, safety and efficacy of all health products, including COVID-19 vaccines and will ensure that the safety and well-being of South Africans will not be compromised in any way,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
Meanwhile, according to the National Health Department, the FDA announced that they approved an extension of the expiry date after careful evaluation of these doses, after determining that the vaccine can be stored in a normal bar fridge for 4.5 months instead of three.
“Work is being undertaken to identify more safe doses for the rest of the mass vaccination programme,” the department said.
In the meantime, the department said it is hoping that more doses of J&J will be made available to the international community, including South Africa, as the US regulator continues to assess some batches.
“Further announcements will follow in due course. 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,” the department said.