Lack of emergency use application to SAHPRA could delay vaccine approval

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Government officials have yet to file an application for a key approval needed for the emergency use of the Oxford/AstraZeneca vaccine, a delay that could see the importation and distribution of the vaccine set back by more than a month.

According to a News24 report, in addition to health officials only filing a Section 21 of the Medicines and Related Substances Act application for the emergency use of the Oxford/AstraZeneca vaccine with the SA Health Products Regulatory Authority (SAHPRA) last week, a further application for a genetically modified organisms (GMO) certificate has yet to be made to the GMO Registrar, which is housed within the Department of Agriculture, Land Reform and Rural Development.

News24 reports that Health Minister Zweli Mkhize announced last week the country had secured a deal with the Serum Institute of India (SII) for 1.5m doses of the Oxford/AstraZeneca vaccine it would manufacture under licence and said the first 1m doses would arrive before the end of January, with 500,000 more doses expected in February.

But, the report says, the Biovac Institute, which was tasked with getting the vaccine doses into the country, has yet to submit an application for the GMO certificate, casting doubt on the timelines for the arrival of the doses as communicated by Mkhize and health officials. The delays in seeking appropriate approvals are despite claims by health officials they have been in discussion with vaccine makers, including the SII and AstraZeneca, since September.

Johnson and Johnson, which President Cyril Ramaphosa said would provide 9m doses to the country, confirmed it had shared data with the SAHPRA since last year, with an eye on the regulatory approval process.

News24 reports that SAHPRA, which referred queries over the missing GMO certificate to the Department of Agriculture, Land Reform and Rural Development, which houses the GMO Registrar, was unequivocal that the vaccine could only be distributed once the SAHPRA had authorised it – an approval that is co-dependent on approval of the GMO certificate.

"The Serum Institute had only given a firm commitment of supply to South Africa in January 2021 which the Minister announced," a health department spokesperson is quoted in the report as saying. "The permit application could only be made after confirmation from the Serum Institute. So it is not a case of lack of oversight – we cannot apply for a product until we are aware the supplier has confirmed supply," the spokesperson said.

The report says the Department of Agriculture, Land Reform and Rural Development spokesperson Reggie Ngcobo confirmed on Friday that Biovac was yet to file the application.

Full News24 report

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