SA intends to fast track regulatory approval for Covid-19 vaccines and expects the first applications within a fortnight, the SA Health Products Regulatory Authority (SAHPRA) has said, as the country faces a second wave of infections.

SA is the continent’s hardest-hit country with more than 828,000 confirmed coronavirus cases and over 22,000 deaths. Health minister Zweli Mkhize said on Wednesday that four provinces are driving a resurgence in cases.

The government hopes to receive its first vaccines from the Covax global vaccine distribution scheme in the second quarter of next year.

“The SAHPRA will prioritise all Covid-19 applications and will apply an expedited approach to health products, including vaccines,” said Yuven Gounden, the authority spokesperson.

The expedited method will include a “rolling review approach” where vaccine candidate evaluation is done as data becomes available, he said.

The regulator will rely on guidance from the World Health Organisation (WHO) and work done by international counterparts, such as European and US pharmaceutical regulators, to avoid repeating work already done that could delay approvals.

“We expect the first vaccine applications in the next week or two,” Gounden said. Formed in 2018, SAHPRA is working to reduce a backlog of approvals for medicines inherited from its predecessor, the Medicines Control Council.



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