South African pharma regulator to fast track vaccine applications

South Africa intends to fast track regulatory approval for COVID-19 vaccines and expects the first applications within a fortnight, pharmaceutical regulator SAHPRA told Reuters, as the country faces a second wave of infections.

South Africa intends to fast track regulatory approval for COVID-19 vaccines and expects the first applications within a fortnight, pharmaceutical regulator SAHPRA told Reuters, as the country faces a second wave of infections. South Africa 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 of the country's nine provinces were 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. "SAHPRA will prioritise all COVID-19 applications and will apply an expedited approach to health products, including vaccines," said Yuven Gounden, spokesman for the South African Health Products Regulatory Authority.

The expedited method will include a "rolling review approach" where vaccine candidate evaluation is done as data becomes available, he added. The regulator will rely on guidance from the World Health Organization and work done by international counterparts, such as European and U.S. 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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