South Africa is ready for vaccine registration process by having established a specialized working group called the COVID-19 vaccine registration working group, said the South African Health Products Regulatory Authority (SAHPRA) on Tuesday.
SAHPRA on Tuesday said the working group on COVID-19 consists of experts in areas of vaccinology, manufacturing, clinical trials, epidemiology, vigilance and other specializations informing quality, safety and efficacy of the vaccines.
"SAHPRA will review the safety and efficacy of each vaccine on a case by case basis and will only grant approval for public use once it has met acceptable standards of quality, safety and efficacy," said Boitumelo Semete-Makokotlela, CEO of SAHPRA.
She stated that they will prioritize all COVID-19 applications and will apply an expedited approach to health products, including vaccines, adding that they would use approaches and work done by other regulators, and expedite reviewing submissions and collaborate through the WHO.
Semete-Makokotlela explained that they may issue terms and conditions requiring the applicant to provide additional data confirming the elements of safety, quality and efficacy. SAHPRA said if the application is approved, the national department of health will determine access, roll-out strategy and distribution.
She said the applicants have to comply with international standards of good laboratory practices. She gave an example that if the candidate COVID-19 vaccine is to be used in pregnant women, developmental and reproductive toxicity studies must be conducted to better understand the risks.
