Regulatory approval of the AstraZeneca vaccine could take longer than 30 days, or longer

Covid-19 vaccine stickers attached and syringes with the logo of the British pharmaceutical company AstraZeneca.

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

News24 understands that, in addition to health officials only filing a Section 21 application of the Medicines and Related Substances Act for emergency use of the Oxford / AstraZeneca vaccine with the SA Health Products Regulatory Authority (SAHPRA ) last week, an additional application for a genetically modified product The certificate of genetically modified organisms (GMOs) has not yet been delivered to the Registrar of GMOs, which is located within the Department of Agriculture, Agrarian Reform and Rural Development.

By law, the GMO registrar must allow a 30-day public participation period, after a public notice has been published, before this certificate can be awarded, a timeframe that excludes other processes that occur by the committee to evaluate and approve an application for a GMO certificate including SAHPRA approval.