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Regulatory approval for AstraZeneca vaccine could be delayed by more than 30 days

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

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.  

News24 understands 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.

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

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