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South Africa's Medicines Regulator Begins Sputnik V Vaccine Review
February 16, 2021 • 7:58 am CST
South Africa’s health ministry stated that the Sputnik V COVID-19 vaccine manufacturers had submitted documentation to local medicines regulator SAHPRA for registration, reported Reuters.
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting, and registering) all health products. This includes clinical trials, complementary medicines, medical devices, and in-vitro diagnostics.
Sputnick V is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated. Adenovirus is used as a “container” to deliver the coronavirus gene to cells and start the synthesis of the new coronavirus's envelope proteins, “introducing” the immune system to a potential enemy.
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