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South Africa reviews Pfizer vaccine

South Africa reviews Pfizer vaccine

WENDELL ROELF SOUTH Africa's medicines regulator is at an advanced stage of reviewing an emergency use application for Pfizer's COVID-19 vaccine. "Pfizer has engaged with SAHPRA via two regulatory pathways, that is registered for full commercial market access and Section 21 authorisation. The Section 21 application is in advanced stages of review," Yuven Gounden, spokesman for the South African Health Products Regulatory Authority (SAHPRA), told Reuters. A Section 21 application, normally valid for six months, is an instrument for emergency use access of a health product that is unregistered. AstraZeneca's COVID-19 vaccine was granted Section 21 approval by SAHPRA in…
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