SAVIMS

January 2020

Ethics, Other scientific evidence, Reference Library, Resource Type, Treatment

South African Good Clinical Practice Guidelines: Overview

Reference: Department of Health. (2020). South African Good Clinical Practice: Clinical Trial Guidelines (3rd ed.). Pretoria, South Africa. Summary: The South African Good Clinical Practice (SA GCP) Guidelines, first established in 2006 and revised in 2020, provide a framework for conducting ethical and scientifically sound clinical trials within South Africa. Mandated by national health legislation, […]

COVID-19, Covid-19 vaccines, Epidemiological surveillance, Other scientific evidence, Resource Type, Statistical evidence, Vaccine effectiveness, Vaccine safety & adverse events, Vaccines, Viral illnesses

Safety and Efficacy of BNT162 RNA-Based COVID-19 Vaccines

Reference: Pfizer. (2020). PF-07302048 (BNT162 RNA-Based COVID-19 vaccines) protocol C4591001. Summary: The document outlines the Phase 1/2/3 clinical trial to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162 RNA-based COVID-19 vaccines, developed by Pfizer and BioNTech. The trial investigates two vaccine candidates: BNT162b1, encoding the receptor-binding domain (RBD), and BNT162b2, encoding the prefusion spike

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