Health
Phase 3 clinical trial for potential COVID-19 vaccine initiation in South Africa
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the start of enrollment in a key Phase 3 COVID-19 vaccine trial in South Africa. A recently expanded study enrolled approximately 44,000 global participants, further increasing the diversity of the study population and developing chronic and stable HIV (human immunodeficiency virus), hepatitis C, or hepatitis B. Includes infected people and improves safety. And effectiveness data.
The choice of South Africa as one of the world’s hosts of research was based on South Africa’s previous experience in conducting local scientific expertise and capabilities, disease epidemiology, and clinical trials. The survey will involve approximately 800 participants and will be conducted at four sites: Houten, Rinpopo and the Western Cape. The study was approved by the South African Health Products Regulator (SAHPRA) on September 22, 2020.
Dr. Essack Mitha has over 16 years of R & D (clinical trials) experience in the medical and pharmaceutical sector, working with both local and international companies to conduct more than 100 clinical trials for three terms. I did. As an executive member of the South African Clinical Research Association, he will be the National Principal Investigator of Research.
“We are proud and excited to be given the opportunity to participate in this global research effort. South African patients play an important role in the fight against COVID-19. We are confident that our site will provide high quality data for this groundbreaking study and that medicine will spread to this pandemic, “says Dr. Misa.
With regulatory approval from the US Food and Drug Administration (FDA) to advance Phase 3 clinical trials for BNT162, Pfizer and BioNTech have begun and are already recruiting more than 35,000 participants worldwide. ..
“As Pfizer, we can bring this important research to the country and the continent of Africa and, in addition to increasing knowledge about the virus, find a lasting and sustainable solution to end this pandemic. I’m proud, “said the doctor. Bha Ndungane-Tlakula, Pfizer’s South African Medical Director.
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