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SA HIV/AIDS vaccine gets the green light
Liz Clarke. The Star. 26 September 2002. Republished courtesy of Independent Newspapers (Pty) Ltd.
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The green light has been given for the manufacture of three potential HIV/AIDS vaccines.
If they are safe and effective, they will bring the first glimmer of hope to a country devastated by the HIV/AIDS pandemic.
The fast-track life-and-death process has been been given a significant multimillion-rand boost after tests by some of the country's top scientists produced "promising data" during laboratory trials.
According to a South African Aids Vaccine Initiative (SAAVI) spokesperson, the vaccines will enter the manufacturing process and safety-testing phase as soon as possible.
Facilities in Britain and the United States, which can produce the products in a manner suitable for initial human clinical trials, are already being considered.
If the resultant vaccines are approved by United Kingdom's Medical Control Council and the US Food and Drug Administration, it could hold good prospects for a similar manufacturing process in South Africa.
At an HIV/AIDS vaccine conference held in Cape Town, the financial backing for the ground-breaking South African initiative was spelled out, with initial contributions amounting to R70-million.
The three candidate HIV vaccine products incorporate the genetic sequences of the South African strains of HIV (subtype C), the most prevalent strain in the region.
The scaled-up manufacturing process is extremely expensive, time consuming and technical. It involves bulk manufacturing, toxicity analyses to ensure product safety before human testing, and a rigorous documentation process for submission to regulatory authorities.
"We need to proceed as rapidly as possible to phase-one human clinical trials to test whether these candidate vaccines, and other promising candidate vaccines, are safe and of potential clinical benefit in preventing HIV infection or disease," says SAAVI director Dr Tim Tucker. |
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