The South African Vaccine Producers facility underwent extensive infrastructure and equipment upgrades, which contributed to the shortage of the production of antivenom
Image: African Snakebite Institute
South Africa faces a critical anti-venom shortage due to infrastructure upgrades at the National Health Laboratory Service (NHLS), leaving snakebite victims at risk.
The NHLS reported that last year, the South African Vaccine Producers (SAVP) facility underwent extensive infrastructure and equipment upgrades, which contributed to the shortage of the production of antivenom.
Mzi Gcukumana, senior communications manager for the NHLS, confirmed the situation was no different at present.
“Due to the extent of the work required, anti-venom manufacturing processes had to be temporarily discontinued during the renovations. While in the middle of renovations, the project experienced delays due to postponed delivery of specialised equipment and the requirement to ensure that the work delivered by contractors met the quality standards prescribed by the rigorous regulatory environment for sterile manufacture,” Gcukumana said.
Stockpiles of spider, scorpion, and polyvalent anti-venoms have been depleted, she said.
“As a result, only the supply of Boomslang anti-venom remains available for distribution. The NHLS is now focusing on the commissioning of the facility. This process entails cleaning, validation, and quality control protocols to meet the regulatory requirements for sterile pharmaceutical production. The NHLS is doing everything possible to speed up the final stages of the process to resume snakebite anti-venom production and will keep providing updates on progress.
“These upgrades were planned and necessary to ensure that ageing infrastructure would not affect compliance with Good Manufacturing Practices (GMP) within the SAVP sterile manufacturing unit. The NHLS is now focusing on the commissioning of the facility. This process entails cleaning, validation, and quality control protocols to meet the regulatory requirements for sterile pharmaceutical production. The NHLS is doing everything possible to speed up the final stages of the process to resume snakebite anti-venom production and will keep providing updates on progress,” she added.
In response to the challenges presented by ageing infrastructure, Gcukumana said a strategic decision was made to undertake renovations to upgrade and modernise the plant and maintain compliance with GMP standards, as prescribed by the South African Health Products Regulatory Authority (SAHPRA).
Nick Evans, founder of the KwaZulu-Natal Amphibian and Reptile Conservation, said: “The chances of people being bitten by snakes if they leave them alone is extremely slim. But if people try to catch or kill snakes, the chances of being bitten are high. Last year, I recorded seven black mamba bites, and six of them were snake catchers or someone trying to capture a snake.
“There's a number of venomous species in KwaZulu-Natal. In Durban, it all depends on where you are. One is most likely to encounter the black mamba, Mozambican spitting cobra, stiletto and night adder. Those are the most common.
“The anti-venom shortage is very serious. I believe the government is trying to resolve the shortage. Some hospitals and vets are importing antivenom from India which is effective and works. It's not as effective but requires more vials than local vaccine producers make. Snake season is all year round in Durban because of the climate. Venomous snakes are all over Durban. Cobras and mambas are encountered by people who live near the bush, nature reserves or valleys,” Evans said.