The World Health Organisation has severely criticised South Africa only polio vaccine-making facility and recommended that it cease production of the vaccine until a new facility is built.
All polio vaccine currently being dispensed in South Africa is imported and local production will only begin when new facilities match the standards set by the WHO.
No polio vaccine produced in this country has been subjected to quality testing outside of the production facility as no such testing facility costs here. But it is likely that as a result of the WHO visit, South Africa may become a test case m how to develop adequate testing facilities. And it is possible the country will become a major supplier of several vaccines regionally in Africa
The criticism of the facility followed a visit to the country by the WHO in September last year at the invitation of the Medicines Control Council (MCC) and the Department of National Health. The move was prompted by a routine inspection by the MCC at the National Institute for Virology, near Johannesburg, which produces the vaccine.
According to Dr Julie Milstien of the WHO in Geneva, the mission was undertaken to see what improvements could be made to South African production; she says the WHO regards it ‘as a real success story with a high level of co-operation from every level.’
According to Professor Peter Folb, the chairman of the MCC, the report of the WHO was critical of the way in which polio vaccine is produced, and made a number of recommendation which will all be adopted.
“They advised us to upgrade the local production of the polio vaccine,” said Folb and the result was that production was stopped. Folb said the MCC required evidence from the Institute for Virology that WHO standards had been met before the material could be used.
However, independent quality testing of the vaccines could not be conducted locally. Milstien confirmed the WHO had offered to assist with the testing. Although it had no facilities of its own, it contracted the testing out.
According to Professor Barry Schoub director of the virology institute the facility, built in the 1950s, requires modernisation, which he had requested previously. A new building would be built soon which would conform to all the requirements set by the WHO. His institute, he said, had not produced vaccine for two years — but had stored five years’ worth of the vaccine
The WHO had also advised that the way in which the vaccine was dispensed needed changing, and changes had been implemented.
Later this month, Schoub said, local vaccine would be dispensed. According to Folb, this vaccine will be tested and any problems will mean continued importing of vaccine.