What South Africa's new vaccine regulatory status means

The World Health Organization announced on Wednesday that the South African Health Products Regulatory Authority has reached a level of maturity where the global body says it has faith the regulator can ensure the safety, quality, and effectiveness of vaccines produced in the country. This lays the groundwork for companies in South Africa to apply for WHO prequalification of vaccine products, Alain Alsalhani, vaccines and special projects pharmacist at Médecins Sans Frontières’ Access Campaign, told Devex. Prequalification is a condition a vaccine must achieve before global organizations like Gavi, the Vaccine Alliance will purchase it. This helps facilitate the process for vaccines produced in the country to have a global reach. The country’s vaccine industry is nascent but has grown significantly during the pandemic. Aspen Pharmacare is involved in late-stage vaccine manufacturing, or fill and finish — where drug substance is produced elsewhere, and shipped to South Africa where it is bottled into vials. This is happening with COVID-19 vaccines and there is a new agreement with the company around fill and finish for routine vaccines. South Africa also hosts the world’s first messenger RNA vaccine technology transfer hub, where it is training companies in lower-income countries on how to produce mRNA vaccines. The hub has developed a vaccine candidate, which it plans to produce end to end, but it must undergo trials. Biovac will be the South African producer of the hub’s vaccines. “It is an important win for vaccine equity, as the country is a major manufacturer of medical products and this regulatory milestone will help maximise the impact of the mRNA vaccine technology hub,” wrote Dr. Tedros Adhanom Ghebreyesus, director general of WHO, in a release. WHO ranks national regulatory systems between levels one and four in an effort to help countries achieve global recognition as their systems advance. Countries can reach these levels in different areas of products, including medicines or vaccines. South Africa has achieved a level three maturity, which means it has a “stable, well-functioning and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines manufactured, imported or distributed in the country.” The only other country on the African continent to achieve maturity level three for producing vaccines is Egypt. Senegal’s Institut Pasteur de Dakar was the first country on the continent to receive WHO prequalification for its yellow fever vaccine, but the country’s regulator is currently not on the maturity level three list. Ghana, Tanzania, and Nigeria have “non-producing” maturity level three status for vaccines, which means they have done a lot of work to show WHO that they have a well-functioning, stable regulatory system, but the ranking wouldn't enable a vaccine developed in the country to enter into the prequalification phase, Alsalhani said. This ranking scheme is not the same as the stringent regulatory authority system, which is the global gold standard and includes regulators like the U.S. Food and Drug Administration or European Medicines Agency — where the regulatory process in these countries validates and registers the product and then, due to a system of reliance on these authorities, the vaccine is streamlined to the WHO emergency use listing, Alsalhani said. WHO relies on these stringent regulatory authorities to help inform their own decision-making and help expedite the process. Once a country is involved in the prequalification process, manufacturers can submit regulatory dossiers to WHO that shows the vaccine is compliant with its requirements. “It’s a very rigorous procedure,” he said. And manufacturers also need to ensure there is demand for the vaccines.