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.