SAHPRA gets first Covid-19 vaccine application

South Africa moves closer to vaccine rollout as regulator receives application to register J&J's Covid-19 candidate.

The global pharma giant Johnson & Johnson became the first developer to submit an application to have its Covid-19 vaccine candidate registered in South Africa, according to the South African Health Products Regulatory Authority (Sahpra). Announced by its chief executive officer, Boitumelo Semete during a press conference on Monday, the application was received on 10 December, and will be undergoing safety, quality and efficacy reviews by experts. However, guidance from the World Health Organization will also be followed to avoid repeating work already performed by other regulators.

To further streamline the application process for applicants, SAHPRA has also held several pre-submission meetings with pharmaceutical companies looking to register their products locally, where it provided guidance about the data required for successful applications. The regulator is also following in the footsteps of its counterparts such as the Food and Drug Administration and the European Medicines Agency which have introduced rolling reviews as part of measures intended to fast-track the process. The rolling review approach allows for data to be reviewed as it becomes available, thus minimizing delays.