The South African Ministry of Health announced an early launch of the COVID-19 vaccine for healthcare workers on February 17, 2021. South Africa secured the Johnson & Johnson (Janssen) COVID-19 single-dose vaccine for use with up to 500,000 healthcare workers in 18 public sector hospitals in all nine provinces.
The safety and effectiveness of the Janssen COVID-19 single-dose vaccine was assessed in the international phase 3 study conducted in Latin America, the United States and South Africa. Around 7,000 South Africans took part; Some were exposed to the coronavirus variant 501.V2.
The South African portion of the study showed that this vaccine offers 57% protection against moderate COVID-19 disease, 85% protection against serious illness, and 100% protection against death.
The long-term follow-up study is ongoing as it is required for the process of regulatory approval by the South African Health Products Regulatory Authority (SAHPRA) for commercial or emergency use. However, as the safety and effectiveness of the vaccine has already been demonstrated, the current rollout is being carried out as part of the Sisonke Open Label program.
The vaccine is not available to pregnant women at this early stage. This is common practice when vaccines are not yet fully approved, e.g. B. during clinical studies. However, the Janssen COVID-19 vaccine can be safely used in breastfeeding women, according to the Sisonke program.
Janssen is the vaccine division of Johnson and Johnson.