More than 10 percent of the health care workers successfully vaccinated through the Sisonke Study

Cape Town | There has been tremendous global efforts to find multiple vaccine candidates to protect against COVID-19 infection and subsequent development of severe disease, this has led to the biggest vaccination campaign in history. South Africa, through the Sisonke Study has managed to vaccinate more than 10% of the frontline health care workers (HCWs).

To support South Africa’s risk-based three-phased National COVID-19 Vaccine Rollout Strategy, the Sisonke Study has enabled government to make the Ad26.COV2.S COVID-19 vaccine (JnJ vaccine) immediately available to HCWs using a research programme.

To ensure an effective rollout in both rural and urban settings, the number of sites have been expanded from 17 to 47 with further expansion into 12 more sites by next week. This includes sites in rural areas to improve access to rural health care workers. These sites located across all nine provinces range from Upington and Kimberly in the Northern Cape, Frere Hospital in the Eastern Cape, Madadeni Provincial Hospital in KZN, to Malamulele Hospital in Limpopo, and Ermelo Hospital in Mpumalanga, where teams of researchers and vaccinators have worked up to 10 hours a day, 7 days a week, to vaccinate HCWs. As at 17th March 2021, a total of 157 286 health care workers have received their single-dose of the Johnson & Johnson’s COVID-19 vaccine candidate. The full list of sites is available below and on the Sisonke website under FAQs and Resources: https://sisonkestudy.samrc.ac.za/.

The Sisonke Study, which is a collaboration between the National Department of Health, SAMRC, Desmond Tutu Health Foundation, CAPRISA, Janssen and Johnson & Johnson is an open label, pragmatic, real world Phase 3b clinical trial of the investigational single-dose Johnson & Johnson’s COVID-19 vaccine candidate among frontline health care workers in the country.

Sisonke was launched following the release of the JnJ clinical trial results at the end of January, which indicated that the vaccine candidate had produced an efficacy rate of 64% protection overall. This vaccine was found to be efficacious against the 501Y.V2 variant, which first emerged in South Africa in October 2020. The Sisonke Study allows for government to make this safe and effective vaccine immediately available to health care workers using a research programme pending full licensing. The South African Health Products Regulatory Authority (SAHPRA) has approved the use of the JnJ vaccine for the Sisonke Study while the full licensing process is underway.

The prioritization of health care workers is in accordance with the three-phased National COVID-19 Vaccine Rollout Strategy – this is necessary to maintain a healthy work force to deal with the predicted third wave of COVID-19 admissions. Next in line will be the essential workers, persons in congregate settings and persons over 60-years and persons over 18-years with co-morbidities then later the general population.

Prof Glenda Gray, SAMRC President and CEO said no one will be left behind. In addressing concerns that have come from some sectors of society about the vaccine rollout in rural areas, Gray reiterated that vaccination sites in rural healthcare facilities were launched since 1 March, and Sisonke is set to be rolled out into more rural areas. “There is also more stock arriving this weekend and the next and we have already applied to SAHPRA and discussed with the Department of Health, the intention to transition to a few more rural sites” says Prof Gray who leads the study as Principal Investigator.

Gray also emphasised the importance of the public to understand that although the vaccine is not yet licensed, this does not mean it is not safe or effective. “We have data on safety and effectiveness of the JnJ vaccine” concluded Gray, who along with President Cyril Ramaphosa, were among the first to receive the JnJ vaccine at Khayelitsha District Hospital, Cape Town, last month to endorse the safety and importance of vaccinations.

NOTE TO THE EDITOR:

About the Sisonke Study:

The Sisonke Study is a collaboration between the National Department of Health, South African Medical Research Council, Desmond Tutu Health Foundation, CAPRISA, Janssen and Johnson & Johnson. This open label, single-arm Phase 3b vaccine implementation study of the investigational single-dose Janssen COVID-19 vaccine candidate aims to monitor the effectiveness of the investigational single-dose Janssen vaccine candidate at preventing severe COVID-19, hospitalizations and deaths among healthcare workers as compared to the general unvaccinated population in South Africa.

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Vaccination sites in both rural and urban areas: