Calling all health personnel to come forward for enrolment in the last week of the Sisonke Phase 3 b study
Cape Town | The Sisonke investigators would like to extend an invitation to all unvaccinated health workers to register for and receive the JnJ vaccine as part of the Sisonke trial.
Sisonke vaccinations resumed Wednesday 28 April after we received approval from the South African Health Product Regulatory Authority (SAHPRA) to proceed with an amended protocol on 23 April and the relevant Ethics Committees in the days that followed. As of end of Thursday 6 May, we have vaccinated 366 101 health workers, 73 478 of whom since we recommenced vaccination. We thank our teams of researchers and department of health staff who are working tirelessly to bring vaccines to as many health workers as possible including in some of the country’s most remote regions such as northern KwaZulu-Natal and rural Eastern Cape.
Calling all unvaccinated health personnel to come forward should they wish to receive a one-and-done dose of the JnJ vaccine through Sisonke: We wish to let health personnel know that we have doses and capacity to extend the Sisonke trial to health workers who are not directly patient-facing. The anticipated third wave has thankfully been slower to arrive than expected and has provided a window of opportunity in which to vaccinate health workers and personnel. We urge all health workers and personnel who have not yet been vaccinated to take up this offer before a resurgence of cases this winter to protect themselves and our health systems. The JnJ vaccine provides excellent protection (more than 80%) against severe COVID-19 and death based on local data. We understand many people may be concerned about the safety of the vaccine following the pause. Severe side-effects are exceeding rare although severe COVID-19 is not. Based on all data from South Africa and the United States we know that severe-side effects like severe allergy (anaphylaxis) or the rare clotting condition called VITT (Vaccine-induced Immune Thrombotic Thrombocytopenia) affect between one and four people per million people vaccinated, whereas severe COVID-19 is likely to kill 35 000 people per million cases should we experience another surge of infections.
Who is eligible for Sisonke: The National Department of Health defines “all people engaged in actions whose primary intent is to enhance health” as health workers. This includes all health personnel who are currently working in any Department of Health office or registered public and private health facility (hospital, clinic, laboratory, pharmacy, care facility) or who provide health services at a community level on behalf of the public or private sector. We specifically wish to highlight that Sisonke is open to all administrative and support staff in the health system including staff from multilateral or global agencies involved in healthcare delivery, community health workers, care home workers, funeral workers and registered traditional health practitioners.
How to put your arm forward for a Sisonke JnJ vaccine: All health workers and personnel, including those over 60 years, must register on the health worker EVDS site: https://vaccination.health.gov.za/#/
The vaccine vouchers that were issued before the Sisonke Study pause on 13th April were withdrawn. All future participants need to read version 2.0 of the participant information leaflet and complete the new consent form. Please follow the link in the SMS received on 26th April to reconsent. You will also be able to access this consent form through EVDS by completing or refreshing your self-registration.
If a new voucher has been issued after Monday 26th April, and you do not know which site to go to, please contact the nearest vaccine site as a direct walk-in between 8am and 2pm. Most sites will be able to provide a vaccine on the same day.
If you have registered having answered the question health care worker/health professional “YES” and have not received an invitation – please review the site where you intend to be vaccinated on your self-registration to ensure that you have chosen an active site. Alternatively you may present yourself to a Sisonke vaccination site with proof of employment or workplace, professional registration (if applicable) and ID or passport. You will be assisted by the site to complete registration and consent.
Update on pregnant and breastfeeding health workers: On 23 April SAHPRA requested that pregnant and breastfeeding women be excluded for the study but have since reconsidered their position and given us approval to enrol such women in the Sisonke trial. We are working with Ethics Committees to revise the appropriate consent procedures for these women, but in the interim have launched an electronic register to collect details so that we can recall them as soon as we are able. We have received multiple enquiries from breastfeeding women asking if they should stop breastfeeding and for how long to expedite access to the vaccine. We wish to appeal to these health workers not to stop breastfeeding their babies. We provide reassurance that while information is limited, there have been no safety concerns for any COVID-19 vaccine in either pregnant or breastfeeding women and their babies, and encourage them to be in touch with their closest vaccination site to ensure they are enrolled on the register.
As we head into the final week of the Sisonke trial, we wish to thank our colleagues at National, Provincial and Site level for their continued partnership, patience and hard work as we have worked together to vaccinate as many health workers as possible before the expected resurgence. A protected health system, rapid extension of vaccines to older people and renewed uptake of non-pharmaceutical measures are essential to mitigating the impact of a resurgence in the coming months.
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 clinical trial 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.