By Stakeholders for COVID-19 VACCINES: African Voices and Values Steering Ethical Decision-Making

1. Since the detection of the first cases of Coronavirus Disease 2019 (COVID-19) in late 2019, the disease has become a global emergency with severe implications on lives and livelihoods worldwide. While several preventative measures could assist in mitigating the impact of the disease, successful immunisation of a critical mass of the population is the only way of achieving prevention of transmission, prevention of deaths, and a minimisation of its social and economic consequences. 2. In South Africa, the National Department of Health (NDoH) planned a risk-based vaccination rollout strategy in three sequential phases with healthcare personnel being prioritised to be vaccinated in the first phase. This was scheduled to start in mid-February 2021. The costs of vaccination would be borne by the NDoH for vaccine recipients who received health care in the public sector. 3. Early in 2021, South Africa’s Council for Medical Schemes added the Covid-19 vaccine to its list of Prescribed Minimum Benefits (PMB). Hence medical aids would cover the costs of vaccination for vaccine recipients who received healthcare in the private sector. PMBs must be paid for by every medical scheme for every member, regardless of their plan, monthly payments or number of claims. Some medical aid providers pledged that for every scheme member who gets vaccinated, the costs of the vaccination for another person without medical aid would also be covered by them. 4. Under such a programme, about 14 million South Africans (including both medical aid members and non-members) could be vaccinated against Covid-19 without the need to erode the budget for COVID-19 vaccinations allocated to the NDoH by the SA Treasury. This would allow for timely access to the vaccine to a greater number of people in the country. 5. Due to evolving scientific evidence, the planned vaccine rollout with the Astra Zenica vaccine purchased by the state in January 2021 had to be called off. However, to ensure that health care personnel received vaccines on time and as planned for in the rollout program, vaccination with the J&J vaccine, which had been shown to have high levels of efficacy against the 501Y.V2 SARS COV 2 variant was implemented as a collaborative Phase 3B study between researchers of the ENSEMBLE Trial and the NDoH. 6. In this manner the first 500 000 health care workers will be vaccinated. Almost all of these individuals would probably have medical aid cover and would have received the Astra Zenica Vaccination as a PMB with the costs of their vaccinations being paid to the NDoH by their respective medical aids. 7. The procurement of COVID-19 vaccines and their deployment has the potential to constitute a considerable financial burden, even when done under Phase 3B study conditions. 8. The principle of justice obliges medical aids to honor their ethical responsibility and reimburse the NDoH for these 500 000 vaccine recipients. This would assist the state’s goal of adequate financing and procurement of vaccine, which is critical towards ensuring vulnerable people are not left behind.

STAKEHOLDERS: SA Medical Research Council Bioethics Advisory Panel; Section 27; Foundation for Human Rights; Treatment Action Campaign; African Alliance for HIV Prevention; Medical Rights Advocacy Network; Progressive Health Forum; South African Medical Association Human Rights, Law and Committee; UNESCO National Bioethics Committee; Academy of Sciences of South Africa; University of the Witwatersrand School of Clinical Medicine; Africa Centre for Disease Control and Prevention; UNESCO Regional Office for Southern Africa.