Minister Zweli Mkhize Public Briefing Statement South Africa’s COVID-19 Vaccine Strategy 3 January 2021

The Deputy Minister Dr Joe Phaahla

Members of the Executive Present

The Director General of Health Dr Sandile Buthelezi Senior Officials of the Department of Health

Members of the Ministerial Advisory Committee on COVID-19 Vaccines and Members of the Vaccine Task Team

Members of the Media

Fellow South Africans

Thank you for the opportunity to present the Department of Health’s Vaccine Rollout Strategy.

We have always said that the second wave is going to come and that the only way we will be protected is by developing herd immunity through vaccination. Because of that we have been working very hard by following all the research and development that has taken place globally. At this point we do believe that the issue of rolling out vaccines has to be handled with urgency and that is what has driven us to expedite the availability of vaccines. We believe that vaccines have to be made available to all the South Africans, starting with front-line health care workers and the most vulnerable to ensure there is protection for them first as the most vulnerable groups.

The vaccines will need to be made available quickly so that most of our citizens are covered by the end of the first year of rollout- this year.

We have taken much of the advice of the MAC on Vaccines, which we introduced to the country in September, and we will ask Professor Barry Schoub, the chair of the MAC on Vaccines, to reintroduce the members in a little while and talk on the work they have been doing. The MAC on Vaccines has been working a grueling schedule since it was formed in September, in partnership with government, to advise us on the developments worldwide , suitability of candidates for our country and rollout strategies. I would like to take this opportunity to thank them for their selfless service to the country and for their expertise and dedication. I would like to indicate that the advisories from MAC will be uploaded by the end of this press briefing

Based on their advisories and input from various stakeholders, including other government departments, we have set up structures to expedite financing, sourcing and procurement and therefore the issue of the vaccine strategy will get undivided attention from Department and government. We therefore want to assure the public that we are very mindful of the urgency, particularly as we feel the impact of the second wave we are currently experiencing.

The purpose is to brief media on work being done to expedite the availability of vaccines for South Africans- I will touch on some of the key issues and Prof Barry Schoub and Dr Anban Pillay from the Department of Health will expand on these is-sues.

We are targeting minimum of 67% of the population to achieve herd immunity and the approach will be a phased rollout of the vaccine beginning with the most vulnerable in our population:

Phase One:

Front line health care workers (HCW). Target population: 1,250,000

Phase Two:

Essential workers. Target population: 2,500,000

Persons in congregate settings. Target population: 1,100,000

Persons >60 years. Target population: 5,000,000

Persons >18 years with co-morbidities. Target population: 8,000,000

Phase 3

Other persons >18 years. Target population: 22,500,000

This means that by the end of phase three,  40 350 000 citizens will have been immunized which is equivalent to approximately 67,25% of the population as we have indicated.

At this stage we have secured the doses that will be acquired through COVAX which will ensure that we immunize 10% of the population through this mechanism and, in line with President’s statement, we expect the processes will have delivered the vaccine by beginning of second quarter. The funds to pay the outstanding amount after the deposit that has been made by the Solidarity Fund , around 1,8 billion, have been allocated and let us take the opportunity to once again appreciate the manner in which the Solidarity Fund has partnered with government.

Having secured for 10% of the population, we have embarked on other efforts to get the rest of the 57% of the population to be targeted by the end 2021 but, more importantly we are making efforts to obtain vaccines much earlier, hopefully as early as February 2021. This will very much depend on the success of current bilateral negotiations we are in the midst of with various companies

Additionally we have embarked on Public Private Partnerships with very good out-comes and we have approached medical aids to be part of the co-financing. The process is now at a stage where the Council for Medical Schemes has engaged various medical schemes and I have signed amendments of regulations to allow for vaccines and other therapeutics to be part of the prescribed minimum benefits

Business has also been engaged, particularly through Business Unity South Africa (BUSA) And therefore the total financing arrangement will include medical schemes, business and government with an arrangement made with Solidarity fund to provide a platform for collection of funds and for expedited and controlled procurement processes.

To optimize availability of stock for ourselves we are negotiating with all the manufacturers and pursuing those who are indicating appetite to make vaccines available sooner. We are in sensitive discussions and at this stage are bound by Non Disclosure Agreements but we will make announcements as soon as negotiations are concluded and the NDA’s have been lifted

We are working closely with SAHPRA for regulatory clearance and so we believe they are ready to rapidly process applications.

Department has embarked on distribution and delivering structures: through national government, public sector, private sector, civil society, labour, traditional leaders and structures that will report to Provincial and District Coordinating Councils. This will ensure that we take all of society with us and get community buy and a well coordinated campaign that is successfully ruled out with good uptake of the vaccinations offered.

A lot of work has been involved and we will be doing more to communicate to the public to dispel some misconceptions and to ensure preparation for this massive campaign particularly because some of the vaccines will require two doses and it will be very important that we do not lose clients to follow up.

I have participated directly in discussions with vaccine manufacturers and we also participate in the ACT- Accelerator- where we are co-chairs with Norway- and the Africa Vaccine Initiative Task Team, which was initiated by president Ramaphosa and this makes us focus on Africa’s acquisition of vaccines as expeditiously as many other countries are able to do so.

I hope this gives an overview of the efforts we have made to ensure that we do not get left behind in the equitable distribution of vaccines globally.

Additional documents:

INTERNAL MEMO

Date:   15 December 2020

To: Minister ZL Mkhize, Honourable Minister of Health        

From:   Prof B Schoub: Chair of the Ministerial Advisory Committee (MAC) on COVID-19 Vaccines

ADVISORY

FRAMEWORK FOR RATIONAL ALLOCATION OF COVID-19 VACCINE IN SOUTH

AFRICA

Problem Statement

Efficacy results from the Phase 3 Covid-19 vaccine trials are becoming available and more are expected in late 2020 / early 2021 and beyond. To date five vaccine trials have reported preliminary efficacy data ranging from 62–95%. In addition, the data suggest that these vaccines have no significant adverse events attributed to them.

Assuming that one or more of these vaccines are approved by SAHPRA, it is unlikely that there will be sufficient vaccines available for use beyond specific high-risk groups in the country before the end of the second quarter of 2021 and even then it is likely that only limited quantities of vaccine will be available.

Rationale

Vaccine allocation will thus have to be based on a framework of prioritisation and need.

The principles underpinning this Framework emphasises an evidence based approach and an ethical and moral perspective, including an African indigenous values context.

The Framework will serve as a guide and will have to be adapted as new scientific information becomes available e.g.:

- information about specific characteristics of available vaccine/s,

- the benefit-risk assessment for different population sub-groups,

- the amount and pace of vaccine supply,

- the epidemiology at the time of vaccine introduction,

- clinical management,

- public health response, and

- economic and social impact of the pandemic.Recommendation

Recommendation

The Ministerial Advisory Committee on Vaccines recommends to the honourable Minister of

Health the adoption of the Framework for the Rational Allocation of Covid-19 Vaccines in South

Africa.

Thank you for consideration of this request. Kind regards,

PROFESSOR BARRY SCHOUB

CHAIRPERSON: MINISTERIAL ADVISORY COMMITTEE ON COVID-19 VACCINES

DATE: 15 December 2020

CC:

»          Dr S Buthelezi (Director-General)

»          Dr T Pillay (Deputy Director-General: Health Regulations and Compliance Management)

****

ANNEXARE A

A FRAMEWORK FOR RATIONAL COVID-19 VACCINE ALLOCATION IN SOUTH AFRICA 15 DECEMBER 2020

Introduction

Efficacy results from the Phase 3 Covid-19 vaccine trials are becoming available and more are expected in late 2020 / early 2021 and beyond. To date five vaccine trials have reported preliminary efficacy data ranging from 62–95%. In addition, the data suggest that these vaccines have no significant adverse events attributed to them.

Assuming that one or more of these vaccines are approved by SAHPRA, it is unlikely that there will be sufficient vaccines available for use beyond specific high-risk groups in the country before the end of the second quarter of 2021 and even then it is likely that only limited quantities of vaccine will be available. Vaccine allocation will thus have to be based on a framework of prioritisation and need. The principles underpinning this framework emphasises an evidence based approach and an ethical and moral perspective, including an African indigenous values context.

The framework will serve as a guide and will have to be adapted as new scientific information becomes available e.g. information about specific characteristics of available vaccine/s, the benefit-risk assessment for different population sub-groups, the amount and pace of vaccine supply, the epidemiology at the time of vaccine introduction, clinical management, public health response, and economic and social impact of the pandemic.

African Indigenous Values and Voices in the Context of COVID-19 Vaccines

It is critical that African voices add not only to the debate but also to influencing the implementation of immunization equity. In particular, the vulnerable and disadvantaged in remote and rural areas and urban slums should not be left behind. Therefore, it is important to consider African indigenous values and draw from the principles of Ubuntu.

The importance of community is clearly indicated by Mbiti when he states “I am because we are, we are therefore I am.” (Mbiti J. Introduction to African religion and philosophy. Oxford/Portsmouth: Heinemann Educational Books. 1991.) In terms of the Nguni and Sotho/Tswana sayings, umuntu ngumuntu ngabantu and motho ke motho ka batho, a human being is a human being because of other human beings. Hence, one cannot function in isolation and independently participate in a community of other people. Inter-dependence and inter-relatedness is at the heart of these values. In the context of access to COVID-19 vaccines and also addressing vaccine hesitancy, this could translate to decision- making towards the greater good for all while protecting vulnerable individuals and groups from exploitation and other forms of harms and wrongs.

Ubuntu leads to an appreciation of the survival of the community as an important ethical consideration. Therefore, the Ubuntu standard, which reflects living in solidarity with other people and humanness that is grounded in social life, comprises the fundamental basis of an African approach towards ethics. This has particular bearing inter alia in the vaccines discussion and decision-making.

Mutually respectful discussion and dialogue in the community as seen with the indigenous African tradition of lekgotla could be likened to meaningful community engagement in vaccines discussions. Members of the community are to be given a chance to voice their opinion towards reaching a consensus and the decisions generated from the process would be socially and communally negotiated.

Framework for prioritization of fair allocation of COVID-19 vaccines

1. Fair Allocation guided by African indigenous values

a.   Affirming the humanity of others: Allocation decisions must be for societal benefit and promote common good while respecting human dignity. Every person has equal dignity, worth, and value, hence allocation decisions must be non-discriminatory. Characteristics such as ethnicity, nationality, gender, sexual orientation, race and religion are not to play a role in allocation decisions. People are to be treated fairly and equally. Allocation decisions are to be impartial and in accordance with fair criteria.

b.  Survival of the community: Allocation decisions are to be based on the best available evidence. In addition, essential service workers and those that contribute towards preventing and treating disease could be considered as essential for survival of the communities. Furthermore, those at greatest risk of severe illness and death could be included in priority groups. In this way, benefits will be maximized and the risks of severe morbidity and mortality caused by transmission due to SARS-CoV-2 reduced, and hence the community will survive.

c.  Social Solidarity: Allocation decisions are to take into consideration the bonds unifying communities, interdependence, attachment to or interest in others and their concerns and the significant social, economic and personal disruptions and hardships experienced. During pandemics inequities may increase among those who are already socially vulnerable and/or new vulnerabilities may emerge for the first time among certain communities or individuals

d.  Meaningful community engagement: Allocation decisions must be trusted and leaders at all levels must be at the forefront of communication to their constituencies. Community engagement allows for authenticity, trust, and ownership of the allocation decisions. Community involvement will be required for both allocation decision-making and addressing vaccine hesitancy. Faced with the challenge of maintaining public trust while simultaneously stemming the pandemic through various control measures, decision-makers need to be trustworthy by ensuring early engagement with stakeholders and that decision-making processes are ethical, transparent and actively communicated. For this, integrity, which reflects the need to act with honesty, reliability, and fairness, and a willingness to be held accountable to explain one's actions, is critical.

The framework proposed for SA is also in accordance with the principles articulated by the WHO SAGE

Protect and promote human well-being including health, social and economic security, human rights and civil liberties, and child development.

Recognize and treat all human beings as having equal moral status and their interests as deserving of equal moral consideration

Ensure equity in vaccine access and benefit within countries for groups experiencing greater burdens from the COVID-19 pandemic

Honour obligations of reciprocity to those individuals and groups within the country who bear substantial additional risks and burdens of COVID-19 response for the benefit of society

Make decisions about vaccine allocation and national decisions about vaccine prioritization through transparent processes that are based on shared values, best available scientific evidence, and appropriate representation and input by affected parties

2. Identification of risk groups

The allocation of vaccines to recipients will be guided by the principles outlined above and will be dependent on several factors including the efficacy of a vaccine for a specific population and on the doses available. It is unlikely that vaccines will be available to all who require them, and some sort of prioritization system will have to be applied.

Based on the principles of affirming the humanity of others, survival of the community and social solidarity and through meaningful community engagement, prioritization should be to those:

(a)  in roles considered to be essential for societal functioning;

(b)  most at risk of infection and serious outcomes, for example, those in overcrowded living arrangements, multigenerational homes, with comorbid conditions; and

(c)  most at risk of transmitting SARS-CoV-2 to others.

Individuals in the roles considered to be essential for societal functioning include those whose absence from their societal roles or work puts others and the society at risk of loss of needed goods and services should they become infected (e.g., doctors, nurses, other health care providers, first responders, workers employed in the food supply system, transportation workers, teachers, etc.).

Those most at risk of serious outcomes and most at risk of transmitting the virus would not only benefit for themselves, but if vaccinated – would prevent the health system and other essential services from becoming overwhelmed.

A phased approach is therefore recommended when limited supplies of vaccines become available. Prioritization of groups and individual groups will be developed.

Health Care workers

Health professionals and general health workers at high risk of infection, care home workers and traditional healers

Persons with co-morbidities and at risk for morbidity and mortality

These include persons 60 years and older, persons living with HIV, tuberculosis, diabetics, chronic lung disease, cardiovascular disease, renal disease, obesity etc

Persons in congregate or overcrowded settings

This includes persons in prison, detention centres, shelters and care homes. In addition, people working in the hospitality and tourism industry, and educational institutions are also at risk.

Essential workers

This group includes police officers, miners and workers in the security, retail food, funeral, banking and essential municipal and home affairs, border control and port health services.

Note that the safety and efficacy of vaccines in children and pregnant women are not known and will probably be the subject of future trials and thus the framework will be revised if necessary.

The only published peer reviewed data are from the Western Cape Province (Boulle et al; Cinical Infectious diseases 2020)

In this population cohort of 3.5 million public sector patients in South Africa, increased COVID-19 mortality (n=625) was associated with HIV, previous and current tuberculosis as well as older age, male sex, diabetes, hypertension and chronic kidney disease. Such data as well as other data from South Africa will be used to determine the priority groups for the country. The details of this step will be provided later with the list of groups in order of priority pending the availability of vaccine doses e.g. 3, 10 or 20% of the total SA population and at varying levels of vaccine acceptance and vaccine efficacy. In addition, the stage of the epidemic will also influence how vaccines will be prioritized e.g ongoing national community transmission, sporadic cases or clusters of cases, no cases. A draft of such a proposal for allocation is appended below.

3. Programmatic implications

Standard operating procedures are currently being developed to ensure that the vaccine rollout programme is effectively managed and implemented. These include:

a. Development of vaccine guidelines: This needs to be completed for each vaccine and provide guidance around eligibility, application, dosage and storage.

b. Vaccine supply management: This includes the ordering and distribution of and the safe storage and handling of vaccines to maintain potency.

c. Heath care worker training: Staff will be trained on how to counsel recipients on the benefits and risks of the vaccines and delivery of the vaccines.

d. Adverse events following immunization surveillance: This is a standard component of the current national Expanded programme on Immunization (EPI) and is being adapted for COVID-19 vaccine rollout as well. In addition, SAHPRA might specify certain pharmacovigilance requirements for specific vaccines.

e. Monitoring and evaluation (M&E): The EPI M&E tools currently in use is being adapted for the COVID-19 vaccine rollout. This should include registration and tracing mechanisms, especially in the event of the requirement for more than one dose per person.

f.  Development of vaccination certification tools: This should be aligned to International Health Regulations (2005) if there are any requirements. These can be paper-based or electronic.

g. Development of a strategy to reach identified target groups: As the target groups vary in terms of where they are located strategies on how to reach them needs to be identified.

4. Communication and social mobilisation

There is an urgent need to put in place a multi-sectoral communications strategy to support the work of government and civil society to ensure that the investment made into COVID-19 related scientific research including vaccine research and the eventual rollout is not jeopardized but protected through the provision of scientifically sound, evidence-based communications and a critical mass of community support.

The development of a Covid-19 vaccine communication strategy should be a joint effort created by government agencies and civil society and will ensure that all stakeholders have clear guidelines within which to communicate scientifically sound, evidence-based messages to the public. The strategy should take into account global research, whilst articulating where appropriate the need for South African research to explore the national context.

The issues around science denialism, anti-vax sentiments and vaccine hesitancy in South Africa should be addressed through an understanding of the main drivers of the hesitancy and the development of effective local responses.

The COVID-19 vaccine communication strategy should be informed by the communication strategies developed for other South African Health programmes (HIV, TB, Diabetes, etc), but it is of importance that the impact of the COVID-19 pandemic on the national psyche should also be taken into account. Engagement with representatives of community and professional groups affected by the COVID pandemic will be essential.

The communication strategy should include the use of online social media platforms (WhatsApp, Facebook, Twitter, etc), as well as traditional media (print, community, radio etc.) as critical platforms for engagements, and should take into account the needs of different target audiences.

Issued by the Ministry of Health, 3 January 2021