Subtitle

Introduction• Similar to other regions in the world, Africa affected considerably by COVID-19 pandemic withhealth, economic and social impacts being most dire and unprecedented on individuals,
families and communities - most brutal economic, social and health impacts of pandemic on the most vulnerable world-wide.
• Globally no country prepared for the devastation - even countries with the best healthcare
systems did not have public health capabilities to cope. Global challenge →several variantsof concern → number of waves. Vaccine inequity (vaccine apartheid) - substantive cause ofvariants of concern - WHO → persistent injustice → variants that could evade vaccines• Africa– already overburdened and in some cases failed health and other social systems.
– with all attention on managing pandemic other viral infections and diseases re-emerged - Ebola (DRC) Lassa
fever (Guinea & Liberia) Rift Valley Fever (Kenya) Marburg Virus Disease (Nigeria, Sierra Leone &Republic ofGuinea)– absence of effective, affordable, easily available treatment regime, value of vaccinating populations widely
underscored.
– lack of established, well financed public health systems– poor to no infrastructure for development, supply and administration of vaccines– lack of confidence by individuals, communities and populations in the vaccine (vaccine hesitancy)– corruption re-emerging as a parallel plague at a number of levels– COVID-19 vaccine research issues ranging from moral imperialism to public health imperative to test novel
COVID-19 candidate vaccines on the African population in background settings of the already struggling
research ethics review processes being further pressurised.

Chapter Objectives• Describe the context with regard to vaccine development andmanufacture on the continent.
• Discuss the African Union and Africa CDC approach to ensuring
access to COVID-19 Vaccines on the continent.
• Analyse the notion of COVID-19 vaccines as a global public goodand discuss the reasons for vaccine apartheid.
• Examine impediments to access including corruption, vaccine
hesitancy and poor uptake of COVID-19 vaccines.
• Explore the ethical issues associated with COVID-19 vaccine
research in Africa.

The context with regard to vaccine development
and manufacture on the continent• For significant period, received only small doses→ supplies unpredicted, little
warning when the vaccines would arrive & what type - Need for developing/augmenting local manufacturing capacity + ensuring procuring raw materials& available infrastructure for transport and administration• Challenges to vaccine manufacturing include– weak investments by African Governments;– weak regulatory capacity for vaccine research, development and production;– low interest in vaccine production in Africa by global vaccine stakeholders;– uncertainties in the demands for vaccines made in Africa by African countries– manufacturers ceasing production as a result of inability to compete with imported
vaccines;– dependence on global supply chains, which at times are hampered by intellectual property
issues, trade barriers, monopolised supply and export bans;– dependability on external suppliers posing severe problems to Africa’s health resilience;– preference by African countries and their governments for ready-made vaccines that they
can import

The context with regard to vaccine development
and manufacture on the continent• Focus - securing deliveries rather than manufacturing →easier to secure funding or pool resources fromforeign donors to facilitate payment & procurement as compared to the cost of vaccine development,
preclinical testing and clinical trials.
• While significant investments and grants, backed by the state are made available to produce vaccines in
wealthier countries, African manufacturers face the high costs of vaccine production with little or no
funding support from the states and a lack of political commitment → problems of sustainability of
initiative.
• African technological innovations undermined to create markets for the Western-led products• Africa’s reliance on foreign suppliers for vaccines, impacts public health security → Africa could remain
last-in-line and face significant procurement challenges in future.
• Barriers in accessing important steps of the value chain, such as pre-clinical research and good
manufacturing practice (GMP) batch manufacturing for clinical trials →currently not possible to move avaccine concept from research through to clinical trials entirely & projects cannot be advanced andcommercialised because of lack of required partners, sponsors, investors, technological transfer, andknow-how. While expertise does exist in Africa, it is spread across the continent, with limited connections.
• Paucity of open and well paid posts, graduates of training programs frequently leave their countries foropportunities in higher-income regions

The context with regard to vaccine development
and manufacture on the continent• 99% of Africa’s vaccines manufactured outside the continent & only .1% of
global supply of vaccines is produced in Africa → millions of lives endangered
and social and economic progress impeded. This market failure needs to beaddressed urgently.
• 7/10 vaccines used in Africa are donated by Global Vaccine Alliance (Gavi)
mainly for childhood immunization programs - manufactured in India or bymultinational vaccine manufacturers in North America or Japan.
• These donations perpetuate dependence and add to the impediments todevelopment of vaccines and other interventions against diseases in Africa.
Donations could result in the perception amongst donees that the challenges
resulting from patent law are no longer an issue that needs to be confronted.
The COVID-19 pandemic underscored how fatal this dependency on imported
vaccines could be. In addition, Africa cannot rely on fellow states in the Global
South. This is well illustrated by India halting vaccine supplies to the continent
early in 2021, at the height of the delta variant outbreak when only 1.5% of theAfrican population had received a vaccine dose at that time

The context with regard to vaccine development
and manufacture on the continent• A foundation to provide financial and strategic support for the development of thepharmaceutical industry and the consolidation of regional vaccination programs in Africa has
been established by the African Export-Import Bank and the African Development Bank.
Currently, about 33% of African countries pay for their vaccine needs. The Partnership for
African Vaccine Manufacturing (PAVM) projects that the value of the total African market
could reach between $3billion and $17biliion by 2040.
• Development and / or expansion of national vaccine industries commenced in several
countries from 2020. Egypt, South Africa, and Senegal partnered with private sector
manufacturers to expand volume capacity. Ghana reconfigured part of its pharmaceuticalindustry to make vaccines. Rwanda commenced on work to manufacture mRNA vaccinesfrom scratch.
• Even though only 1% of vaccines used in Africa are manufactured on the continent, there are
more than 30 new vaccine manufacturing initiatives underway, with momentum gathering to
make the expansion possible.
• Nevertheless, there is a need for coordination at a continental or even regional level to assist
with ensuring long-term sustainability and equitable access to vaccines

The AFRICAN UNION and AFRICA CDC approach toensuring access to COVID-19 vaccines on thecontinent• New Public Health Order - aims to safeguard the health and economic securityof the continent, with a key pillar being that of expanding the local manufactureof vaccines, diagnostics, and therapeutics.
• Partnerships for African Vaccine Manufacturing (PAVM) established by AU todeliver on the goal of enabling the African vaccine manufacturing industry todevelop, produce, and supply over 60 percent of the total vaccine doses for
Africa by 2040 with interim goals → 10 percent by 2025 and 30 percent by
2030.
• For New Public Health Order to be realised →integrated ecosystem approachnecessary. Investment will be required in all steps of the vaccine manufacturing
supply chain. This includes research and development (R&D), drug substance,
and fill and finish. R&D will need to increase to include pre-clinical and clinical
trials. Supporting industries will need to grow as well for the provision of raw
materials, active ingredients, inactive ingredients and consumables like vials,
sterile bottles, syringes, and rubber stoppers. Key benefits of developing an
enabling environment include reducing production costs and increasingsustainability of vaccine production on the continent thereby promoting selfreliance and health security.

AU & ACDC Framework for Action• Program 1: Creating an African Vaccines Procurement Pooling• Program 2: Establishing a vaccine manufacturing Deal Preparation Facility andsupporting fundraising for ecosystem enablers• Program 3: Strengthening National Regulatory Agencies and Regional Centresof Regulatory Excellence to build vaccine regulatory excellence• Program 4: Supporting the transfer of vaccine technologies and intellectual
property through a TT & IP Enablement Unit
• Program 5: Creating Regional Capability and Capacity Centres to support talentand critical skills development• Program 6: Putting in place Vaccine Research and Development Centres and a
Research and Development Coordinating Platform• Program 7: Undertaking Advocacy for enabling trade policies for vaccines• Program 8: Ensuring an effective Continental Strategy for delivery and oversightNew Public Health Order• Plan by the AU and Africa CDC is laudable albeit ambitious.
• It will require positive political will and shared responsibilities fromwithin individual countries on the continent to see it executed
successfully.
• Pandemic of corruption in Africa poses a significant impedimentto achieving the envisaged New Public Health Order.
• What is also required to successfully implement this plan are
ethical African leadership and governance.

COVID-19 VACCINES: A GLOBAL PUBLIC
GOOD VS VACCINE APARTHEID• The COVID-19 pandemic exposed the excessive self-egotism and greedof many of the globe’s rich countries who, in this unprecedented crisis
entirely disregarded the global nature of the problem.
• By March 2021, globally, 559 million doses had been administered; with
10% of the economies, accounting for 77% of the total number
vaccinated.
• This situation made apparent the depth of unfairness globally and thatthe right to health for all was once again being denied.
• As with other crises, exacerbations of pre-existing inequalities acrossthe world became patently evident, with the most vulnerable being
effected the most.
• Even the United Nations strongly stipulated that vaccine equity affirms
human rights and that vaccine nationalism denies it, stating also thatvaccines must be a global public good, accessible and affordable to allGlobal Public Good•

A good whose impacts are equitably spread across the globe without causing division.

• No price can be placed on the benefits of these goods and hence the principle of exclusion
cannot be applied to them.
• When one individual uses these goods, their availability to others cannot be allowed to be
reduced.
• The good and its benefits are not marketable and therefore must be available at negligible orzero cost to all in the global village.
• Two criteria determine a public good:– non-rival in consumption - consumption by one person must not interfere with the goods being available toothers equally– non-excludable - suppliers cannot deny them to those who are unable to pay its market price.

• In the arena of public goods and costs, climate change is often quoted as an example.
Climate change is usually caused by unsustainable practices of the richest countries but
impacts all regions and in particular the poorest.
• Because of the transboundary implications of public goods, international cooperation andaction is ethically imperative.

VACCINE APARTHEID• Derived from the South African Afrikaans language and means ‘the state of being apart’ or ‘separateness’- illustrates the situation of systematic institutionalized racial discrimination that was present inSouthwest Africa and South Africa until their transition to democracy‘• Separateness from vaccine access and programs for LMICs. From late 2020, while many high-income
countries (HICs) reduced severe outcomes against COVID-19 with vaccination, LMICs globally and inparticular in the poorest countries suffered due to vaccine inequity, vaccine nationalism, vaccine shoppingand hoarding• WHO, concern - spearheaded a coalition, the COVID-19 Vaccine Global Access (COVAX) facility with the
Global Alliance for Vaccines and Immunisation (Gavi), and the Coalition for Epidemic Preparedness
Innovations (CEPI). This was an ambitious effort to create equitable access to effective vaccines globally.
It tried to create a global risk-sharing mechanism for pooled procurement and equitable distribution of thevaccines when registered for use. However, several signatories to the facility, including Canada, the UK
and the European Union, by negotiating bilateral deals directly with industry through advanced market
commitments, undermined COVAX’s goal to counter vaccine nationalism, and hence payed lip-service toits principles of global equitable access and fairness• By mid-January 2021, more than 39 million doses were administered in 49 higher income countries, butalmost no vaccines had been administered in low-income countries.
• DG of WHO - “catastrophic moral failure” in the sharing of COVID-19 vaccines• Already, at that stage, it was shown that twice as many deaths could have been averted, and it could cost
the global economy up to USD 1.2 trillion in GDP if vaccine inequity continued and LMICs were notgranted equitable access to this public good

COVID-19 VACCINES: A GLOBAL PUBLIC
GOOD VS VACCINE APARTHEID• Additional complexity to COVID-19 interventions being a public health good was the “business as usual”
implementation of intellectual property rights (IPR) by vaccine manufacturers.
• Several HICs robustly opposed the application lodged by South Africa and India to the World Trade
Organization (WTO) for a temporary waiver of IPR for COVID-19 vaccines during the pandemic.
• A waiver, together with technology transfer and building of infrastructure would assist in ensuring fair andequitable access to the much-needed public good.
• Given that manufacturers were resistant to sharing, and that they were supported by HICs, the nonexcludable criterion for the vaccine being a public good was impeded. They did not even consider the
many calls made by the UN and WHO for global equitable access to the vaccines. Moreover, they seemed
oblivious to the UNESCO’s Statement on Global Vaccine Equity and Solidarity which, refers to the COVID19 vaccines as a “Global common good” (article3). The Statement firmly rejected vaccine nationalism as
a “predatory rush”, raised ethical concerns on the regulation of patenting and ownership rights andstressed that responses to the pandemic needed to be built on equality, justice and solidarity. For true
equity in the global access to the vaccines, a shared understanding of health as a global common good
without territorial limits, and new global legal instruments for economic and political treaties wererequired. The Statement further highlighted that the Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS) and the agreements of the WTO were not designed to manage situations such as
pandemics (29).

Impediments to access of COVID-19 Vaccines• Poor infrastructure for the development, supply andadministration• Vaccine apartheid• Poor health infrastructure• Negatively politicising the vaccine in some countries• Corruption• Vaccine hesitancy• Poor Uptake

Corruption• Abuse of trust and intentional violation of duty by the ‘use, misuse or abuse’ of
public office or resources for private gain - may be actual or potential,
financial, or even political.
• Impacts negatively on population health outcomes, in particular for the poorand disadvantaged.
• Devastating effects of the COVID-19 pandemic were worsened by widespreadand pervasive corruption in Africa some of which were from funds frommultilateral organisations. Several donor agencies supported African
governments with various financial packages. Together, the International
Monetary Fund and World Bank provided about $57-billion to help Africa.
• Procurement of personal protective equipment, essential goods and services,and vaccines were fast-tracked. Given that most of these items were procured
under a certificate of emergency, public scrutiny was evaded and accountability
measures to monitor the use of these funds were relaxed. Corruption related to
COVID-19, mainly in procurement, was seen across the continent.

CORRUPTION• Cameroon - misuse of $333-million meant for the pandemic response in 2020
• Malawi some government officials colluded with the private sector and squandered $1.3million of COVID-19 funds through procurement and allowance irregularities.
• Kenya - $400-million meant to buy medical equipment was allegedly stolen by the Kenya
Medical Supplies Authority; Kenyan Ethics and Anti-Corruption Commission revealed further
irregular expenditures of about $71.96 million & the Kenyan Auditor-General’s report on
COVID-19 expenditure revealed that over $69-million of COVID-19 funds misused.
• Nigeria - Federal Ministry of Health allegedly bought 1,808 face masks for $96,000.
• Uganda - four top officials arrested for allegedly overpricing COVID-19 food relief items,
leading to a loss of $528,000.
• Zimbabwe - health minister dismissed reportedly for illegally awarding a multimillion-dollar
contract which resulted in inflating the cost of medical equipment.
• Ghana, health minister purchased the Russian Sputnik Vaccine @ $19 instead $10 factory
price• South Africa - health minister placed on leave, then resigned - irregular contracts of about$10-million were being investigated + suspected inflation of government contracts forpurchase of $900-million worth of medical supplies.
•

Public anger, responsive civil society and media

Vaccine Hesitancy• Once vaccines available for use, achieving immunity incommunities largely dependent on their willing uptake. Any
initiative towards allocating vaccines fairly would fail if people
were unwilling to receive them. Vaccine hesitancy, i.e. thereluctance to receive vaccines →one of top ten threats to global
health• Instrumental factors propelling vaccine hesitancy - contextspecific, include:– concerns about safety and efficacy,– lower education,– mistrust in science, health authorities, governments– Misinformation– limited efficacy of COVID-19 vaccines in preventing infection against newcirculating variants.

Vaccine Hesitancy• Africa – additional factors:– bad experiences during previous frequent unethical medical experiments– poor inconsistent messaging – out of touch with reality of context• Improved access to technology → use of social media increased– spread of misinformation across different social networks proliferated
through the anti-vaccination movement.
– Where social media was used to spread healthy messages by healthcare
workers, compliance with public health strategies improved.

• Socio-demographic factors – higher: in males in Nigeria / nothaving a university degree in South Africa / those earning morethan the median income in Ghana.

Vaccine Hesitancy• As we continue our journey through COVID-19 and prepare for the
next pandemic, it would be prudent for us to include programs tocounter resistance to public health measures, including early,
honest, culturally appropriate and focussed messaging by ourgovernments and health authorities. This should not only bethrough mainstream media but also via use of technologies
including social media. Policies to counter spread of
misinformation could be considered. Most importantly though, isthat governments need to work very hard at regaining trust,because vaccine hesitancy is high where there is mistrust of
governments. For the trust deficit to be eradicated, it is requisitethat governments exercise political will to tackle corruption headon.

Ethical issues associated with COVID-19 vaccine
research in Africa• Globally, there are many challenges to conducting research during
a pandemic. Some of these challenges are specific to LMICs.
• A pandemic in itself puts pressure on the need for research, inparticular where treatments options are limited and mortality andmorbidity are high.
• While expedience is necessary, it does not justify unethicalpractice.
• Local contexts need to be understood, voices from thecommunity and other relevant stakeholders heard and included,
dignity respected and rights upheld

Ethical issues associated with COVID-19 vaccine
research in Africa – Ethics Dumping• April 2020 - two French doctors participated in a television debate
where they discussed whether COVID-19 vaccine trials should be donein Africa. They suggested that the trials should be done on thecontinent considering there were no masks, no treatments, noresuscitation, and hence the populations would be highly exposed.
Considering that this would not be acceptable in HICs, these two
doctors proposed a perpetuation of the double standard in research.
Despite these two doctors being forced to publicly apologise, whatbecame patently clear was:

– that ethics dumping from HICS continues in Africa despite international and local
norms, standards and guidelines.
– also underscored is that moral imperialism and colonialist thinking in somemultinational clinical trials persists and– perhaps researchers from HICs see no need for ethical guidelines to apply inregions like Africa where research that will not be allowed in their countries canbe outsourced to the continentEthical issues associated with COVID-19 vaccine
research in Africa - Ethics Dumping• Africa communities remain suspicious of researchers from HICs +reluctant to participate in multinational clinical trials.
• Building trust – essential• Community engagement & consultation critical early on during
the planning of research, in particular pandemic vaccine research.
• Because of pressure for research to be carried out speedily,balancing benefits vs the harms to individuals and communities
will be requisite.
• Respecting autonomy and dignity must be ensured albeit
language and cultural barriers→ research participants will need to
be properly informed and understand the risks and benefits before
being enrolled in the study

Ethical issues associated with COVID-19 vaccine
research in Africa• REC Capacity: review and approve the research in a timely manner.
• African governments and institutions not adequately invested in setting
up RECs– poor infrastructure leading to delays and inefficiencies in the administrative
processes.

• Pandemic - rapid review and approval of novel approaches necessary to
avoid delays.
– RECs on the continent did struggle to respond to the needs of the COVID-19
pandemic.

• REC over-reach and paternalism was also a problem.

– for example, in one of the sites in South Africa, after unblinding in the
Chadox/AstraZenica vaccine study, participants under 30 years were not allowedby the REC from receiving the investigational product, contrary to the regulatory
and other REC approvals

Ethical issues associated with COVID-19 vaccine
research in Africa• Unconscionable vaccine nationalism - essential for principle ofproportionality to be implemented• Vaccine trials conducted globally and included LMICs.
• Both HICs and LMICs contributed to the development of the vaccines.
• Justice as in fairness makes it an ethical requirement that all countries
contributing to the research are given a fair chance to access theseinterventions if proven efficacious.
• Proportionality principle could facilitate the application of fairness bymaking it necessary for countries to be given the opportunity topurchase the vaccines in line with the proportion of research
participants enrolled and their contribution to the studies. This could
mean that Africa would not be last in the queue to purchase vaccines,
as has been the case until now.

CONCLUSION• National pandemic preparedness has been low on the priority list of most Africancountries where failing or failed healthcare infrastructure was further exposed by
COVID-19.
• Equitable access to health care and in particular to interventions developed for
management of pandemics as a global public good need to be considered apriority with regard to international policy making.
• Ethical leadership and governance and the eradication of corruption is necessary,
especially if the populations are to take public health preventative measures
seriously.
• African governments must be trustworthy and must ensure accurate, reliable
messaging for citizens to transition from vaccine hesitancy to vaccine confidence.
• Ethical imperialism and ethics dumping in Africa and other LMICs has to besafeguarded against.
• It is hoped that the initiatives emanating from the African Union and Africa CDC are
successfully implemented and not left as paper to gather dust on the shelves of therespective organisations.