Good Participatory Practice, Clinical Trials Awareness and COVID-19 Vaccine Acceptance in Sub-Sahara Africa

"Clear and consistent communication by the pharmaceutical industry, national and regional medicinal agencies, and government officials is key to building public confidence in vaccine programs."

As of February 2021, several COVID-19 vaccines have gained approval for general population use, yet the majority of low- and middle-income countries (LMICs) have either vaccinated only a small section of their population or are yet to implement vaccination distribution strategies. Furthermore, the majority of the vaccines' manufacturing capacity is located in developed nations. In light of the fact that anti-vaccination activists have campaigned in multiple countries against the need for a vaccine and have spread misinformation, this article addresses the need for governments, public health officials, and advocacy groups to be prepared to address vaccine hesitancy and build vaccine literacy so that Africans will accept immunisation when it is available. The article focuses on the importance of stakeholder engagement - both for clinical trials and vaccine acceptance.

The paper begins with a review of COVID-19 vaccine trials in Africa, arguing for the "critical need for competency to conduct clinical trials in sub-Saharan Africa because the biological, economic, and sociopolitical factors associated with the emergence of diseases, epidemics, and pandemics are over-represented in many countries of the region..." In an effort to provide appropriate vaccines to Africans, in July 2020, the African Union (AU) created a consortium with global vaccine developers, international pharmaceutical companies, policymakers, and organisations that conduct clinical trials in Africa called the Africa Centers for Disease Control and Prevention (CDC) Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT). The reactions shared within the comment section of TrialsiteNews website discussing an interview with by Professor Pontiano Kaleebu on the planned trials in Uganda is a testimony to the necessity for clinical trials awareness and literacy campaigns. For example, people have asked: "Why are the trials on Uganda? Are we one of the countries having high numbers of deaths and infections?....We are tired of being guinea pigs for the Western world science."

As outlined here, the Good Participatory Practice Guidelines for Emerging Pathogens (GPP-EP) can guide stakeholder engagement in the design, financing, and implementation of prevention and treatment trials during health emergencies. The African Vaccine Regulatory Forum (AVAREF) "should champion strategic communications regarding vaccine trials in the continent....Clinical trial performed within target regions and with the participation of local stakeholders, will enable informed decision making when advocating for the adoption of such vaccine candidate or other COVID-19 vaccines."

Specifically, essential GPP-EP stakeholder engagement practices applicable to sub-Saharan Africa include:

• Formative research, relevant for formal collection of information on the sociocultural norms, practices, perceptions, traditions, and local history of research that may influence the recruitment and retention of community members as study participants;
• Stakeholder engagement plan and a communications and issues management plan based on the findings of the formative research;
• Protocol development - i.e., rationale, objectives, design, methodology, statistical considerations, ethical considerations, and implementation of the trial shaped by the findings from formative research with stakeholders;
• Informed consent, which involves is the engagement of third parties who are important in the decision-making processes of individuals - e.g., relatives and community leaders;
• Adherence to standards of disease prevention and care for vaccine research; and
• Negotiation of policies on trial-related physical, psychological, financial, and/or social harms, with attention paid to individuals or groups who may be vulnerable, marginalised, and/or stigmatised.

In conclusion: "Engaging stakeholders in the designing, implementing, monitoring, and disseminating COVID-19 vaccine clinical trials is crucial both for awareness and acceptance of not just the clinical trials, but ultimately, the successful vaccine candidates in sub-Saharan Africa. AVAREF, CONCVACT and other relevant regional clinical trial regulators, should promote and monitor stakeholder engagement following the GPP-EP guidelines. Efforts directed towards COVID-19 vaccine acceptance should be planned strategically before the vaccine is commercialized and distributed."