Supporting the Manufacturing of Medical Supplies in Africa: Collaboration Between Africa CDC, Partners, and Member States

Inadequate supply of PPE, vaccines, and diagnostics during the COVID-19 pandemic in Africa created an opportunity to promote local manufacturing. Authors describe Africa CDC's contributions and highlight strategies for strengthening the pandemic response.


INTRODUCTION
4][5] These goals are central to the mission of the New Public Health Order, a roadmap that strives to strengthen the resilience of health systems across the region. 6In this commentary, we describe the collaborations between Africa CDC, member states, and partners in boosting the production of PPE, vaccines, and diagnostics in Africa and highlight activities to be prioritized.
The detrimental impact of the ongoing COVID-19 pandemic across Africa's health, social, and economic sectors necessitated a special event-"Africa's New Public Health Order: Rejuvenating the Global Health Security Agenda"held on the sidelines of the 77th Session of the United Nations General Assembly. 6One of the New Public Health Order's 5 pillars is the expansion of local manufacturing of health products.All vaccine purchasing mechanisms, such as Gavi, the Vaccine Alliance and other stakeholders, are requested to purchase at least 30% of their vaccines from manufacturers in Africa. 7In addition, governments, multilateral organizations, and civil society organizations have been requested to remove barriers related to trade and intellectual property to support local production of health products within the region.e Yale School of Medicine, Yale University, New Haven, CT, USA.f African Field Epidemiology Network, Kampala, Uganda.g UK Health Security Agency, London School of Hygiene and Tropical Medicine, London, United Kingdom.Correspondence to Olayinka Ilesanmi (ileolasteve@yahoo.co.uk).

Cooperation
The Africa Task Force for Novel Coronavirus was established by the Africa CDC on February 4, 2020, shortly before the first case of COVID-19 was discovered in Africa, to organize the pandemic response throughout the continent. 8All 55 of the continent's ministers of health attended an emergency conference called by Africa CDC to examine the COVID-19 pandemic and agree on a continental plan. 8To avoid overloading the already overworked health care institutions across the continent, this strategy centered on limiting transmission and minimizing community spread. 9uch continental leadership has ensured a coordinated response to the pandemic and given direction to member states.

Collaboration
This continental strategy was combined with regional cooperation, of which collaboration within the East African Community is a good example.African nations' top priority was to halt the spread of the virus; thus, the East African Community invested in the development of a regional electronic cargo and driver tracking system to monitor COVID-19 cases as they crossed international borders.The use of truck traffic across borders to transport necessities like medication enabled Rwanda to digitally communicate the COVID-19 test results of the truck drivers. 8,9ithout other preventive measures, the adoption of border closure in African countries had little impact on the occurrence of COVID-19. 10hile many Western nations delayed closing borders, the majority of African nations handled border closure seriously to protect their citizens. 9To complement the preventative plan, lockdowns and border closures were put into place as soon as the first few cases were reported on March 15, and flights were prohibited. 9Most African countries also promptly adopted other prevention interventions, such as the use of face masks, handwashing, and social distancing. 10

Coordination
The African Union Commission and the Africa CDC launched the Partnership to Accelerate COVID-19 Testing (PACT) strategy to facilitate implementation of the Africa Joint Continental Strategy for COVID-19 that was endorsed by African ministers of health and approved by the Bureau of the Assembly of the African Union Heads of State and Government in March 2020. 8ACT focused on the establishment of warehousing and distribution hubs across Africa, in partnership with organizations including the World Food Programme and Ethiopian Airlines.The warehousing model has been used to successfully distribute medical supplies and donations from the Jack Ma Foundation Initiative.Efforts are ongoing on the rehabilitation of the warehouse at Yaoundé, Cameroon.
The PACT strategy focused on coordinating pooled procurement of diagnostics and other commodities for distribution across the continent and mobilizing support for deploying 1 million community health care workers for contact tracing. 8s part of the goal for economic recovery and reopening, the strategy placed a high priority on data analysis and prompt dissemination of results on technological platforms to increase public confidence in testing data, epidemiological models, and essential health forecasting methods.

Communication
Many African countries used social media channels and other traditional media sources, such as radio, to improve community sensitization about COVID-19 and its preventive measures.This open communication channel and adequate community involvement boosted the community's trust in the public health system and contributed to the public's adherence to prevention and response guidelines. 8he Rwandan government used robots to measure individuals' temperature in public settings and health facilities.Likewise, they used drones for mass communication, surveillance, and medicine delivery.

Jack Ma Foundation
During the early stages of the COVID-19 pandemic, Africa CDC, in collaboration with the Jack Ma Foundation, organized online seminars and training sessions for public health officials. 11,12our webinar series were conducted (in English and French), each of which comprised 6 weekly sessions. 11These online sessions took place during April-December 2020 and catered to participants from various AU countries.The English webinars trained participants from 48 AU countries, while the French webinars trained participants from 37 AU countries.
To ensure wider accessibility, all webinars were recorded and made available on the Zoom The PACT strategy focused on coordinating pooled procurement of diagnostics and other commodities for distribution across the continent and mobilizing support for deploying 1 million community health care workers for contact tracing.cloud and YouTube.By December 31, 2020, the recordings had amassed a total of 3,616 views. 11dditionally, the webinars were streamed live on social media platforms, such as Facebook, which attracted a total of 5,630 viewers.Among them, 2,539 watched the English webinars, while 3,091 tuned in for the French webinars. 11Health workers who watched the webinars were encouraged to conduct additional trainings for their colleagues at their primary workplaces.

Susan Thompson Buffett Foundation
With the aid of a grant from the Susan Thompson Buffett Foundation that is on sexual and reproductive health services, Africa CDC prioritized the needs of vulnerable groups as core elements of essential health services. 13To enhance health outcomes during the COVID-19 pandemic, it was imperative to focus on increasing accessibility to maternal and child health services.One of the achievements of the partnership with the foundation was the purchase and distribution of medical supplies to health care facilities providing maternal and child care and sexual reproductive health services in 10 of the member states. 13

Jack Ma and Ali Baba Foundations
During the COVID-19 pandemic, the Jack Ma and Ali Baba Foundations provided consignment of medical equipment in 3 phases. 14These included nearly 2 million test kits, swabs, ventilators, and infection control materials. 14

Mastercard Foundation
The Mastercard Foundation and the Africa CDC have partnered on the 3-year, US$1.5 billion Saving Lives and Livelihoods initiative. 15This initiative aims to speed up Africa's economic recovery after the COVID-19 pandemic by saving the lives and livelihoods of millions of people.More than 65 million people are receiving immunizations because of the Saving Lives and Livelihoods initiative. 15The partnership between Mastercard Foundation and Africa CDC extends beyond the acute phase of the pandemic, with goals to integrate COVID-19 vaccination into the health care system and strengthen primary health care in Africa.

Vaccine Production
The goal of the vaccine manufacturing plan for Africa is to ensure prompt access to vaccines for safeguarding public health by creating a support system for vaccine development and manufacturing within Africa.A key target is to locally produce 60% of Africa's regular immunization requirements by 2040, in line with the New Public Health Order. 6,16Many actors have been involved in the realization of this goal.

Saving Lives and Livelihood Initiative
In addition to its work during the acute phase of the pandemic, the partnership has also paved the way for vaccine production in Africa and strengthened the manufacturing of human vaccines. 15

African Development Bank
Through a flagship program, the African Development Bank supports local vaccine manufacturing in line with its 2030 Vision for the Development of Africa's Pharmaceutical Industry and the 2040 AU/ Africa CDC vision for increased local vaccine manufacturing. 17The Bank's interventions are part of a strategic pillar to increase the maturity of the industry through the development of local production capacities and 4 enablers, including (1) enabling regional logistic integration, (2) supporting the implementation of quality industry standards, (3) seeding the creation of research and development capacities, and (4) paving the way for increased vaccine manufacturing. 17

Afreximbank
Afreximbank replicated its successful collaboration with the AU and Africa CDC during the COVID-19 pandemic to support the vaccine manufacturing platform at various stages of the vaccine manufacturing value chain. 17This has been achieved through early-stage project preparatory support, financial advisory services, project finance, and risk-bearing instruments.

African Medical Supplies Platform
The Africa CDC, the Economic Commission for Africa, Afreximbank, and AU Special Envoy Strive Masiyiwa collaborated to create the African Medical Supplies Platform (AMSP). 18AMSP was intended to last beyond the pandemic, though it was established in the context of the opportunities and challenges of COVID-19.The purpose of the platform was to address supply chain issues such as shortages, delays in distributing supplies, accessibility, and affordability. 18The sector of the African economy that manufactures medical supplies is growing partly due to AMSP. 19e goal of the vaccine manufacturing plan for Africa is to ensure prompt access to vaccines for safeguarding public health by creating a support system for vaccine development and manufacturing within Africa.

Africa Medical Devices Forum and the Africa Medical Regulatory Harmonization Consortium
The Africa Medical Devices Forum and the Africa Medical Regulatory Harmonization consortium are major continent-level regulatory agencies that are being enhanced to address regulations and standards for the manufacturing of PPE. 20he vision of the consortium was to strengthen institutional regulatory capacity, provide programs with a single set of guidelines for transparency with regulatory processes and clear timelines, and enable resource pooling, including twinning programs, with the aim of expediting approval of medical products. 20The consortium has engaged 55 national medicines regulatory agencies across the continent but found variability in national approaches to medicines and devices regulation. 21ence, while efforts are geared toward strengthening individual country regulatory capacity, the long-term goal is to establish a continent-wide regulatory agency, the Africa Medicines Agency.The creation of the Africa Medicines Agency will promote the implementation of a harmonized regulatory framework for regulation of medical devices and in vitro diagnostics, as well as support training and capacity development in the Africa region. 21The South Africa Bureau of Standards assures the quality of critical products, including their safety and reliability. 22Cross-country peerto-peer exchange learning systems have also been established, where countries with limited capacity are supported to understudy countries equipped with capacity in accreditation and regulations, which facilitates knowledge transfer and adoption of best practices. 22The structure and process used by United Nations agencies for medical device standardization, including post-market surveillance, have also been initiated. 22Based on the existing diverse country-level experience and varying degrees of PPE standards, an essential framework for the standard testing of PPE has been defined. 22

UNICEF
As a stopgap measure, African countries have collaborated with UNICEF for quality assurance to promote safe and efficient production of PPE, which has helped the continent conform to ISO standards for quality management systems in the provision of medical devices. 23Additionally, predelivery inspection and certification have been scaled up to foster quality assurance. 23Predelivery inspection is carried out at the supplier's premises and is a requirement before shipping goods.Certification is a conformity assessment process whereby an independent neutral body confirms that a product or service complies with relevant specifications or standards. 23,24AMEWORKS GUIDING AFRICA CDC MEDICAL SUPPLIES Framework for the Standard Testing of PPE The Standard Testing of PPE Framework outlines the guidelines and protocols developed by Africa CDC for the rigorous evaluation and assessment of PPE. 5,10This framework provides a standardized approach for testing the effectiveness, quality, and safety of various types of PPE, such as masks, gloves, gowns, and face shields.It aims to ensure that PPE used in Africa meets the necessary standards and offers optimal protection for health care workers and the general public during infectious disease outbreaks or other public health emergencies.The framework is being implemented through the establishment of testing facilities, training programs for laboratory personnel, and the dissemination of testing protocols.By establishing consistent testing procedures, the framework enhances the reliability and confidence in the performance of PPE and supports the procurement and distribution of high-quality equipment across African countries. 5

Framework for Regulation of Medical Devices and In Vitro Diagnostics
This framework provides a set of regulatory standards and requirements for the approval, registration, quality control, and post-market surveillance of medical devices and diagnostics.It aims to ensure that these products meet the necessary safety, efficacy, and quality standards and are appropriate for use in health care settings across Africa. 25The regulatory framework also establishes mechanisms for monitoring and assessing the performance and safety of medical devices and in vitro diagnostics, promoting transparency, and facilitating the harmonization of regulatory practices among African countries.By implementing this framework, Africa CDC aims to enhance the availability, accessibility, and reliability of medical devices, in vitro diagnostics, and vaccines to contribute to improved health care outcomes and public health in the region. 25

Framework for Action on Vaccine Manufacturing
The Framework for Action (FFA) answers the call made by the African Union Commission and the Africa CDC at a summit in April 2021 to develop a framework that will enable Africa to manufacture 60% of its vaccine needs locally by 2040.The fundamental idea behind the FFA is that Africa has the ability and should strive to establish a comprehensive interconnected system that stimulates investment in every stage of vaccine production, including research and development, drug substance manufacturing, and the final packaging process. 26The FFA advocates for expanding research and development efforts to encompass preclinical and clinical trials, with a specific focus on diseases that have significant consequences on the African continent.Additionally, the FFA suggests an increased emphasis on investment in the manufacturing of drug substances essential for vaccines that are crucial for Africa. 26

FUTURE AREAS FOR CAPACITY-BUILDING Upgrade Current Vaccine Capacity
At the moment, the vaccine supply for the African continent depends on the world market. 26urrently, vaccine manufacturers are based in only 5 African nations-South Africa, Morocco, Tunisia, Egypt, and Senegal.Research and development activities on the continent have been limited, with a narrow disease focus at the moment, hence justifying the need to upgrade.However, activity is increasing due to recent outbreaks like Ebola. 26frican nations will need to invest in manufacturing capabilities to build a domestic vaccine manufacturing business.Such investments are not immediately appealing.The majority of equipment will need to be imported into Africa (especially equipment that is compliant with current good manufacturing practices), which will increase setup costs and subsequent revenue generation.

Prioritize Diseases for Vaccine Production
The FFA designates the manufacture of vaccines for 22 diseases as a critical top priority using the integrated ecosystem strategy (Table ). 26These include vaccines for 10 endemic or pandemic diseases for which vaccines are required, such as HIV, malaria, and COVID-19, which are typically high volume and can provide economies of scale; 6 expanding diseases, which are typically not yet commoditized vaccines or have relatively higherpriced vaccines; and 6 outbreak diseases, such as Ebola and Disease X (caused by a hypothetical, unknown pathogen and likely to result in an epidemic). 26By concentrating on these diseases, vaccinations that would be practical and desirable to produce might meet the urgent medical requirements of the continent.
To meet the 2040 manufacturing target of 60% local production, it will also be essential to develop vaccines for 5 of the prioritized diseases for which no approved vaccine currently exists-HIV, chikungunya, Rift Valley fever, Lassa fever, and Disease X (upon emergence). 26The FFA also gives priority to 7 vaccine manufacturing methods to allow producers of these vaccines enough flexibility.These include both established technologies, like the production of live attenuated viruses, which will be essential in producing the high-demand vaccines, and cutting-edge ones, like mRNA, which are likely to expand in scope as the research and funding backing them develop.By supporting vaccine development for these priority diseases, pandemic preparedness is heightened, and the risk of zoonotic transmission of communicable diseases (e.g., Lassa fever) across international borders becomes significantly reduced. 26Furthermore, antimicrobial resistance becomes achievable through the development of therapeutics for these priority diseases.

Gavi Graduation
South Africa, Morocco, Tunisia, Egypt, and Senegal are currently involved in local vaccine production that meets approximately 1% of the total continental vaccine demand and should rank topmost in capacity-building for increased production. 26New or potential African manufacturers often find it challenging to access Gavi markets because of very competitive pricing that can only be achieved with significant economies of scale over time.By investing in existing manufacturers, challenges in market access can be overcome.Local manufacturers in these 5 countries are able to sell to Gavi-supported countries that can achieve volume certainty at scale.

National Regulatory Agencies
Presently, 92% of the African national regulatory agencies that have conducted the World Health Organization benchmarking using the global benchmarking tool are still at maturity level (ML)1, and only 2% have attained ML2. 26 Most importantly, while Ghana and Tanzania are the only countries to have reached ML3, neither of them produces vaccines. 26Because Ghana and Tanzania have reached African nations will need to invest in manufacturing capabilities to build a domestic vaccine manufacturing business.
ML3, they should also be prioritized for capacitybuilding in vaccine production using the national regulatory agencies criterion.Both countries will require support with the national regulatory system, registration and marketing authorization, licensing of premises, market surveillance and control, vigilance, regulatory inspections, clinical trials oversight, laboratory access and testing, and lot release.

Demographics
In terms of demographics, Ethiopia (Eastern Africa), Nigeria (Western Africa), South Africa (Southern Africa), Egypt (Northern Africa), and the Democratic Republic of the Congo (Central Africa) should be prioritized.These 5 countries have the largest populations in Africa and should be adopted for capacity-building.

Prioritize Point-of-Care Diagnostics
Point-of-care (POC) testing should be prioritized for both human and veterinary health sectors.POC testing refers to medical or diagnostic testing conducted near the patient or animal, allowing for rapid results and immediate decision-making. 27,28his approach offers several advantages, including quicker diagnosis, faster treatment initiation, and reduced reliance on centralized laboratory facilities.In the human health care sector, POC testing should be prioritized for various applications, including: Infectious disease testing.POC tests for infectious diseases, such as HIV, malaria, tuberculosis, or respiratory infections, can facilitate early diagnosis and prompt initiation of appropriate treatment.This is particularly important

Manage the Strategic Reserve: Current and Future Strategies
To serve as a strategic reserve, the African Union Commission has designated 2 storage spaces with a combined area of 2,600 square meters at the AU Continental Logistics Base in Douala, Cameroon. 29he Africa CDC has implemented this strategic reserve with the aim of strengthening Africa's ability to prepare for and respond to health crises and outbreaks. 11The Africa CDC encourages member states to maintain strategic reserves to ensure the availability of essential medical resources, such as vaccines, therapeutics, and PPE, during outbreaks or public health emergencies. 11This facilitates a rapid response and prevents delays in obtaining crucial supplies.By establishing a strategic reserve, Africa reduces its reliance on external sources for medical provisions.This promotes self-sufficiency and reduces vulnerability to disruptions in the global supply chain, ensuring that African countries have access to essential health care resources when needed.
The Africa CDC has played a role in facilitating the creation of strategic reserves by formulating guidelines to assist countries in establishing and overseeing such reserves.Moreover, capacitybuilding initiatives have been implemented to train national authorities and health care practitioners responsible for managing strategic reserves.These training programs encompass various areas, including inventory management, cold chain logistics, quality control, and distribution strategies, to ensure the efficient use of reserves.Furthermore, the Africa CDC has taken the lead in establishing regional stockpiles strategically positioned throughout the continent.These stockpiles function as regional centers for storing and distributing essential medical resources, thereby strengthening regional readiness and response capabilities.

Recommendations
The Africa CDC should collaborate with international entities responsible for managing global stockpiles, such as the World Health Organization's Contingency Fund for Emergencies and the Global Health Security Agenda.These global stockpiles can offer additional resources during public health emergencies.Similarly, regional organizations like the AU's AMSP should maintain their own regional stockpiles.The Africa CDC should work in coordination with these organizations to access and distribute supplies from these reserves whenever necessary.
The Africa CDC should conduct assessments and analyses to determine the optimal quantities of commodities required for the strategic reserve.These evaluations should consider various factors, including disease prevalence, population size, historical outbreak data, and resource availability.Regular reviews and updates should be carried out to ensure that the stockpile remains appropriate and relevant to the current situation.The Africa CDC should establish secure and suitable storage facilities to accommodate the strategic reserve, ensuring that different commodities are stored under the necessary conditions to maintain their quality and usability when needed.Distribution plans should also be devised, considering logistics, transportation, and the prioritization of resources to areas facing the most critical needs during emergencies.
A strategic reserve promotes selfsufficiency and reduces vulnerability to disruptions in the global supply chain, ensuring that African countries have access to essential health care resources when needed.
To effectively manage the strategic reserve, Africa CDC should implement monitoring systems to track stock levels, expiration dates, and usage rates.Based on this information, regular replenishment can be carried out to ensure that the strategic reserve remains adequately stocked.

CONCLUSION
With the right resources, support, and enabling environment, local manufacturers could successfully rise to the challenge of meeting Africa's PPE, vaccine, and diagnostic needs.Public-private partnerships will be critical to achieve this, which should include efforts by multilateral and regional institutions to patronize the production and supply from local manufacturers in line with international standards.Member states and their ministries of health must foster stronger collaborations with national regulatory agencies to share best practices and resources; harmonize standards; provide opportunities for post-marketing surveillance and flagging of substandard PPE, vaccines, and diagnostic equipment; and identify ways to enforce their standards to ensure safe, high-quality, and effective products are produced, procured, and used while adhering to international standard practices.
Four concepts-cooperation, collaboration, coordination, and communication-are underlined in the Africa CDC's strategy and the New Public Health Order.

a
Africa Centres for Disease Control and Prevention, Addis Ababa, Ethiopia.b Health Maxima, LLC, Gaithersburg, MD, USA.c Nigeria Centres for Disease Control and Prevention, Abuja, Nigeria.d African Union Development Agency-NEPAD, Midrand, South Africa.

TABLE .
Twenty-Two Diseases Prioritized for the Africa CDC Framework for Action Disease X refers to a hypothetical, unknown pathogen that could emerge and result in an epidemic.Disease surveillance and outbreak management.Rapid and on-site testing of animals, such as livestock or pets, can help in the early detection and control of infectious diseases, ensuring timely interventions to prevent further spread and minimize economic losses.
bIn this context, outbreak influenza.c