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Vaccines remain among modern science’s most powerful tools against infectious diseases. Globally, they have prevented deaths and disabilities to the quantum of billions, eradicated once- devastating diseases like Smallpox and brought others, such as Polio, to the brink of elimination. Vaccine Research and Development (R&D) as a field has advanced rapidly over the years, leveraging cutting edge technologies such as applied genomics (RNA and DNA), nano-particle platforms, and powerful adjuvants. These advancements have significantly cut down product development time from decades to practically a few months. The development of vaccines during the COVID-19 pandemic in record time is testament to this progress. Africa bears a substantial burden of vaccine-preventable diseases globally, with more than 30 million children under five suffering from vaccine preventable diseases each year. Of these, over half a million die annually due to limited access to immunization services, accounting for 58% of all global deaths from vaccine-preventable diseases. Recurrent outbreaks also continue to affect many countries across the continent and have been on the rise since the COVID-19 pandemic Despite advancements in vaccine R&D and the continent’s pressing need for vaccines, Africa continues to lag behind in vaccine production. Africa consumes 12% of global vaccines, yet only manufactures less than 1% of global vaccine volumes, all of which are consumed domestically. For comparison, India produces 25% of global vaccine volumes, 60% of its domestically consumed vaccines, and supplies a substantial number of vaccines to Africa, accounting for 20% of its exports. This stark contrast suggests that Africa has been relegated primarily to the role of a consumer, missing critical opportunities to build local industries, drive economic growth, and, crucially, ensure regional vaccine supply security. Vaccine development is a multibillion-dollar industry, and Africa must position itself to actively participate. In this article, we address three critical challenges at the core of this issue: poor R&D capacity, inadequate regulatory systems, and polarised markets. Issues affecting Africa’s pursuit for local vaccine production 1. Poor R&D Capacity Historical and colonial trends where our education systems do not drill down to innovation and invention have persisted in the 21st century. This legacy has limited Africa’s capacity for innovation and invention, perpetuating dependency and leaving us to access to only products handed down to us by the North and West. This affects the prioritization agenda and it means we are unable to address our challenges as we see them. This dependency was glaringly evident during the COVID-19 pandemic. While wealthier nations prioritized their populations, Africa was left to wait. Beyond pandemics, this has meant that diseases unique to the continent, remain neglected and the case in point are diseases such as Lassa fever, dengue, trypanosomiasis, and mpox, to mention a few. Figure 1 Africa region’s percentage consumption of Global Vaccines has dropped from approx. 20% to 12%. This drop has been attributed to the region’s lower consumption of COVID-19 vaccines (WHO, 2023) Figure 2 Comparison of volume of COVID-19 vaccine and all other vaccines used (WHO, 2022) Africa’s capacity to regulate and oversee vaccine R&D and licensure remains very poor. Only a handful of countries have appropriate regulatory capacity to support research, development and licensure of vaccines. Most African nations operate at World Health Organisation (WHO) regulatory capability levels 1-2, far below the level 3 minimum required to support vaccine development. This means that even where technical and infrastructural progress is made, poor regulatory support hampers any advancement. It is evident that industrialization and regulatory capacity. 2. Weak Regulatory Systems Africa’s capacity to regulate and oversee vaccine R&D and licensure remains very poor. Only a handful of countries have appropriate regulatory capacity to support research, development and licensure of vaccines. Most African nations operate at World Health Organisation (WHO) regulatory capability levels 1-2, far below the level 3 minimum required to support vaccine development. This means that even where technical and infrastructural progress is made, poor regulatory support hampers any advancement. It is evident that industrialization and regulatory capacity must develop in tandem for meaningful progress to occur Figure 3 Only six countries in Africa (Egypt, Chana, Senegal, South Africa, United Republic of Tanzania and Zimbabwe) have National Regulatory Authorities operating at Maturity Level 3 (WHO, 2024). 3. Polarized Markets Consequent to the above challenges, procurement of vaccines and other commodities across Africa remains largely tied to colonial legacies, limiting opportunities for local manufacturers. Although the renowned WHO Pre-qualification process is well intended, it inadvertently perpetuates Africa’s dependence and is a hindrance when it comes to development of the industry on the continent. Small and emerging African industries will struggle to compete on an open market dominated by pharmaceutical giants with over a century head-start. Unless deliberate continental efforts are instituted to protect development of local manufacturing industries for example through appropriate positive discriminatory strategies, the gap will only widen. The only way to close this gap is for Africa to take the bold stance, “Africa must begin to buy African”  Rewriting Africa’s Vaccine Narrative I was honored to address these issues at the African Academy of Health Sciences, where I was recently appointed to the Board of Directors. Headquartered in Dakhla, Morocco, the Academy brings together leading African experts to foster collaboration in health research and innovation. I was inspired by the Academy’s collective spirit and remain deeply grateful to His Majesty King Mohammed VI of Morocco for supporting this initiative. In the same spirit of Pan-Africanism, we must work together to rewrite Africa’s vaccine narrative. Achieving this requires deliberate action and bold strategies, including: 1. Enhanced Collaboration and information sharing: We must identify and address the root causes of our inability to produce vaccines and work together to address these issues through better networking and information sharing. 2. Support for Continental Initiatives: Initiatives such as the African Vaccine Regulatory Forum (AVEREF) and the Pan-African Vaccine Manufacturing Network must be recognised locally and supported within countries to complement the rhetoric at continental political level. 3. Investment in Infrastructure and Basic Science Research: There is need for investment in infrastructure, equipment and basic

On August 14, 2024, the World Health Organization (WHO) declared Mpox a Public Health Emergency of International Concern (PHEIC) in accordance with the International Health Regulations (IHR) (article 12) due to its rapid spread in Africa. This followed the Africa Centre for Disease Control and Prevention (ACDC) declaring it a Public Health Emergency of Continental Security on August 13, 2024. The rapid spread of a new virus strain, clade 1b, along with cross-border transmission to previously unaffected countries, necessitated the declaration of the ongoing Mpox outbreak as a PHEIC. A PHEIC is a formal declaration by WHO of an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response.This declaration has significant implications, especially for affected and at-risk countries. It will help mobilise specific response resources, including unlocking access to essential funding, and strategic vaccine stockpiles. Additionally, it will prompt international coordination of risk communication and community engagement (RCCE), surveillance, and epidemic response against Mpox. Previous Mpox OutbreaksMpox, an Orthopoxvirus (similar to viruses that cause small pox), was first detected in humans in 1970 in the Democratic Republic of Congo. It is considered endemic to Central and West Africa. However, in recent years, Mpox cases have steadily increased, spreading to countries. The current PHEIC declaration is the second related to Mpox in two years; it was first declared a PHEIC by WHO from July 2022 to May 2023. During that time, 7,146 suspected cases were reported in 2022, and 14,957 cases in 2023. Zambia Remains on High AlertAs of the current declaration, Mpox has affected at least 12 countries, with over 17,000 suspected cases reported in 2024. Of these, 2,863 have been laboratory confirmed and 517 have resulted in deaths. The vast majority of cases, and about 87% of the deaths have occurred in the Democratic Republic of Congo. Fortunately, Zambia has not reported any confirmed cases of Mpox. Despite this, your disease intelligence agency, Zambia National Public Health Institute (ZNPHI), remains vigilant and on high alert. ZNPHI has activated a robust surveillance system that is actively monitoring potential Mpox cases in communities and healthcare facilities. The system is swiftly identifying and responding to any suspected cases. Additionally, a National Contingency Plan for Mpox has been developed, with orientation of staff and enhanced screening at all points of entry, especially at international borders identified as priorities. The country also has diagnostic capacity at the Zambia National Public Health Reference Laboratory. While we await the WHO’s temporary recommendations, safeguarding Zambia from a potential Mpox outbreak requires collective action. We must maintain ‘high alert’ at all levels of our health system and ensure timely and accurate dissemination of information to inform public health actions. Our geographical proximity to DRC with a very long 2,388 kilometer border stretch through which people freely cross, makes us particularly at high risk For further information or assistance, please visit the Ministry of Health or ZNPHI websites and follow their social media platforms. You can also contact ZNPHI via their information lines at 0974 493553, 0953 898941, or 0964 638726. Alternatively, you can call the toll-free line 909 on MTN and Zamtel networks Further reading

The public and stakeholders about whom the New Public Health Order is framed need to know: Coined by the Africa Centre for Disease Control and prevention (Africa CDC), the new public health order is often quoted by countries, Ministries of Health, Institutions and indeed individual technocrats. But what is the new public health order, and what implications does it have on our approach to health security? The Africa Union(AU) Assembly of Heads of State and Government at its 35th Ordinary Session in February 2022 granted Africa CDC operational autonomy. InJuly 2022, AU Assembly, delegating its authority to the AU Executive Council, adopted the revised statute of the Africa CDC. These decisions mean that Africa CDC is now able to handle all its operations and therefore move faster to support any health emergencies; will handle all its administrative, financial, procurement and human resource needs; has authority to declare Public Health Emergency of Continental Security (PHECS); and now has a Committee of Heads of State and Government as the highest decision- making body in its governance. Africa CDC’s vision of a New Public Health Order for Africa constitutes a paradigm shift in Africa’s approach to health security and public health. Briefly, it is hinged on five pillars namely: (1) Strengthened public health institutions at country and continental levels; (2) Strengthened Public Health Workforce; (3) Expanded local manufacturing for health products; (4) Increased domestic resources including financing; and (5) Action-oriented and respectful partnerships based on Africa’s priorities The Africa CDC works with Ministries of health in all member states, and where already established through National Public Health Institutes (NPHI), as is the case for Zambia. According to the Africa CDC the African continent has 23 countries with well-established and functioning NPHI, 19 in the process and 13 not yet decided.  Whether a NPHI is established or not in a given country is not the issue; the question is, how resilient is the emergency preparedness and response mechanism? This issue, in most if not all African countries, requires some form of dedicated team of staff working on these because regular Ministry of Health staff are often overstretched with mundane aspects of providing healthcare services to the public. It does require consistent adjustments to streamline surveillance mechanisms, data systems and continuous revies to have a sense of ongoing disease intelligence functions. The public health workforce is another key pillar often misunderstood. Our medical education system was historically designed to make diagnosis and provide appropriate treatment; and indeed, the infrastructure and health sector establishment accordingly aligned. But present-day emergency threats require a rather different approach. This is why the new public health order appropriately urges countries to invest in training and retraining disease detective’s cadre whose orientation is forward looking to anticipate, rather than respond. This requires dedicated training, equipment and appropriate policy framework to support such operations. In future statements, we shall address and justify local manufacturing, domestic resourcing and respectful partnerships. For now, we emphasize that the new public health order is not an optional choice, it is an imperative. We thank the government of Zambia and the Ministry of Health for the steps so far taken in the right direction. Indeed, His Excellency President Hichilema made the point on 16th July 2022 through the Lusaka Declaration when he called on all African leaders to ensure that they have established and functional Public Health Emergency Operations Centers (PHEOCS). Prof. Roma Chilengi Director General/Health Advisor to the Republican President

As your institute mandated to spearhead public health security, we wish to remind the Zambian public that it is time to enhance the fight against cholera towards its elimination. The fight against cholera requires a multifaceted approach that encompasses prevention, detection, treatment, and control measures. Key to this journey is everyone taking up their responsibility, hence the emphasis on multisectoral approaches. The fight requires all to throw targeted and strong punches. Indeed, the fight against cholera is an ongoing battle that requires sustained efforts from governments, private sector organizations, researchers, academics, communities, and individuals worldwide. Cholera is an ancient disease associated with lack of access to safe drinking water. Failure to provide safe water is nearly always associated with poor sanitation. These factors are really two sides of the same coin and characteristic of “under development”. Unfortunately, our current context in Zambia presents these faces everywhere one looks, especially the urban areas – without exception. Urbanization in our country, and indeed the wider developing world carries with it large populations typically living in high-density unplanned or inadequately planned areas where social services are grossly lacking. The result is always the same: poor housing which is unfit for habitation, lack of safe water supply, poorly managed waste, high population density and often the label “cholera hot spot”. The most affected communities on the other hand, somehow seem unable to understand that their living conditions predispose them to many public health dangers, among which cholera is just one. Despite community engagement activities where health education is applied, the adoption of the social and environmental public health measures remains a huge gap. The wanton behaviour generally oblivious to the reality that basic hygiene is the beginning of all personal, and indeed public health. Common beliefs which result in people dying at home are reminiscent of ancient history. In the 1840s, one of the prominent health theories of the time – the Miasma Theory – suggested that bad smells and bad air, especially at night, led to people contracting diseases like cholera and the Black Death. It is really disturbing that in 2024, affected people of Zambia would attribute cholera in their homes as being due to “Chimpepo” (“bad air”). The reactive approach of bombardment of public places and water sources with intense chlorination, temporary supply of “imported” water by bowsers, forced burying of shallow wells, and in some cases a cholera vaccine is not a sustainable strategy for public health. The Zambia National Public Health Institute (ZNPHI) – your disease intelligence wing – is deeply concerned by the current drop in guard and return to business and politics as usual. The Call by His Excellency the President of the Republic of Zambia Mr Hakainde Hichilema, who is also the Global and SADC Champion for cholera elimination, to transition into medium- and long-term actions requires all Zambians to rally behind, get to work and sustain the cholera fight. The ZNPHI calls on all stakeholders and reminds that a more deliberate effort in significantly moving the agenda on cholera control and elimination must be done at this time acknowledging the support rendered so far. As a country, and individually, we need to make up our minds and work towards preventing cholera NOW! If we do not, we must as well be preparing to again open Heroes Stadium, not for football matches, but for cholera case management! The control and eventual elimination of cholera requires a coordinated approach focused on prevention through water, sanitation, and hygiene (wash) interventions; vaccination campaigns; continuous surveillance and early detection; treatment and case management; health education and community engagement towards social behavioural change; strengthened coordination and collaboration. Addressing the underlying social determinants and vulnerability factors; and supporting research initiatives for the development of new tools, technologies, and strategies for cholera prevention, diagnosis, and treatment. A clarion call is here made publicly that unless serious attention is given to these matters, we risk shutting down the country and economy because there will again be so much cholera – it’s only a matter of time. Sincerely, Prof. Roma Chilengi Director General/Health Advisor to the Republican President