Scientists developed vaccines against a new disease in less than 12 months. And yet, 18 months after the first of these vaccines, against COVID-19, were rolled out, just 15% of people in low-income countries have been fully vaccinated. Such inequity costs lives and unmasks a long-standing problem: that some regions of the world have been compelled to rely on others for life-saving science and technology. It is unacceptable, for example, that in Africa, a continent of 54 independent countries and 1.2 billion people, 99% of vaccines are imported.

The World Health Organization (WHO) is searching for a way to get vaccines to more people more efficiently. Last year, the WHO launched a radical initiative called the mRNA vaccine technology transfer hub. The aim of the initiative is to set up a system that develops and produces mRNA vaccines and treatments (for COVID-19 and other diseases) from the technology used in Pfizer and Moderna’s highly successful COVID-19 vaccines.

Crucially, the ambition is to achieve this through collaborations between universities and companies based in low- and middle-income countries. In a significant move, on 8 July, the US National Institutes of Health, where much of the foundational research on mRNA vaccines was conducted, joined this mission to build capacity in lower-income countries.

However, as Nature reports in a Feature, the hub must overcome challenges presented by the global vaccine market, world trade rules and an intellectual-property (IP) system that often benefits established corporations, universities and governments in high-income countries.

One hurdle will be convincing governments and organizations to buy locally made vaccines: such products might initially cost more than those made by established companies that produce at larger scales and can afford to drop prices. But for this initiative to be viable over time, local manufacturers of mRNA vaccines and therapeutics need to be assured that there will be demand for their products. For this to happen, up-front contracts will be needed from buyers.

A key buyer is Gavi, the Vaccine Alliance, a public–private global health partnership that procures vaccines for dozens of lower-income countries, funded largely by high-income countries and the Bill & Melinda Gates Foundation, a non-profit organization based in Seattle, Washington. Gavi has said that it is committed to supporting vaccine manufacturing in Africa; however, it has not specified how much extra money it would spend on regionally made vaccines, and it has not yet promised to buy vaccines from the companies working with the mRNA technology transfer hub.

In May, the leaders of a number of African Union (AU) member states called on Gavi to commit to buying at least 30% of all COVID-19 vaccines produced in Africa as new manufacturers come online. Such a commitment will be essential to reaching the AU’s ambition for 60% of Africa’s vaccines to be produced on the continent by 2040.

Adjusting the scales

Barriers created by IP rights represent yet another hurdle in the hub’s path. Earlier this year, the company at the core of the hub, Afrigen Biologics and Vaccines in Cape Town, South Africa, successfully reproduced small quantities of Moderna’s mRNA vaccine. But Moderna has not agreed to license its IP or share data that could help Afrigen to ensure that its vaccine candidate meets similar safety and efficacy metrics.

Sadly, last month, the World Trade Organization (WTO) ended some 20 months of negotiations on a waiver proposed by South Africa and India covering IP on COVID-19 vaccines, drugs and diagnostic tests, which would have allowed faster knowledge sharing. The campaign, which Nature supported, faced strong opposition from the European Union and the pharmaceutical industry.

The WTO members instead agreed on a deal to amend existing rules on IP sharing in emergencies; however, these will be cumbersome to implement and do not amount to a waiver. Many researchers who have devoted their careers to studying mRNA want to see it save more lives, rather than widen inequality, and question whether the current IP regime is, in fact, stifling the kind of innovation that could see the mRNA hub succeed.

The hub is a refreshing, ambitious alternative to the existing model for vaccine research and development (R&D). With collaboration and knowledge sharing at its core, it aims to create and boost home-grown R&D and innovation in low- and middle-income countries. But it is clearly a threat to a system in which companies are able to claim IP rights on lifesaving products that are often created using findings from publicly funded research.

As economists Mariana Mazzucato and Jayati Ghosh, with innovation-policy researcher Els Torreele, have argued, there is something wrong with a system in which people’s taxes pay for science, yet, in the middle of a pandemic, relatively few companies and governments are permitted to control who has access to lifesaving products derived from research, and on what terms (see go.nature.com/3ixz3dd).

The WHO and its partners are right to seek to adjust the scales. In addition to the justice imperative, outbreaks would end sooner if every region of the world could rely on its own defences, stifling the spread of emerging pathogens and viral variants. As Larry Brilliant, an epidemiologist who helped to eradicate smallpox, told Nature: “Equity is often thought of as a burden, but it is a strategic need in the battle against pandemics.”

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With high prior rate of infection and apathy, demand is dwindling for jabs on the continent 

The signing of a licensing deal late last year for South Africa’s Aspen Pharmacare to bottle and sell the Johnson and Johnson Covid-19 vaccine across Africa was hailed as a lifeline for a continent that lost out in the rush for jabs early in the pandemic. But six months later, the factory is on the brink of closure because of lack of demand. Asked if she will get a booster shot after receiving two Pfizer jabs last year, 70-year-old Agnes Mohale could not see the point. “I don’t know what it’s for,” said the pensioner who lives in Johannesburg’s biggest township, Soweto. “I won’t go for a third one. I’m not worried.”  Mohale’s reluctance to seek extra protection reflects faltering demand in South Africa, where only 5 per cent of people have received a booster shot and just under a third of the 60mn population are double vaccinated. It is part of a broader trend across Africa that helps to explain why the future of the continent’s biggest vaccine manufacturing plant is in doubt.

The death toll from Covid-19 has been lower across Africa than other continents. Africa has accounted for just 8.3 per cent of the world’s 14.9mn excess deaths during the pandemic, according to a World Health Organization analysis, despite having 16.7 per cent of the global population. Some experts say the low death rate could be due to Africa being the youngest continent, with a median age of 19.7 against 42.5 in Europe. The resulting reluctance to get jabs — and poor health infrastructure — means Africa could continue to be blighted by the disease long after Covid has become endemic elsewhere and give rise to more potent new variants, experts say. Meanwhile, the possible loss of local vaccine production could leave the continent ill prepared for future diseases.

“This lack of momentum on vaccinations is affecting our dynamic state of readiness for the next variant or the next viral threat,” said Dr Ayoade Alakija, co-chair of the Africa Vaccine Delivery Alliance. “It is endangering the local and regional vaccine production efforts that have popped up . . . to ensure we don’t return to the stage zero of the pandemic.” The struggle to remain commercially viable does not bode well for efforts to build up vaccine production. At the onset of the Covid pandemic, there were just four African countries with vaccine manufacturing capacity: South Africa, Egypt, Senegal and Tunisia. Now, there are 15 African nations with vaccine manufacturing projects in the works. Read More.

 

 

Addis Ababa, Ethiopia: The Africa Centres for Disease Control and Prevention today released the results of a new 27-country analysis on the health and economic impact of COVID-19 vaccination.  The retrospective study on the roll-out of COVID-19 vaccine programmes demonstrated that earlier start dates and rapid scale-up delivered greater health benefits – measured in terms of hospitalizations and deaths averted – and were more cost-effective when compared with programs that started later and scaled more slowly. Furthermore, the benefits of COVID-19 vaccines vary widely depending on the pace of roll-out, the population targeted, and the type of vaccines used in the campaigns. The analysis also drew on research from Kenya, Nigeria, Ethiopia and South Africa.

The analysis demonstrated that vaccine programs deliver the best value for money when focused on the most vulnerable, including the elderly, pregnant women, health workers and those with comorbidities. This is especially true in countries with a low overall risk of severe outcomes from COVID-19, such as nations with younger populations or that have already had significant exposure to the virus. In Kenya, researchers found that scaling up to 30% of the population, but focusing on the elderly, was far more effective than reaching 70% coverage of the general population. Nigerian researchers found the same result when modelling targeted scale-up to 25% of the population. 

“The evidence is clear – countries should aim to vaccinate those most at risk, as quickly as possible, with the most cost-effective vaccines available to them,” said Dr. Ahmed Ogwell Ouma, Deputy Director of the Africa CDC. “This is how we can save the most lives and deliver the highest value for money.”

The research found that it is not only the overall vaccine coverage reached that determines the benefits of a vaccine program. Rather, starting early and moving quickly are critical levers to increase the impact of any COVID-19 vaccine program. In South Africa, a 40% vaccine coverage achieved through a fast roll-out was found to provide greater health benefits over a year than 67% coverage attained slowly. For countries where large numbers of the population remain unvaccinated, moving with urgency and scaling up quickly is critical. The study also found COVID-19 vaccine efforts become less cost-effective – or not cost-effective at all – as countries take longer to scale their programs.

“This new research gives us a clear direction of travel,” said Prof Edwine Barasa, Director at the Nairobi Programme of the KEMRI-Wellcome Trust Research Programme. “Many countries are struggling to scale – but if we can move faster and in a more targeted way, we can get the job done.”

There have been 11.5 million confirmed cases of COVID-19 in Africa, with more than a quarter-million lives lost. While scale-up of vaccine programs continues apace and more than 20% of Africans have now received one dose of a COVID-19 vaccine, this masks wide disparities across the continent. Several African countries have nearly vaccinated 70% of their populations with two doses; while others have not yet reached 1% of their populations with the first dose.

The study also explored how the choice of vaccines impacts the cost-effectiveness of vaccine programs across the continent. While the efficacy of COVID-19 vaccines does not vary significantly across products, mRNA vaccines tend to have significantly higher procurement and delivery costs. Choosing the least expensive vaccine options, especially in the case of budgetary limitations, is a pragmatic way to improve the cost-effectiveness of COVID-19 vaccine programs. 

“There is no doubt that COVID vaccines remain cost-effective under a number of scenarios,” said Dr. Justice Nonvignon, Ag. Head of the Africa CDC Health Economics Programme. “But it is equally clear that as the pandemic evolves, we need to be thoughtful about how we spend our time and money. In certain contexts, African countries may deliver greater health benefits to their citizens by investing in other more cost-effective health programs.”

Cost-effectiveness studies weigh the benefits of a health program compared to its costs. This analysis included a detailed range of COVID-related costs. To measure the cost of COVID-19 vaccine programs, researchers studied the cost of the vaccines themselves as well as associated delivery costs for campaigns. To measure the costs of COVID-19, the study explored impacts on disability-adjusted life years (DALYs), a widely used measure for health benefits that includes years of life lost due to COVID-19 and years lived with disability for symptomatic cases, hospital stays in a general or critical bed, including long COVID.

The analysis was conducted by a broad coalition of local and international research groups. The Kenya Medical Research Institute – Wellcome Trust, University of Nigeria; Ethiopian Public Health Institute and the University of Warwick all contributed to the country-specific case studies; while the London School of Hygiene and Tropical Medicine prepared the regional analysis, with inputs from the Center for Global Development and the international Decision Support Initiative (iDSI). The Africa CDC oversaw the studies.

Source - Africa CDC

The global roll-out of COVID-19 vaccines to date is neither inclusive nor adequately planned: Many countries are already administering boosters while the rest of the world is being left far behind. Despite the urgent need to increase vaccination, Africa has received too few vaccines from the global supply: As of this writing, out of more than 9 billion vaccines doses produced, Africa has only received approximately 540 million (about 6 percent of all COVID vaccines, despite having 17 percent of the world’s population) and administered 309 million doses. Less than 10 percent of Africans are fully vaccinated.

In other words, approximately 1.2 billion Africans have not received a single dose of vaccine and, at the current rate, much of Africa may not be vaccinated until 2023.

Michel Sidibé

Michel Sidibé

African Special Envoy for the African Medicines Agency - African Union 

Former Executive Director of UNAIDS and Under-Secretary-General - United Nations

The COVID-19 pandemic has exposed our continent’s vulnerabilities in ensuring access to vital drugs, vaccines, and health technologies. More specifically, it has underscored the critical gap in vaccine manufacturing as a whole: Before COVID-19, Africa produced less than 1 percent of the vaccines that it consumed—importing over 99 percent—despite consuming over 25 percent of vaccines globally.

Such vaccine inequality is not simply unjust; given the potential for dangerous mutations that could affect vaccine effectiveness, it is epidemiologically wrong. As a result, Africa may well become the COVID epicenter.

There is no greater test of moral solidarity and the world’s ability to come together than this global health challenge.

The issue is no longer one of supply but rather one of unequal distribution. Despite the acute vaccine supply shortage in Africa, global vaccine production has been increasing at a secure rate, around 1.5 billion doses per month. By December 2021, over 1.2 billion doses could be available for donation by the G7 alone. Western countries should agree to transfer their vast stockpile of unused vaccines to COVAX to ensure that the vaccines reach the places most in need. In addition, to ensure the best allocation and distribution of vaccines, COVAX should work with the African Vaccine Acquisition Task Team (AVATT), which has pooled resources to procure vaccines for its member states.

There is no greater test of moral solidarity and the world’s ability to come together than this global health challenge. Moreover, the solution is not charity: Given the emergence and spread of variants, the pandemic will not be over until it is over everywhere. Africa cannot and must not be left out of the vaccination conversation. Delays in vaccinating everyone have an economic cost as well. A recent study from The Economist estimated that, among other regions, sub-Saharan Africa will register the highest economic losses (3 percent of GDP from 2022-2025) due to slow vaccination rates.

Given the emergence and spread of variants, the pandemic will not be over until it is over everywhere

THE FUTURE OF AFRICA’S HEALTH SYSTEMS CAN BE BRIGHT

Africa accounts for 23 percent of the world’s overall disease burden yet only 1 percent of global consumption of healthcare goods and services, of which 44 percent is financed by government and the remainder is from out-of-pocket payments. This indicates that there is a significant health financing gap to treat the continent’s disease burden.

The African pharmaceutical sector is expected to grow from $19 billion in 2012 to $66 billion by 2022—the fastest growing in the world; the health and wellness sector is projected to be worth around $259 billion by 2030, with the potential to create over 16 million jobs. Already, pharmaceutical manufacturers have announced plans to create factories in the region—although challenges in infrastructure, regulation, and know-how, among others, may hinder those efforts.

Given these complex challenges, the pandemic has also confirmed the integral role of a strong regulatory system in a well-functioning health ecosystem. The African Medicines Agency (AMA), launched in September 2021, is the second continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC), with the mandate of enhancing regulatory oversight across the continent and meeting the challenges of access to quality, safe, and efficacious medicines.

The AMA can take advantage of and build on the ongoing efforts towards regulatory harmonization and economic inclusion through other key Africa programs:

  • African Continental Free Trade Area: Facilitates trade through simplification of regulation and minimization of red tape.
  • Partnerships for African Vaccine Manufacturing (PAVM): Supports local manufacturing.
  • African Medicines Regulatory Harmonization (AMRH) and African Vaccine Regulatory Forum (AVREF): Both focus on medical products and regulation.

The pandemic has also confirmed the integral role of a strong regulatory system in a well-functioning health ecosystem.

By partnering with these key programs, the AMA will be able to further strengthen continental research and development capacity, harmonize drug registration regulations, and help African countries comply with best practices and international standards.

These institutions, including AMA, do not exist in a vacuum. Some of the greatest strengths are when they work across institutions and sectors. And only in partnering together will they be able to safeguard the health security of Africa and the world as a whole.

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