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First African-manufactured medicine to prevent malaria in pregnant women and infants quality-approved by WHO

Universal Corporation Ltd (UCL), with support from MMV and Unitaid, becomes the first African manufacturer to gain WHO prequalification of sulfadoxine-pyrimethamine  

  • Sulfadoxine/pyrimethamine (SP) is a well-tolerated, effective and affordable medicine used to prevent malaria in pregnant women and infants 
  • Nearly all malaria cases and deaths occur in Africa, yet until now, the continent was completely reliant on imported quality-assured SP  
  • This breakthrough responds to the need for local production of quality medicines for use in Africa, a major gap that was critically highlighted when the COVID-19 pandemic left the continent with limited access to vital health products in 2020 

Geneva, Switzerland and Kiambu, Kenya – Local supply of a medicine used to prevent malaria across Africa received a boost recently, as the World Health Organization (WHO) issued a quality certification to the first African manufacturer of a key antimalarial drug used to prevent infection in pregnant women and children. Called pre-qualification, this certification will enable Kenyan manufacturer Universal Corporation Ltd (UCL) to support regional efforts to combat malaria through local production of high-quality sulfadoxine-pyrimethamine (SP). UCL’s pre-qualification was achieved with funding from global health agency Unitaid and support from MMV.   

Pre-qualification is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. Quality assurance of UCL’s SP product Wiwal® opens a route for procurement by global scale-up partners that will improve access and help strengthen Africa’s ability to combat endemic diseases.   

“Unitaid welcomes the certification of UCL to produce this quality-assured antimalarial medicine in Africa, where about 95% of all illness and death from malaria occurs. Reinforcing local production of medicines where they are needed most is critical to building stronger and more resilient health responses,” said Dr Philippe Duneton, Executive Director of Unitaid.  

Young children and pregnant women are among the most vulnerable to the burden of malaria, with children under five accounting for 80% of all malaria deaths in Africa. SP is a generally well-tolerated, effective, and affordable medicine used to prevent malaria, yet adequate delivery and scale-up of these interventions are hampered in part by inadequate and unstable supply and, until now, have completely relied on imported or poor-quality drugs.   

“UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. We are not only the first pharmaceutical company to receive pre-qualification of sulfadoxine-pyrimethamine in Africa, but one of only five manufacturers in Africa to have received this quality certification for any product. We’re filling a much-needed gap,” said Perviz Dhanani, Founder and Managing Director of UCL.  

The lack of pre-qualified manufacturers in Africa raises concerns about the quality of medicines and supply insecurities that compromise the treatment of chronic and infectious diseases – risks that were clearly revealed when COVID-19 disrupted global supply chains and left Africa with limited access to vital products. The production of quality medicines on the African continent is critical not only for the safety of Africa’s people but also for supporting regional supply availability and diversification in global production of medicines.   

Increased supply of SP is crucial to the long-term success of Unitaid’s malaria chemoprevention strategy, which includes nearly US$ 160 million invested to date to optimize and scale up delivery of SP through seasonal delivery and intermittent preventive treatment in pregnant women and infants. With Unitaid funding, MMV is working to strengthen global supply chains and support appropriate use of quality medicines critical to the malaria response.   

“Researchers and manufacturers from the countries hardest hit by malaria must be at the forefront of efforts to defeat the disease, which is why we welcome this wonderful news,” said David Reddy, MMV’s CEO. “We congratulate Universal Corporation Ltd for becoming the first African manufacturer to receive WHO pre-qualification for SP for the prevention of malaria in pregnant women and infants and are delighted to have partnered with them in this effort.”

NOTES FOR EDITORS  

Additional quotes   

“We at Africa CDC gladly welcome the news of Universal Corporation Ltd receiving a WHO Prequalification for sulfadoxine-pyrimethamine,” said Dr Nicaise Ndembi, Africa CDC’s Chief Science Advisor. “This is the result of a remarkable collaborative effort through UCL, MMV and Unitaid, and aligns with our purpose to support public health initiatives and strengthen the capacity of public health institutions.”  

“The news of Universal Corporation Ltd receiving a WHO Prequalification for sulfadoxine-pyrimethamine is incredible news,” said Ms Joy Phumaphi, Executive Secretary of the African Leaders Malaria Alliance and MMV Board member. “Ensuring the availability and accessibility of quality treatment for underserved communities, particularly women, newborns, and children who are disproportionately at high risk of death from malaria is a critical component to the full realization of the right to health.” 

Background on the malaria burden 

According to the latest World Malaria Report, released on 6 December 2021, there were an estimated 241 million cases of malaria and 627,000 resulting deaths worldwide in 2020. This represents about 14 million more cases in 2020 compared to 2019, and 69,000 more deaths. Approximately two-thirds of these additional deaths (47,000) were linked to disruptions in the provision of malaria prevention, diagnosis and treatment caused by the COVID-19 pandemic.   

The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2020, the region was home to 95% of all malaria cases and 96% of all deaths. About 80% of all malaria deaths in the region are among children under five years of age.  

In 2020, six countries accounted for just over half of all malaria deaths worldwide: Nigeria (27%), the Democratic Republic of the Congo (12%), Uganda (5%), Mozambique (4%), Angola (3%) and Burkina Faso (3%). 

Background on seasonal malaria chemoprevention, perennial malaria chemoprevention and intermittent preventive treatment in pregnancy  

There are a number of recommended malaria prevention interventions targeted at those most vulnerable to malaria infection and adverse effects (pregnant women, infants, children) that depend on the accessibility of SP. Adequate supply of SP is crucial to achieving scale up of these interventions to benefit all those at risk across the African continent.  

Seasonal Malaria Chemoprevention (SMC) is a preventive treatment strategy for children under five living in areas of the Sahel and sub-Sahel at greatest risk of seasonal malaria. It involves administering monthly doses of SP to children during peak malaria season. Unitaid invested US$ 68 million in the first evaluation to determine the effectiveness of SMC on a large scale, a strategy which contributed to a reduction in malaria infections in children of more than 85%. According to the latest World Malaria Report, in 2020, 33 million children were reached with SMC. 

Perennial malaria chemoprevention (PMC) is another strategy for preventing malaria in infants and children, in areas where malaria transmission is not seasonal. Those belonging to age groups at high risk of severe malaria are recommended to receive antimalarial medicines at predefined intervals to reduce disease burden.  

Intermittent preventive treatment in pregnancy (IPTp) is recommended by WHO in malaria-endemic areas to reduce disease burden in pregnant women. This intervention relies on administration of at least three doses of SP, starting as early as possible in the second trimester and spaced at least one month apart.    

Unitaid is currently funding a large-scale project to generate operational evidence that will help implementers scale-up PMC in higher burden areas. This project is building on the success of the recent TIPTOP project, a Unitaid investment that demonstrated innovative ways to reach more women with IPTp across Africa.  

Background on strengthening local production of medicines and other health technologies to improve access 

Attaining the highest standard of health is a fundamental right for all. Access to quality‐assured, safe, effective, and affordable medicines and other health technologies for all is a specific component of the Sustainable Development  Goals target  3.81  and  in  achieving Universal health coverage.

For more information, visit: Strengthening local production of medicines and other health technologies to improve access (WHO).

MEDIA CONTACTS 

MMV

Elizabeth Poll, Director of Communications
Phone: +41 79 709 59 92
Email: polle@mmv.org  

Unitaid

Maggie Zander, Communications Officer
Phone: +41 79 593 17 74
Email: zanderm@unitaid.who.int

MMV Disclaimer 

This document contains certain forward-looking statements that may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions, or by discussion of, among other things, vision, strategy, goals, plans, or intentions. It contains hypothetical future product target profiles, development timelines and approval/launch dates, positioning statements, claims and actions for which the relevant data may still have to be established. Stated or implied strategies and action items may be implemented only upon receipt of approvals including, but not limited to, local institutional review board approvals, local regulatory approvals, and following local laws and regulations. Thus, actual results, performances or events may differ from those expressed or implied by such statements.   

We ask you not rely unduly on these statements. Such forward-looking statements reflect the current views of Medicines for Malaria Venture (MMV) and its partner(s) regarding future events and involve known and unknown risks and uncertainties.    

MMV accepts no liability for the information presented here, nor for the consequences of any actions taken on the basis of this information. Furthermore, MMV accepts no liability for the decisions made by its pharmaceutical partner(s), the impact of any of their decisions, their earnings and their financial status. 

An insectary by the Zambezi river

A photo story on the insectary set up by the Unitaid-funded BOHEMIA project, being implemented in Mopeia (Mozambique) by the Barcelona Institute for Global Health (ISGlobal) and the Manhiça Health Research Centre (CISM).

Photos: Olaba TV, Canva

Text: Murchana Roychoudhury / Caroline Kiuru

View the complete photo story

Vector control, one of the most effective malaria strategies, now stands to be threatened by widespread insecticide resistance and residual transmission. It was in this context of slowed progress and the emergence of new threats that the BOHEMIA project was born.

This ‘World Mosquito Day’, follow the steps of BOHEMIA’s entomology team, as they collect mosquitoes with various baits and traps, and study them in the locally set-up world class insectary in the Mopeia district.

Unitaid report analyses the state of malaria testing technologies today to identify opportunities and improve equitable access

World Mosquito Day, commemorated each year on 20 August, marks the day in 1897 that researchers discovered that female Anopheles mosquitoes transmit malaria to humans.

This year, with progress against malaria stalled and global targets to reduce infections falling short, Unitaid has published a new report analyzing the landscape of diagnostic tools to identify opportunities and accelerate access to tests and improve malaria case management.

More than 4 billion people in 85 countries live in areas where malaria is prevalent. Being able to diagnose the infection early is essential to treating malaria quickly. It is also critical to ensuring that patients with fevers not caused by malaria are not given malaria drugs, a common mistake that, over time, causes medicines to become less effective.

The landscape report looks at the market conditions and technology pipeline for malaria tests to determine opportunities for greater impact as well as gaps that, with swift and adequate action, can be addressed to improve malaria control efforts.

As the threat of resistance and biological threats expands, more diagnostic options are needed to support countries to deploy effective resistance management strategies. Notably, the report calls out the urgent need for high-quality tests for diagnosing malaria in settings where gene deletions in the malaria parasite are making detection more complex.

The report also assesses the technology pipeline, examining innovative and promising products in all stages of development, and evaluating needs to ensure they can succeed and reach those who need them. Research and development into new technologies and rapid tests that are effective in detecting evolving strains of malaria are urgently needed.

Strong collective action is key to promoting sustainable access for malaria diagnostics. A series of market-based and community-led interventions can help strengthen access to the right technologies for diagnosing malaria but successful execution of these efforts will require the participation and buy-in from stakeholders across global health, working in close collaboration with the private sector and affected communities.

Access the Malaria Diagnostics Market and Technology Landscape here.

Media contact:

For more information and media requests:

Maggie Zander

Communications officer

M: +41 79 593 17 74

zanderm@unitaid.who.int

Malaria diagnostics market and technology landscape

Unitaid and the Government of Kenya strengthen collaborative partnership to advance global health goals 

Nairobi/Geneva – Global health agency Unitaid and the Government of Kenya are launching a newly reinforced cooperation, with a memorandum of understanding between the two parties signed in Nairobi.

Over its decade and a half history, Unitaid has worked closely with Kenyan partners to enable affordable, equitable, and rapid access to game-changing health innovations for those who need them. These include early infant HIV diagnostics, best-in-class antiretroviral drugs for adults and children with HIV, child-friendly tuberculosis (TB) medicines, cutting-edge screen-and-treat solutions for cervical cancer, indoor sprays to curb malaria, and access to COVID-19 tests and medical oxygen, among many others.

The agreement will further improve alignment between Unitaid investments and Kenyan health priorities, enable early access to innovations, and strengthen capacity of Kenyan health services, systems, research institutions and manufacturers.

“Unitaid’s collaboration with Kenya dates from its very beginnings 15 years ago. Nearly 80% of Unitaid’s US$1.5 billion currently invested supports work on the African continent. Kenya is a close partner in these efforts – both as one of the countries where the greatest number of Unitaid projects are running, and as one of the quickest countries to adopt and scale up critical health innovations,” said Dr Philippe Duneton, Executive Director of Unitaid. “This partnership will further advance our shared goals to improve health in Kenya and beyond.”

“Advances in health innovations hold game-changing potential when implemented widely and equitably, but ensuring products reach the last mile is far from guaranteed. This is why our partnership with Unitaid is so valuable: together we will design the most impactful solutions so no one is left behind,” “said Sen. Mutahi Kagwe, Cabinet Secretary for Health of the Republic of Kenya.

Joint efforts will focus on advancing sustainable approaches to reduce the burdens of HIV, TB, malaria, cervical cancer, hepatitis and COVID-19, improve the health of women and children, increase regional and domestic manufacturing of essential health products and strengthen pandemic preparedness and response efforts.

Media contact:

For more information and media requests:

Maggie Zander

Communications officer

M: +41 79 593 17 74

zanderm@unitaid.who.int

Transforming IPT for Optimal Pregnancy (TIPTOP) & the Supply Side Grant, Evaluation Summary

Unitaid Strategy 2023-2027

World Malaria Day: Unitaid drives forward equitable access to innovation to reduce the burden of malaria

Geneva, 22 April 2022 – In advance of World Malaria Day, 25 April, global health agency Unitaid reaffirms its strong commitment to reducing the burden of malaria by improving access to critical innovations that prevent, diagnose, and treat the disease. 

Even before the COVID-19 pandemic created new setbacks, the rate of progress in the fight against malaria had reached a plateau. Despite commendable efforts to quickly secure continuity of key malaria control services, global malaria deaths rose by 12% in 2020. 

The most significant burden of disease is increasingly being carried by a handful of countries where the situation is growing in severity. The World Health Organization reports that just 11 countries – all but one located in Africa – account for approximately 70% of all cases and deaths caused by malaria. And while many countries with lower rates of malaria progressed towards elimination targets despite the pandemic, the countries with the highest burdens lost ground.   

“The same troubling trend we have seen put so starkly in relief since the COVID-19 pandemic began has been quietly playing out in our efforts against malaria and other diseases for decades,” said Dr Philippe Duneton, Executive Director of Unitaid. “Quality innovations are slow to reach the countries that need them most and we see a divergence in global health responses, as higher income countries tackle challenges and move on, and interest and funding to extend efforts equitably wanes.” 

Much of the progress achieved over the past two decades was due, in large part, to the massive mobilization of funds and interventions, which helped cut deaths from malaria in half between the years 2000 and 2015. But as the number of countries facing acute crises decreased, so too did the galvanized efforts required to sustain and advance the fight. 

This World Malaria Day, the WHO has issued a call for greater investments and increased innovation to improve tools and approaches and reduce the burden of malaria. With more than US$330 million currently invested to optimize delivery, update tools, and test new strategies, Unitaid is advancing efforts to protect people everywhere from malaria. 

No single tool or strategy will solve the problem of malaria alone. Unitaid’s investments endeavor to increase access to the proven tools that work, while investing in developing new and updated products to build a more robust arsenal of malaria-fighting interventions. 

Unitaid is funding efforts to improve coverage of antimalarial preventive treatments for pregnant women and young children, who are most vulnerable to adverse events from infection. Through community interventions, the Unitaid-funded TIPTOP project demonstrated how to drastically increase the number of women reached with life-saving preventive treatment during pregnancy. And new investments launched last year are working to enhance delivery of preventive medicine that will reach more children with antimalarial protection over their first two years of life. 

More than two-thirds of all deaths from malaria occur in young children under five in Africa. With pilots co-funded by Unitaid, the Global Fund and GAVI, the world’s first malaria vaccine is being delivered to children as part of a comprehensive package of preventive care. 

Vector control, which targets disease spreading mosquitoes, is a highly effective and vital component of malaria elimination strategies. With investments into next-generation bed nets that combat growing mosquito resistance, new spatial repellents, and by treating humans and livestock with medicine that kills mosquitoes who bite them, Unitaid is driving progress to advance new and effective tools. 

And with work to improve screening and treatment for relapsing P. vivax malaria – the most common type of malaria outside of sub-Saharan Africa – Unitaid is helping improve care for people in Asia-Pacific and Latin American countries, including many that are close to elimination targets. 

The WHO global malaria strategy calls for a 90% global reduction of cases and death by 2030. Achieving this goal requires urgent global investment to support the development and deployment of crucial innovations to ensure people in all countries are protected from malaria.  

Media contact:

For more information and media requests:

Maggie Zander

Communications officer

M: +41 79 593 17 74

zanderm@unitaid.who.int