Today, the World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL). The test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately.
WHO’s EUL procedure assesses the quality, safety and performance of essential health products based on the available evidence, while ensuring they meet minimum international standards and address the needs of low- and middle-income countries.
Through this mechanism, WHO aims to accelerate access to reliable diagnostic tools for early case detection, timely clinical care, disease surveillance and effective outbreak response. The EUL also supports United Nations procurement agencies and governments in making informed decisions about the procurement and use of these products in public health emergency settings.
"Public health emergencies require not only speed, but also confidence that the health products being used meet standards for quality, safety and performance," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. "During a fast-moving outbreak, timely access to quality-assured diagnostic tests can make a critical difference in containing transmission. Through this Emergency Use Listing, WHO is helping countries access trusted diagnostic tools more rapidly so that they can respond more effectively.”
On 17 May 2026, WHO Director-General Dr Tedros Adhanom Ghebreyesus declared a public health emergency of international concern over the outbreak of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo, with cases in Uganda. Less than two weeks later, WHO launched a call for manufacturers of IVDs for Bundibugyo virus to submit Expressions of Interest for Emergency Use Listing.
The listing comes at a critical time as countries respond to the largest recorded outbreak of Ebola disease caused by BDBV, which continues to expand. As of today, 1406 laboratory-confirmed cases and 438 deaths had been reported in the Democratic Republic of the Congo alone.
With support from WHO and the Africa Centres for Disease Control and Prevention (Africa CDC), laboratory testing capacity has expanded from a limited number of sites – primarily Institut National de Recherche Biomédicale in Kinshasa and Goma, with an estimated combined capacity of approximately 200–400 tests per day – to a broader network of 10 laboratories across affected provinces, with a reported capacity of over 2000 tests per day. Rapid and reliable diagnosis remains essential to identify cases early, guide timely patient care, interruptand help bring outbreaks under control.
WHO continues to work closely with manufacturers, global partners and countries to expand the availability of and access to safe, effective and quality-assured life-saving health products. Additional applications for BDBV IVDs submitted through the EUL procedure are currently under review.
In parallel, WHO and Africa CDC, with partners including PATH, FIND and CHAI, and with support from Unitaid, are establishing a joint validation platform to rapidly evaluate the performance of a selection of diagnostic products, including laboratory-based molecular tests, near-point-of-care molecular tests and antigen rapid diagnostic tests. The platform will generate critically needed clinical evidence on the performance of these products in outbreak settings.
Bundibugyo virus disease is a severe, often life-threatening disease caused by BDBV, one of three Ebola virus species known to cause large outbreaks in humans. The virus can spread from animals to humans and then from person to person through contact with a person sick or deceased and their infected bodily fluids or surfaces or items contaminated by these fluids.
Information on active EUL applications for IVDs for BDBV nucleic acid detection can be found on these WHO webpages.
Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life.
We are the UN agency for health that connects nations, partners and people on the front lines in 150+ locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health issues and expanding access to medicines and health care. Our mission is to support countries to promote, provide and protect health.
“Together for health. Stand with science”, the theme of World Health Day 2026 marks a year-long campaign to highlight science as the foundation for protecting health and well-being worldwide.
The World Health Organization (WHO) today calls on countries to expand newborn screening for birth defects, highlighting how early detection and treatment can save lives and reduce lifelong disability for millions of children.
A new WHO report, Strengthening capacity for newborn screening, diagnosis and management of birth defects, identifies newborn screening as an important opportunity to accelerate progress in child survival.
Many conditions can be successfully treated if identified early after birth. These include congenital hypothyroidism, sickle-cell disease, hearing impairment and some metabolic disorders. Yet millions of children are still diagnosed too late or never receive treatment at all.
Worldwide, an estimated 8 million babies are born with a birth defect each year, and birth defects now account for almost 8% of all deaths among children under five. An estimated 90% of children born with serious birth defects live in low- and middle-income countries, where access to screening, diagnosis and treatment remains limited.
"No child should miss the chance for a healthy future because a congenital condition was not detected early enough," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "Around the world, countries are showing that newborn screening for one or more conditions can save lives, prevent disability, and give a newborn the best opportunity to fulfil her or his potential ."The gap between countries is stark: some countries screen all newborns for more than 50 conditions, while others are unable to screen for any. WHO encourages every country to begin newborn screening — starting with a priority condition in the country and progressively expanding as capacity grows.
The report shows that birth defects account for a growing proportion of under-five deaths in many regions. Between 2000 and 2023, the proportion of under-five deaths attributable to birth defects increased from 1% to 4% in sub-Saharan Africa and from 3% to 11% in South Asia. Part of this shift reflects genuine progress in the reduction of deaths from infectious and other preventable causes.
The WHO report aims to support ministries of health, especially in low- and middle-income countries, to prioritize conditions for newborn screening depending on the country context.
It showcases countries across Africa, Asia and the Americas that are already demonstrating the successful integration of large-scale newborn screening programmes into routine health services:
Argentina: Increased newborn screening coverage to nearly universal levels.
Brazil: Expanded nationwide screening for multiple life-threatening conditions.
Egypt: The ‘newborn care pathway’ integrates universal newborn screening for hearing and congenital hypothyroidism into its primary health care services.
India: The national programme has screened more than 28 million children over three years, identifying approximately 900,000 children with a birth defect and connecting them with diagnosis, treatment and support, including long term care and rehabilitation services through district early intervention centres.
Philippines: A programme that began as a pilot in 24 hospitals now screens newborns for 29 conditions through more than 7000 facilities nationwide. All conditions screened for have diagnostic and management pathways within the national health system. Newborn screening is covered by national health insurance and mandated by law.
Sri Lanka: Newborn screening is integrated into routine care and includes visible birth defects and congenital hypothyroidism. Around 80% of newborns are now screened for congenital hypothyroidism.
Uganda: A state-led programme for sickle-cell disease in high burden areas identifies affected infants early and provides them with lifesaving treatment and long-term follow-up care.
WHO is urging governments to integrate newborn screening, diagnosis and treatment into routine health services and universal health coverage programmes, beginning with conditions that are country priorities, and that can be effectively detected and feasibly managed within their health system.
The report was informed by a global WHO consultation bringing together government representatives, technical experts, clinicians, researchers, professional associations, civil society organizations and families affected by birth defects to identify priorities for strengthening newborn screening, diagnosis and long-term care.
About WHO
Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life. We are the United Nations’ agency for health that connects nations, partners and people in 150+ locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health issues and expanding access to medicines and health care. Our mission is to support all countries to promote, provide and protect health.
“Together for health. Stand with science”, the theme of World Health Day 2026, marks a year-long campaign to highlight science as the foundation for protecting health and well-being worldwide.
Dear Leaders of the G7, the G20, BRICS and of all nations,
We write to you together, from Geneva and from Brasília, with one shared conviction: that the world must finish what it started, and that you can help it do so.
We begin not with an institution or an annex, but with a memory the whole world shares. Not so long ago, our hospitals overflowed. Families said goodbye to the people they loved through glass, or by telephone, or not at all. Children lost grandparents. Doctors and nurses, exhausted beyond anything we had a right to ask of them, kept going anyway. Estimates from WHO and others put the lives lost at up to twenty million. Humanity promised itself, in the rawness of that grief, that it would not face such a day again unprepared.
A little over a year ago, the world kept the first part of that promise. After the deadliest pandemic in a century, the nations of the world chose cooperation over division and adopted the WHO Pandemic Agreement to strengthen how countries can work together to prevent, prepare for, and respond to pandemics. In a divided world, that outcome was not to be taken for granted. It was an act of hope, and an act of faith in one another. We write to you now because that hope is not yet fulfilled, and because it lies within your hands to help fulfil it.
One piece remains. To respond to future pandemics in time, countries must be able to quickly identify pathogens with pandemic potential and share their genetic information and material so scientists can develop tools: the tests, the treatments, the vaccines that decide who lives and who does not. The system that makes this possible, fairly and on equal footing, is the Pathogen Access and Benefit-Sharing annex. It is the last piece of the puzzle, not only for the Pandemic Agreement but for everything WHO and Member States have built from the hard lessons of COVID-19. Until it is finished, the Agreement cannot enter into force. The promise stays unkept.
We will not pretend the road has been easy. When Member States closed their most recent session on the first of May, they had made real progress, but agreed that more time was needed. The hardest questions, including how the benefits of shared pathogens are defined and shared, how the system is governed, and how equity is guaranteed on equal footing, are difficult for a reason. They are the very questions that went unanswered last time, while people who could have been protected were not. The world is wrestling with them now precisely because they matter so much.
Negotiators will meet again from 6 to 17 July. We believe in them, and we have seen their dedication up close. But we also know there are moments when good people, doing their best around a negotiating table, need their leaders to lift their eyes to the horizon. This is one of those moments, and it is yours.
So we come to you, plainly, with three requests.
First, political will at the highest level. The remaining issues will not be solved by technical effort alone. They need the clear signal that only a head of government can give: that finishing this annex is a national priority, and that your negotiators may reach for consensus with courage rather than caution. Solidarity is our best immunity, but solidarity has to be chosen, and it has to be chosen at the top. We know, too, that you may be asked if the Pandemic Agreement compromises state sovereignty. It does not, and the PABS annex, as an integral part of it, will not either. Article 22, paragraph 2 says so plainly: nothing in the Agreement gives WHO any authority to direct or alter a country’s laws or policies, or to require measures such as lockdowns, travel restrictions or vaccination mandates. Those decisions remain with sovereign states. So we ask you, concretely, to instruct your negotiators to come to the July session ready to conclude, and to give them the flexibility to close the remaining gaps and finalize the annex in this round.
Second, a spirit of equity. The PABS system rests on a simple, fair bargain: those who share dangerous pathogens quickly must be able to trust that the vaccines and treatments born from that sharing will reach their own people too. Every one of us has a stake on both sides of it. When Brazil held the G20 presidency in 2024, it led the G20 to recognize, for the first time, inequality as a driver of pandemics. This is not charity, and it is not only conscience. It is also strategy: PABS exists to stop an outbreak at its source, and containing a threat where it begins is far cheaper, in lives and in resources, than fighting a pandemic once it has spread to every continent. A virus left to burn anywhere will, in time, find everyone. There is a further reason equity matters, one that governments and industries everywhere will grasp at once: predictability. Today the rules for accessing a pathogen and sharing what flows from it are improvised case by case, often mid-crisis. PABS replaces that with a single framework known in advance, stable rules that let laboratories and partners across the world move at the speed an outbreak demands. Legal certainty does not compete with equity; it makes equity work. We ask you to ensure the annex carries equity in its operational detail, not only in its preamble, so that access and benefit-sharing are guaranteed in practice.
Third, a sense of urgency. The next pandemic will not wait for us. Scientists estimate there is close to a one in four chance of another pandemic within the coming decade, and the ground beneath our old assumptions is shifting. Climate change, changing land use and evolving agriculture are redrawing the map of where dangerous pathogens emerge; the comfortable belief that outbreaks begin only in distant places is no longer true, and future hotspots may arise in or near your own countries. At the same time, advances in biotechnology, matched unevenly by biosafety, raise the risk of accidental or deliberate release. None of these dangers respect a border. So we ask you to treat 17 July as a deadline, not a milestone, and to say so publicly, sending your negotiators, and the world, the unambiguous signal that this is the round in which the work is finished.
And we already know the price of being unready. The last pandemic took lives on a staggering scale, with estimates from WHO and others putting the toll at up to twenty million, and the International Monetary Fund estimates it cost the world economy over thirteen trillion dollars in lost output, a loss borne in every nation, in shuttered businesses, broken supply chains and a generation of disrupted schooling. Against that, the investment in a system that catches an outbreak early is small. As we write these words, an Ebola outbreak is being fought across two countries, with no approved vaccine and no cure, by responders who are risking their own lives to protect strangers. That is not a distant abstraction. It is happening now. Every month this annex stays unfinished is a month the world is less ready than it could be, and people are less safe than they deserve to be.
The nations of the world, together, have stood at every great turning point in the story of human health. Together we helped wipe smallpox from the earth. We pushed polio to the very edge of history. We turned back the tide of HIV, tuberculosis and malaria, and in doing so helped save more lives than any of us will ever be able to count. Finishing this Agreement is not a departure from that legacy. It is its natural next chapter, and it is within reach.
We made a promise to the millions we lost, and to the families who carry their absence still. Let us be the generation that keeps that promise. Finalizing this Agreement, through a shared commitment to one another, is our collective promise to protect humanity. Let us keep it, together, and in time.
With respect, and in the shared cause of protecting human life,
| Luiz Inácio Lula da Silva President Federative Republic of Brazil | Dr Tedros Adhanom Ghebreyesus Director-General World Health Organization |
The Africa Centres for Disease Control and Prevention (Africa CDC) and the World Health Organization (WHO) today launched a joint continental preparedness and response plan on the ongoing Ebola outbreak caused by the Bundibugyo virus. The plan aims to raise US$ 518 million to support African countries together with partners to prepare for, rapidly detect and respond to the outbreak.
The six-month plan, covering June to November 2026, brings together governments, partners and communities under a unified ‘One Response’ approach to strengthen outbreak response measures, including emergency coordination, disease surveillance, laboratory testing, infection prevention and control, clinical care, community engagement, research, logistics and support for essential health services.
The plan complements national response plans launched by the Governments of the Democratic Republic of the Congo and Uganda.
“The only way to beat this outbreak is through close partnership, working together under the leadership of the affected countries in one coordinated effort, guided by a simple principle: one plan, one budget, one team,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Containing Ebola depends on political commitment, sustained financing, and the trust and engagement of communities. This plan places communities at the centre, because without their participation, contact tracing falters, safe care is delayed, and transmission continues.”
Dr Jean Kaseya, Director-General of Africa CDC, said: “Ebola moves fast. Africa must move faster. This joint plan gives the continent a clear path to act with speed and unity: to save lives, support the affected countries and protect neighbouring communities. With Member States, WHO and partners, Africa CDC is turning commitment into action and resources into response for the communities at risk.”
The plan also focuses on protecting vulnerable populations, strengthening cross-border collaboration, and supporting countries to respond quickly to new cases. At a time when there are no licensed vaccines or therapeutics specifically approved for the Bundibugyo species of Ebola, the plan aims to strengthen health systems to ensure resilience even as countries respond to acute health emergencies.
Implementation of preparedness and response activities is already underway across affected and at-risk countries. Furthermore, in 10 priority countries critical measures are being strengthened to enhance public health emergency preparedness and ensure early detection and swift response.
The plan emphasizes the need to maintain support for other ongoing health emergencies, including mpox, cholera and measles, to prevent disruptions to critical response efforts and safeguard progress towards stronger, more resilient health systems.
This coordinated effort comes as response operations accelerate in the Democratic Republic of the Congo, where authorities, with support from Africa CDC, WHO and partners, are ramping up efforts to curb the spread of the virus and end the outbreak.
Africa CDC and WHO urge Member States to strengthen screening and public health measures at points of entry and enhance cross-border coordination and solidarity to support a timely, effective and evidence-based response to the outbreak.
Through the joint preparedness and response plan, the continent is mobilising its collective expertise and resources to reinforce response measures, acting as one to control the outbreak and protect communities across the region. Its successful implementation will require strong political commitment, sustained investment and close collaboration among governments, health workers, communities and partners.
Drawing on lessons learned from previous Ebola outbreaks and recent public health emergencies, the plan also provides a pathway to broadly strengthen Africa’s capacity to prevent, detect and respond to future health threats while protecting lives and livelihoods.
The Africa Centres for Disease Control and Prevention (Africa CDC) is the public health agency of the African Union. As an autonomous institution, Africa CDC supports AU Member States to strengthen health systems, improve disease surveillance, and enhance emergency preparedness and response. Africa CDC works with Member States, Regional Economic Communities and partners to prevent, detect and respond quickly and effectively to disease threats and outbreaks across the continent.
For more information, visit www.africacdc.org and follow Africa CDC on LinkedIn, X, Facebook and YouTube.
Dedicated to the well-being of all people and guided by science, the World Health Organization leads and champions global efforts to give everyone, everywhere an equal chance at a safe and healthy life.
We are the UN agency for health that connects nations, partners and people on the front lines in 150+ locations – leading the world’s response to health emergencies, preventing disease, addressing the root causes of health issues and expanding access to medicines and health care. Our mission is to promote health, keep the world safe and serve the vulnerable.
“Together for health. Stand with science”, the theme of World Health Day 2026 marks a year-long campaign to highlight science as the foundation for protecting health and well-being worldwide.