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WHO urges rapid access to mpox diagnostic tests, invites manufacturers to emergency review
WHO has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL). WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.
Testing is key for people to get treatment and care as early as possible and prevent further spread. Since 2022, WHO has delivered around 150 000 diagnostic tests for mpox globally, of which over a quarter have gone to countries in the African Region. In the coming weeks, WHO will deliver another 30 000 tests to African countries.
With as many as 1000 suspected cases reported in the Democratic Republic of the Congo alone this week, the demand for diagnostic tests is on the rise. In this heavily affected country, WHO has worked with partners to scale up diagnostic capacity to respond to the upsurge of cases. Since May 2024, six additional labs have been equipped to diagnose mpox, enabling a decentralization of testing capacity from major cities to affected provinces. Two of these labs are in South Kivu, selected to respond to the outbreak of the new viral strain, called Ib. Thanks to these efforts, testing rates have dramatically improved in the country, with four times as many samples tested in 2024 so far as compared to 2023.
WHO has also updated its diagnostic testing guidance to detect the new virus strain and is working with countries to roll it out. Earlier, WHO issued target product profiles to guide manufacturers in the development of new diagnostic tests.
WHO Director-General Dr Tedros Adhanom Ghebreyesus declared on 14 August 2024 that the upsurge of mpox in the Democratic Republic of the Congo (DRC) and in a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Manufacturers of IVDs are now asked to submit available quality, safety and performance data to WHO as soon as they can. IVDs are tests done in laboratories to detect a pathogen. Detection of viral DNA by PCR (Polymerase Chain Reaction) testing is the gold standard for mpox diagnosis. It detects the virus's DNA in samples taken from skin lesions, such as fluid or crusts from vesicles or pustules. Testing of blood is not recommended for routine diagnosis and antibody detection methods may be used for retrospective case classification but not for diagnosis.
Through the EUL procedure, WHO can approve medical products such as vaccines, tests and treatments for use, evaluating the acceptability of using specific products for time-limited procurement in emergency situations. The process aims to assist countries, which have not approved the medical products through national approval processes, to procure the critically needed products such as tests through UN agencies and other partners.
Mpox is an illness caused by the monkeypox virus, a species of the genus Orthopoxvirus, that can be transmitted to humans through contacts with someone who is infectious, with contaminated materials, or with infected animals.
Expanding access to diagnostic services is urgently needed as tests are essential to critical measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection, and timely reporting. As a package, these help countries identify chains of transmission, detect cases early, prevent further spread, and monitor the virus in real-time. The establishment of Emergency Use Listing procedures for mpox diagnostic tests will help advance towards this goal.
WHO and International Paralympic Committee team up to highlight power of assistive technology at Paris 2024 Paralympics
The World Health Organization (WHO) and International Paralympic Committee (IPC) are joining forces to highlight the transformative impact of assistive technology on sports during the Paris 2024 Paralympic Games. The "Equipped for equity" campaign emphasizes the crucial role of assistive technology for Paralympic athletes to advocate for concerted global action to improve access to these essential health products.
Throughout the Games, WHO and IPC will leverage the Paralympics platform to share messages and information focused on the importance of assistive technology, how athletes use it, and why universal access is essential. Examples of assistive technology used by Paralympians include: running blades, wheelchairs, and release braces in archery.
The “Equipped for equity” campaign will also feature personal stories from athletes who rely on assistive technology for sport and in daily life and highlight national successes in advancing access to these critical health products.
“The Paralympics show us what is possible, and the important role that assistive technology plays for these extraordinary athletes,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “But around the world, many people still do not have access to crucial assistive technology, due to its high cost and low availability. We call on governments, donors, and civil society to prioritise these neglected but critical products, by integrating them in primary care programmes as part of their journey towards universal health coverage.”
Andrew Parsons, President, IPC noted, “The Paralympic Games are one of the only global events that put persons with disabilities front and centre, and in many events highlight how assistive technology can support athletes to compete at the highest level. These technologies allow them to redefine what is possible in sports and inspire millions around the world.”
“While we get ready to celebrate incredible athletic success, it is critical to remember that access to assistive technology remains a significant concern. We must advocate for more affordable and accessible solutions globally, ensuring that everyone, regardless of where they live, has the opportunity to lead a full life and contribute to society.”
WHO estimates that access to assistive technology remains severely limited in many parts of the world, with more than 2.5 billion people in need of assistive technology across the world. For instance, only 5-35% of the 80 million people who need a wheelchair have access to one, depending on where they live, and only 10% of the global demand for hearing aids is currently met. Without access to assistive technology, persons with disabilities are denied the right to participate in all aspects of life, and are also more at risk of exclusion, isolation and poverty.
The "Equipped for equity" campaign will showcase examples like Zimbabwe’s recent tax exemption on assistive technology and the pre-Paralympic tax reductions on assistive technology for sports in France and Japan. By highlighting these initiatives, the campaign calls on countries to implement similar initiatives and integrate assistive technology into primary health care and universal health coverage.
Measures to make assistive technology more accessible and affordable are essential not only for empowering individuals to participate fully in life but also for driving broader societal and economic development. Expanding access to quality-assured, safe, and affordable assistive technology reduces health and welfare costs such as recurrent hospital admissions, and promotes a more productive labour force, indirectly stimulating economic growth.
WHO is also supporting the IPC and the Government of France to ensure a healthy and safe environment for all athletes and spectators at the Paris 2024 Paralympics. Joint public health advice, developed with the European Centre for Disease Prevention and Control, has been provided to support travellers attending the Games.
Fourteen African countries, key partners unite to provide critical resources for health in WHO’s first-ever Investment Round
In an unprecedented show of unity in support of the World Health Organization, 14 African countries and many partners pledged over US$ 45 million to the WHO Investment Round, a three-month-old initiative aimed at generating sustainable financing for the organization at the center of the global health architecture. The commitments were made during the World Health Organization (WHO) Regional Committee for Africa, with heads of state and government from across the continent underscoring the importance of investing in global health and ensuring a strong WHO.
“I thank our African Region Member States for actively supporting WHO’s first Investment Round to mobilize predictable and flexible resources needed for our core work over the next four years,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Full, sustainable funding will enable WHO to support countries better in their work to build healthier, more resilient, and more prosperous populations.”
The countries and partners came together for the historic event aimed at sustainably funding WHO and thus enabling it to more effectively fulfil its mandate and advance key objectives to promote, provide and protect health and well-being for all. The countries included Botswana, Cabo Verde, Chad, Congo, Ethiopia, Gambia, Mauritius, Namibia, Niger, Rwanda, Senegal, Seychelles, South Africa, and the United Republic of Tanzania.
Many partners joined Members States in making commitments of support to WHO and committing to providing pledges later in the year, including Helmsley Charitable Trust, World Diabetes Foundation, Roche, Kuwait Fund for Arab Economic Development, the Bill & Melinda Gates Foundation, African Development Bank and the WHO Foundation.
“A strong, predictable and sustainably financed WHO is essential for our region and the world to meet the multiple health threats we face; and support the prevention of disease based on the vast evidence at our disposal,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “Every pledge and every partnership counts. Together, we can achieve a future where health and well-being are accessible to all.”
The WHO Investment Round will continue in the coming months and feature key pledging moments around the world. Learn more about the WHO investment Round.
Launched at the World Health Assembly in May 2024, the Investment Round aims to generate contributions that are flexible and thereby aligned with WHO’s strategy as approved by its Member States; predictably provided at the start of the four-year budget cycle to enable strategic decision-making; and resilient in that they will derive from a larger, more diverse set of donors.
Global strategic preparedness and response plan launched by WHO to contain mpox outbreak
The World Health Organization (WHO) today launched a global Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of mpox through coordinated global, regional, and national efforts. This follows the declaration of a public health emergency of international concern by the WHO Director-General on 14 August.
The current plan is subject to inputs by Member States, who were briefed on the plan on Friday, 23 August.
The plan covers the six-month period of September 2024-February 2025, envisioning a US$135 million funding need for the response by WHO, Member States, partners including Africa Centres for Disease Control and Prevention (Africa CDC), communities, and researchers, among others.
A funding appeal for what WHO needs to deliver on the plan will be launched shortly.
The plan, which builds on the temporary recommendations and standing recommendations issued by the WHO Director-General, focuses on implementing comprehensive surveillance, prevention, readiness and response strategies; advancing research and equitable access to medical countermeasures like diagnostic tests and vaccines; minimizing animal-to-human transmission; and empowering communities to actively participate in outbreak prevention and control.
Strategic vaccination efforts will focus on individuals at the highest risk, including close contacts of recent cases and healthcare workers, to interrupt transmission chains.
At the global-level, the emphasis is on strategic leadership, timely evidence-based guidance, and access to medical countermeasures for the most at-risk groups in affected countries.
WHO is working with a broad range of international, regional, national and local partners and networks to enhance coordination across key areas of preparedness, readiness and response. This includes engagement with the ACT-Accelerator Principals group; the Standing Committee on Health Emergency Prevention, Preparedness and Response; the R&D Blueprint for Epidemics; and the interim Medical Counter Measures Network (i-MCM Net).
The WHO R&D Blueprint, along with Africa CDC, Coalition for Epidemic Preparedness Innovations (CEPI) and National Institute of Allergy and Infectious Diseases, will host a virtual scientific conference on 29-30 August 2024 to align mpox research with outbreak control goals.
“The mpox outbreaks in the Democratic Republic of the Congo and neighbouring countries can be controlled, and can be stopped,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Doing so requires a comprehensive and coordinated plan of action between international agencies and national and local partners, civil society, researchers and manufacturers, and our Member States. This SPRP provides that plan, based on the principles of equity, global solidarity, community empowerment, human rights, and coordination across sectors.”
WHO headquarters and regional offices have established incident management support teams to lead preparedness, readiness and response activities, and are significantly scaling up staff in affected countries.
Within the Africa Region, where need is greatest, the WHO Regional Office for Africa (AFRO) in collaboration with Africa CDC, will jointly spearhead the coordination of mpox response efforts. WHO AFRO and Africa CDC have agreed on a one-plan, one-budget approach as part of the Africa Continental Mpox Strategic Preparedness and Response Plan, currently under preparation.
At the national and sub-national level, health authorities will adapt strategies in response to current epidemiological trends.
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