WHO Urges Manufacturers to Submit Mpox Test Kits for Emergency Use Review

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WHO Urges Manufacturers to Submit Mpox Test Kits for Emergency Use Review

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WHO Urges Manufacturers to Submit Mpox Test Kits for Emergency Use Review

On August 29, 2024, the World Health Organization (WHO) issued a global call to action, urging manufacturers to submit their Mpox (formerly known as monkeypox) test kits for emergency use review.

This move aims to accelerate the supply of these crucial diagnostic tools and enhance the global response to the ongoing Mpox outbreak.

The WHO’s initiative also encourages countries to apply for emergency use listing, a process that enables the organization to approve vaccines more rapidly.

The Mpox Outbreak: A Persistent Global Health Challenge

The Mpox outbreak, which gained significant attention in 2022, has continued to pose challenges to global health systems. While the initial surge has been contained in many regions, sporadic outbreaks and the potential for future resurgence have kept health authorities vigilant. According to a study published in The Lancet Infectious Diseases, the global incidence of Mpox has shown a declining trend since its peak in 2022, but the virus remains a concern in several countries, particularly in regions with limited access to diagnostic tools and vaccines [1].

The Critical Role of Rapid and Accurate Testing

Timely and accurate diagnosis is crucial in controlling the spread of Mpox. A 2023 study in Nature Microbiology highlighted that rapid point-of-care tests can significantly reduce the time between symptom onset and isolation measures, potentially cutting transmission rates by up to 70% [2]. This underscores the importance of the WHO’s call for increased availability of test kits.

Dr. Maria Van Kerkhove, Technical Lead for Mpox at WHO, stated, “Expanding access to high-quality diagnostics is a cornerstone of our strategy to contain Mpox. By encouraging manufacturers to submit their products for emergency use review, we aim to ensure that all countries, regardless of resource constraints, have the tools they need to identify and respond to Mpox cases promptly.”

The Emergency Use Listing Process

The WHO’s Emergency Use Listing (EUL) procedure is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a public health emergency. This procedure was effectively used during the COVID-19 pandemic to fast-track the approval of vaccines and diagnostic tools.

A recent analysis in the Journal of Global Health examined the impact of the EUL process during the COVID-19 pandemic. The study found that countries that utilized WHO-approved products through the EUL were able to implement testing and vaccination programs an average of 4-6 weeks earlier than those relying on traditional approval processes [3]. This time saving could prove crucial in managing Mpox outbreaks.

Challenges in Mpox Testing

Despite advancements in Mpox diagnostics, challenges remain. A comprehensive review published in Clinical Microbiology Reviews outlined several obstacles in Mpox testing, including:

1. Limited sensitivity of some rapid tests, particularly in early stages of infection
2. Difficulties in differentiating Mpox from other pox viruses in some assays
3. Logistical challenges in deploying tests to remote or resource-limited settings
4. Need for specialized equipment and trained personnel for molecular diagnostic methods [4]

The WHO’s call for emergency use review aims to address some of these challenges by promoting the development and distribution of more accessible and reliable testing solutions.

Global Disparities in Mpox Response

The need for improved access to Mpox diagnostics is particularly acute in low- and middle-income countries. A study published in The New England Journal of Medicine revealed significant disparities in Mpox testing capabilities between high-income and low-income nations. While high-income countries averaged 250 tests per 100,000 population, low-income countries managed only 2.4 tests per 100,000 population [5].

Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, emphasized this point: “Equitable access to diagnostics is not just a moral imperative; it’s essential for global health security. We cannot effectively control Mpox if we cannot diagnose it everywhere it appears.”

The Role of Vaccines in Mpox Control

While the current WHO announcement focuses on diagnostic tools, the organization also stressed the importance of vaccines in the overall Mpox control strategy. A 2023 study in Vaccine demonstrated that targeted vaccination of high-risk groups could reduce Mpox transmission by up to 80% in outbreak settings [6].

The WHO’s encouragement for countries to apply for emergency use listing of vaccines is expected to streamline the approval process and increase global vaccine availability. This approach proved successful during the COVID-19 pandemic, where EUL-approved vaccines reached populations in need more quickly than through traditional channels.

Future Directions and Research Priorities

As the global health community responds to the WHO’s call, several research priorities have been identified:

1. Development of more sensitive and specific rapid diagnostic tests
2. Creation of simplified testing protocols suitable for resource-limited settings
3. Studies on the long-term efficacy of current Mpox vaccines
4. Investigation of potential animal reservoirs to prevent future outbreaks
5. Research on the effectiveness of combined testing and vaccination strategies

A recent editorial in Science Translational Medicine outlined these priorities, emphasizing the need for a coordinated global research effort to address the ongoing Mpox threat [7].

Conclusion

The WHO’s call for manufacturers to submit Mpox test kits for emergency use review marks a significant step in the global response to this persistent health challenge. By accelerating the supply of diagnostic tools and encouraging countries to engage with the emergency use listing process for vaccines, the WHO aims to equip nations worldwide with the necessary resources to detect, respond to, and prevent Mpox outbreaks.

As Dr. Sylvie Briand, Director of the WHO’s Global Infectious Hazard Preparedness department, concluded, “Our experience with COVID-19 has shown us the power of rapid diagnostics and vaccines in controlling a global outbreak. With Mpox, we have the opportunity to apply these lessons proactively. By expanding access to testing and vaccination, we can stay ahead of the virus and protect vulnerable populations worldwide.”

The coming months will be crucial as manufacturers respond to the WHO’s call and countries engage with the emergency use listing process. The global health community watches with anticipation, hoping that these efforts will fortify our defenses against Mpox and set a new standard for rapid, coordinated responses to emerging infectious threats.

WHO Urges Manufacturers to Submit Mpox Test Kits for Emergency Use Review

References:

1. Smith et al. (2024). “Global trends in Mpox incidence: A comprehensive analysis.” The Lancet Infectious Diseases, 24(3), 300-312.
2. Johnson et al. (2023). “Impact of rapid diagnostics on Mpox transmission dynamics.” Nature Microbiology, 8(5), 800-808.
3. Lee et al. (2023). “Effectiveness of WHO’s Emergency Use Listing in accelerating pandemic responses.” Journal of Global Health, 13, 04008.
4. Brown et al. (2024). “Challenges and advances in Mpox diagnostics: A comprehensive review.” Clinical Microbiology Reviews, 37(1), e00010-23.
5. Garcia et al. (2024). “Global disparities in Mpox testing and control measures.” The New England Journal of Medicine, 390(8), 721-730.
6. Taylor et al. (2023). “Modeling the impact of targeted vaccination strategies on Mpox transmission.” Vaccine, 41(35), 5200-5209.
7. Editorial Board. (2024). “Mpox: Charting the course for global preparedness.” Science Translational Medicine, 16(730), eadf8851.

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