The World Health Organization (WHO) has called on manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL). This move, aimed at addressing the urgent need for effective diagnostics, comes as suspected mpox cases rise, particularly in the Democratic Republic of the Congo (DRC), which reported around 1000 suspected cases last week.1
To combat the outbreak, WHO has increased testing capacity and established six new labs in affected provinces, including South Kivu. Testing rates have quadrupled in 2024 compared to the previous year. WHO’s updated diagnostic guidance now includes protocols for detecting a new viral strain, Ib, and additional tests are being dispatched to African countries, with 30,000 more scheduled for delivery in the coming weeks.1
WHO’s updated diagnostic guidance includes protocols for detecting the new virus strain. Earlier, WHO issued target product profiles to assist manufacturers in developing new diagnostic tests. The organization has delivered approximately 150,000 tests globally since 2022, with over a quarter allocated to African countries. An additional 30,000 tests are set to be delivered to Africa in the coming weeks.1
Main Takeaways
- The WHO is urging manufacturers to submit diagnostics for Emergency Use Listing to address the rising mpox cases, particularly in the Democratic Republic of the Congo.
- Emergent BioSolutions' ACAM2000 vaccine has been FDA-approved for mpox prevention, with 50,000 doses to be donated to Central Africa as part of a broader global response.
- The global health community is intensifying efforts to combat mpox through increased diagnostic testing, expanded vaccine use, and international collaboration amid a surge in cases and new viral strains.
Concurrently, Emergent BioSolutions Inc announced that the FDA has approved its supplemental Biologics License Application (sBLA) for ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live). This approval expands the vaccine’s use to include mpox prevention in high-risk individuals. ACAM2000, initially approved for smallpox in 2007, is now also indicated for mpox, an infectious disease endemic to Africa.2
ACAM2000 is a single-dose vaccine delivered using a bifurcated needle. Originally approved by the FDA in 2007 for preventing smallpox, it is now also indicated for mpox.2
The approval comes as mpox cases surge globally, prompting the WHO to declare a public health emergency. The company has filed an Expression of Interest with WHO to add ACAM2000 to the EUL and will donate 50,000 doses for potential deployment in Central Africa.2
Emergent’s CEO, Joe Papa, emphasized, “This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”2
The 2022 global outbreak of clade II mpox saw over 95,000 cases across 115 non-endemic countries. The clade I variant, including the newly identified clade Ib strain, has shown more severe outcomes, increasing the urgency for effective vaccines like ACAM2000 in the present day.
ACAM2000 is also stockpiled in the US and internationally for bioterrorism emergencies and is licensed in Canada, Australia, and Singapore. The vaccine’s labeling includes warnings for individuals with severe immunodeficiency and risks such as myocarditis and skin infections.
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