Emergent BioSolutions Takes Action Amid Mpox Surge in Africa
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Emergent BioSolutions Takes Action Amid Mpox Surge in Africa
Emergent BioSolutions is actively engaging with the World Health Organization (WHO), the U.S. government, and global health leaders to combat the surging cases of mpox in Africa. The company has pledged to donate 50,000 doses of its ACAM2000, a smallpox (Vaccinia) vaccine, to Direct Relief, an organization with extensive experience in deploying aid in areas facing severe health crises.
This initiative aims to provide vital resources to challenging-to-reach locations, with guidance from local health authorities. The recent declaration by the WHO has amplified the urgency of the situation, categorizing this outbreak as a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Critical Response to Mpox Outbreak
Dr. Raina McIntyre, a professor at the University of New South Wales, noted that the Africa CDC estimates a requirement of 10 million doses to mitigate the epidemic across the continent. Given the global demand for third-generation vaccines, there are serious concerns regarding the adequacy of supply to address Africa's needs.
Emergent BioSolutions is taking a proactive approach; in October 2023, it filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA). The application seeks an expanded indication for the ACAM2000 vaccine to include immunization against the mpox virus. The review from the FDA is targeted for completion in the third quarter of 2024.
Supporting Global Health Initiatives
The sBLA provides evidence of human safety and data from a well-controlled study indicating the effectiveness of ACAM2000 in protecting against mpox virus exposure. This vaccine, a single-dose administration via a bifurcated needle, has previously been provided to U.S. government stockpiles and international partners.
Emergent BioSolutions has also expressed its willingness to respond to the WHO’s invitation for mpox vaccine manufacturers to submit their products for an Emergency Use Listing (EUL). This process aims to facilitate quicker availability of such crucial vaccines during public health emergencies.
Understanding the Mpox Virus
Mpox is a viral disease related to the variola virus responsible for smallpox. The recent global outbreak associated with West Africa saw over 95,000 cases in 115 non-endemic countries. The more severe Clade I, common in Central Africa, has a higher fatality rate and vulnerability to heightened transmissibility, leading to increased cases affecting children and families.
Joe Papa, CEO of Emergent BioSolutions, emphasized the company's preparedness and commitment to scale response efforts. With existing stockpiles, the company is ready to increase the supply of ACAM2000 by approximately 40 million doses if necessary. The donation of 50,000 doses highlights their immediate support to control this outbreak across Africa.
Historical Context and Public Health Preparedness
The World Health Organization declared smallpox eradicated in 1980; however, emergence risks persist, especially in the context of bioterrorism. There is a significant concern about the current low immunity levels against mpox in many populations worldwide.
Emergent BioSolutions remains committed to addressing these urgent public health threats through its portfolio of vaccines, including ACAM2000, which serves as a key element in preparedness strategies against orthopox viruses such as mpox and smallpox. Its safety labeling recommends caution for individuals with severe immunodeficiencies, as vaccination risks must be carefully weighed against potential smallpox infections.
About Emergent BioSolutions
For over 25 years, Emergent BioSolutions has dedicated itself to protecting public health by preparing for potential health crises. The company has developed a comprehensive range of vaccines and therapeutics, working not just with governments but also with biotech partners. They aim to enhance and protect the lives of one billion people by the year 2030 through their public health initiatives and innovative solutions.
For further inquiries, please contact:
Investor Contact:
Richard S. Lindahl
Executive Vice President, CFO
lindahlr@ebsi.com
Media Contact:
Assal Hellmer
Vice President, Communications
mediarelations@ebsi.com
Frequently Asked Questions
1. What actions is Emergent BioSolutions taking in response to the mpox outbreak?
Emergent BioSolutions is donating 50,000 doses of its ACAM2000 vaccine to Direct Relief and working closely with the WHO and U.S. government to address the outbreak.
2. What is the significance of the ACAM2000 vaccine?
ACAM2000 is a smallpox vaccine that is being proposed for use against mpox and is crucial for public health preparedness against orthopox viruses.
3. What did the WHO declare regarding the mpox outbreak?
The WHO declared the surge in mpox cases in Africa as a public health emergency of international concern, necessitating immediate global health interventions.
4. How does the mpox virus differ from smallpox?
Mpox is caused by a similar virus to the variola virus that causes smallpox, but it exhibits different characteristics, including potentially higher morbidity in certain outbreaks.
5. How can the public access more information about Emergent BioSolutions' efforts?
For more information, interested parties can reach out via the contact emails provided for richard S. Lindahl and Assal Hellmer or visit the company’s website.
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