Emergent BioSolutions Responds to Mpox Surge in Africa
Emergent BioSolutions is taking proactive steps to address the rising cases of mpox in Africa by collaborating with the World Health Organization (WHO), the U.S. government, and global health leaders. The company has committed to donating 50,000 doses of its ACAM2000 vaccine, which is designed to protect against smallpox (Vaccinia), to Direct Relief, an organization well-versed in providing aid during severe health crises.
This initiative aims to deliver essential resources to hard-to-reach areas, guided by local health authorities. The WHO's recent declaration has intensified the urgency of the situation, labeling this outbreak as a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Urgent Response to Mpox Outbreak
Dr. Raina McIntyre, a professor at the University of New South Wales, highlighted that the Africa CDC estimates a need for 10 million doses to effectively combat the epidemic across the continent. With the global demand for third-generation vaccines, there are significant concerns about whether there will be enough supply to meet Africa's needs.
In a proactive move, Emergent BioSolutions filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) in October 2023. This application requests an expanded indication for the ACAM2000 vaccine to include protection against the mpox virus. The FDA is expected to complete its review by the third quarter of 2024.
Advancing Global Health Efforts
The sBLA includes data demonstrating human safety and results from a well-controlled study that shows ACAM2000's effectiveness in protecting against exposure to the mpox virus. This vaccine is administered in a single dose using a bifurcated needle and has previously been included in U.S. government stockpiles and shared with international partners.
Emergent BioSolutions has also expressed readiness to respond positively to the WHO’s invitation for mpox vaccine manufacturers to submit their products for an Emergency Use Listing (EUL). This initiative aims to expedite the availability of vital vaccines during public health emergencies.
Understanding the Mpox Virus
Mpox is a viral disease closely related to the variola virus, which causes smallpox. The recent global outbreak linked to West Africa has resulted in over 95,000 cases across 115 non-endemic countries. The more severe Clade I, prevalent in Central Africa, carries a higher fatality rate and poses a greater risk of increased transmissibility, particularly affecting children and families.
Joe Papa, CEO of Emergent BioSolutions, emphasized the company's readiness and commitment to scaling up response efforts. With existing stockpiles, the company is prepared to boost the supply of ACAM2000 by around 40 million doses if necessary. The donation of 50,000 doses underscores their immediate support to help control this outbreak in Africa.
Historical Context and Public Health Preparedness
Although the World Health Organization declared smallpox eradicated in 1980, the risks of re-emergence remain, particularly in the context of bioterrorism. There are significant concerns about the current low immunity levels against mpox in various populations worldwide.
Emergent BioSolutions is dedicated to tackling these pressing public health threats through its range of vaccines, including ACAM2000, which is a crucial component in preparedness strategies against orthopox viruses like mpox and smallpox. The vaccine's safety labeling advises caution for individuals with severe immunodeficiencies, as the risks of vaccination must be carefully considered against the potential for smallpox infections.
About Emergent BioSolutions
For over 25 years, Emergent BioSolutions has focused on safeguarding public health by preparing for potential health crises. The company has developed a wide array of vaccines and therapeutics, collaborating with both governments and biotech partners. Their goal is to enhance and protect the lives of one billion people by 2030 through innovative public health initiatives and 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 is collaborating closely with the WHO and U.S. government to tackle 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 plays a crucial role in public health preparedness against orthopox viruses.
3. What did the WHO declare regarding the mpox outbreak?
The WHO declared the rise in mpox cases in Africa as a public health emergency of international concern, highlighting the need for immediate global health interventions.
4. How does the mpox virus differ from smallpox?
Mpox is caused by a virus related to the variola virus that leads to smallpox, but it has different characteristics, including potentially higher morbidity in certain outbreaks.
5. How can the public access more information about Emergent BioSolutions' efforts?
For more details, interested individuals can reach out via the contact emails provided for Richard S. Lindahl and Assal Hellmer or visit the company’s website.
