• Active engagement with the World Health Organization, U.S. government and other global health leaders on critical efforts to prevent mpox disease transmission
• 50,000 doses of ACAM2000^®, (Smallpox (Vaccinia) Vaccine, Live) will be donated to Direct Relief for potential deployment across often difficult-to-reach locations, and as informed by local and regional health authorities

Emergent BioSolutions  announced it is proactively working with the World Health Organization (WHO) and the U.S. government to partner and help address the current mpox outbreak across Central Africa, and has pledged to donate 50,000 doses of its ACAM2000^®, (Smallpox (Vaccinia) Vaccine, Live), through Direct Relief, a humanitarian relief organization with a long history of providing vital medicines to the Democratic Republic of the Congo (DRC), as well as the other impacted countries of Burundi, Kenya, Rwanda, and Uganda. These efforts are in response to the WHO’s Director-General’s August 14 statement declaring that the upsurge of mpox in the DRC and a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR).

“Africa CDC estimated they will need 10 million doses to control the epidemic in the continent,” said Dr. Raina McIntyre, Professor of Global Biosecurity, NHMRC L3 Research Fellow, Head, Biosecurity Program, Kirby Institute, University of New South Wales Sydney. “It is unlikely there will be enough supply of 3^rd generation vaccines to control the epidemic in Africa, given demand in other countries.”

In October 2023, Emergent filed a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking an expanded indication for ACAM2000^® vaccine to include immunization against mpox virus. The sBLA, which has an FDA target for review completion in the third quarter 2024, includes previously available human safety data and data from a well-controlled animal study in which ACAM2000^® vaccine has been shown to be effective in protecting against mpox virus exposure. ACAM2000^® is a single-dose vaccine administered via a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine.

Accordingly, Emergent has also responded to the WHO invitation for manufacturers of mpox vaccines to submit an Expression of Interest for the WHO’s assessment of ACAM2000^® vaccine to be added as an Emergency Use Listing (EUL), which is a WHO risk-based procedure for assessing and listing unlicensed medical products in various countries with the aim of expediting the availability of these products needed in public health emergency situations like the current mpox outbreak.

“As the WHO has declared, the mpox outbreak is a public health emergency of international concern, and Emergent is ready to scale up response efforts and partner with U.S. and global public health leaders,” said Joe Papa, president and CEO, Emergent BioSolutions. “For years, Emergent has supplied ACAM2000^® to the U.S. and allied governments in support of preparedness and stockpiling initiatives. Currently, we have additional product already in inventory, with the ability to increase supply by approximately 40 million doses, if and potentially when needed. In the meantime, 50,000 doses of ACAM2000^® vaccine will be donated to help control the outbreak across the African continent.”

Mpox is a disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. In 2022, the world experienced a global outbreak of clade II mpox, associated with West Africa, which led to more than 95,000 cases across 115 non-endemic countries.

Clade I is endemic to Central Africa and is characterized by more severe clinical outcomes and a higher case fatality rate. The recently identified clade Ib variant, exhibiting enhanced transmissibility through close contact, has led to an increase in cases, particularly in Central Africa, and a sizable impact on children and families. According to the WHO, clade I mpox tends to cause a higher number of severe infections and have a higher mortality rate than clade II mpox.

Papa continued, “The increasing outbreaks of mpox around the world should raise concerns and spur ongoing efforts to produce and stockpile vaccines and treatments to address all orthopox viruses, including mpox and smallpox.”

In 1980, the WHO officially declared smallpox eradicated; however, the threat of reemergence by intentional introduction (e.g., bioterrorism) persists and minimal immunity in populations today against mpox exists. Vaccines like ACAM2000^® formed the basis of one of the most successfully integrated public health responses in the eradication of smallpox.