Emergent BioSolutions Secures $400M in 2024-2025 for Smallpox and Mpox Preparedness

Emergent BioSolutions Inc. has announced securing around $400 million in orders for 2024 and 2025 linked to its vaccinia, smallpox, and mpox product lineup. This involves the U.S. government contract modification for ACAM2000® and exercised contract options for CNJ-016® (Vaccinia Immune Globulin Intravenous, Human) in 2023 and 2024. So far in 2024, nearly $210 million worth of ACAM2000® and VIGIV products have been delivered. An additional $185 million in orders is confirmed for delivery through the rest of 2024 and into 2025.

Joe Papa, Emergent's president and CEO, expressed confidence in the company’s long-standing role in public health preparedness, emphasizing the importance of their products and capabilities in addressing serious viral threats like smallpox and mpox. The company’s commitment spans 25 years of public health readiness amid an increasingly hazardous global landscape.

Emergent has also been actively combating the ongoing mpox outbreak. In August, the U.S. Food and Drug Administration updated the ACAM2000® label to include mpox prevention for individuals at high risk. Following this regulatory milestone, Emergent submitted an Expression of Interest for the ACAM2000® vaccine to be considered for Emergency Use Listing (EUL) by the World Health Organization (WHO). This submission is part of a broader WHO effort to support the global mpox response. Emergent is currently in discussions with the WHO about the next steps for potential EUL or Prequalification submission for ACAM2000®.

In alignment with their commitment to the global mpox response, Emergent has donated 50,000 doses of ACAM2000® for potential use in affected countries across Africa.

The ACAM2000® vaccine is approved in the U.S. for preventing smallpox and mpox in high-risk individuals but carries several contraindications and warnings. It is not recommended for individuals with severe immunodeficiency due to the risk of severe infection. Other risks associated with the vaccine include myocarditis, encephalitis, severe skin infections, and potential complications that can lead to blindness or death.

CNJ-016®, or Vaccinia Immune Globulin Intravenous (Human) (VIGIV), is an immune globulin used to treat vaccinia vaccination complications. It is indicated for various conditions, such as progressive vaccinia and eczema vaccinatum but is not effective for postvaccinial encephalitis. VIGIV should not be used in patients with certain hypersensitivities or those with isolated vaccinia keratitis. It carries risks like acute renal failure, thrombosis, hemolysis, and aseptic meningitis, among others. Special precautions are necessary for patients with pre-existing conditions or potential for severe reactions.

Emergent BioSolutions is dedicated to protecting and enhancing life, with a mission to defend against public health threats. The company offers a range of vaccines and therapeutics and integrated contract development and manufacturing services. The goal is to safeguard communities and enhance their preparedness for potential health emergencies.