Emergent BioSolutions Inc. announced it has secured a contract award valued at approximately $54 million USD to deliver CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) to the Administration for Strategic Preparedness and Response (ASPR), part of the U. S. Department of Health and Human Services (HHS), for smallpox preparedness. ASPR exercised an option from its existing 10-year contract (75A50119C00037) for additional doses of VIGIV, a treatment for complications due to smallpox vaccination.

In addition, Emergent has secured new incremental orders with an international government partner valued at $6.6 million USD. This represents product orders for ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) within Emergent’s medical countermeasures portfolio and will support the partner’s smallpox biodefense strategy. These orders stem from a recurring international customer and demonstrate the importance of threat preparedness around the world.

“We are pleased to support both the U.S. government and a longstanding international partner with critical smallpox medical countermeasures that directly align with their national security and public health preparedness efforts,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “Our strong track record of developing, manufacturing and supplying biodefense products to international governments reinforces the strength of our partnerships, particularly in light of the growing risk of biological threats globally.”

This announcement follows Emergent’s recent execution of multi-year agreements with the Government of Canada valued up to $140 million CAD to support the country’s biologic threat preparedness and response infrastructure, of which, more than $35 million CAD orders will be received in 2026.

U.S. FDA-Approved Indication and Select Important Safety Information for CNJ-016^® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV)

Indication
VIGIV is an Immune Globulin (Human), 5% Liquid, indicated for the treatment of complications due to vaccinia vaccination including eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, vaccinia infections in individuals who have skin conditions, and aberrant infections induced by vaccinia virus (except in cases of isolated keratitis). VIGIV is not indicated for postvaccinial encephalitis.  

Important Safety Information
Warning: Interactions with Glucose Monitoring Systems

Blood glucose measurement in patients receiving Vaccinia Immune Globulin Intravenous (Human) (VIGIV) must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Maltose in IGIV products may give falsely high blood glucose levels in certain types of blood glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.

Contraindications: VIGIV is contraindicated in isolated vaccinia keratitis, individuals with a history of anaphylactic or severe systemic reaction to human globulins, and IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity.

Warnings & Precautions:

• Hypersensitivity to human immune globulin (acute anaphylaxis)
• Acute renal dysfunction/failure
• Thrombosis may occur with immune globulin products, including VIGIV. For patients at risk of thrombosis, administer VIGIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity
• Hemolysis or hemolytic anemia
• Aseptic meningitis syndrome (AMS)
• Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)]
• Transmission of infectious agents from human plasma
• Monitor renal function and urine output in patients at risk of renal failure; check baseline blood viscosity in patients at risk of hyperviscosity; and conduct confirmatory tests if hemolysis or TRALI is suspected

Adverse Reactions: The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness.