Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract modification has been secured 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.
“Securing this contract modification for VIGIV treatment underscores Emergent’s ongoing partnership with the U.S. government to support its overall smallpox preparedness strategy,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “We are proud to fulfill our mission to protect and save lives and stand ready to provide our diverse medical countermeasures through our North American supply chain and capabilities for stockpiling to help address public health threats in the United States and around the world.”
This contract modification award follows Emergent’s recently announced BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] contract amendment with ASPR under contract 75A50119C00075.
Indication and Select Important Safety Information for CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV)
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. (See full prescribing information for complete boxed warning)
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.
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.
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