FDA approval of Vaccinia Immune Globulin to treat adverse reactions to smallpox vaccination

Computer Sciences Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved its Vaccinia Immune Globulin (VIGIV), an intravenous immune globulin, to treat rare adverse reactions to smallpox vaccination. The VIGIV program is managed by DVC LLC, a CSC company, for the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office.

VIGIV is the first FDA-licensed product for both DVC and the JVAP. The VIGIV program was granted fast-track and orphan drug designation by the FDA. "Orphan" designation is a special status granted to a product that treats a rare disease or condition.

"The licensure of this product marks a significant milestone in the history of JVAP and our eight-year relationship with DVC," said JVAP Product Manager Lieutenant Colonel Travis Bernritter. "This is the culmination of years of hard work, which will ultimately benefit our country's armed forces."

JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to protect the war fighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.

DVC is a biopharmaceutical company dedicated to the development and licensure of safe and efficacious biodefense vaccines and therapeutics. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2002 to support programs enhancing U.S. security.



The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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