was first delivered into the SNS in 2002 and was subsequently licensed in the U.
DVC, a biopharmaceutical company and developer of biodefense products, is the first company to be granted an FDA license to produce VIGIV.
DVC is contracted by the Department of Defense Joint Vaccine Acquisition Program (JVAP) to produce VIGIV.
VIGIV is produced by hyperimmunizing volunteers with the smallpox vaccine and then collecting their blood plasma.
VIGIV was requested from CDC and administered intravenously on June 25 because of concerns about the location and extent of lesions and the potential for further spread.
In light of the number, location, and extent of lesions and the recently recalled history of eczema, CDC released VIGIV for the patient with tertiary infection, and he was admitted to the hospital.
On day 12, in an attempt to reduce viral replication and prevent progressive vaccinia, a second 6,000 IU/kg dose of VIGIV was administered along with the investigational antiviral agent, ST-246 (SIGA Technologies, Corvalis, Oregon).
Although her treatment with 2 doses of VIGIV and ST-246 might have contributed to her recovery, the role of these agents is difficult to assess.
As of May 18, MILVAX provided 22 and the Strategic National Stockpile (SNS) provided 254 vials of VIGIV used in treatment of this case.
The improvement of progressive vaccinia in this patient was associated with receipt of VIGIV (the only licensed product for treatment of vaccinia adverse events stockpiled by the SNS), ST-246, and CMX001, and an increase in lymphocyte count.
Before VIGIV administration, serum was positive for antiorthopoxvirus immunoglobulin M (IgM) and negative for immunoglobulin G (IgG) by enzyme-linked immunosorbent assay.
The mother was isolated voluntarily in the same room as her son; on March 10, she received VIGIV treatment.