FDA approves VIG for smallpox shot complications

Feb 24, 2005 (CIDRAP News) – An intravenous form of vaccinia immune globulin (VIG), used to treat serious reactions to smallpox vaccine, has gained approval by the Food and Drug Administration (FDA) for the first time.

The FDA announced approval of Vaccinia Immune Globulin Intravenous (VIGIV) Feb 18. The product is made by DynPort Vaccine Co. LLC, based in Frederick, Md. DynPort is under a long-term contract to produce vaccines and related products for the Department of Defense (DoD).

VIG previously has been available only under "investigational new drug" (IND) rules. In older formulations, it could be injected only into muscle because it contained too much aggregated protein to be given intravenously, according to the Centers for Disease Control and Prevention (CDC).

VIG is derived from the plasma of people recently inoculated against smallpox; it contains antibodies to vaccinia, the virus used in the shot. VIGIV is made from plasma given by immunized US military personnel. The product is used to treat serious vaccinia complications such as generalized vaccinia, eczema vaccinatum, and progressive vaccinia.

The FDA said VIGIV was tested clinically in 111 volunteers and was well tolerated. "When adverse effects were noted, they were mild to moderate and included headaches, hives, and other rashes," the agency's news release said.

DynPort reported in August 2004 that it had tested VIGIV in separate studies involving 33 and 78 volunteers, none of whom had a serious reaction to the product. At the time, the company said VIGIV would be its first licensed product.

Current information on the CDC Web site says about 2,700 doses of VIG are available. In the past VIG was used at the rate of 47 doses per 1 million primary vaccinees and 2 doses per million revaccinees, according to the CDC. About 39,600 civilian healthcare personnel have received smallpox shots in the past 2 years in a CDC effort to prepare for the risk of a bioterrorist release of smallpox virus.

DynPort spokeswoman April Finnen referred questions about how many doses of VIGIV the company is making to DoD officials. As of this writing, DoD had not provided any information in response to questions asked yesterday.

In the current DoD smallpox vaccination program, three people have been treated with VIG out of 730,000 military personnel vaccinated as of Feb 21, according to the DoD's latest smallpox vaccination safety update. Two of the patients had ocular vaccinia infections and one was a burn patient.

Another company, Cangene, based in Winnipeg, Man., has a 5-year contract to produce up to 100,000 doses of VIG for the CDC. The product is in "late stage clinical development," according to the company Web site.

See also:

CDC information on VIG
http://www.bt.cdc.gov/agent/smallpox/vaccination/mgmt-adv-reactions.asp

DoD smallpox vaccination safety summary
http://www.smallpox.army.mil/event/SPSafetySum.asp

CDC VIG fact sheet for the public
http://www.bt.cdc.gov/agent/smallpox/vaccination/vig.asp

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