Staff Writer

With an FDA nod for its vaccinia immune globulin, DVC LLC will provide the U.S. military with a product addressing the serious side effects of the smallpox vaccine.

Although smallpox was declared globally eradicated about 25 years ago, there is fear that terrorists could get their hands on the limited scientific samples of the virus that remain.

That is why DVC (formerly DynPort Vaccine Co.), which became wholly owned by El Segundo, Calif.-based Computer Sciences Corp. (CSC) last year, began working on the intravenous product vaccinia immune globulin (VIGIV) in 1998. Its research was part of a project spanning eight years with the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office.

VIGIV has orphan drug designation and it is the first FDA-licensed product for both JVAP and DVC.

"Because the smallpox vaccine is made of the live virus, even though it's a weakened version of the virus, it can occasionally cause serious side effects," said Terry Irgens, president of DVC.

The Centers for Disease Control and Prevention in Atlanta said about 1,000 people in every 1 million vaccinated experience serious reactions, such as a vaccinia rash, or a toxic and allergic rash. Less serious reactions include soreness where the vaccine was administered, large and sore glands in the armpits, a low fever and trouble sleeping and conducting daily tasks.

VIGIV is designed specifically to address the rash, which can spread all over the body and can be transmitted by contact with another person. The vaccine for the side effect is given only when the serious reaction occurs after administration of the smallpox vaccine.

Inventing a smallpox vaccine that does not contain a live virus could help thwart the serious rash side effect, but it would take several years to develop.

Following the terrorist attacks of Sept. 11, 2001, military personnel began taking the smallpox vaccine as a precautionary measure. While DVC already was working in that area, the company accelerated the production of the doses on hand and prepared for mass vaccination, Irgens told BioWorld Today.

"It definitely heightened the concern," he said. "Of course, the CDC classified smallpox as the greatest threat to public health."

VIGIV now may have FDA approval, but DVC does not intend to market it to the general population - at least not at this point in time.

"All of the product that we have on hand and the doses that we will be making in the future have all been designated for the Department of Defense," Irgens said.

The company already has received payment for the development and licensure of the vaccine. If an emergency occurs within the general population, the FDA approval allows VIGIV to be made and used for people other than military personnel, Irgens said.

Another company, Winnipeg, Manitoba-based Cangene Corp., is developing the same product, called vaccinia hyperimmune globulin, for the CDC and the Department of Health and Human Services. That product is awaiting FDA approval. (See BioWorld Today, Aug. 4, 2004.)

DVC's biologics license application for VIGIV consisted of Phase I data that showed no serious adverse events among 33 healthy volunteers who each received a 100-mg dose per kilogram of body weight. A previous study also showed no serious adverse events in 79 volunteers receiving doses up to 500 mg per kilogram of body weight.

DVC initially evolved as a joint venture of DynCorp, of Reston, Va., and London-based Porton International plc. CSC acquired DynCorp in 2003, and it acquired Porton's interest in DVC last August.

Aside from VIGIV, DVC is working with the government on vaccines for botulinum neurotoxin, tularemia, Venezuelan equine encephalitis, anthrax and plague.

CSC's stock (NYSE:CSC) dropped 7 cents Wednesday, to close at $44.93.