U.S. officials are contracting with two companies for thousands of doses of vaccinia immune globulin, the only clinically tested antidote for many reactions to the smallpox vaccine, the New York Times reported today (see GSN, Nov. 7).

If U.S. officials were forced to begin mass inoculations against smallpox today, they would not have enough of the globulin, known as VIG, according to the Times.  Regardless of which smallpox immunization plan U.S. President George W. Bush chooses, the United States will need substantial quantities of VIG, which is produced from plasma extracted from the blood of people who have been recently immunized against smallpox (see GSN, Oct. 17).

Health officials have told the Defense Department’s VIG producer to expect one case of severe adverse effects from the vaccine for every 8,000 immunizations (see GSN, Nov. 8).

“Given the uncertainties here, that may not be a bad estimate,” said Raymond Strikas, an epidemiologist at the U.S. Centers for Disease Control and Prevention.

In October, the United States had less than 700 doses of VIG, but U.S. health officials hope to have 5,000 doses by the end of the year, enough to treat the complications of 40 million immunized people.  It might take as long as two years to produce enough VIG to protect the entire country safely.  Officials are unsure exactly how much they need because conditions that cause adverse reactions — including suppressed immune systems and a variety of skin rashes — have increased substantially since the last study on side effects in the 1960s (see GSN, Oct. 18).

VIG Production Underway

The United States has ordered VIG from DynPort Vaccine Company in Maryland and Cangene Corporation of Winnipeg, Canada.  Using stored plasma from immunized soldiers, DynPort has produced VIG to treat 660 reactions, according to David Smith, the company’s chief scientist.  DynPort has tested the antidote on volunteers, and no adverse side effects have arisen, even with dramatically increased dosages, Smith said.

The U.S. government has tasked Cangene with producing as many as 100,000 doses over the next five years, the Times reported.  The company plans to immunize 10,000 volunteers — who must be previously immunized and are medically screened — and use their plasma to produce the VIG.  The company has found 1,300 donors to date and has not experienced any adverse reaction to the immunization (McNeil/Altman, New York Times, Nov. 12).

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