Pinellas lab in smallpox program

A Dunedin lab is among several that will use volunteers to produce doses of antibodies for those who suffer reactions to the smallpox vaccine.

By WES ALLISON, Times Staff Writer
© St. Petersburg Times
published December 4, 2002

DUNEDIN -- As the United States prepares for a potential smallpox attack, health officials need more than just the vaccine and a plan to distribute it: They also need an antivenin, of sorts, for people who suffer dangerous reactions to the vaccine.

The only way to get that antivenin -- a booster shot of smallpox antibodies -- is from the blood of people recently inoculated.

Now a small number of clinics across the country, including one in Dunedin in Pinellas County, are beginning to recruit volunteers for a federal program designed to restore stocks of Vaccinia Immune Globulin, or VIG, which will be used to treat those who suffer serious complications from the vaccine.

Many of the 2,300 people signed up so far say they want the protection of the vaccine and want to help out. They include Steve Jones of the Orange County Sheriff's Office, who spent an hour Tuesday morning at a clinic in suburban Orlando with a needle in his arm, squeezing a rubber ball to make his blood pump faster.

He received the smallpox vaccination about six weeks ago and will give plasma twice a week as long as his immune system keeps producing active antibodies. He's paid $50 for each visit.

"I did it because I didn't want to get infected and bring it home to my 21/2-year-old daughter," Jones said. "Plus, I feel I like I'm giving something back to the community."

The smallpox vaccine is not available to the public. For this project, it is provided by the U.S. Centers for Disease Control and Prevention under the auspices of a clinical trial.

The CDC wants 30,000 doses of VIG by this time next year and roughly 100,000 doses within the next five years. It has contracted with a Canadian biologics company, Cangene Corp., to produce it.

Cangene, which expects to earn about $60-million this year from the deal, has hired about 16 U.S. biologics labs to recruit volunteers, administer the vaccine and harvest their plasma.

They include DCI Biologicals in Dunedin and Orlando; a lab in Jacksonville; and Mid-Florida Biologicals Inc. in Altamonte Springs, where Orange County Sheriff Kevin Beary got his vaccination Tuesday.

He has encouraged his department's 2,100 deputies and staff to do so as well, making his the first major police agency in the nation to offer widespread smallpox vaccinations to its officers.

DCI Biologicals in Dunedin plans to begin recruiting volunteers by Christmas and also will shop the idea first to local police, firefighters and rescue workers -- many of whom may want the shot -- before targeting the general public. But anyone can apply.

"It's open-ended," said Eric Bigon, the immunization coordinator at DCI Biologicals Dunedin Inc. "We're hoping to get as many as possible."

Routine smallpox vaccination ended in 1972, and federal health officials say the United States would be vulnerable to an attack from a terrorist group or rogue state such as North Korea or Iraq, which both are thought to have the virus.

That has prompted federal health officials to consider reinstituting vaccination. President Bush is expected soon to announce plans for inoculating roughly 500,000 hospital workers, 500,000 soldiers and some 10-million emergency workers. The vaccine may then be made available to the general public.

In the meantime, the CDC wants to build up stores of VIG to treat complications from the vaccine. Although the smallpox vaccine is generally safe, minor complications are common, and health officials say they can expect a handful of deaths for every 1-million people vaccinated.

CDC spokesman Curtis Allen said the agency wants one dose of VIG for every 30,000 doses of smallpox vaccine, but right now it has just 700 doses. The nation has tens of millions of doses of smallpox vaccine available.

Cangene says it expects to enroll about 10,000 participants, and all must meet the same criteria: The study is open to anyone aged 18 to 60 who has previously been vaccinated against smallpox, although this cuts out most people under 30.

They cannot be pregnant or have any one of a variety of health conditions. They must undergo a short initial screening, then a thorough physical before being accepted.

Once vaccinated, participants must give plasma twice a week for at least five weeks. They will be paid $50 for most visits.

How the Vaccinia Immune Globulin works is fairly straightforward. The smallpox vaccine is made from a live virus that causes a minor infection at the vaccination site. Normally, this prompts the body to produce antibodies to attack and kill the infection, as well as provides long-term immunity, teaching the immune system to recognize smallpox if it shows up again later.

Some people, however, can't fight the initial infection, so they get sick, or develop severe skin conditions. This usually is the result of diseases or treatments that suppress the immune system, such as HIV or chemotherapy. Even eczema can cause problems.

Although state and federal plans for mass vaccination call for careful screening before administering the shot, some who shouldn't get the vaccine will slip through. And there may be times when the risk of not giving the vaccine outweighs the risk of giving it.

In those cases, VIG provides a shot of pure, smallpox-fighting antibodies that can stop the initial infection, experts said.

"You're giving that immune system a boost to get over that short-term hump," said Dr. Ronald D. Brown, the principal investigator of the study at Mid-Florida Biologicals. "It protects them from the vaccine."

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