There are side affects so be careful if you do.

President Bush's expected plan to offer smallpox vaccination to about 1 million Americans in preparation for possible bioterrorism raises a host of questions about the risks of a vaccine that could cause life-threatening illnesses in some of the people it is intended to protect.

If, as expected, the White House endorses a vaccination plan, experts say there will likely be at least some serious illnesses and possibly deaths caused by the vaccine itself. Yet, they say, if nothing is done to protect vulnerable Americans, a single case of smallpox could ignite an epidemic that could kill millions.

The last known case of smallpox occurred in Somalia in 1977, and the only legitimate stocks of the virus are locked in labs in Russia and at the Centers for Disease Control and Prevention in Atlanta. But scientists and military experts believe that clandestine stockpiles of smallpox exist in Iraq, North Korea and elsewhere. As talk of war with Iraq heats up, concern about how best to protect the public has grown more urgent.

Smallpox is highly contagious and spreads from person to person through the air. It kills about a third of its victims and leaves many survivors blind or disfigured. The vaccine, which contains a live virus similar to smallpox called vaccinia, has not been used routinely in the USA since 1972, so almost all Americans age 30 or younger are completely vulnerable.

In October, a panel of public health experts, the Advisory Committee on Immunization Practices, endorsed vaccination of health workers in every state to create a pool of immunized doctors, nurses and others who could safely care for the first victims, should terrorists set the virus loose. In addition, the Pentagon is expected to vaccinate U.S. troops in advance of a possible war with Iraq.

For every million people who get the vaccine for the first time, the CDC says, there could be 1,000 reactions severe enough to require medical care, 14 to 52 that are potentially life-threatening, and one or two deaths.

If all Americans ages 1 to 65 were vaccinated today, as many as 4,600 serious illnesses and 285 deaths could result, according to a report published last spring in the journal Effective Clinical Practice.

Revaccination not as risky

Among people being revaccinated, side effects are far rarer, experts say. In Israel, where about 12,000 health care workers, police and other emergency personnel were recently vaccinated, no serious reactions have been reported.

That's not a surprise, says Jerry Hauer, head of the Office of Public Health Preparedness at the Department of Health and Human Services. "The people they're choosing to vaccinate now have been previously vaccinated," Hauer says, so while U.S. officials are keeping a close eye on the Israeli experience, "it makes it difficult to take anything from it right now and try to look at what our experience potentially could be, if the president moves forward with the program."

More than a third of those vaccinated for the first time in a recent study got sick enough to miss work or other activities or had trouble sleeping.

If the vaccine were offered to all Americans as a precaution, about 25%, or roughly 70 million people, would be ineligible to take it because of health conditions such as cancer, AIDS or skin infections like eczema, which could put them at higher risk for serious vaccine side effects. People who have ever had eczema, even if the condition was mild, are at risk of eczema vaccinatum, a condition in which the virus in the smallpox vaccine spreads in the body and causes lesions over the area once afflicted by eczema. It is usually mild but can be severe and, in rare cases, fatal.

Pregnant women and people who live in households with immune-suppressed people or those with a history of eczema are also excluded from vaccination.

The vaccine poses a special risk to millions of people with impaired immune systems, such as those with HIV or who are undergoing chemotherapy or other medical treatments. They could contract potentially fatal vaccinia infection from recently vaccinated relatives or other close contacts.

Although some political leaders and parents groups have pushed for voluntary vaccination for all Americans, others urge caution. They cite historical data that found many of the illnesses associated with smallpox vaccine occurred in people who weren't even vaccinated; they contracted the vaccinia virus from household members.

Such infections can be treated — though it's not clear how effectively — with vaccinia immune globulin, or VIG, a substance taken from the blood of previously vaccinated people. Currently, there are 700 doses of VIG, which the CDC says is what would be needed if up to 6 million people were vaccinated. More VIG is being produced, and 3,000 more doses are expected to be available by March.

In addition to VIG, a drug called cidofovir, used to treat eye disease in AIDS patients, has been effective in animal studies. The CDC says there are 3,500 doses of it available, enough to treat the reactions expected if 15 million people were immunized against smallpox.

How much protection?

In healthy people, vaccinia virus prompts an immune response that provides full protection against smallpox for about five years, waning thereafter. Some experts say the millions of adults who received smallpox vaccinations as children might still have some level of protection against the disease, possibly enough to prevent death, if not illness.

The vaccine was used successfully in the global smallpox eradication effort of the 1960s and 1970s, but some scientists fear that terrorists could genetically alter the virus to create a vaccine-resistant strain.

While it's technically doable, scientists say, getting genetically altered smallpox into a form that could be used as a weapon, then testing and producing it, could be beyond the capability of terror groups. "We can't rule it out," bioterrorism expert D.A. Henderson said at a recent meeting, "but it seems unlikely, and very difficult."

Current stockpiles of vaccine — 15.4 million doses that can be diluted five times to make 77 million doses, plus 80 million to 90 million doses of frozen vaccine — were manufactured decades ago, but recent tests suggest they are still potent, even when diluted. In addition, the Department of Health and Human Services has contracted to buy 209 million doses of vaccine produced using modern manufacturing methods. Those are going through FDA review. Still, health officials say there is already enough vaccine to protect every American from smallpox should an attack occur.

Despite its risks, many people are ready to roll up their sleeves. A national survey in May found that 59% of those polled said they would get the vaccine, even though it causes side effects.

Philadelphia pediatrician Paul Offit is not among them. A member of the Advisory Committee on Immunization Policy, which makes vaccine recommendations to federal health agencies, Offit says he has seen babies who suffered reactions to smallpox vaccine. He says that, in the absence of a single case of smallpox anywhere on earth, the vaccine is too risky to use.

"A vaccine that I would consider to be unsafe is a vaccine whose risks outweigh its benefits," he says. With smallpox, there is not enough information to make that call. "Its benefits are solely theoretical," he says. "It's a dilemma. This is a vaccine that absolutely has serious side effects, worse than any current vaccine."

Offit favors waiting until there is a confirmed outbreak of smallpox, then vaccinating anyone who may have had contact with the victim or victims, an approach known as "ring vaccination." Studies show that vaccination up to four days after exposure will prevent the disease, or at least minimize its severity. Even if vaccination is delayed up to seven days after exposure, doctors believe it will provide some protection.

New anti-viral medications that could be effective against smallpox are being developed, as are safer versions of the vaccine, Offit says. But it may be years before they're available, and in the meantime, no one knows how urgent is the threat.

"I think we can make a better vaccine," Offit says. "The question is, can we wait?"

4LOVE said:

You go first and then eye'll do it.