Smallpox Questions

By ELIZABETH M. WHELAN

The Bush administration, in an astonishing change of policy, is preparing to abandon its previous resistance to widespread "pre-attack" vaccinations and offer the smallpox vaccine to all Americans.

The dramatic shift may be the result of growing public demand for the vaccine, as echoed in newspaper editorials around the nation. Or it may be that the administration knows something that we don't about the terrorists' access to the smallpox virus and their intention to use it as a weapon. (Inevitably there will be some cynics who argue that making the vaccine available will rachet up national anxiety levels and bolster calls for pre-emptive action.)

Whatever the reason, millions of Americans will venture into what is basically a large, uncontrolled experiment. Certainly we should have the right to make our own decisions on how to protect our health. But as we move toward the prospect of mass vaccination, we face a number of unanswered questions:

• How does one make an informed decision about whether or not to be vaccinated? Unlike routine childhood and flu shots, the smallpox vaccine carries known risks even for healthy people, with an estimated death rate of one or two per million, and a significantly higher rate of other side-effects from adverse reactions, including brain swelling. How do we weigh a hypothetical risk of being exposed to smallpox with a small but real risk of vaccine-related death or illness? Don't count on your physician to make a decision for you: he does not have much more information on this than you do.

• In case of adverse effects from vaccine, who would be liable? Health facilities or personnel? Manufacturers? Government? Certainly providers and manufacturers would have to be protected from suit, or no one would participate.

• How do you determine if you are vulnerable and should avoid the vaccine? Clearly, pregnant women, children under the age of one, and immune-compromised individuals should be excluded. But serious negative consequences can occur in others, possibly including people suffering from, or having a history of, eczema. (Recently, some virologists and dermatologists have held that this risk is overstated and only those with active cases of this eczema are at risk.)

• If you choose to be vaccinated, what type of risk might you pose to unvaccinated individuals at home or at work? Some experts fear those with weakened immune systems may become ill by being in close contact with a recently vaccinated person. Would you have to isolate yourself for some period, or eschew the vaccination entirely if your spouse suffered from a condition that left him or her vulnerable?

• Exactly who would give the vaccinations, where and by whom would they be trained in this procedure, and who would perform the normal professional duties of these individuals while they were vaccinating?

• Should there be a priority system for vaccine distribution, giving it first to those born after 1972 since they have never been vaccinated? This would be prudent because, as noted by researchers in the New England Journal of Medicine, those who were vaccinated 35 or more years ago may still have considerable immunity.

We don't have answers to these questions now but we will learn a great deal about the logistics and the extent of adverse effects from observing what happens when we first vaccinate up to 500,000 American health providers. Further evidence may emerge by mid-October, when Israel is due to complete its early phases of "first responder" immunizations -- and we should not forget that mass pre-attack inoculation is not our only option here for saving lives.

For some, a more palatable alternative would be assured access to the vaccine only after it was confirmed that smallpox was indeed available as a terror weapon -- or even after exposure to smallpox had occurred, as the vaccine is effective in preventing the disease when administered within a few days of exposure. Further, a sense of urgency for widespread use of a vaccine would be reduced if there were effective anti-viral medications in place. The FDA-approved drug Cidofovir (Vistide), used in AIDS-related viral eye infections, prevents death and disease in primates with monkey-pox -- similar to smallpox in humans. Cidofovir and other future anti-virals offer considerable promise for effective treatment. Additionally, the vaccination would be regarded as less dangerous if there were a more plentiful supply of vaccinia immune globulin (VIG), now in very short supply, which can effectively treat severe reactions. And indeed the government has just awarded a contract to Cangene to develop substantial supplies of this drug.

Finally, we should not lose sight of the fact that smallpox is a purely hypothetical risk -- we do not know if terrorists have it -- while there are real, but less-discussed threats looming, e.g., anthrax (for which there is a safe, effective vaccine). And we know that Saddam has stockpiled it. Our efforts to protect ourselves from the unthinkable must not be limited to smallpox, but rather should be as diverse and encompassing as are the arsenals of our enemies.