Today, the idea of smallpox heralded as a bioterrorist weapon has mobilized
health forces. Perhaps there is something US intelligence knows about
the terrorists access to the smallpox virus and their intention
to use it as a weapon. Regardless, as individual citizens who should
make informed decisions, the facts of the known risks of the smallpox
vaccine ought to be discussed, as well as other ways to ameliorate the
disease should it surface.
The term vaccine was derived in the 18th century when Edward
Jenner reported that inoculation with vaccinia (the infectious agent
known to cause cowpox) protected people from smallpox. Smallpox is a
highly contagious infection caused by variola, a virus very similar
to the cowpox virus (vaccinia). Jenner was the first to actually develop
immu-nization, with the term vaccine generated out of his early experimentation.
The smallpox scourge went on for centuries: in 1967, millions of cases
were reported in Asia and Africa. In 1977, the last known case was reported
in Somalia, signifying the success of the vaccination campaign based
on science that eradicated the infection from the globe.
Despite the success, government-run laboratories in the United States
and the Soviet Union have kept stocks of the virus. There is ongoing
conjecture that recent financial constraints in Russian government laboratories
might have allowed for some of the virus to become available for bioterrorist
use. Since smallpox is a highly contagious and fatal disease, claiming
the lives of 30 of those exposed, it is of great concern.
So here is the dilemma: the U.S. stopped vaccinating Americans in 1972,
some 30 years ago. If smallpox should re-emerge through an act of terrorism,
would citizens be protected? Should we preemptively vaccinate Americans
for protection against the disease? Are we willing to accept the vaccines
risks, which are likely to include an increased morbidity and mortality
for recipients?
The major reason not to begin vaccination in the absence of actual
exposure to variola or cases of smallpox is the complications of vaccination.
It has been known for decades that this live vaccine, which produces
a local infection in the skin, can occas-sionaly produce a life-threatening
progressive lesion or spread even in those who are healthy.
Further, even those who are unvaccinated are susceptible to infection
as they can have reactions if the virus spreads to them from those who
have been vaccinated. It is estimated that two people per million vaccinees
will develop progressive vaccinia or vaccinia gangrenosa; four people
per million will develop encephalitis.
This is a great communication and policy challenge as there are so
many unknowns and what ifs.... One should recall that
it was only during the anthrax scare in 2001 that U. S. Secretary of
Health and Human Services Tommy Thompson calmed...Americans
fears by guaranteeing there would be enough smallpox vaccine for every
American. The debate and dialogue on the actual risk of exposure, the
harms of the vaccine itself, and the cost...to assure
public health are blighted by the rhetoric of the war on
terrorism...and protection of homeland security. If we followed
Thompsons suggestion, we would have over 250 deaths from the vaccine
itself (one in a million) and a multitude of cases of encephalitis and
other vaccine induced illness. There are more ways to be prepared than
just a pre-attack...mass vaccination.
Prior to mass vaccination, a number of policy options ought to be considered
with appropriate risk and benefits shared and debated with experts,
citizens, and professionals.
First, prepare by guaranteeing access to the vaccine only after it
is confirmed that smallpox is indeed available and deployable as a terror
weapon. In fact, even if variola is used, a system for vaccination in
the area of exposure in the three to four days post-exposure offers
significant protection against a fatal outcome. In fact, it is unclear
if those
born before 1972, who were immunized, might still have some immunity
to the fatal disease.
Second, we should explore effective anti-viral medications that might
reduce the fatalities of those exposed and unvaccinated. The drug Cidofovir
(Vistide), used in AIDS-related viral eye infections, prevents death
and disease in primates with monkey-poxsimilar to smallpox in
humans. Research and support for developing Cidofovir and other
related anti-virals might offer an effective treatment.
Third, there is an effective treatment to treat severe reactions, vaccinia
immune globulin (VIG). VIG was used in the past to treat and reduce
the severity of any of these complications, but currently little is
available. Until 1968, at least 40 individuals per million vaccinees
developed significant and possibly life-threatening complications for
which VIG was used.
Today, there is only a hypothetical risk for smallpox exposure
hence, no real hazard or risk. Yet, the risks of vaccination are known:
Unlike routine childhood and flu shots, the smallpox vaccine carries
known risks even for healthy people, with life threatening reactions
in 15 of every million vaccinated and an estimated death rate of one
or two per million.
Communication can assist Americans to become more risk literate and
weigh a hypothetical risk of being exposed to smallpox with a small,
but real risk of vaccine related death or illness. This communication
could include a discussion of compensation and support in the case of
adverse effects from the vaccine.
Communication of exclusion due to vulnerability is also necessary beyond
pregnant women, children under the age of one, and people of known immune-compromised
status. Serious negative consequences might occur in others with masked
or undiagnosed diseases. Should there be laboratory tests for hepatitis
B and C, HIV or others? Also, what about the over 15 million Americans
who suffer from or have a history of eczema?
Finally, communication can assist policymakers to make prudent decisions
to mobilize public health forces if a case occurs. First respondersparamedics,
firefighters and police officersmight join the military as preferred
recipients. Hospital workers and ring vaccination could follow along
with VIG and other potential anti-virals.
Clearly, this is not a simple policy reponse. Ongoing communication
with professionals and policymakers is paramount concomitant with ethical
media coverage. Public health is at risk if faulty communication leads
to decisions that threaten the very basis of our public health system.
The World Health Organization preamble should be a guiding principle
of our efforts: Informed opinion and active cooperative
on the part of the public are of the utmost importance in the improvement
of health of the people.We should hope we never see a case
of smallpox ever again, but if we do, we should be
prepared to protect the public health with a mobilized instant response
to limit its scorge.
__________
Scott C. Ratzan MD, MPA is Editor-in-Chief of the Journal of
Health Communication: International Perspectives.
2/01/04