EDITORIAL OBSERVER
Ruminating on Smallpox Vaccine and the Swine Flu Fiasco
By PHILIP
M. BOFFEY
s
public health officials debate whether to offer smallpox vaccine to
every American who wants it, they would do well to recall what
happened a quarter-century ago when a mass vaccination campaign
ended in disaster. That experience — in the ill-fated swine flu
immunizations of 1976 — does not mean that health officials should
shrink from offering smallpox vaccinations today. But it does
suggest there are lessons to be learned on how best to do it.
In 1976, concern was ignited by an outbreak of illness at Fort
Dix, N.J., that included both a normal strain of influenza and a
strain that seemed related to the swine flu of 1918 that killed
anywhere from 20 million to 100 million people around the world.
Although the swine strain at Fort Dix mysteriously disappeared after
infecting some 500 soldiers, no one could say whether it would
re-emerge or how lethal it might be if it did.
Some experts who had nervously been awaiting the return of a
killer flu could hardly wait to spring into action to stop it.
Brushing aside all qualms, health officials at the Centers for
Disease Control in Atlanta and officials in Washington pushed
through a presidential decision to vaccinate every man, woman and
child in the country — more than 200 million Americans in all. Brief
thought was given to simply making and stockpiling the vaccine so
that it would be available should the swine flu reappear. But that
was rejected on the theory that influenza moves too fast for a
vaccination campaign to keep up with it.
Unfortunately, pretty much everything that could go wrong did go
wrong. Manufacturing the vaccine took far longer than expected. The
vaccine didn't work well in children. Bitter arguments over who
should accept liability for side effects almost derailed the effort
until the government assumed responsibility. And the states differed
greatly in their enthusiasm and competence, resulting in extensive
vaccination in some areas and very little in others.
Meanwhile, three coincidental deaths among elderly vaccinees at a
Pittsburgh clinic forced a suspension in 10 states. Then, in the
blow that killed the campaign for good, a rare side effect — a
paralytic disease known as Guillain-Barre syndrome — appeared
unexpectedly. This was a devastating shock to health officials who
had considered influenza vaccines extremely safe. In all, some 532
people contracted Guillain-Barre after being vaccinated, and 32 of
them died.
Many of these cases would have occurred anyway, but the vaccine
itself was blamed for causing roughly 1 case of Guillain-Barre for
every 100,000 people vaccinated. That seems like a small risk, but
when the swine flu failed to reappear and the media zoomed in to
record every disastrous side effect, the damage looked very big
indeed. The campaign was halted after reaching only 45 million
people. It was widely condemned as a fiasco, a debacle, a ghastly
mistake, a medical Vietnam.
Now, once again there is a threat that could be dire but may not
materialize. Nobody knows if terrorists or rogue states have access
to the smallpox virus or a means to deliver it. The smallpox vaccine
is considered one of the most toxic, causing life-threatening
complications in 15 of every million vaccinees, of whom one or two
might die. Health officials worry that in the absence of a smallpox
attack, the vaccine damage will look just as awful in a media
spotlight as Guillain-Barre did in 1976.
Still, the very existence of a vaccinated population should
lessen the likelihood of smallpox being used as a weapon. When swine
flu failed to appear, it was deemed evidence that the vaccination
campaign was misguided. If no smallpox attack occurs, it could very
well be due to a successful vaccination campaign.
Virtually all analyses of the 1976 failure suggest that the
government must plan more carefully and prepare for the worst in
such a huge undertaking. In some respects, the government is off to
a better start this time. It separated the production of vaccine
(already under way) from the decision over whether to stockpile it
or administer it (yet to be made). It has adopted a phased approach,
offering vaccine to health personnel first and only later, if at
all, to the public. It has issued guidelines for states to follow in
the event of attack. Officials are already pondering liability
issues to iron out problems before the vaccinations start. And they
are openly discussing the risks of the vaccine, ensuring that the
downside of any campaign is recognized before it is launched. One
big difference from 1976 is that the virus used in the smallpox
vaccine has the potential to spread from those vaccinated to their
close contacts, possibly endangering vulnerable people. That problem
will have to be addressed with great care.
Most of the mistakes in the swine flu campaign were driven by the
perceived urgency of acting quickly before a new flu strain could
flash through the population. This time around, with no smallpox
attack in immediate sight and vaccine stockpiles ready just in case,
the deadlines for distribution are less tight. There is plenty of
time for President Bush to get it right.
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