The voluntary smallpox vaccination campaign announced by President Bush three years ago did not produce the plethora of side effects many in the medical community feared, an analysis released yesterday found. But it remains a mystery why a few dozen adults who were inoculated suffered severe, and in some cases fatal, heart complications.
Centers for Disease Control and Prevention officials said the findings prove that careful screening, education and monitoring can dramatically reduce the dangerous complications associated with a live vaccine that has not changed since it was first developed in the late 1700s. Of the 38,000 civilian volunteers vaccinated, none developed the life-threatening rashes that were more common when the vaccine was used widely four decades ago, said the CDC's Gina Mootrey.
Some independent researchers however, questioned the original rationale for the program and said the results highlighted the enormous costs -- both financial and medical -- associated with inoculating even a tiny fraction the population.
"This was the safest possible vaccination program that could be undertaken with the smallpox vaccine, but at its best it remains a very hazardous vaccine," said William Schaffner, a vaccine expert at Vanderbilt University Medical Center. "Eighty-five hospitalizations, two permanent disabilities, 10 life-threatening reactions and three deaths. This is not a safe vaccine."
Routine smallpox vaccination ended in the United States in 1971, and by 1980 the World Health Organization declared the disease eradicated. In December 2002, as the nation prepared for the Iraq war, Bush called for as many as 10 million health care workers and emergency personnel to be vaccinated so they could serve as the front-line responders in the event of a bioterrorist assault.
Doctors and nurses balked, complaining that the risks of the ancient vaccine far outweighed the threat of a smallpox attack.
"The reason this vaccination campaign was undertaken was spurious. It was a mirage, there was no threat of smallpox from Iraq," Schaffner said. "And that remains a powerfully sad coda to this whole episode."
Just 38,000 first responders came forward, and since then, Bush and other high-ranking officials have rarely mentioned the effort. More than 75,000 doses of expired vaccine have been discarded.
"The program still exists," Mootrey said. "However, it's up to the states to determine whether they wish to have any potential response team members vaccinated."
Of those immunized, 822 reported an adverse reaction, though the vast majority were complaints of itching, pain or rash that dissipated quickly, according to the article, being published in today's edition of the Journal of the American Medical Association. One hundred cases, or 12 percent, were designated as serious. Those included six heart attacks, two of which were fatal, and 21 cases of nonfatal inflammation of the heart muscle.
Since the data were collected, 1,000 more people have been vaccinated.
The data did little to quell the debate over whether the administration should pursue its stalled campaign.
"For sure, 39,000 civilians immunized is nowhere near enough to respond adequately to a bioterrorism event," said William Bicknell, a former Massachusetts public health director. "There are whole aspects of bioterrorism preparedness where we really have not moved significantly in the last several years."
But White House spokesman Trent Duffy said the inoculation of 39,000 civilians "is a lot better than where we were three years ago. We believe plans are in place to vaccinate the entire U.S. population within 10 days" of an attack.
Both Bicknell and bioterrorism expert Michael T. Osterholm said that if there is a suspected case of smallpox, it would be critical for first responders to be able to safely examine and treat potential cases and then inoculate the general public.
Without that cadre of immunized workers, "lines would start to form outside emergency rooms and we would lose control in the first 72 hours," said Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "The program did not get us prepared for a basic response to smallpox."
A second article detailed adverse reactions in 600,000 military personnel who were inoculated. The complication rates were similar to what would be expected in that age group, the authors found.
Bicknell said the ongoing military program highlights the need to revive civilian immunizations. "If it's a threat to the military, it's a threat to civilians too," he said.