PEPFAR was on its way, but the problem of bioterrorism and smallpox vaccines and the question of what we needed to protect the country had not gone away. One thing we did know was that our stockpile of smallpox vaccines was inadequate.
One of the first projects that we pursued to correct that problem after 9/11 was to demonstrate in a clinical study that we could dilute the existing stock of smallpox vaccine by one to five or one to ten and still maintain the desired potency. This meant that the 15 million doses of undiluted vaccine in our stockpile could now be extended to anywhere between 75 and 150 million doses. There would likely be even more doses available because we had contracted months before to produce a second-generation smallpox vaccine that would raise our supply to more than 280 million doses by the end of 2002.
There was considerable disagreement over what to do with this expanded supply. Some U.S. public health officials and politicians argued that we should now vaccinate all first responders and emergency personnel in anticipation of a smallpox bioterror attack. A recently updated plan and guidelines put out by the CDC recommended a “ring vaccination” approach; if cases of smallpox were identified, patients with suspected or confirmed smallpox would be isolated, and their contacts would be traced, vaccinated, and kept under close surveillance, as would the household members of those contacts. The plan called for identifying other high-risk people who might have had direct or indirect contact with the patients and who therefore also should be vaccinated. In essence, one would vaccinate in “rings” around the index or original case. Local quarantining and travel restrictions also could be enforced if deemed appropriate. This approach had been successfully used in the global smallpox eradication program. While the CDC did not recommend mass vaccination campaigns either in response to documented cases of smallpox or in anticipation of a potential outbreak, some argued for just the opposite—preemptive mass vaccination of the general population because this would essentially take off the table the threat of smallpox as an agent of bioterrorism. A supporting argument for this approach was that this would eliminate any confusion and panic that would most likely accompany simultaneous attacks at different locations. Weighing against preemptive mass vaccination was the concern about vaccine-related adverse events. Historically, there was an incidence of one to two deaths per million recipients of the vaccine in addition to hundreds of cases of serious complications such as generalized vaccinia, which is characterized by spread of the virus throughout the skin and other parts of the body, as well as post-vaccine encephalitis, or inflammation of the brain.
I was leaning heavily against universal vaccination from the start. I wanted to clarify the issue of incidence of adverse events. I reviewed the medical literature on the subject. It was clear that the rate of complications in previously unvaccinated people, predominantly the younger people in the population, was considerably higher than the complications in the previously vaccinated group, namely those who were old enough to have been vaccinated during childhood many years ago, before smallpox vaccinations were discontinued in 1972. There was a considerable amount of residual immunity in the population among those who had been vaccinated even decades ago. In other words, they would likely already be protected in the event of a smallpox attack. This argued against the need of vaccinating the entire population of the United States even if there were a massive smallpox attack. My reluctance to go along with universal vaccination was strengthened by this information.
Vice President Cheney, however, was leaning toward a broader vaccination program. It soon became clear why. It was all about Iraq. There were continual rumors that we would soon preemptively attack Iraq to neutralize it before it used or obtained the capacity to employ weapons of mass destruction, including a deliberate release of smallpox in the United States or in an allied nation such as Israel.
Over the following weeks, the palpable tension regarding possible war with Iraq intensified. Carol Kuntz, special assistant to Vice President Cheney, told me that the president would soon announce that the Pentagon was ordering that 250,000 to 500,000 frontline military personnel in high-risk areas be vaccinated. Once the vaccinations of the military began, a policy regarding vaccination of civilians would have to be put in place. I was in favor of the voluntary, not mandatory, vaccination of up to 500,000 members of smallpox response teams and emergency personnel. However, my default recommendation was not to take the vaccine if you were just a member of the general public. I believed that the risk of a massive smallpox bioterror attack was just too small compared with the risk of the rare but serious incidence of adverse events with the vaccine.
I found myself in one meeting after another at HHS headquarters to nail down what would be the most appropriate vaccination program in case of a smallpox terror attack. Saddam Hussein was reportedly refusing to allow international inspections to rule out the possibility that he had weapons of mass destruction. An invasion of Iraq seemed inevitable. The press was reporting that the president planned to start bombing Iraq sometime during the second week of January 2003. President Bush wanted to start vaccinating the half a million people who would constitute the country’s smallpox response teams by December 1, 2002. The atmosphere was heavy and tense.