On Dec. 13, 2002, President Bush announced an initiative to prepare the United States for a possible smallpox attack.
That day, U.S. health officials described a two-part program in which an estimated 500,000 smallpox response personnel would first receive the vaccine followed by up to 10 million emergency responders.
In that briefing, Health and Human Services Secretary Tommy Thompson said, "There are 439,000 individuals that we've designated right now in order to receive the vaccination in the first [phase]," adding that the plan was "a voluntary program and not every one of those individuals will receive it."
CDC Director Julie Gerberding added that she was encouraging states to implement the first wave quickly. "In our planning guidance, we recommended that they try to accomplish this in 30 days from the point at which they actually open the clinics and begin the immunization," she said.
The program began Jan. 24 and The Washington Post reported that participation has been limited to 4,200 people, as of Feb. 24. Potential volunteers are concerned about sicknesses associated with the vaccine and several medical unions have delayed endorsing the plan until a compensation plan is provided for patients who experience the vaccine's side effects.
CDC spokesman Tom Skinner told Global Security Newswire Wednesday that the "the 500,000 number was floated around," but that the immunization plan's sole goal was to prepare the United States to respond to a smallpox attack.
"We're trying to do a better job of clarifying what the purpose of this program is, and the purpose of this program is to better prepare our country to respond to a bioterrorism event involving smallpox," Skinner said.
The plan's two phases still exist, he said, but they are "seamless."
CDC officials will determine when to begin immunizing firefighters, police and other emergency workers-phase two-and the progress of the plan will not depend on passing a fixed number of immunized volunteers or a set date, according to Skinner.
He denied that health officials had set 500,000 immunized first responders as a target for the first phase. In planning their separate vaccination scenarios, states and major cities collectively estimated they would need between 400,000 and 500,000 inoculated personnel in phase one, but federal health officials never adopted that number as a target, according to Skinner.
"This is a tremendous amount of backpedaling. This is very embarrassing for them, and it should be," said Yale University professor Ed Kaplan, a vocal critic of the CDC's smallpox vaccination plans.
U.S. officials began distancing themselves from the 500,000 figure in early February, when it became apparent that the program was plagued by low turnout.
"It would be a success if no one receives the vaccine, but we offered this opportunity to all the right people," said Joe Henderson, CDC associate director for terrorism preparedness, at a Feb. 5 bioterrorism conference hosted by the National Governors Association.
Some medical experts said it was reasonable to work without using the 500,000 figure as a benchmark.
That figure "is more of a planning number and somehow it became the goal," said Patrick Libbey, executive director of the National Association of County and City Health Officials.
Libbey said that the CDC's discussion of readiness, instead of numbers, "is not throwing me a curve."
"The exercise has always been about readiness, the 500,000 was a number out of the air," said Georges Benjamin, executive director of the American Public Health Association.
"The number issue really is a moving target," he added.
Kaplan said the CDC is not solely to blame for the low turnout, or the slowly moving immunization plan, but health officials are stuck with the shortfalls in the plan.
"We haven't seen too much senior discussion of this plan since it was discussed in December," he said.
Experts agreed that readiness is the ultimate goal, and they said that the United States is not yet prepared.
The smallpox vaccination program has not been widely adopted, said Paul Offit, chief of the Philadelphia Children's hospital's infectious diseases section and a member of the CDC's Advisory Committee on Immunization Practices. "If the intent was a first line of defense, that intent is not being met, it's at best a very leaky first line of defense," he said.
Offit, and other experts said preparing an effective plan to respond to a smallpox attack was more important than immunizing limited numbers of first responders today.
"The more pressing issue is, what would we do if there was an event in the United States … what plans are there in place to distribute that vaccine in large numbers?" Offit asked.
Skinner said the CDC is working with states to develop a mass vaccination plan, which he described as "evolving."
"We might tweak this plan a little bit as we go," he said.
Experts said they did not believe the United States is prepared to respond to a smallpox attack with mass vaccinations.
The United States needs to immunize "a hell of a lot more than 4,000 people," Kaplan said. He applauded CDC Director Gerberding's assessment that the United States will be prepared when officials can vaccinate the entire country in 10 days, but he estimated that effort would require more than a million immunized medical workers.
"It's disconcerting … the bottom line is that I'm quite worried," Kaplan said.
The CDC does not know what is needed to immunize the entire country in 10 days, according to William Bicknell, a former Massachusetts public health commissioner who is now a professor of public health at Boston University and a member of the state's smallpox working group.
"Right now I do not think the nation is adequately protected," Bicknell said.
He called for an examination of how many immunized personnel and vaccination sites would be needed for a nationwide vaccination campaign.
"I don't believe anybody has calculated that number. That's a mistake. That's an oversight," he said.
Kaplan suggested that the United States attempt to immunize 50,000 volunteers in one day, "just to see if you can do it."
"The machinery needs to be ready. Somebody needs to test these things out," he said.
Experts and officials have acknowledged that it will be difficult to know when the nation is ready because it is hard to predict what form an attack would take.
"I don't think anybody knows what an actual event might look like," Skinner said.
U.S. officials do not know what to expect and do not know if they have prepared sufficiently, and because of that fact, the CDC should plan for the worst possible scenario, Bicknell said.
"It's always hard to measure ready," said the APHA's Benjamin.