WASHINGTON – The Bush administration plans to make the smallpox vaccine available to all Americans eventually, but officials will recommend that only those who are at greatest risk of encountering a patient get the shots.
Under plans not yet final, the administration would recommend that emergency room workers and special smallpox response teams take the vaccine. The shot soon would be available to other health care workers and emergency responders, but states would have a say in which ones it would be recommended for, administration officials said.
The general public eventually would be offered the shots but not encouraged to get them.
Questions about who should be offered the vaccine, which carries risks including death, and whether to recommend it or just make it available have occupied federal health officials and now the White House for months. Administration officials say a decision from President Bush is expected soon, possibly next week.
Bush also is close to approving a plan for vaccinating U.S. military forces against the disease.
Smallpox was wiped out worldwide two decades ago, but experts fear the contagious, often fatal disease could return through an attack by terrorists or a hostile nation. Routine vaccinations ended in the United States in 1972, meaning nearly half the population is without any protection from the virus. Health officials aren't sure whether those vaccinated decades ago have any level of residual protection.
Under the administration plan, the vaccine would be offered in stages, beginning with those most likely to encounter a smallpox patient. That includes people on state response teams, who would investigate suspicious cases of smallpox, and those who work in hospital emergency rooms.
Federal officials believe that this group, expected to number about a half-million, should get the shot, and they plan to recommend it for them, according to two administration officials who spoke on condition of anonymity.
In the second phase of vaccination, the shot would be offered to other health care workers and emergency responders such as police, fire and emergency medical technicians. Federal officials probably will recommend the shot for these roughly 10 million people too.
Federal officials plan to work with states and hospitals to identify who within that larger group definitely needs to be inoculated and who might not, one official said. Another explained that they want to give states flexibility to whittle down the number for whom the shot is recommended.
Plans are not complete for how the vaccine would be offered to the public, but officials do not plan to recommend it for Americans who have no particular risk of exposure.
That's because of the risk of the vaccine itself. Based on studies from the 1960s, experts estimate that 15 out of every 1 million people vaccinated for the first time will face life-threatening complications, and one or two will die. Reactions are less common for those being revaccinated.
Using these data, vaccinating the nation could lead to nearly 3,000 life-threatening complications and at least 170 deaths.
But the administration has concluded that the government cannot make it available to some people and not others who may also want it, said a third administration official.
There are several possibilities. Most of the vaccine on hand is not yet licensed by the Food and Drug Administration, and what is licensed will be saved for people in stages one and two. For the general public, federal officials could simply wait until more vaccine is licensed, probably in early 2004. They also could enroll interested people in experimental trials and offer the shot that way.
Meanwhile, states are working on their own smallpox plans, due next week at the Department of Health and Human Services. They are to deal with how they would inoculate mass numbers of people if the smallpox virus were to be released. That includes early planning for vaccinating key personnel in advance.
The question of whether to recommend the vaccine or just offer it is particularly important to federal health officials, who remember last year's anthrax attacks. In that case, they offered the anthrax vaccine without a recommendation either way to people who were exposed to the deadly spores and finishing up two months of antibiotics.
Health authorities didn't know what risk those people still faced or whether the vaccine would help. The result was considerable confusion and widespread criticism.