President has already ordered smallpox vaccine for all in U.S.

The New York Times

In late September, in the days before a series of anthrax-tainted letters made bioterrorism a reality in the United States, President Bush decided that the federal government should acquire enough vaccine to protect every American against an even more menacing biological threat — smallpox.

And as the federal government starts negotiating to procure smallpox vaccine, a separate effort has begun to obtain large quantities of the scarce medicine needed to treat people with adverse reactions to the vaccine, federal health officials said on Sunday.

Although smallpox was eradicated as a disease in the 1970s, American intelligence suspected for years that Iraq and North Korea, and possibly other rogue nations, had maintained clandestine stocks of the deadly smallpox virus.

But officials say it was the Sept. 11 attacks on the World Trade Center and the Pentagon, and not any new intelligence information, that prompted the president’s decision, which was not publicly announced, to greatly expand the nation’s smallpox vaccine stockpile.

Senior administration officials quietly sped up their timetable for acquiring the smallpox vaccine, and last week announced their plans to stockpile it so that it could be used in the event of an outbreak.

Smallpox is highly contagious; there is no treatment. The disease kills one-third of the people it infects.

"I think the American people will feel much more comfortable knowing they have their name on a vaccine shot in our inventory," said Tommy Thompson, secretary of the Department of Health and Human Services, who has said there are no immediate plans to inoculate every citizen against smallpox. He added, "It’s the security of knowing you have enough for every American."

The decision to purchase 300 million doses will vastly accelerate an existing vaccine program that, in the view of many scientists and federal officials, was hampered by bureaucratic inefficiency and was moving too slowly. Initially, that program was to have provided the government with 40 million doses of vaccine to add to its existing stockpile of about 15 million doses. But the vaccine would not have been delivered until 2004 at the earliest.

On Oct. 4 — just hours before Thompson announced to the nation that a Florida man had become sick with pulmonary anthrax —he secured Bush’s commitment to pay for his entire $1.6 billion bioterrorism preparedness package.

But the possibility raised last week of renewing vaccinations for Americans against smallpox, in the absence of any cases of smallpox anywhere in the world, is raising eyebrows among some public health experts.

Bioterrorism expert Dr. Jonathan Tucker noted that a recently vaccinated person can spread the virus to others, possibly making them ill. In the absence of disease, it does not make sense to reinstitute vaccinations, he said.

"Given that this is a live virus vaccine, there is a small but significant risk of serious complications," Tucker said, adding that one in a million who were vaccinated in the 1960s died or had brain damage. The vaccine can cause severe infections in one of 18,000, with the virus spreading throughout the body.

Also, federal rules say a colorless liquid known as vaccinia immune globulin must be on hand before smallpox vaccinations can be administered. The medicine can be obtained only from people recently inoculated against smallpox, and existing American reserves may have deteriorated.

Even when given to healthy people, smallpox vaccines infrequently produce dangerous reactions because the vaccine uses a live vaccinia virus that is similar to smallpox.

Vaccinia virus can cause large, oozing lesions spreading from the site of the vaccine, especially in people with immune system problems or severe skin problems. It can be life-threatening. A large but unknown number of Americans now have immune systems that are either depressed because of HIV, the virus that causes AIDS, or have been chemically suppressed during treatments for cancer, organ transplants, severe burns, autoimmune diseases such as lupus and other health problems.

The Food and Drug Administration said two years ago that the nation’s small stockpile of vaccinia immune globulin had mysteriously turned pink, and barred its use. An agency official said on Sunday that the agency had concluded that the pink liquid could be used only as an "investigational new drug" under close medical supervision.

Routine vaccinations against smallpox were discontinued in the United States in 1972, when the disease was declared eradicated worldwide. A new vaccine would be made with more modern methods and would presumably have fewer side effects. Nevertheless, experts caution that some side effects are inevitable.