President Nearing Decision on Who Receives the Smallpox Vaccine

By SHERYL GAY STOLBERG

ASHINGTON, Nov. 27 — After months of speculation and internal White House debate over who should have access to the smallpox vaccine, President Bush is nearing a decision and is likely to announce his policy, or parts of it, in the next month, administration officials said today.

Mr. Bush is widely expected to offer the vaccine to some members of the military and about 500,000 health care workers. But officials said today that the president had yet to resolve the most difficult issue before him: whether to offer the vaccine to millions of ordinary Americans as a precaution against a biological attack.

The decision is not just one decision, but rather a series of decisions about who should get the vaccine, and when. It is complicated by the fact that the government's stockpile includes various versions of smallpox vaccine, and only a small amount of vaccine is licensed.

A central question, one official said, has been whether the public should have access to the unlicensed vaccine under the so-called investigational new drug, or I.N.D., rules, which permit people to take experimental medicines with approval from the Food and Drug Administration.

"The big problem is, do you offer the vaccine under I.N.D. to average people or do you wait until it is licensed?" this official said. "That is where the debate is falling out for people who want rapid access for the whole population."

Because Mr. Bush has yet to announce his decision, this official and others interviewed spoke on condition they not be identified. But this official said that if Mr. Bush did permit access to the vaccine under the I.N.D. rules, people would be required to "make a case" that they really needed it. "It would be a lot of paperwork," the official said.

Once the entire vaccine stockpile is licensed, the official said, the president could revisit the question of whether it should be made widely available. But that is not expected until 2004.

In recent weeks, several developments have brought the president closer to a decision, officials said. In October, the Food and Drug Administration licensed certain lots of aging smallpox vaccine, clearing the way for Mr. Bush to offer it to a limited number of soldiers and health care workers.

This week, the president signed the homeland security bill, which gives liability protection to doctors and other health care workers who administer the vaccine. "That was an issue that was important to address," a second official said.

Smallpox was declared eradicated in 1980, and routine vaccinations in this country ended in 1972. But smallpox has re-emerged as a potential biological weapon, and officials say several nations, including Russia, Iraq and North Korea, may have clandestine stocks of the virus.

After the terrorist attacks on Sept. 11, 2001, the Bush administration began building a stockpile of smallpox vaccine, enough to vaccinate every American. Vice President Dick Cheney has been said to favor widespread vaccination.

But the vaccine is made from a live virus, vaccinia, and it carries potentially fatal complications, particularly for people with immune deficiencies.

So the decision about who should get it, and when, may not be announced all at once, officials said. "It's safe to say some parts of the decision will be made this year," a senior administration official said today, adding, "There are some things the president is still weighing."