Friday, July 04, 2003

By Christopher Snowbeck, Post-Gazette Staff Writer
 

In the latest sign that the nation's smallpox vaccination program has fallen short of expectations, public health officials in several large states say they may end up throwing away more smallpox vaccine than they have used.

Pennsylvania says it could wind up destroying three doses of smallpox vaccine for every dose it has administered.

Public health officials contacted in Pennsylvania and four other big states -- New York, Ohio, Illinois and California -- said they still have plenty of vaccine. Of the combined 53,800 doses they've received for health care workers, the states have prepared just 15,300 for use. But out of those prepared doses, only 5,041 people have been vaccinated.

The unused vaccine doesn't represent a safety problem or even raise much of a cost concern, but it does show a dramatic change in attitude that has taken place during the past two years.

"The fact that the doses aren't being used is a marker of what's commonly recognized: that the vaccine campaign failed in meeting its original objective," said Dr. Linda Rosenstock, dean of the School of Public Health at the University of California, Los Angeles. "I don't think [the campaign] was ever sufficiently well-justified to the medical and scientific communities that the risk of [smallpox] exposure was so great as to warrant such an aggressive approach."

In December 2002, President Bush announced the campaign to vaccinate public health officials, hospital workers and emergency first responders who "could be on the front lines of a biological attack." The plan envisioned vaccinating more than 500,000 people.

But for a host of reasons, which included the small but real risks of dangerous side effects posed by the vaccine and concerns about who would be liable for those harmed by vaccination, relatively few people have volunteered to get them.

The government has shipped nearly 300,000 doses of vaccine to state and local health departments, but only about 40,000 people have been vaccinated so far. Called Dryvax, the vaccine comes in powder form. Once a solution is added to the powder, each 100-dose vial is good for 90 days.

Pennsylvania has received 10,000 doses, but prepared only 1,200 of them for use. Of those, 256 doses have been successfully administered. Some of the remaining 944 doses have already expired and the remainder will expire by August.

"There's going to be some wasted," said Richard McGarvey, Pennsylvania Department of Health spokesman.

In California, 6,400 doses were prepared, but only 1,847 people -- equal to about a third of the doses -- have been vaccinated so far. In Illinois, just 291 out of 1,800 prepared doses have been used.

While state health officials in California and Illinois suggested that at least some of their prepared doses might still be used, their counterparts in the city of Los Angeles and in Ohio and New York state said that their campaigns to vaccinate health care workers and emergency responders were pretty much over.

Ohio successfully used 1,902 out of the 3,400 doses it prepared. In New York state outside New York City, the ratio was 745 people vaccinated to 2,500 doses prepared.

The federal Centers for Disease Control and Prevention is not tracking the number of prepared doses of vaccine and comparing them with the number used.

Michael K. Huff, acting director of the Office of Public Health Preparedness at the Pennsylvania health department, said he still hopes for more vaccinations here. But the number of takers has dwindled. Allegheny County, which leads the state in the number vaccinations, has ended its program and returned all unused vaccine to Harrisburg.

Huff said people seem less worried about smallpox than they once were, which he traces to several factors, including "the fact that the war is over, the fact that our alert status has been reduced, [and] the fact that there is no blatant evidence of biologicals in Iraq," he said.

But there were also problems with the vaccine itself that dampened enthusiasm, Huff said. The smallpox vaccine is safe for the vast majority who receive it, but carries a small risk of dangerous side effects. Health departments were so careful to explain these risks to health care workers that "we talked them out of it," Huff said.

"That's a good thing," he added, noting that health officials were also diligent to exclude those with health conditions that could be complicated by the vaccine. "In Pennsylvania, we've had no adverse events."

Wasted vaccine is not surprising considering that it came in 100-dose vials, said Dr. Brian Strom, a public health professor at the University of Pennsylvania School of Medicine and chairman of the Institute of Medicine committee that is monitoring the vaccination campaign.

Strom argued that smaller states likely have had an easier time than larger ones in moving around open vials to minimize waste.

"When you have a clinic and you advertise that people are supposed to come in and only four people show up, you still have to open that vial," Strom said.

What's more, some vaccine was probably wasted as public health workers learned how to administer it, said Claire Hannan, senior director for immunization policy for the Association of State and Territorial Health Officials. Smallpox vaccine is delivered with a bifurcated needle and public health workers received training in its use.

Hannan and other public health officials said that the campaign should not be judged simply on numbers.

Enough people have been inoculated to increase preparedness, said Donna Knutson, senior adviser to the terrorism program at the federal Centers for Disease Control and Prevention. Health departments have developed plans and capabilities to handle mass vaccinations, should the need arise.

"There's enough doses out there that they can be administered quickly if there's an outbreak," Knutson said. "Preparedness means more than just having a shot in the arm -- it can also mean the vaccine is closer to the arm."

Getting smallpox vaccine into some health care workers proved useful just last month in responding to the first-ever human cases of monkeypox in the United States.

Smallpox vaccination provides protection against monkeypox, and that meant a public health worker in northwestern Ohio was able to safely respond to a probable case, said Jay Carey, an Ohio Department of Health spokesman.

The spread this year of severe acute respiratory syndrome has also underscored the importance of a health care worker vaccination program, because so many SARS victims were doctors and nurses, said Bill Pierce, spokesman for the U.S. Department of Health and Human Services.

Rosenstock, the dean of public health at UCLA, said, however, that the wasted doses aren't the only waste associated with the vaccination campaign.

"The far greater waste was the amount of attention, funding and human resources dedicated to this," said Rosenstock, who argued that government secrecy undercut the campaign.

"Medical professionals ... are used to trying to get a sense of what's the risk, what intervention are you proposing and what are its benefits and risks, and then making a judgment," she said. "I do think that, at the beginning, we were supposed to just take the [Bush] administration's word that this was a serious risk."

(Christopher Snowbeck can be reached at csnowbeck@post-gazette.com or 412-263-2625.)