Anthrax Vaccine Deemed Safe, Effective, but Flawed

Institute of Medicine finds no link to chronic illnesses

WEDNESDAY, March 6, 2002 (HealthDayNews) -- A government advisory panel said today that the anthrax vaccine is "reasonably safe" and effective at protecting humans against the disease, including the dreaded inhalation form.

However, the vaccine has plenty of room for improvement, concluded a report by Institute of Medicine (IOM), a division of the National Academy of Sciences.

"Our committee concluded it is sufficiently safe," said Dr. Brian Strom, the panel's chairman and a professor of biostatistics and epidemiology at the University of Pennsylvania School of Medicine. Moreover, Strom added, "we concluded that the anthrax vaccine, as licensed, is an effective vaccine to protect against anthrax infection, including the inhalation form."

The committee started its work in September 2000, but moved more quickly once anthrax became a bioterrorism weapon last fall. The bacterium, which was sent through the mail, has infected 22 people, killing seven of them. Eleven of those victims -- including all who died -- contracted the inhalation form of the disease, while the rest were infected through the skin.

The infections created a nationwide scare because the country was still reeling from the Sept. 11 terrorist attacks and because anthrax, though feared as a terrorist weapon, was until then a rare and naturally occurring disease in this country. Between 1955 and 1999, only 256 cases were reported. The vast majority of them were the skin form; the last case of inhalation anthrax had been reported in a yarn worker in 1976.

The vaccine was approved in 1970, but was limited to people who worked with animals or animal products. However, the Department of Defense, concerned that rogue nations like Iraq might use it as a weapon, stepped up its vaccine program in 1997. It ordered all personnel to get the shot.

So far, about 2 million doses of the vaccine have been administered, but the Pentagon's order met with some resistance. About 400 people have refused the shot, citing concerns that they could come down with chronic fatigue, memory loss or other conditions.

U.S. Rep. Christopher Shays, R-Conn., an opponent of the vaccine, criticized the report in a prepared statement.

"Nothing in this report indicates the current vaccine should be used broadly by military or civilian populations," the statement read. "Even conceding the vaccine is as safe and effective, as the IOM speculates, it has never been proved safe or effective enough to protect those most threatened by anthrax exposure -- pregnant women, children or the elderly."

Even the IOM investigators concede the vaccine is far from perfect. The panel urged the Defense Department to monitor people who got the shot for any long-term health problems, although it couldn't find any. However, Strom noted the shot has been in widespread use for just a few years.

The committee also said the government should seek a better vaccine with more up-to-date technology. The existing one created some short-term reactions like inflammation, especially among women. None were any more serious than reactions from other vaccines adults get, the panel concluded.

The committee also recognized the manufacturing problems of its maker, BioPort Corp. of Lansing, Mich., and urged the U.S. Food and Drug Administration (FDA) to continue monitoring the company. The company had not been making the vaccine since 1998 because it hadn't met safety standards, but the FDA announced in January that BioPort's upgraded facility passed muster.

The IOM also said research should begin on a newer generation of the vaccine -- one that would cause fewer reactions and would require only three doses instead of six.

Shays responded to these points as well. "The current vaccine may be all we have, but it is far less than we need to meet the threat of weaponized anthrax," his statement said.

The panel knew that people reported falling after getting the vaccine, and interviewed many of them. "Clearly there are people who got the vaccine who suffered," Strom said. "We empathize with them completely." However, he said, it's "important to recognize that people get sick whether or not they get a vaccine."

There is "no support" for the theory that "the vaccine caused it," Strom said. "We can't say what made these people sick."

Critics of the vaccine may not be heartened by the committee's finding. However, Dr. Hugh Tilson, a professor of epidemiology and health policy at the University of North Carolina's School of Public Health and another committee member, said that could be good news.

"If you know that there isn't an association here, then it helps the doctors in a search for other causes," he said.

Kevin Haas of New York City, a Gulf War veteran who has multiple sclerosis, wondered aloud today if his condition is attributable to two anthrax vaccines he received before reporting for active duty in the Gulf.

"I have MS. Is it related? I don't know," Haas said. "I have definitely thought about it. I didn't want to take them. I had to take them."

If used in conjunction with antibiotics, Strom said, the vaccine could prevent anyone exposed to the bacteria from coming down with the disease. The Centers for Disease Control and Prevention has not recommended that civilians get the vaccine.

Strom said the committee was well aware that it was "dealing with difficult issues, both scientifically and politically," adding that it operated "in a charged arena."

What To Do

This is the official Defense Department site of the Anthrax Vaccine Immunization Program.

To view a House of Representatives report criticizing the vaccine, read "Unproven Force Protection".

Learn more about anthrax from the CDC.

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