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Anthrax Vaccine Possibly Linked to 21 Deaths


Global Security Newswire

The existing anthrax vaccine could be linked to 21 deaths and more than 4,100 illnesses, Newsday reported yesterday (see GSN, Nov. 2).

Experts also questioned whether the vaccine now being stockpiled or those being developed could protect people who inhale the pathogen during a terrorist attack.

BioPort Corp. has received orders worth nearly $250 million from the federal government for 10 million doses of its existing anthrax vaccine, while VaxGen Inc. of California is being paid at least $877 to produce 75 million doses of a new vaccine.

The Food and Drug Administration in December 2004 said that BioPort’s vaccine could be linked to 16 deaths. When questioned by Newsday, that number rose to 21.

The agency also noted 347 “serious” illnesses among the 4,100 adverse reactions possibly linked to the treatment since 1990.

The rate of serious illness linked to the anthrax vaccine is lower than those connected to treatments for smallpox, influenza and other diseases, according to the Food and Drug Administration.

“The vaccine is as safe as any,” said BioPort spokeswoman Kim Brennen Root.

The BioPort vaccine is known to protect against anthrax contracted through the skin, but its effectiveness against inhalational anthrax — the form most likely to be used in a large-scale terrorist incident — remains in question.

“The number of doses they are amassing is wildly out of proportion to any possible threat from anthrax,” said David Ozonoff, a professor at the Boston University School of Public Health. “What the benefits are is very unclear and there are always (health) risks … when you vaccinate a whole lot of people.”

The single significant study of the BioPort vaccine found that it had to be used along with antibiotics following inhalation to be effective in test animals, Newsday reported. VaxGen officials are so far unsure that their vaccine — now being tested on animals — could provide adequate, safe protection against aerosolized anthrax.

“We’d hopefully achieve a high level of protection, and the alternative is severe disease,” said Harry Keyserling, an Emory University School of Medicine pediatrics professor who was involved in early trials of the VaxGen vaccine.

A study led by the U.S. Army Medical Research Institute of Infectious Diseases in Maryland found the best results for treating monkeys exposed to anthrax came from using both the BioPort vaccine and antibiotics. All monkeys that received both treatments following exposure survived. Roughly 90 percent of monkeys survived if they received only the antibiotics, while only 20 percent of the monkeys that received only the vaccine lived.

The vaccine was “not meant to be given after exposure,” said lead study author Arthur Friedlander. “The vaccine alone doesn’t protect and we wouldn’t expect it to protect” those already infected with anthrax (Thomas Maier, Newsday, Nov. 20).

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