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Israel develops anthrax vaccine
By Ellis Shuman   December 20, 2001
 

12/19 Government offers vaccine to people exposed to anthrax mail
USA Today

12/19 U.S. Offers Anthrax Vaccine to Thousands
Washington Post

10/10 Why anthrax vaccine is scarce
Wired News




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Israel has recently completed development of an anthrax vaccine that would be more effective and safer than the vaccine currently in use in the United States. The vaccine was developed at the Nes Ziona Biological Institute over the course of nearly ten years at the cost of millions of dollars.

According to a report published today in Yediot Aharonot, the Israeli vaccine was developed in one of the country's most secretive research programs and just finished initial clinical testing. The vaccine, given in the form of a shot, is not yet available for commercial use. But the minute approval is given, medical sources say, sufficient quantities of the vaccine could be produced for the entire Israeli population within a matter of months, the paper reported.

The vaccine was tested on volunteers from the IDF, who

 

Israeli vaccine would be administered in one shot and would not produce side effects
were not exposed to the disease but rather were checked for side effects from the drug. During testing the volunteers were inoculated with the vaccine, and weeks later were checked for the presence of anthrax antibodies in the blood. The presence of such antibodies was proof that the vaccine was successful.

Yediot Aharonot reported that the existence of an Israeli vaccine has surfaced in the media a number of times. According to media reports, the vaccine was developed through genetic engineering in cooperation with the IDF and the Israeli Ministry of Health.

Reports of the initial success of the Israeli vaccine appeared in the American Society of Microbiology's journal, Infection and Immunity, in August 2000. A study conducted at Nes Tziona and led by institute director, Dr. Avigdor Shafferman, tested the affect of the vaccine on guinea pigs and concluded that it led to immunization against anthrax spores.

"We believe, therefore, that [the use of genetically engineered anthrax spores] represents a platform of a prototypic, safe, and efficacious recombinant vaccine for further development and evaluation against a variety of virulent B. [anthrax] strains," concluded the abstract of the Nes Tziona study.

American anthrax vaccine was controversial
The Israeli vaccine is only the third such vaccine against anthrax existing in the world today. An American vaccine was developed in the United States over forty years ago and has been in widespread use there since 1970, when the Food and Drug Administration licensed it. According to the U.S. Surgeon General, the "vaccine has been safely and routinely administered in the United States to veterinarians, laboratory workers, and livestock handlers."

The American vaccine was mandatory for troops serving in the Persian Gulf War. The vaccine became the focus of controversy because some soldiers refused to get inoculated due to their worries about the vaccine's safety. There were numerous reports of the vaccine's severe side effects. Only one American company, BioPort of Lansing, Michigan, produced the anthrax vaccine, but the Food and Drug Administration halted vaccine production at the plant in recent years because of improper manufacturing practices.

During this year's anthrax scare, five Americans died of inhalation anthrax, the most serious form of the disease, and more than 12 others became sick. As a result, more than 30,000 Americans were placed on antibiotics as a precaution. Even so, the U.S. refused until now to release the military's vaccine to the public.

This week, U.S. Secretary of Health and Human Services Tommy Thompson announced that as many as 3,000 Americans who had been exposed to anthrax-laced letters would be offered anthrax vaccine and 40 more days of antibiotics to kill any living spores still present in their bodies.

Vaccine distribution after exposure is unprecedented
This is the first time the American vaccine will be made available for treatment. The strategy, medical sources say, is unprecedented. Vaccines are typically given before exposure to a disease to prevent illness, not afterward. The vaccine would be given in three doses over four weeks, Thompson said.

But Dr. D.A. Henderson, Health and Human Services's director of public health preparedness, said, "If this were a vaccine which… had no associated reactions [and] would work very well, that would be one thing, but this vaccine does have reactions associated with it, so there's a negative side to it."

Among known side effects are swelling and rashes -- caused by the shot itself -- that can be "quite dramatic," said Kathryn Zoon, director of the Food and Drug Administration's center for biologics.

The Israeli vaccine would have two major advantages over the American vaccine, Yediot Aharonot reported. It would be administered in one shot, and, according to medical sources familiar with the vaccine's development, it would not produce side effects.

It is not yet known what the cost of the Israeli vaccine will be. BioPort sold its vaccine to the American military at a cost of $3 per dosage. An Israeli medical source told Yediot Aharonot, "If we have to administer the vaccine to the entire Israeli population, the price will be such that Israel could afford it."