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What 's the evidence that anthrax vaccine will protect people after a bioterrorist attack?

by Meryl Nass, M.D.

Back to Basics:
What 's the evidence that anthrax vaccine will protect people after a bioterrorist attack?

Actually, there is no evidence from any study that the licensed anthrax vaccine (aka Biothrax) has protected anybody against any form of anthrax. What, you say? How did it get a license? Well, the vaccine licensed in 1970 was quite different from the current vaccine, which is approximately 100 times stronger, according to the Government Accountability Office's report to Congress. But even the 1970 vaccine lacked evidence of human efficacy. Philip Coleman of CDC admitted there was "no real method of determining the protection afforded."

The ad hoc committee that reviewed the licensing data for anthrax vaccine for NIH, pointed out that the lack of cases of anthrax in an Alabama mill whose workers were vaccinated was hardly evidence of efficacy, since there was no evidence anyone at the mill had been exposed to anthrax. Dr. Margaret Pittman of NIH signed a letter to the manufacturer, the Michigan Department of Public Health, granting the license anyway, but asking Michigan to perform a clinical trial demonstrating efficacy. Yet there is no evidence the trial was ever conducted.

Everyone knew the vaccine might or might not work, but looked the other way. In 1985, the army decided to try and obtain a live spore anthrax vaccine instead, issuing a request for proposals, and admitting that "there is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent." The army proposal request also acknowledged that the current "vaccine is, however, highly reactogenic, requires multiples boosters to maintain immunity and may not be protective against all strains of anthrax bacillus." No live spore vaccine was ever licensed, however, in the United States, although similar vaccines are used in Russia and China.

Also in 1985, the FDA's advisory committee that reviewed the anthrax vaccine license to determine if the license was warranted by the evidence, pointed out that the efficacy of the vaccine against inhalation anthrax could not be determined. Their report was published in the December 13, 1985 Federal Register--but FDA decided to continue the license nonetheless.

In 1995 the military's Joint Program Office for Biological Defense published an information paper on anthrax vaccine that, again, admitted "there was insufficient data to show protection against inhalation anthrax" and that the vaccine's inability to protect against some anthrax strains "limits the breadth of efficacy claims that can be made. To date, no animal or other potency test has been demonstrated to be well correlated with protection in humans." This is an important concept: scientific studies over the past twenty years have uniformly failed to find a way to correlate animal data with human efficacy, so animals studies cannot be used to support the vaccine license. Yet animal studies are all the Defense Department and FDA have to go on--which fails to meet current and past regulatory standards for licensure. Therefore, the current legal challenge to the vaccine's license has an excellent chance to prevail.

Still interested in the animal data? I reviewed all the mouse and guinea pig data in a 1999 publication, showing that the US anthrax vaccine led to more animal deaths than the Russian and British human vaccines, and the US animal vaccine, when vaccinated rodents were later exposed to anthrax spores.

The Defense Department likes to tout their scientists' monkey studies, claiming a 95% survival rate in exposed, vaccinated rhesus monkeys. But what DOD fails to acknowledge is that many of the vaccinated monkeys actually did get anthrax, and were ill for up to two weeks. (Did the Army scientists keep them on life support?) Not only that, the monkeys were given human doses of vaccine, even though they only weighed about ten pounds. This would be equivalent to humans getting almost twenty doses of vaccine at a time. Would you call this a fair trial? Yet it is this type of data that the Army uses to "prove" the vaccine's effectiveness.

In a nutshell, anthrax vaccination successfully immunizes only the Defense Department's medical officers, and no one else--immunizing them against possible future charges of negligence, if troops ever did face anthrax. It gives the leaders cover, so they can say, "We did our best to protect the troops," even though they know perfectly well this vaccine is unfit for human consumption, and its only value has been to Bioport/Emergent Biosolution's bottom line.

But that isn't the end of this sorry tale. Bioport/Emergent Biosolutions, the vaccine's manufacturer, has spent over 2 million dollars in 2006 alone, to lobby the government to purchase this vaccine for civilians, too. Guess what? A former US Surgeon General, an Army Surgeon General, a former head of the Joint Chiefs and other former Generals have been on Bioport's payroll. Their lobbying has succeeded: 10 million doses have already been delivered to the National Strategic Stockpile, and now the Department of Health and Human Services has proposed buying another 20 million more, at a current cost of approximately $500 million. Civilians could face mandatory anthrax vaccinations in future, if the HHS Secretary (or governors of states that have passed enabling legislation) declared an emergency or a potential anthrax emergency, as a result of legislation passed hurriedly in the wake of 9/11.

When will the responsible federal agencies within DOD and HHS finally come to grips with this vaccine's dreadful performance and checkered history and junk the license and the stockpile?