ANTHRAX AND THE VACCINE

October 1999
		Which is worse -- a deadly disease, or the vaccine that guards against it? Experts answer your questions.

Forum Introduction. Who in the military must take the vaccine? Is Anthrax a national health problem? What are the side effects? Who is at risk for side effects? What company makes the vaccine? Is the vaccine approved by the FDA? Is there a medical resource on the topic?.     Oct. 21, 1999: The growing controversy over the Anthrax vaccine. Jan. 7, 1997: Gulf War Syndrome Update. Nov. 7, 1996: Chemical weapons debate. Sept. 11, 1996: Chemical weapons vote. Browse the NewsHour's coverage of defense and health.       Anthrax, from the Secretary of Defense Anthrax Vaccine Web site Centers for Disease Control and Prevention American Gulf War Veterans Association Arnot Ogden Medical Center Anthrax Links and Information: Created by opponents of the vaccine	Barry Silvers of Boca Raton, Fl asks: Has this vaccine been approved by the FDA and if not, why not? In percent how effective is it? Dr. Meryl Nass responds: The vaccine was approved by the NIH in 1970, before FDA approved vaccines. This was two years before efficacy data were required. No long-term safety data was supplied with the license application, and none has yet been supplied to the FDA. The data which were used to support the license application was gathered using a DIFFERENT anthrax vaccine, and the information in the package insert comes from the study of this earlier vaccine. In that study, conducted in the 1950s in goat hair mills, volunteers were checked at 24 and 48 hours after vaccination. There was no active followup for side effects after that time. Thus the package insert lists a systemic side effect rate of 0.2%, but two unpublished DOD vaccine studies cited by the Government Accounting Office (of the current vaccine) had systemic side effect rates of 43% and 48%. This is over 200 times higher than expected, according to the package insert, and alone should have triggered an investigation and vaccine recall. But FDA and DOD have ignored this major discrepancy. These numbers, I should emphasize, are for short-term adverse effects, as no long-term adverse effect rates have been released by the DOD. There is an ongoing study of long-term adverse effects in progress at Tripler Army Medical Center, Hawaii. Six hundred medical personnel who began their vaccinations 13 months ago have been asked to report all symptoms that developed. Sufficient time has passed to learn how this group is faring. But these data have not been made available for review. Four Congressmen recently called on FDA to hold off on approval of the license supplement for the refurbished manufacturer until numerous questions about the vaccine have been satisfactorily addressed. In terms of effectiveness, there is no good answer. The survival rate in animals depends on the anthrax strain used, so presumably it does in man, also. It is feared that if a genetically engineered strain of anthrax were used, such as one made public by Russian scientists in 1997, the vaccine could be useless. Lt. Col. Randy Randolf responds: The vaccine was developed in the United States during the 1950s and 1960s for humans. The vaccine was licensed by the National Institutes of Health's Division of Biologics Standards for general use on November 4, 1970. In 1972, responsibility for vaccine regulation was transferred from NIH to the Food & Drug Administration (FDA). Since 1970, anthrax vaccine has been used by at-risk veterinarians, at-risk laboratory workers, and at-risk livestock handlers in the United States.