December 21, 2001

"I am concerned about this new voluntary vaccine program for workers who may have possibly been exposed to anthrax bacteria. Without better guidance from the Centers for Disease Control as to who should take the vaccine, citizens cannot make an informed decision about their health.

"The original anthrax vaccine licensed by the Food and Drug Administration in 1970 was never licensed as a vaccine for inhalation anthrax. It was to be used as a protective measure against cutaneous exposure. As a vaccine for inhalation anthrax, it is still considered by the FDA to be an experimental drug for post-exposure use.

"Changes in the vaccine's manufacturing process raise substantial questions as to whether today's vaccine is the same as the vaccine licensed by the FDA for human use. There are currently differing opinions on the number of people who will face side effects from this vaccine. Although the consent form states that anywhere from 5 percent to 35 percent of people who take the vaccine will have side effects, the anthrax manufacturer's own literature states that a total of 34.2 percent of people will have side effects, and a GAO survey of National Guard and reserve forces found that 85 percent of those who took it had some reaction.

"As the GAO explained, unlike public health vaccines, such as measles and mumps, which have been fully tested and approved and are continuously being monitored to ensure that the vaccine is working properly, the anthrax vaccine has only been evaluated in emergency situations.

"This program is considered by the FDA to be a clinical investigation. People receiving the vaccine should be made aware that they are part of a federal experiment.

"The consent form, which will be provided by the federal government to individuals interested in receiving this vaccine, does not fully disclose all of the questions or concerns that have been raised regarding its use and its possible side effects. I believe the federal government should be more forthcoming, particularly in this matter such intensely personal concern. There should be full disclosure of the date of manufacture, in light of the highly significant problems that caused previous closure of the vaccine production plant and FDA criticism.

"I encourage those that may have been exposed to anthrax to consult with their physicians prior to taking the vaccine."

Contents
Official Documents
Congressional Testimony
Position Papers
Troop Experiences
News Articles
Government Contact Information
Opinion
Informative WWW Sites
Benefit versus Risk

Last revised: February 2002