Post-exposure use is recommended, although this is not an approved indication per FDA. Therefore, the ACIP recommends that anthrax vaccine be administered under an Investigational New Drug (IND) application or an Emergency Use Authorization (EUA). The Emergency Use Authorization was passed to handle emergencies, not to provide a loophole for planned use of experimental drugs. (However, a loophole was built into this law by stating that emergecies could be actual or potential.)
See what DHHS officials said about the IND mechanism for vaccine campaigns in 2007:
Although an IND mechanism is well-suited for a clinical study and can be used in an emergency situation for an individual patient, the mechanism is ill-suited for situations such as a universal vaccination campaign against a life-threatening infectious disease taking place in the context of a national emergency.What HHS found unacceptable in 2007 CDC had its advisory committee recommend in 2009. (WHY is ACIP making legal recommendations, for that matter? Aren't they doctors?)
Wouldn't it make more sense for the manufacturer to apply to FDA to approve post-exposure use, if data support the use? One hundred ninety-eight people were enrolled in a CDC study and received post-exposure anthrax vaccine in 2001-2 under an IND. Where are the safety and efficacy data from this study? Why isn't there animal efficacy data, which could support licensure using the so-called Animal Rule for bioterrorism drugs and vaccines?
The increasing use of the IND provision--intended as a mechanism for safely performing research in human subjects, not for allowing treatment using untested products--as a legal means for using unlicensed products, or products unlicensed for their intended use, is troubling.
If a particular use of a product is planned in advance, then the product should be demonstrated to be safe and effective for that use ahead of time. At a minimum, efforts to test its safety and efficacy for the new indication should be undertaken by the time such use is recommended. After all, this recommendation was issued by the Advisory Committee on Immunization Practices: the group that makes decisions at the federal level for use of all U.S. vaccines.
Treatment is treatment, and research is research. Advance planning is not the same as emergency use. Jumbling them together to enable mass experiments is bad medicine and bad science. Such intent flies in the face of the Nuremberg Principles, which demand free, complete and informed consent from all subjects who participate in research.
But would human subjects participate if they learned they are being studied before the mice or guinea pigs, and before the human data that do exist have been reviewed by FDA?
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