Tuesday, November 1, 2011

Anthrax Vaccine Testing in Kids?

It's a post-modern world. Here's the Washington Post's headline on a Friday story: "No testing of anthrax vaccine on children _ for now _ federal advisory board tells regulators." The next day, the San Francisco Chronicle's headline on a story written by a Washington Post reporter reads, "Panel endorses anthrax vaccine test on children." Global Security Newswire's headline? "Panel Urges Ethics Study of Testing Anthrax Vaccine on Minors." And yes, you guessed it, all these articles are about the same report. In fact, the "final draft report" of the National Biodefense Science Board actually recommends the following:

"HHS should develop a plan for and conduct a pre-event study of AVA in children, to include a research IND. HHS should submit the study protocol to one or more IRBs, and comply with the 21 CFR 50.54 / 45 CFR 46.407 federal review process. This recommendation should be revisited if new anthrax vaccines or other therapeutic countermeasures become available."

Translation: do the Anthrax vaccine study in kids after IRB review.

The NBSB report gave considerable attention to the ethics of testing Anthrax vaccine in kids, but it didn't end up "urging an ethics study" or saying "no testing for now." The report takes the position that it's important to understand how the vaccine works in kids before it's used in an emergency--important enough for kids to incur the risks of the trial, given the informed consent of their parents. The recommended trial would begin with older kids and work its way down to lower ages as results come in.

Note that the intended use of the vaccine is not as a routine population-wide prophylactic, since Anthrax isn't infectious. Rather, it would be given to selected people (including children) after they'd been exposed to Anthrax spores, to prevent disease development. Here's the second sentence of the executive summary of the report: "In this emergency scenario, [anthrax vaccine] would be used in conjunction with antibiotics to prevent the development of infection and illness following exposure to anthrax spores, a form of therapy termed “post-exposure prophylaxis." That's why Steven Salzberg's righteous indignation in this Forbes article seems to me to be misplaced; he seems to think that NBSB is contemplating huge and wasteful population-wide vaccination, but it's not.

UPDATE: Here's a nice piece by Art Caplan predicting that the study on kids won't happen. Basically Art is arguing that the likelihood of an anthrax attack is so small, the risks of the vaccine so uncertain, and the likelihood of vaccination being used as a response to an attack so uncertain, that no IRB will ever think the vaccine test has a good enough risk/benefit profile to permit it. Highly recommended!

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