A few comments on Dr. Steven Salzberg’s  posting in Forbes on October 30:    Link

Testing the Anthrax Vaccine on Children:
Getting the Facts Right

I cannot comment on the wide range of opinions within the biodefense, public health, and medical communities regarding the testing of the anthrax vaccine on children, but I will comment on my recent conversations with senior FDA personnel regarding this subject.

My understanding is that FDA wants to ensure a program would be in place to collect data on children if there was a national emergency and parents were offered the opportunity for children to receive the vaccine. This is a far different issue than what Dr. Salzberg discussed.

Furthermore, Dr. Salzberg states, “…anthrax is not infectious.”  Unfortunately it is.  Anthrax is not contagious, it does not pass from human to human, but that fact does not mean that a vaccine is therefore not required.  Tetanus is not contagious, yet the vaccine is critically important to public health.  That is because the bacterium, Clostridium tetani.  Is ubiquitous in nature.  That is why CDC recommends a tetanus shot every ten years, or more often after a potential exposure.

Bacillus anthrasis (the causative agent of anthrax) exists in nature, which is why Ted Turner lost nearly 300 buffaloes on his Montana ranch in the summer of 2008. The good news is that currently we are not experiencing a public health emergency from anthrax exposure. That could, however, change quickly since anthrax remains the top bioterrorism threat.  An act of bioterrorism in major city would put millions at risk—a certain number from the initial release, and a far larger number from the potential of secondary aerosolization.

This secondary risk was demonstrated on the island of Gruinard off the coast of Scotland where the British tested anthrax weapons during World War II.  Anthrax is the one potential bioweapon that is persistent. It took the British four decades to adequately “clean” the environment on Gruinard. (Virtually all other pathogens would be rendered harmless by environmental conditions within hours/days.)

The recent WMD Center’s Bio-Response Report Card (www.wmdcenter.org) gave failing grades for America‘s capability to properly cleanup after an aerosol release of anthrax.  This means there would only be two courses of action following a large-scale outdoor release in an urban area:  evacuate for months, possibly years, or vaccinate the population.

I commend FDA for considering the implications and taking actions in preparation for what the bipartisan Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stated was the top WMD threat—an anthrax attack.

Whether or not we do studies on children prior to a national emergency is highly controversial issue. However, if an attack occurred, I would want the vaccine to be an option for all parents, and I would expect FDA to have a plan for collecting information.

This is an important debate, and even more important that the debaters get the facts right.