The Anthrax Vaccine: Why You Should Be Concerned

Recently, the National Biodefense Science Board (NBSB) posted notice of a public meeting to be held on September 22, 2011, in Washington, DC. One of the issues to be discussed at that meeting is that discussed in an earlier public engagement workshop held this July. The workshop focused on the controversial issue of a pediatric anthrax vaccine, and led to the establishment of an Anthrax Vaccine Working Group under the NBSB, which was to conduct a cost-benefit analysis of using the anthrax vaccine adsorbed in children and examine issues related to testing the vaccine on children. The Working Group will present its findings at the September 22 meeting, when it will issue its recommendations to the Assistant Secretary for Preparedness at the US Department of Health and Human Services (HHS), Nicole Lurie, who had initially charged NBSB with further evaluating the issues related with the pediatric vaccine trial.

Behind these public meetings lie years of discussion around the issue of pediatric anthrax vaccines. As early as 2005, Senator Jeff Bingaman (D-NM) wrote a letter to Mike Leavitt, then Secretary of HHS, regarding plans for anthrax vaccine trials in children. In that letter, Senator Bingaman made the following points:

  •  Before testing any vaccine in children, researchers should have gathered considerable information on how the vaccine affects adults. If there are significant adverse effects of the vaccine (as there have been to the anthrax vaccine adsorbed, which is still the only anthrax vaccine used in the US today), it should not be tested in children at all.
  • Extensive data should be gathered particularly on any experimental vaccine before testing it on children.

  • The Institute of Medicine report on Ethical Conduct of Critical Research Involving Children, which was included in the Best Pharmaceuticals for Children Act of 2002 noted that any research conducted on healthy children would have to involve minimal risk on their part. The anthrax vaccine adsorbed, which has been linked to serious adverse events including death and permanent disability, cannot be seen to pose minimal risk to healthy children. Children with disorders or conditions can be exposed to higher risk in research, but no children have been exposed to anthrax, and so there can be no justification to conduct such trials.

The vaccine trials planned in 2005 were cancelled, but for the most part, Senator Bingaman’s concerns have still not been addressed. The anthrax vaccine adsorbed, as I mentioned earlier, is still the only anthrax vaccine used in the U.S., and it is still being considered for testing in children, as the NBSB workshops and meetings indicate.

Meanwhile, Nicole Lurie’s letter to the NBSB shows that the vaccine is still controversial. Indeed, a letter to the Secretary of HHS, Kathleen Sibelius, from the Alliance for Human Research Protection, underlines serious problems with the anthrax vaccine adsorbed. In addition to the points underlined by Senator Bingaman, above, the letter added:

  • There is no scientific evidence that the anthrax vaccine prevents people from catching the disease after exposure – antibiotics work just as well, if not better, to protect people from anthrax.

  • The vaccine is not safe, and has been concluded to be unsafe by, among others Bill Frist, M.D., bioterrorism expert and Senate Majority Leader right after the anthrax attacks, who said, “There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that.” The government agencies responsible for evaluating vaccine safety have already acknowledged significant gaps in the science and safety of vaccines. People are becoming increasingly concerned with both short and long term side effects of vaccine ingredients, preparations, combinations and schedules, and adding even more vaccines with a very dubious safety profile does nothing to ease their anxiety over the lack of appropriate safety of the recommended vaccine schedule.

  • Given the state of the current economy, purchase of the vaccine (which would cost over one billion dollars) is a waste of taxpayer money.

This last point references a report by the Center for American Progress, titled “Getting Rich on Uncle Sucker: Should the Federal Government Strengthen Efforts to Fight Profiteering?” This report points out that the makers of the anthrax vaccine adsorbed, Emergent BioSolutions, Inc., are selling the vaccine to the government at a mark-up of almost 300 percent. To put it another way, the government is paying Emergent BioSolutions around 300 percent more than the cost of the vaccine.

This is a mind-bogglingly high profit margin. It becomes even more difficult to understand when you realize that the government developed the vaccine in the first place. Emergent BioSolutions did not have to cover the costs of development, nor did it have high start-up costs related to setting up the facility. According to the company, it required a high mark-up at one point in order to have the funds to comply with government regulations regarding vaccine manufacture, but that was some time ago.

It should come as no surprise, however, that Emergent BioSolutions has more lobbyists than most companies its size, and that these lobbyists, as well as company officers, have made substantial gifts to politicians and committees over and above what the company Political Action Committee has given. This has made it difficult to get political support for new, safer options to the anthrax vaccine adsorbed, among other things.

To get a full description of the ways in which taxpayer dollars are going towards paying exorbitant amounts for a vaccine that is less than safe, see the Center for American Progress report for yourself. It is definitely worth a read. And if you can, attend the NBSB public meeting on September 22 and let the board know that children should not be subjected to a vaccine that has been proved dangerous. Because if we don’t act, who will?

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