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Let's Test Anthrax Vaccine in Children/ Bio Prep Watch

Posted May 03 2011 10:09pm
Yesterday it was announced that the government would be purchasing 3.42 million doses of anthrax vaccine to add to the civilian anthrax vaccine stockpile.  This is on top of the military stockpile, and comes out of DHHS funds.  This purchase adds about $100 million to the total contract for DHHS' anthrax stockpile , which is now worth about $500 million, and could climb to over 2 billion if the government purchases the 75 million doses it said it neededEmergent Biosolutions, the vaccine's manufacturer, also secured a $186.6 million contract for a recombinant protein antigen to combat anthrax and a $28.7 million contract for a third-generation vaccine.   Emergent's Board ( 2007 and 2011 ) is made up of national political operatives with little anthrax experience.

Vaccine vials expire after 3-4 years, requiring continuous replenishment.  What a business model! And what a way to throw taxpayer money into a black hole.

Apparently the gaping yaw of Emergent Biosolutions was still not satisfied. Emergent's courtiers in Washington decided only one thing would appease it:  the sacrifice of virgins on the anthrax vaccine altar.

Children would have to become test subjects to "prove" the vaccine's "safety".  Later, children everywhere could receive anthrax vaccine, were the government to declare an anthrax emergency. At present, the vaccine has never been tested in children, and it is not FDA-approved for their use.

According to BioPrepWatch :
"Nicole Lurie, the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, last week asked the National Biodefense Science Board to investigate the safety concerns of collecting data on the effects of anthrax vaccine in children.
 Dr. Nicole Lurie
There is currently no safety, immunogenicity or efficacy data in pediatric and special populations that would allow the U.S. Food and Drug Administration to evaluate the drug for its utilization under an Emergency Use Authorization.  In the case of an emergency, adults could receive the countermeasures under the less stringent EUA status, while an investigational protocol would still need to be developed for its use in children and special populations. This would present an array of logistical, clinical and communication challenges during a public health crisis." (emphasis added)
There are several ways to read this.  The first is, YES: giving anthrax vaccine to children would present an array of insurmountable challenges, since an anthrax vaccine trial fails to meet the legal standard with respect to clinical trials in children, which must entail no more than minimal risk if a child does not have a condition that would benefit from the intervention being studied.

Another way to read it is that the federal government could not justify using the vaccine in children, let alone adults, in an emergency, given the following facts. But then how would it explain the large vaccine stockpile?  On the other hand, if DHHS was able to generate scientific evidence to support vaccine use, it might circumvent the following challenges:

a)   LOGISTICAL:  The vaccine takes 5 weeks and 2 doses before it provides significant immunity

b)   CLINICAL:  Antibiotics (and monoclonal antibodies) are effective immediately, so there is probably no meaningful role for a vaccine whose benefit only starts 5-6 weeks after exposure.
  • Remember, antibiotics were 100% effective at preventing anthrax after the letters attack, while at best, this vaccine is no more than 90% effective, and may be 50% or less effective.  
  • Remember, we are talking about preventing and treating a fatal disease.  No matter what the government says, doctors cannot in good conscience switch from a highly effective drug treatment to a less effective vaccine, sacrificing patients to a theory of vaccine benefit.  
  • Be aware there exist no human efficacy data to support the use of the current anthrax vaccine after exposure to inhaled anthrax.
c)   COMMUNICATION:  Government spokespersons would look like morons trying to justify use of the vaccine in children, when the media present both sides of the story... as they already have with anthrax vaccine.  In 2001, 32,000 people who were possibly exposed to anthrax took antibiotics and were offered additional vaccine; only 198 (less than 1%) chose to take the vaccine, the rest having watched the news.
Current law does allow FDA to issue an Emergency Use Authorization (EUA) for drugs that have not been tested for safety in humans, during emergencies. (So the proposed child research is not, strictly speaking, necessary, despite DHHS claims.)

FDA issued an EUA in 2005 for use of anthrax vaccine in military servicemembers.  The EUA  allowed the military to continue to use the vaccine, after a federal judge revoked its license due to lack of proof it worked.  FDA knows about the vaccine's dangers; it has collected thousands of reports of illnesses related to anthrax vaccine .   Perhaps FDA did not want to sign off on an Emergency Use Authorization (EUA) for children, given the known facts about the vaccine.

Or perhaps DHHS decided the agency would be in a stronger legal position if  evidence of anthrax vaccine "safety" in children were generated before widespread use.  This is because DHHS, not the manufacturer, is on the hook for damages if the vaccine causes injuries , as a result of the 2005 Public Readiness and Emergency Preparedness Act.

Did Nicole Lurie, M.D. want an honest, independent review of anthrax vaccine and research in children?  If so, she took her concerns to the wrong place.  Who are the members of the National Biodefense Science Board , an entity created by Dr. Lurie in part to add support for controversial decisions?

One member is John Grabenstein, Ph.D., who led the military anthrax vaccine program from 1999 through the late 2000s, supervised multiple poorly conducted studies of anthrax vaccine safety, then moved to Merck Vaccine as a VP.  (I and others have critiqued the research projects on this blog and elsewhere.)

A second member is retired Major General John Parker, a former Fort Detrick Commander, where anthrax vaccine was developed and has been researched for over 60 years.  He is a strong anthrax vaccine proponent, and currently a vice president of SAIC, which happens to be in the military vaccine business.  No one else in Lurie's advisory group is an anthrax vaccine expert.  Since only the military has used the vaccine, the other members will likely defer to the two experts on the panel, whose reputations rely on the vaccine being safe and effective.

The panel will issue its recommendation in the fall.  Whose children will then be sacrificed in the name of Biodefense Preparedness?
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