Anthrax Vaccine:  Its checkered history, excessive stockpile and the human and financial costs

By Meryl Nass, MD*

The current vaccine (Biothrax, manufactured by Emergent Biosolutions or EBS) has never been proved effective in humans.

One human trial took place in the 1950s using a different, Merck-manufactured anthrax vaccine.  Efficacy studies of the current vaccine have only measured antibody levels, but it remains uncertain if vaccine-generated antibodies will protect recipients from death, if exposed to spores.

Anthrax vaccine is not safe.  According to its label: http://www.biothrax.com/prescribinginformation_biothrax_us.pdf

•                  It is designated Pregnancy Category D, known fetal risk
•                  Common side effects in the label include fainting, fatigue, muscle aches, headaches
•                  Fifteen percent of recipients may develop a severe side effect
•                  It may cause Gulf War Syndrome
•                 1-2% of recipients may develop a severe or disabling illness and rarely death
  http://www.gao.gov/new.items/d07787r.pdf

When the vaccine was a product of the Michigan Department of Health and its subsidiary MBPI (from 1970-1998) the cost per dose was under $3.00.  Vaccine was manufactured for the US military, and most was used for animal experiments.  Some was given to special ops troops and some to anthrax researchers.

In 1997 the military announced that it would be vaccinating all troops for anthrax, as it began the roll-out of a program to protect against many bioterror threats.  Anthrax was the first vaccine to be used, as it was already licensed and the military had a nine million dose stockpile.

When EBS bought the facility from Michigan in Sept 1998 for $3.28 million and loans from the state of Michigan, the per-dose cost was $4.36 initially, dropping to $2.26/dose in the contract’s second year.   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2040369

The federal government paid to rebuild the plant in 1998-9 after it failed an FDA inspection, and the Secretary of the Army indemnified the new owner against claims based on lack of efficacy or injuries from the vaccine.

Problems arose with the stockpile (7 million doses were quarantined by FDA for having failed lot release tests, leaving only 2 million usable doses) and soldiers did not want to receive the vaccine.  After hundreds of refusals and over 100 court-martials for refusing, the military vaccine supply ran out. 

FDA did not approve any anthrax vaccine that was made in the new facility (which had been rebuilt with federal funds). Between mid 1999 and January 2002 the anthrax vaccine plant failed several FDA inspections and no new vaccine was released.

In August 2001 memos reveal the Pentagon was leaning toward scrapping the whole anthrax vaccine program.  Then in September 2001 the anthrax letters were sent.

In response, DHHS Secretary Tommy Thompson told the American people that the anthrax vaccine plant would soon open for business, and in January 2002 FDA approved the new anthrax vaccine plant and vaccine, saying it was virtually the same as the old vaccine and therefore the new anthrax vaccine could be grandfathered in, without going through a full approval process.

In 2004 a lawsuit ended mandatory military anthrax vaccinations, as federal judge Emmett Sullivan found the vaccine had never gone through appropriate processes for approval, despite original licensure in 1970.  But by 2006 the vaccine was reapproved by FDA, and has remained mandatory for deploying military troops since then.

Following the anthrax letters of 2001, the federal government decided that a civilian stockpile of about 75 million anthrax vaccine doses was needed.  A better anthrax vaccine was needed, too, and hundreds of millions of federal dollars have been expended in this quest, but no second generation vaccine has yet been approved or purchased for the stockpile.  Last month a new initiative for this was announced.
http://www.govexec.com/management/2012/12/us-push-new-anthrax-vaccine-2017/60063/

Despite expenditures of 60 billion dollars for the federal bioterrorism response since 2001, many questions remain about the wisdom of how the money was spent, and what has been gained.  http://www.nytimes.com/2011/10/30/magazine/how-ready-are-we-for-bioterrorism.html

Despite such questions, the anthrax vaccine manufacturer has sold 55 million vaccine doses to the US government,
http://www.bioprepwatch.com/news/government-orders-44-75-million-doses-of-anthrax-vaccine-from-emergent-biosolutions/273933/

and is engaged in supplying up to 44.75 million additional doses over the next few years, via a 2011 contract.
http://www.nti.org/gsn/article/us-signs-contract-for-4475m-anthrax-vaccine-doses/

Most of the anthrax vaccine supplied since 2005 was sold to the government for about $27/dose.  However, the vaccine now retails for $90/dose. http://www.hopkinsguides.com/hopkins/ub/view/Johns_Hopkins_ABX_Guide/540030/all/Anthrax+vaccine

The vaccine requires 5 initial doses and yearly boosters.  Referring to the latest contract, EBS’ founder and major shareholder Fuad El-Hibri said, “In coming to agreement, Emergent and the Centers for Disease Control and Prevention worked diligently to establish business terms that incorporate substantial price concessions.”http://www.bioprepwatch.com/news/government-orders-44-75-million-doses-of-anthrax-vaccine-from-emergent-biosolutions/273933/

Anthrax vaccine has a 3 or 4 year shelf life, and in 2007 vaccine had to be discarded and replaced at a cost of about $100 million/ year, when the stockpile was smaller.   http://www.washingtonpost.com/wp-dyn/content/article/2007/10/22/AR2007102202111.html

“The Food and Drug Administration permits anthrax vaccine doses to be retained for one year after expiration, after which point the material must be eliminated, said a CDC spokesman who provided the information on condition of anonymity.”
http://www.nti.org/gsn/article/us-offer-anthrax-vaccine-first-responders-trial-basis/

Recently, plans have been made to give close-to-expiry anthrax vaccine to civilian first responders, and Presidential Commission member Dr. Alexander Garza recently testified to Congress about this.http://www.nti.org/gsn/article/us-still-preparing-offer-anthrax-vaccine-first-responders/

However, we should recall that the original anthrax letters were grown from a seed stock that was derived from a collection at the US Army Medical Research Institute for Infectious Diseases, Fort Detrick, Maryland.  The US was not attacked with anthrax by a foreign enemy.  Who sent the anthrax and their motive is uncertain.  However, the biodefense industry has been a major beneficiary.

In the intervening 11 years, there has been no attack on the US using anthrax or any other biological or toxin agent.  The justification for the CDC’s Strategic National Stockpile of drugs and vaccines to combat such threats is uncertain, and the cost of maintaining the stockpile is very high.
http://www.cdc.gov/phpr/stockpile/stockpile.htm

The justification for maintaining a 2 billion dollar stockpile of anthrax vaccine is unclear, and the rationale for mandatory anthrax vaccinations is similarly opaque.

The Center for American Progress wrote a 2010 report on federal anthrax vaccine procurement titled ‘Getting Rich on Uncle Sucker.’ 

It noted a 300% markup in the price of the vaccine compared to its production costs.  It also noted that over the past decade the company made over a billion dollars in profit.  http://www.americanprogress.org/issues/open-government/report/2010/10/20/8544/getting-rich-on-uncle-sucker/

Now the federal government wishes to expand the potential recipient pool to children, and has asked two federal advisory committees to make recommendations about testing anthrax vaccine in children.  The National Biodefense Science Board approved the proposal, pending agreement by a federal ethics board.http://www.phe.gov/Preparedness/legal/boards/nbsb/recommendations/Documents/avwgrpt1103.pdf

The Presidential Commission for the Study of Bioethical Issues was then tasked with reviewing the ethical implications of such a trial.  The Commission will have its final meeting next week, January 14-15, 2013 to complete its recommendations on a pediatric anthrax vaccine trial, and report on the larger issue of testing biodefense drugs and vaccines in the pediatric population.http://www.gpo.gov/fdsys/pkg/FR-2012-12-26/pdf/2012-31037.pdf

Because children will not benefit from such tests and may be seriously harmed, coupled with the fact that children are legally incapable from providing informed consent, they have been protected by federal law from being exposed to risks in such non-therapeutic experiments.

Even Dr. Paul Offit, a pediatric vaccine developer and strong proponent, advised against such a trial.
http://news.sciencemag.org/scienceinsider/2011/10/advisory-panel-urges-us-to-condu.html

But a brave new world of human experimentation may be looming.  A major question now is, “Whose children will be chosen as the experimental subjects, and how will their parents be honestly informed about the risks and lack of proposed benefit?”  

*Dr. Meryl Nass is a physician specializing in chronic fatigue syndrome, fibromyalgia and Gulf War Illnesses Dr. Nass is also an expert on anthrax and biological terrorism, and a US authority on adverse reactions due to anthrax vaccine. Dr. Nass has testified on anthrax before three congressional committees and the National Academy of Sciences,  She is a board member of AHRP.