According to BioPrepWatch.com , the Obama administration is seeking to obtain a green light to conduct an anthrax vaccine safety experiment  on US children.  The stated rationale for such a trial, articulated by Dr. Nicole Lurie, US Dept. of Health and Human Services,  is that there are no data about the safety of exposing children to the anthrax vaccine. And if an emergency arises, a trial "would present an array of logistical, clinical and communication challenges during a public health crisis." 

No child would benefit from exposure to a vaccine that has generated thousands of adverse event reports--including deaths--in adults.

Current law allows the FDA to issue an Emergency Use Authorization (EUA) for "protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people." The FDA Commissioner "may allow countermeasures to be used in an emergency to diagnose, treat, or prevent serious life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives."

In the absence of a national emergency from an anthrax bioterrorist attack, an anthrax vaccine trial in children would violate federal legal and ethical standards which prohibit exposing children to greater than minimal risk if a child does not have a condition that would benefit from the experimental intervention.  45 CFR 46 Subpart D

The Anthrax vaccine is highly controversial and US courts prohibited mandatory vaccination of the military from 2004-2006:

Even when anthrax-laden letters were mailed to several congressional leaders in 2001, Senate Majority Leader, Sen. Bill First, a doctor, criticized the anthrax vaccine on CNN  stating,

"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. I do not recommend widespread inoculation for people with the vaccine in the Hart Building ...There are too many side effects and if there is limited chance of exposure- the side effects would far outweigh any potential advantage."

Between 2001 and 2004, the FDA Vaccine Adverse Event Reporting System (VAERS) received 4,136 spontaneous adverse event reports: 347 (8.4%) were reported as serious.

  *Serious adverse events include: death, hospitalization, permanent disability, or are life-threatening. There were 16 deaths.

According a 2007 report by the Congressional watchdog agency, the Government Accountability Office (GAO), the Center for Disease Control and the Vaccine Healthcare Centers of the Dept. of Defense estimate that "between 1 and 2 percent" of vaccinated military personnel, experienced "severe adverse events, which could result in disability or death." 

So, what is the catalyst that prompted public health officials in the Obama administration to request permission to conduct a wholly non-therapeutic experiment that would expose children to serious risk of harm? Such an experiment would callously disregard children's human right to "Life, Liberty and Security of the Person"--as guaranteed by the Universal Declaration of Human Rights, 1948.

Could it be that the request by DHHS to conduct an anthrax vaccine safety trial in children is prompted by commercial, rather than public health considerations?

Mery Nass, MD whose anthraxvaccine.blog examines illogical and dishonest public health responses--the anthrax vaccine being a primary focus, has revealed that the board of directors of Emergent Biosolutions, the manufacturer of the anthrax vaccine (2007 and 2011) is made up of national political operatives with little anthrax experience--but plenty of ties to government policymakers. 

Emergent broadens CDC contract by $101m

On May 2, 2011,  Emergent Biosolutions (formerly Bioport, the manufacturer of Biothrax, the only anthrax vaccine approved by the FDA) announced that the federal government would be purchasing 3.42 million doses of anthrax vaccine to add to the civilian anthrax vaccine stockpile. (reposted below)

This purchase adds about $101 million to the total contract for DHHS' anthrax stockpile, which is now worth about $500 million. The company has made $2.4 billion since 2004, which could climb to over $2 billion if the government purchases the 75 million doses it said it needed. This is in addition to the military anthrax vaccine stockpile.

Washington Business Journal reports that Emergent derives the bulk of its revenue from federal public health agencies.

“Emergent proudly supports the U.S. government’s efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This contract is an indication that BioThrax remains a critical component of the government’s arsenal of biodefense medical countermeasures. In addition to this contract modification, we are continuing discussions with the U.S. government regarding a follow-on procurement contract, which we anticipate will cover a multi-year period.” 

Emergent Biosolutions 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. 

So, how did Emergent secure such profitable US government contracts for anthrax vaccine?

The answer is described by Scot Lilly in "Getting Rich on Uncle Sucker: Should the Federal Government  Strengthen Efforts to Fight Profiteering?"

The Emergant model extracts contracts from the US government at exorbitant high profit margins, compared to the cost of manufacture. The vaccine vials expire after 3-4 years, requiring continuous replenishment--guaranteeing sales of at least $100 million / year to the manufacturer for the foreseeable future.  However the expenditure throws taxpayer money into a black hole.

We say to President Obama: do not even consider the suggestion by your DHHS officials who recommend that children should be put at risk (i.e., sacrificed) to justify anthrax vaccine profits.   

Vera Hassner Sharav

May 02, 2011  

U.S. Government Expands BioThrax Procurement Contract to 17.92M Doses from 14.5M Increasing Contract Value by up to $101 Million

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a modification to its current procurement contract (200-2009-30162) with the U.S. government to supply an additional 3.42 million doses of BioThrax^® (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent proudly supports the U.S. government’s efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines”

This modification to the contract is valued at up to $101 million for the delivery and shipping of additional doses of BioThrax beginning 3Q 2011. Delivery of these doses will commence immediately following early completion of final delivery of the original 14.5 million doses of BioThrax under the contract prior to this modification. Emergent anticipates completing all deliveries of these additional 3.42 million doses of BioThrax during the remainder of 2011.

“Emergent proudly supports the U.S. government’s efforts and unwavering commitment to meet its stated need of 75 million doses of anthrax vaccines,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This contract is an indication that BioThrax remains a critical component of the government’s arsenal of biodefense medical countermeasures. In addition to this contract modification, we are continuing discussions with the U.S. government regarding a follow-on procurement contract, which we anticipate will cover a multi-year period.”

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent's marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2011, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax^® procurement; our ability to obtain new BioThrax^® sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax^®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Annual Report for the year ended December 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Contacts

Emergent BioSolutions
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
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Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
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