Obama Administration Seeks to Test Anthrax Vaccine in Children

The Alliance for Human Research Protection ^ | Friday, 06 May 2011 | Vera Hassner Sharav

[GonzoII]

Obama Administration Seeks to Test Anthrax Vaccine in Children

Friday, 06 May 2011

Whose children will be sacrificed in an illegal and unethical experiment in the name of Biodefense Preparedness?

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

[FreeMaine]

Do you mean to suggest there might be some additional unmentionable kids, hanging around, that we may not know about?

Nope, while I certainly wouldn't rule out that Mrs. O may have killed off a bunch of her "mistakes" before having the two she parades around, I am only suggesting that he get those two injected before he comes near anyone elses.

I tend to doubt that the usurper can sire anything.

[chainsaw]

After all nothing wrong here because “it’s for the children!”

Wrong It's:After all nothing wrong here because “it’s to the children!”