“But Emergent, which was already producing an outdated anthrax vaccine, spent large sums of money on a lobbying campaign against Vaxgen, including hiring two former aides to Vice President Dick Cheney.”

It may surprise you that the currently used anthrax vaccine is neither crude nor outdated. It was approved by the FDA as being safe and efficacious in the 1970s, and used by thousands of government civilians and hundreds of thousands of military personnel since then. Merely because the vaccine was formulated more than three decades ago doesn't mean it is outdated – the basic threat of anthrax organisms has not changed since then, the equipment and processes for developing the vaccine has been constantly updated, and the overall percentage of bad reactions to the vaccine has been much, much lower than any other vaccine currently used.

I know it may be nice to cast BioPort/Emergent BioSolutions as the bad guy here, and yes, they played politics (as does every defense firm), but as long as HHS followed the rules, it ought to be hard to define a “bad guy” here. The military (as well as HHS) does want a vaccine that can be administered in less than six shots and that has fewer side effects, but that doesn't mean that the current anthrax vaccine has anything wrong with its formulation or use. If you want a villain, blame the constantly changing BioShield program and the overly ambitious goals that the Bush administration laid out in 2004.

BEGIN:
October 3, 2002 – Brisbane, Calif. -VaxGen Inc. (Nasdaq: VXGN), the
current leader in AIDS vaccine development, has been awarded a contract from the
National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH), to develop a new anthrax vaccine and to
create a feasibility plan to manufacture an emergency stockpile of 25 million
doses. NIAID is expected to award a separate contract in 2003 to manufacture the
stockpile.

The only anthrax vaccine currently licensed, BioThrax(R), requires six
injections over 18 months. The goal of the new government contract is to develop
a vaccine that proves to be safe in humans, efficacious in animal challenge
studies and requires no more than three injections.

Under the initial phase of the NIAID contract, VaxGen will be awarded
$13.6 million to advance the development of a vaccine candidate initially
developed by the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID). If results from the first phase are positive, VaxGen will be
eligible for an additional $13.6 million in 2003 as a continuation of the
current contract to support a Phase II clinical trial. A second, much larger
contract to manufacture the 25-million dose stockpile will be awarded by NIAID
through a competitive bid process next year.

“This award builds on VaxGen's expertise in the development, testing and
manufacturing of vaccines, and reflects our commitment to develop a broad array
of biopharmaceutical products for the prevention and treatment of human
infectious diseases,” said VaxGen Chief Executive Officer Lance K. Gordon, Ph.D.
“Our objective is to meet or exceed the government's requirements and be
selected to supply vaccine for the stockpile. If successful we would also plan
to sell the vaccine to other approved governments and private customers.”

As a major sub-contractor to VaxGen, Battelle of Columbus, Ohio, will have
primary responsibility for initial manufacturing of the vaccine candidate as
well as for conducting pre-clinical safety and efficacy studies in accordance
with FDA guidelines. VaxGen has budgeted approximately $4.5 million for
Battelle's contributions to this urgent initiative. Battelle has substantial
experience in biologics research and development, specifically including anthrax
vaccines.”
END

A few technical notes: the Bioport/Emergent vaccine is the one that was injected into hundreds of thousands of soldiers in the most egregious human guinea pig experiment of this generation. Numerous sensitive individuals had severe, even life-terminating responses – this is your “Gulf War Syndrome”, as Gary Matsumoto reported in his fairly good book on the topic.

However, claims that Vaxgen had a superior product were not true – their product was apparently just as lethal and never made it into human trials. It was a recombinant product as well, and let's explain what this means:

Battelle was screwing around with genetically engineering anthrax bacteria. This private non-profit corporation deserves a large amount of immediate scrutiny – they've already been caught in violation of U.S. biological warfare treaties several times. For more details, please read http://www.armscontrol.org/act/2004_10/Tucker.asp

“On September 4, 2001, exactly one week before the terrorist attacks in New York and Washington, a front-page story in The New York Times revealed the existence of three secret threat-assessment projects being conducted by the U.S. intelligence community and the Department of Defense:

“But Emergent, which was already producing an outdated anthrax vaccine, spent large sums of money on a lobbying campaign against Vaxgen, including hiring two former aides to Vice President Dick Cheney.”

It may surprise you that the currently used anthrax vaccine is neither crude nor outdated. It was approved by the FDA as being safe and efficacious in the 1970s, and used by thousands of government civilians and hundreds of thousands of military personnel since then. Merely because the vaccine was formulated more than three decades ago doesn’t mean it is outdated – the basic threat of anthrax organisms has not changed since then, the equipment and processes for developing the vaccine has been constantly updated, and the overall percentage of bad reactions to the vaccine has been much, much lower than any other vaccine currently used.

I know it may be nice to cast BioPort/Emergent BioSolutions as the bad guy here, and yes, they played politics (as does every defense firm), but as long as HHS followed the rules, it ought to be hard to define a “bad guy” here. The military (as well as HHS) does want a vaccine that can be administered in less than six shots and that has fewer side effects, but that doesn’t mean that the current anthrax vaccine has anything wrong with its formulation or use. If you want a villain, blame the constantly changing BioShield program and the overly ambitious goals that the Bush administration laid out in 2004.

BEGIN:
October 3, 2002 – Brisbane, Calif. -VaxGen Inc. (Nasdaq: VXGN), the
current leader in AIDS vaccine development, has been awarded a contract from the
National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S.
National Institutes of Health (NIH), to develop a new anthrax vaccine and to
create a feasibility plan to manufacture an emergency stockpile of 25 million
doses. NIAID is expected to award a separate contract in 2003 to manufacture the
stockpile.

The only anthrax vaccine currently licensed, BioThrax(R), requires six
injections over 18 months. The goal of the new government contract is to develop
a vaccine that proves to be safe in humans, efficacious in animal challenge
studies and requires no more than three injections.

Under the initial phase of the NIAID contract, VaxGen will be awarded
$13.6 million to advance the development of a vaccine candidate initially
developed by the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID). If results from the first phase are positive, VaxGen will be
eligible for an additional $13.6 million in 2003 as a continuation of the
current contract to support a Phase II clinical trial. A second, much larger
contract to manufacture the 25-million dose stockpile will be awarded by NIAID
through a competitive bid process next year.

“This award builds on VaxGen’s expertise in the development, testing and
manufacturing of vaccines, and reflects our commitment to develop a broad array
of biopharmaceutical products for the prevention and treatment of human
infectious diseases,” said VaxGen Chief Executive Officer Lance K. Gordon, Ph.D.
“Our objective is to meet or exceed the government’s requirements and be
selected to supply vaccine for the stockpile. If successful we would also plan
to sell the vaccine to other approved governments and private customers.”

As a major sub-contractor to VaxGen, Battelle of Columbus, Ohio, will have
primary responsibility for initial manufacturing of the vaccine candidate as
well as for conducting pre-clinical safety and efficacy studies in accordance
with FDA guidelines. VaxGen has budgeted approximately $4.5 million for
Battelle’s contributions to this urgent initiative. Battelle has substantial
experience in biologics research and development, specifically including anthrax
vaccines.”
END

A few technical notes: the Bioport/Emergent vaccine is the one that was injected into hundreds of thousands of soldiers in the most egregious human guinea pig experiment of this generation. Numerous sensitive individuals had severe, even life-terminating responses – this is your “Gulf War Syndrome”, as Gary Matsumoto reported in his fairly good book on the topic.

However, claims that Vaxgen had a superior product were not true – their product was apparently just as lethal and never made it into human trials. It was a recombinant product as well, and let’s explain what this means:

Battelle was screwing around with genetically engineering anthrax bacteria. This private non-profit corporation deserves a large amount of immediate scrutiny – they’ve already been caught in violation of U.S. biological warfare treaties several times. For more details, please read http://www.armscontrol.org/act/2004_10/Tucker.asp

“On September 4, 2001, exactly one week before the terrorist attacks in New York and Washington, a front-page story in The New York Times revealed the existence of three secret threat-assessment projects being conducted by the U.S. intelligence community and the Department of Defense: