[NVIC] FDA Fast Tracks Biodefense Vaccines

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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BL Fisher Note:

Fast tracking these biodefense vaccines could well result in vaccine

manufacturers being allowed to by-pass former standards for proof of safety

and efficacy. Fast tracking may well mean that these vaccines will be

targeted for not only mandatory use by the military but also mandatory use

by civilian populations. Whenever vaccine manufacturers spend considerable

sums of money developing a new vaccine and public health officials allocate

considerable sums of taxpayer monies supporting the development and use of a

new vaccine, both stock holders and politicians expect widespread public use

of the new vaccine. Mandates soon follow licensure. There is no reason to

believe it will be any different for these biodefense vaccines.

But who is doing the research into the genetic and other biological high

risk factors for adverse responses when given singly or in combination with

other vaccines? Who will evaluate the cumulative effects of repeated

aytpical manipulation of the human immune system with the mass use of these

and other vaccines on the biological integrity of the US population?

http://biz./prnews/050914/law033.html?.v=25

PR Newswire via

Wednesday September 14, 9:00 am ET

FDA Grants Fast Track Designation to DVC Biodefense Vaccine Development

Programs

EL SEGUNDO, Calif., Sept. 14 /PRNewswire-FirstCall/ -- Computer Sciences

Corporation (NYSE: CSC - News) today announced that DVC LLC, a CSC company,

has received Fast Track designation status from the U.S. Food and Drug

Administration (FDA) for three biodefense vaccine development programs it is

working on for the Department of Defense Joint Vaccine Acquisition Program

(JVAP) Product Management Office.

ADVERTISEMENT

DVC programs to develop recombinant vaccines for plague and botulinum

neurotoxin serotypes A and B, and the company's program to develop a live,

attenuated vaccine for Venezuelan equine encephalitis have received the Fast

Track designation. Fast Track status allows the FDA to expedite review of

drugs and biologics that demonstrate the potential to address unmet medical

needs and are intended to treat serious or life-threatening conditions.

" At DVC, our mission is to expedite the development of biodefense products

to protect the nation's operating forces and citizens, " said DVC Chief

Scientific Officer Dr. V. House. " We do this by applying for Fast

Track status, which enables us to work closely with the FDA to more

efficiently meet military biodefense needs. "

JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine

products to protect the warfighter against biological warfare agents. JVAP

consolidates Department of Defense efforts for the advanced development,

testing, FDA licensing, production and storage of biological defense

vaccines.

DVC is a biodefense company dedicated to the development and licensure of

safe and efficacious biological products. DVC is part of CSC's Enforcement,

Security and Intelligence organization, which CSC created in 2001 to support

programs enhancing U.S. security.

The safety and efficacy of these vaccines in humans has not been

established. These products are currently under clinical investigation and

have not been licensed by the FDA.

About CSC

Founded in 1959, Computer Sciences Corporation is a leading global

information technology (IT) services company. CSC's mission is to provide

customers in industry and government with solutions crafted to meet their

specific challenges and enable them to profit from the advanced use of

technology.

With approximately 78,000 employees, CSC provides innovative solutions for

customers around the world by applying leading technologies and CSC's own

advanced capabilities. These include systems design and integration; IT and

business process outsourcing; applications software development; Web and

application hosting; and management consulting. Headquartered in El Segundo,

Calif., CSC reported revenue of $14.3 billion from continuing operations for

the 12 months ended July 1, 2005. For more information, visit the company's

Web site at www.csc.com.

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