Jump to content
RemedySpot.com

U.S. Department of Homeland Security Certifies BioThrax(R) (Anthrax Vaccine Adsorbed) As An Approved Product For Homeland Security

Rate this topic


Recommended Posts

Posted

Once again - Bioterrorism Acts are putting the citizens of this country at

large in a dangerous situation. Note what the SAFETY Act Protections

include.

News Release Tuesday 29 August 2006, 12:00 GMT

http://www.prnewswire.co.uk/cgi/news/release?id=177829

U.S. Department of Homeland Security Certifies BioThrax® (Anthrax Vaccine

Adsorbed) As An Approved Product For Homeland Security

GAITHERSBURG, land, August 29 /PRNewswire/ --

- BioThrax® is the First Known Vaccine to Obtain SAFETY Act Protections

Emergent BioSolutions Inc., a privately held biopharmaceutical company,

today announced that the United States Department of Homeland Security (DHS)

has granted the company's application for designation and certification of

BioThrax® (Anthrax Vaccine Adsorbed) as a " qualified anti-terrorism

technology " under the " Support Anti-Terrorism by ing Effective

Technology Act " (SAFETY Act).

BioThrax®, the only FDA-approved vaccine for the prevention of anthrax

infection, is the first known vaccine to be granted such SAFETY Act

coverage. BioThrax® is manufactured by BioPort Corporation, a subsidiary

of Emergent BioSolutions.

The Company submitted its SAFETY Act application to DHS pursuant to its 2005

contract with the Department of Health and Human Services (HHS) under which

HHS purchased 5 million doses of BioThrax® for the Strategic National

Stockpile (SNS). In May 2006, the Company executed a second contract with

HHS for the delivery of an additional 5 million doses of BioThrax for the

SNS.

The SAFETY Act, which Congress passed as part of the Homeland Security Act

of 2002, is intended to encourage the development and deployment of

anti-terrorism technologies by providing certain liability protections for

providers of " qualified anti-terrorism technologies " (QATTs) for claims

arising out of acts of terrorism.

To obtain SAFETY Act coverage, the applicant must submit to DHS

comprehensive data and materials regarding the safety, efficacy, and

deployment history of the technology. DHS then evaluates whether the

technology meets the criteria for SAFETY Act coverage, including whether it

is aimed at preventing, detecting, identifying, or deterring acts of

terrorism, or limiting the harm that such acts might otherwise cause, and

whether it performs as intended, is safe for use, and conforms to the

manufacturer's specifications.

DHS granted BioThrax® both types of protections available under the SAFETY

Act: " Designation " and " Certification. " " Designation " provides the seller of

a QATT with several benefits, including exclusive jurisdiction in federal

court, limitation of liability to a specified amount of insurance coverage,

and a bar on punitive damages. " Certification " confers status as an

" Approved Product for Homeland Security " and enables the seller to invoke a

rebuttable presumption that the government contractor defense applies,

potentially eliminating liability for claims arising from acts of terrorism.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to

protecting life through the development, manufacture, and commercialization

of immunobiotics, which are pharmaceutical products that induce the immune

system to prevent or treat disease. These include products for prophylactic

and therapeutic use against infectious diseases with significant unmet or

underserved medical needs and against biological agents that are potential

weapons of bioterrorism. The Company currently employs more than 450 people

with sites in land, Michigan, the United Kingdom, Germany, and the

Republic of Singapore. More information about Emergent BioSolutions is

available at http://www.emergentbiosolutions.com .

Web site: http://www.emergentbiosolutions.com

Distributed by PR Newswire on behalf of Emergent BioSolutions Inc.

Randi Airola

517-819-5926

When Good People do Nothing....

" Today Americans would be outraged if U. N. troops entered Los Angeles to

restore order; tomorrow they will be grateful! This is especially true if

they were told there was an outside threat from beyond, whether real or

promulgated, that threatened our very existence. It is then that all people

of the world will plead with world leaders to deliver them from this evil.

The one thing every man fears is the unknown. When presented with this

scenario, individual rights will be willingly relinquished for the guarantee

of their well being granted to them by their world government. "

~ Henry Kissinger

They that can give up essential liberty to obtain a little temporary safety

deserve neither liberty nor safety - lin

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...