HHS Statement concerning the rPA Anthrax Vaccine Contract Modification
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Marc Wolfson, a spokesman for the U.S. Department of Health and Human Services, issued this statement to The Post Wednesday night in relation to the VaxGen dispute, asking that it be attributed to Noreen Hynes, director of research and development coordination in the HHS office responsible for biodefense.
The requirements established in the November 2004 contract with VaxGen for rPA anthrax vaccine remain unchanged.
There are no new requirements in the contract modification of May 2006. The modification is an extension of time and effects no substantive changes to the contract work.
Appropriate standards for demonstrating safety, efficacy, stability and manufacturing consistency were established in the November 2004 contract, and remain.
We are working to implement Project BioShield responsibly, particularly with regard to our ability to accept products into the Strategic National Stockpile (SNS) in advance of the Food and Drug Administration's licensure/approval.
HHS understands the urgency of medical countermeasure development and acquisition and COMMITTED TO AGGRESSIVELY PURSUING our biodefense mission.
