Office of Research and Development Coordination

Acquisition of rPA Anthrax Vaccine for the Strategic National Stockpile

Purpose:

The primary purpose of this project is the acquisition and maintenance of up to 75 million doses (single dose units) of licensed rPA anthrax vaccine for the SNS to protect the U.S.citizens against inhalation anthrax.

Background:

Recent significant changes in both the nature, regularity, and degree of the threat posed by the use of infectious agents as weapons of biological warfare have generated increased concern for the safety of the general American populace. With the deliberate exposure of citizens of the United States, postal workers, and other United States Government (USG) employees to Bacillus anthracis (B. anthracis) spores in 2001, there is an urgent need to stockpile appropriate and effective medical countermeasures to protect those living in the United States from the harmful effects of B. anthracis spores when used as instruments of terror. Thus, this enduring threat requires an accelerated pace of recombinant protective antigen (rPA) anthrax vaccine development, testing, manufacturing, and acquisition to provide a sufficient stockpile for emergency preparedness and response.

The Department of Health and Human Services (HHS) has been designated as the lead agency for public health and medical response to manmade or natural disasters. In HHS, the Office of Public Health Emergency Preparedness (OPHEP) holds responsibility for implementation of a comprehensive HHS strategy to protect the civilian population from acts of bioterrorism and other public health emergencies.

The Office of Research and Development Coordination (ORDC) in OPHEP has the primary responsibility within HHS to contract with industry for advanced developed licensable products, which will require large-scale manufacturing for delivery into the Strategic National Stockpile (SNS). Vaccine acceptance into the SNS is dependent on the accumulation and submission of the appropriate data to support the use of the product (under IND) in a post-exposure situation. However, all vaccine manufactured and acquired under this Contract must meet the regulatory deliverables as required for licensure.