# Presentation: 335297

## Project BioShield: A Model for US Government Acquisition of Vaccines

- Enter Title of Presentation on Master Slide

**U.S. Department of Health and Human Services**
**Office of Public Health Emergency Preparedness**

**Project BioShield****:**** ****A Model for US Government Acquisition of Vaccines**

***Monique K. Mansoura, Ph.D.***
***Office of Research and Development Coordination***
**NVAC Workshop on Strengthening the Supply of Vaccines in the U.S.**
**25 January 2005**

**Notes:**
Dr. Russell, the Director of the ORDC regrets that he cannot be here, but sends his regards.  I would like to thank the conference organizers for the opportunity to participate on this panel and the audience for their interest in this topic.

## Project BioShield: Government Goals

**Accelerated development of Medical Countermeasures**
- Develop, acquire, and stockpile the medical countermeasures needed to protect the US population against bioterrorism
- Support development and acquisition programs that will attract industry to respond USG requirements
- Coordinate stockpile acquisitions with response plans
- Make balanced investments in countermeasures commensurate with the threat(s) and response plans and within the limits of the BioShield budget

## Project BioShield

- Announced by President Bush in his State of the Union address on  28 January 2003.

- Secretaries Thompson (HHS) and Ridge (DHS) jointly transmitted the “Project BioShield Act of 2003 to Congress on 26 February 2003.
- - The House version of the bill (H.R. 2122) was passed by a vote of 421-2 on 16 July 2003.
-  The Senate version of the bill (S. 15) was passed by a vote of 99-0 on 19 May 2004.
**  ****The bill (P.L. 108-276) was signed by the President on 21 July 2004**

## Project BioShield

- Three-pronged program:
**Establishes a secure ****funding**** source for purchase of security countermeasures**
- Increases NIH/NIAID authorities and flexibility to expedite research and development of critical biomedical countermeasures
- Establishes an Emergency Use Authorization for medical products

## Project BioShield

- The DHS appropriations bill (PL 108-90) signed by President Bush on 1 October 2003 **created a discretionary reserve of $5.6 billion to fund the program through FY2013. An amount not to exceed $3.4 billion may be obligated during FY2004-2008.**
- Funding is available for countermeasures once production of licensable products is judged scientifically feasible.  **HHS will be the procuring authority**.
**Amounts appropriated become available only upon the approval by the President.**

## Release of BioShield Funds

- Interagency Approval of Requirement
- Findings by Secretaries of  DHS and HHS
- Determination of material threat
- Countermeasures are necessary
- Appropriateness of the countermeasure
- Numbers of doses required
- Production & delivery is feasible within 8 years
- Evaluation of commercial market
- Approval by the President

## Project BioShield: Contract Terms 

- No payment may be made until delivery has been made of a portion of the total number of units contracts for
- Discounted payment for product that is not licensed, cleared, or approved at the time of delivery.
- Delivery to the SNS is contingent on the availability of sufficient data to support emergency use
- Vendor must seek approval, clearance, or licensure of product.
- Additional payment upon licensure, clearance or approval
- Contract duration will be 5-8 years

## Project BioShield:  A Work in Progress

**In Progress**
- Large scale manufacturing capability of rPA and attenuated  smallpox vaccines (RFI posted Aug 03)
- Anthrax therapeutics (RFP posted Aug 04)
- Botulinum antitoxin (Presolicitation posted Sept 04)
- Acute Radiation Syndrome (RFI posted Oct 04)
- Licensed anthrax vaccine (Presoliciation posted Nov 04)
- Pediatric Potassium Iodide (Presolicitation posted Dec 04)
- HU-BChE Therapeutic to Nerve Agents (RFI posted Dec 04)
**Awarded**
- Anthrax rPA vaccine (Contract awarded Nov 04)

## Is BioShield a Relevant Model Beyond Biodefense?

| Factors for Consideration | Biodefense | Non-biodefense |
| --- | --- | --- |
| Market Assurance |  |  |
| Need for well-defined USG requirements |  |  |
| Long-term commitment |  |  |
| Risk-sharing |  |  |
| Funding support throughout the research & development pipeline |  |  |
| Dependence on the private sector |  |  |
| Regulatory pathway uncertainties |  |  |
| Economically viable |  |  |