# Presentation: 786164

## Preparing for BioShield

***Preparing for BioShield***

***Philip K. Russell, M.D.***

***National Vaccine Advisory Committee***
***4 February 2004***

## Project BioShield

- BioShield was announced by President Bush in his State of the Union address on January 28, 2003.

- The DHS appropriations bill (PL 108-90) signed by President Bush on 1 October 2003 provided **$890 million in discretionary funds in FY2004 and created a discretionary reserve of $5.6 billion to fund the program through FY2013. **
- Funding is available for countermeasures once production of licensable products is judged scientifically feasible.  **HHS will be the procuring authority**.

## Release of BioShield Funds

- Interagency determination of the requirement
- Findings by Secretaries of DHS and HHS
- Determination of material threat - DHS
- Determination that countermeasures are       necessary. Determination that the security countermeasure is appropriate for inclusion in the stockpile – HHS
- Coordination with OMB and joint recommendation to President
- Approval by the President

## coordinate national requirements, acquisition strategies, and requests for Project BioShield funding 

**HHS has a leadership role in the WMD Medical Countermeasures**
**Committee**
**This Committee will**
**coordinate national requirements, acquisition strategies, and requests for Project BioShield funding**** **

- POTUS

- Principals

- Deputies

- Counterproliferation Technology
- Coordinating Committee
-  (NSPD-17/HSPD-4)

- Intel

- Non
- Medical
- CM

- Detector/
- Surveillance

- Counter
- Force

- CTWG

- WMD
- Medical
- CM

- BIOLOGICAL

- CHEMICAL

- RAD / NUC

- Vaccines, Therapeutics, Diagnostics

## Potential BioShield ProcurementsUnder Consideration

- rPA anthrax vaccine
- Next generation smallpox vaccine
- Botulinum antitoxin (Equine)
- Anthrax immune globulin products
- Recombinant plague vaccine
- Botulinum vaccine
- Anti-radiation drugs and Chemical antidotes

## Potential Future Candidates for BioShield Procurement

- Ebola-Marburg vaccine
- Rift Valley Fever Vaccine
- Novel antibiotic/antinfective
- Novel antiviral
- Human anthrax and botulinum antitoxins from transgenic animals
- 3rd Generation anthrax vaccine

## Features of the HHS Next Generation (rPA) Anthrax Vaccine Program

- Early Development - Open competitive solicitation
- September 30, 2002  two NIH contracts worth $22.5 million awarded to VaxGen (California) and Avecia (UK)
- 12 mo. to complete 5 milestones through Phase 1
- Advanced Development - Open competitive solicitation
- September 30, 2003 two contracts worth $151 were awarded to VaxGen and Avecia
- 3 years to complete 17 milestones through manufacturing scale-up, Phase 2 trials, pre/post exposure animal models
- BioShield Acquisition – anticipated in 2004

**Notes:**
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## rPA Vaccine Development – 2003 Highlights

- Milestones completed or in progress under existing contracts
- cGMP manufacture of clinical trial lots
- IND approval
- Phase 1 clinical trials
- Animal efficacy studies
- Feasibility plans for manufacture and delivery of 25 million doses
- Preclinical, Clinical and Regulatory Plans to support product licensure

## Acquisition of  rPA Anthrax Vaccine

- RFI issued August 03 to collect information about large-scale manufacturing capacity
- We anticipate that initial delivery of IND product to the Strategic National Stockpile is possible by late 2004

**Notes:**
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## Additional Anthrax Countermeasures

- Acquisition of an immune-based anthrax countermeasures for treatment of symptomatic patients
- Next generation anthrax vaccine with improved delivery systems
- In Dec 2003, HHS sponsored a conference, “Innovative Administration Systems for Vaccines,” to provide a forum to facilitate the development of vaccine delivery systems that will enable rapid implementation of mass vaccination programs

## Safer Smallpox Vaccine

- NIH funded R&D program for MVA progressing well
- Two contracts awarded in February 2003
- Bavarian Nordic
- Acambis
- Phase 1 and non-human primate studies
- NIH Advanced Development award(s) for MVA in mid-late 2004
- VaxGen independently developing LC16m8