# Presentation: 147180

## The NVPO Unmet Needs Program: FY 2005 Update 

- Ben Schwartz
- National Vaccine Program Office

- National Vaccine Advisory Committee Meeting, June 2005

## Needs from NVAC

- Suggestions of priority categories for FY06 new proposals
- NVAC member volunteers to review, score, and select proposals for funding

## The NVPO Unmet Needs Funding Program, 1

- Provides support for high priority vaccine and immunization projects
- Based on National Vaccine Plan (1994) & current HHS, NVPO, and NVAC priorities
- “Seed money” and “catalytic funding” to address new and emerging issues
- Applicants include scientists/project officers from HHS agencies, DoD, and USAID

## The NVPO Unmet Needs Funding Program, 2

- Projects funded for a maximum of 2-years
- Intramural and extramural
- Research and conferences
- Domestic and international
- About $5 million distributed annually for new and continuation projects
- Funding decisions made competitively based on a defined review process
- New proposals for FY06 solicited in September

## NVPO Unmet Needs Priority Categories: FY04 and FY05

- FY 2004
- Adolescent vaccines
- Adult vaccines
- Future vaccines
- Recently licensed vaccines
- Maternal immunization
- Racial/ethnic disparities
- Pandemic influenza
- Vaccine supply & financing
- Vaccine safety
- Vaccine risk communications

- FY 2005
- Adolescent vaccination
- Future vaccines for emerging infections or with near term U.S. licensure
- Annual or pandemic influenza
- Vaccine supply, financing, & economic analysis
- Vaccine safety

## New Unmet Needs Proposals  Funded in FY05

| By priority area* | By agency |
| --- | --- |
| Future vaccines – 10
Influenza – 8
Safety – 3
Adolescent vac – 2
Supply/financing – 1  | CDC/NCID – 7 
FDA – 7 
CDC/NIP – 6 
NIH – 1 
USAID – 1  |

- *Several projects are included in more than one priority group

- 22 of 89 new proposals funded

## Future Vaccine Proposals Funded in FY05

- Epidemiological studies
- Burden of typhoid fever in Bangladesh
- Burden of severe pertussis infection
- Cross-reactivity of emerging lyssaviruses (rabies)
- CMV surveillance
- Vaccine development
- Influenza vaccine – DNA prime, adenoviral boost
- Evaluation of Sabin IPV vaccines
- Novel PE antigens of mycobacteria
- Vaccine evaluation
- Rotavirus vaccine evaluation in Honduras
- New assay for antibody response to HPV vaccine

## Vaccine Safety and Supply Proposals Funded in FY05

- Vaccine safety
- Reverse vaccinology safety evaluation
- Long term safety of vaccine adjuvants
- Improved safety and production of pandemic influenza vaccine
- Vaccine supply
- US and global polio vaccine stockpiles

## Criteria & Process for Selection of Projects for Unmet Needs Funding

- Proposal review criteria
- Meets NVPO priority criterion
- Importance
- Scientific quality and feasibility
- Inter-Agency collaboration
- Proposal review process
- Review committee composed of Agency representatives and NVAC members

## Next Steps for the Unmet Needs Program 

- Program review – identify accomplishments of projects funded between 1996 and 2001
- What was published and presented?
- What was sustained?
- What led to additional follow-on activities?
- What training was accomplished?
- Begin FY06 process
- Develop priorities
- Consider revisions to process

## Volunteer NVAC Reviewers: Scope of Work

- Participate in discussions with agency representatives on priority categories and approach to soliciting and reviewing proposals
- In Oct-Nov, review and score ~10-15 proposals
- 3 pages plus bio-sketches of investigators and budget
- In January, participate in 2-day review meeting in DC where proposals are discussed and scored by all reviewers