The NVPO Unmet Needs Program: FY 2006 Update Ben Schwartz National Vaccine Program Office National Vaccine Advisory Committee Meeting, June 2006.

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Presentation transcript:

The NVPO Unmet Needs Program: FY 2006 Update Ben Schwartz National Vaccine Program Office National Vaccine Advisory Committee Meeting, June 2006

Presentation Objectives Describe Unmet Needs program Objectives Approach Priorities Funded projects Obtain NVAC input Potential program modifications to better support NVPO & NVAC needs and priorities Priority issues for FY’07

NVPO Unmet Needs Program 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” Addresses new and emerging issues that fall outside regular agency funding cycle Applicants include scientists/project officers from HHS agencies, DoD, and USAID

NVPO Unmet Needs Program Projects funded for a maximum of 2-years Intramural and extramural Research and conferences Domestic and international $4 to $5 M provided annually for new and continuation projects Funding decisions made competitively based on a defined review process

NVPO Unmet Needs Program: Proposal Evaluation Process Agency review and ranking Preliminary review Proposal scored by 2 agency, 2 NVAC, and 1 NVPO reviewer Technical review panel meeting Agency, NVAC, NVPO representatives Discuss proposals in rank order from preliminary review All participants score all proposals

NVPO Unmet Needs Program: Proposal Evaluation Criteria Evaluation criteria Agency priority (5 pts) Interagency collaboration (5 pts) Importance (25 pts) Methods (30 pts) Feasibility (20 pts) Personnel (10 pts) Budget <$180,000 (2.5 pts) Addressing an NVPO priority is considered in scoring “importance”

Goals of the National Vaccine Plan Goal 1: Develop new and improved vaccines Goal 2: Ensure the optimal safety and effectiveness of vaccines and immunization Goal 3: Better educate the public and members of the health professions on the benefits and risks of immunization Goal 4: Achieve better use of existing vaccines to prevent disease, disability, and death

Unmet Needs Program Priority Categories, Category’04’05’06 Adolescent vaccination (and vaccines)XXX Adult vaccination (and vaccines)XX New and future vaccines (various defs)XXX Maternal immunizationX Racial & ethnic disparitiesX Pandemic (and annual) influenzaXXX Risk communicationX Vaccine safetyXXX Vaccine supply and financing (and economic analysis) X

NVPO/NVAC Priorities & Unmet Needs Funding Priorities NVAC Subcommittee or Working Group (2005) FY’06 Unmet Needs Priority Vaccine safety subcommitteeVaccine safety Vaccine coverage subcommitteeAdult vaccination Adolescent vaccination New vaccines Future vaccines subcommitteeFuture vaccines Influenza working groupAnnual and pandemic influenza Vaccine supply working group Vaccine financing working group Vaccine supply and financing

“You Can Lead a Horse to Water”: Priority Categories Addressed by Unmet Needs Proposals, FY’06 Priority Rank 1 – 20 Rank Total (n=93) Future vaccines13848 Pandemic/annual flu 4521 Vaccine safety 1-11 Adol & adult vaccine 4410 Economic studies -2 8 Risk commun & public engagement -2 4 Vaccine financing -- 1 Vaccine supply -- - More than one category may apply

New Unmet Needs Proposals Funded in FY’05 and FY’06 FY’05FY’06 By priority area Future vaccines Influenza Safety Adolescent vaccination Vaccine supply/financing By agency CDC/NCID FDA/CBER CDC/NIP NIH USAID, DOD, CDC/NCHSTP Year N FY0522 FY0614

FY’06 Funded Projects: New and Future Vaccines New Vaccines MCV4 effectiveness in adolescents Rotavirus VE and impact on serotype distribution Baseline HPV incidence and prevalence using VSD data Future vaccines Vaccines against enteric diseases (meeting) Second generation Shigella soneii vaccine development Effect of S. pneumoniae serotype replacement on formulation of next generation vaccines Genotype specific in vitro assays for hepatitis C

FY’06 Funded Projects: Other Priorities Pandemic influenza Development of methods for rapid production of strain- specific reagents Improving reliability of reverse genetic methods Pre-clinical development of cross-protective vaccine Other (safety & adolescent vaccination) Development of biomarkers of neurotoxicity in new vac. Development of rapid methods to assess adjuvant effectiveness and safety Assessing vaccination status of 13 year old adolescents

Future Vaccine Proposals Funded in FY05 Epidemiological studies Burden of severe pertussis infection Cross-reactivity of emerging lyssaviruses (rabies) CMV disease burden surveillance Vaccine development Influenza vaccine – DNA prime, adenoviral boost Evaluation of Sabin IPV vaccines Novel PE antigens of mycobacteria Vaccine evaluation New assay for antibody response to HPV vaccine

NVAC and CMV Unmet Needs Project Vaccine development to prevent CMV disease: Report from NVAC (Arvin et al, CID 2004) Recommend expanded epidemiological surveillance including population-based data 2005 Unmet Needs project: Development of new assay and baseline congenital CMV surveillance Yr 1: development of PCR assay using dried blood spots Yr 2: population-based study in CA evaluating rates of congenital CMV by racial/ethnic group Cost :~$140,000 per year

NVAC and Polio and Rabies Unmet Needs Projects Polio NVAC working groups: lab containment (report 1/04); polio vaccine stockpile (report 2/04) NVAC presentations: lab containment (2/04); outbreak of vaccine derived poliovirus infection (2/06) Unmet needs project FY’05: Preclinical evaluation of efficacy of improved IPV vaccine Rabies NVAC presentation: emerging lyssaviruses (2/05) Unmet needs project FY’05: Surveillance for emerging lyssaviruses and cross-reactivity of vaccine and RIGs

How can the Unmet Needs program be improved to better meet the needs of NVPO and NVAC?

Potential Modifications to the Unmet Needs Program Current program vs potential option Investigator initiated research Directed research Broad prioritiesNarrower priorities Limited per project fundingLarger funding levels Interagency, NVAC, NVPO review Other review strategy

Discussion Questions How can the Unmet Needs program be improved to better address the needs of NVPO and NVAC? Priorities? Type of solicitation? Type of projects submitted? Type of projects funded? Evaluation process?