# Presentation: 034322

## 2nd NVAC Workshop on Strengthening the Supply of Vaccines in the United StatesNational Vaccine Advisory Committee

- Charles Helms, M.D., Ph.D.
- February 8, 2005
- Washington, D.C.

## Strengthening the Supply of Routinely Recommended Vaccines in the United States

**Recommendations from NVAC***
**expanding vaccine stockpiles**
**increasing support for regulatory agencies**
**maintaining and strengthening liability protections **
**improving communication among stakeholders**
**increasing availability of public information**
**a campaign emphasizing benefits of vaccination**
**evaluating appropriate financial incentives for manufacturers**
**streamlining the regulatory process without compromising safety or efficacy**

***JAMA 2003; 290:3122-3128**

## Vaccine Supply Workshop Framework

- Increasing support for regulatory agencies; streamlining regulatory process without compromising safety or efficacy

- Expanding vaccine stockpiles

- Maintaining and strengthening liability protections

- Evaluating appropriate financial incentives for manufacturers

- _First Workshop Strategies_

- _Second Workshop Strategies_

- Strategy:  Regulatory Processes (Orenstein)

- Strategy:  Utilizing Vaccine Stockpiles (Cochi)

- Strategy:  Liability Issues (Evans)

- Strategy:  Increasing Financial Incentives for Research, Development, Production and Administration (Myers)

## Vaccine Supply Workshop Proposals

- Increase ”demand” for vaccines through increased public education, focusing especially on increasing awareness and promoting use of vaccines for adolescents and adults.
- Attract manufacturers by reducing regulatory and financial disincentives whenever safe and reasonable (e.g. by limiting costs of clinical trials, allowing investment tax credits for construction to meet FDA requirements, removing price caps from CDC purchase of vaccines).
- Attract “infrastructure” for vaccine delivery through economic incentives (e.g. by reducing the risk of up-front purchase costs to providers and by assuring administration fees that accurately reflect provider work effort).

**Increasing Financial Incentives**

## Vaccine Supply Workshop Proposals

- The FDA should consider a change from cGMP-focused oversight of production facilities to final product-focused characterization.
- Re-institute the system of informal consultations between manufacturers and FDA throughout the processes of development, approval and manufacture.
- Harmonize the regulatory process to encourage the availability of foreign vaccines in the US market and US vaccines in foreign markets.
- Increase funding of CBER.

**Regulatory Processes**

## Vaccine Supply Workshop Proposals

- Resolve the “revenue recognition issue” through negotiations with SEC or legislation.
- Provide external input to CDC on pediatric vaccine stockpile composition and target quantities.
- Endorse the Vaccine Management Business Improvement Project as a mechanism for more efficient and effective management of the US vaccine supply, including vaccine stockpiles.

**Utilizing Vaccine Stockpiles**

## Vaccine Supply Workshop Proposals

- VICP petitioners should be required to file with the VICP first before pursuing legal remedies in the tort system.
- Language defining a “vaccine” should include not only the biological, but also preservatives, additives and other excipients.
- Enact legislation under consideration in previous Congress to improve VICP processes.

**Liability Issues**

## Next Steps

- NVAC members review, modify and prioritize general Workshop proposals
- Working Group holds interim meetings to better evaluate selected proposals
- Working Group prepares final Workshop report with recommendations
- Final draft report circulated to NVAC for approval
- Final report sent to Dr. Beato before June

## Acknowledgements

- Jerome Klein, MD, NVAC
- Bruce Gellin, MD, NVPO
- Stephen Cochi, MD, NIP/CDC
- Geoffrey Evans, MD, HRSA
- Walter Orenstein, MD, Emory University
- Martin Myers, MD, U. of Texas Medical Branch
- Sarah Landry, NVPO
- Emma English, NVPO