2nd NVAC Workshop on Strengthening the Supply of Vaccines in the United States National Vaccine Advi

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2nd NVAC Workshop on Strengthening the Supply of
Vaccines in the United StatesNational Vaccine
Advisory Committee

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

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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 2903122-3128
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Vaccine Supply Workshop Framework
First Workshop Strategies
Second Workshop Strategies

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

• Strategy Regulatory Processes (Orenstein)

• Expanding vaccine stockpiles

• Strategy Utilizing Vaccine Stockpiles (Cochi)

• Maintaining and strengthening liability
  protections

• Strategy Liability Issues (Evans)

• Evaluating appropriate financial incentives for
  manufacturers

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

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Vaccine Supply Workshop Proposals
Increasing Financial Incentives

• 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).

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Vaccine Supply Workshop Proposals
Regulatory Processes

• 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.

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Vaccine Supply Workshop Proposals
Utilizing Vaccine Stockpiles

• 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.

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Vaccine Supply Workshop Proposals
Liability Issues

• 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.

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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

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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