Vaccines, Vaccine Allocation and Vaccine Research

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Overview

Vaccination is one of the most effective ways to minimize suffering and death from influenza. The U.S. Government is working to expand domestic flu vaccine production capacity to be able to produce pandemic influenza vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic and pandemic influenza vaccine will require that the limited supply be allocated or prioritized for distribution and administration.

The government has developed Guidance on Allocating and Targeting Pandemic Influenza Vaccine (PDF - 1.83 MB) which provides strong guidance to states, territories, and tribes for the allocation of limited supplies of vaccine, and describes the scientific and ethical framework for how this guidance was developed.

A tiered allocation for vaccines in severe pandemics is recommended with the following objectives considered the most important:

• Protect those who are essential to the pandemic response and provide care for persons who are ill;
• Protect those who maintain essential community services;
• Protect children;
• Protect workers who are at greater risk of infection as a result of their job, and
• Protect those who maintain homeland and national security.

Because there will likely be a limited supply of vaccine, research is underway to develop adjuvants. An adjuvant is a substance that is added to a vaccine to improve the immune system's production of antibodies, which is the desired response to vaccines. The successful addition of an adjuvant means that a given supply of vaccine can be used to treat more people.

H1N1 Flu (Swine Flu)

Currently, there is no commercially available vaccine for the new H1N1 flu in humans. Research efforts are underway to develop seed stock of the H1N1 flu virus that could be tested, and eventually be distributed to vaccine manufacturers.

• HHS Announces Advanced Development Contract for New Way to Make Flu Vaccine (U.S. Department of Health and Human Services)
  Using new recombinant influenza vaccine technology, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods
• First Batch of a Swine Flu Vaccine Produced (Voice of America)
  The Swiss pharmaceutical company Novartis says it has produced a first batch of a vaccine, weeks ahead of expectations by using cell-based production.
• HHS 2009 H1N1 Vaccine Development Activities (U.S. Department of Health and Human Services)
  Overview of vaccine development activities for a 2009 H1N1 vaccine.
• HHS 2009 H1N1 Vaccine Development Next Steps: Questions and Answers (U.S. Department of Health and Human Services) 
  Questions and answers in related to the development of H1N1 influenza vaccine
• U.S. 2009 H1N1 Vaccine Strategy [PDF - 580KB] (U.S. Department of Health and Human Services) 
  Graphical depiction of the predicted waves of the outbreak and the expected timeframes for vaccine development, manufacturing, and distribution and administration.
• HHS Takes Additional Steps Toward Development of Vaccine for the Novel Influenza A (H1N1) (U.S. Department of Health and Human Services)
  Learn how parts of an H1N1 vaccine will be produced, stored, and used in clinical studies.
• Vaccines for the Influenza A (H1N1) (World Health Organization)
  Read questions and answers about vaccine development for H1N1 flu (swine flu).

H5N1 Flu (Avian Flu)

Research efforts have led to the development of a vaccine for one of the two known strains of the H5N1 influenza virus in humans.

Vaccines

• HHS Awards $487 Million Contract to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine (U.S. Department of Health and Human Services)
  The development of the first cell-based vaccine manufacturing facility in the United States is expected to increase the nation’s capacity to make pandemic influenza vaccine by at least 25 percent. The cell-based influenza vaccine can be produced faster and in greater quantities than the traditional egg-based vaccine.

  • Availability of a New Recombinant H5N1 Vaccine Virus (World Health Organization)
    A new H5N1 recombinant vaccine virus has been developed and is available for distribution, under a Material Transfer Agreement (MTA), to institutions, companies and others interested in pandemic vaccine development.

• Questions and Answers on Pandemic Influenza Vaccine (World Health Organization)
• Learn the difference between seasonal influenza vaccines, "pre-pandemic" vaccines, and pandemic vaccines.  Vaccine development, vaccine production, and universal access to pandemic influenza vaccine are also discussed
• FDA Approves the First U.S. Vaccine for Humans Against H5N1 Virus (Food and Drug Administration)
• The vaccine was obtained from a human strain and is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus contained in the vaccine.
• Vaccine Production in Cells
  Provides background on a new method of producing vaccines and current efforts to develop cell-based vaccines for influenza.

Vaccine Allocation

• Guidance on Allocating and Targeting Pandemic Influenza Vaccine (PDF - 1.83 MB), July 23, 2008
  The guidance provides a planning framework to help state, tribal, local and community leaders ensure that vaccine allocation and use will reduce the impact of a pandemic on health and minimize its disruption to society and the economy.
• Citizen Voices on Pandemic Flu Choices -- A Report of the Public Engagement Pilot Project on Pandemic Influenza, December 2005
  This report describes the convening of a representative group of stakeholders and citizens-at-large, the structure and process of stakeholder and citizen dialogues and deliberations, and the decisions made and recommendations that were developed.
  • Preface & Executive Summary (PDF - 298.92 KB)
  • Full Report (PDF - 1.11 MB)
  • Attachments (PDF - 1.27 MB)

Vaccine Research

• Use of Pneumococcal Vaccines for Influenza Pandemic Preparedness (Centers for Disease Control and Prevention)
  CDC urges healthcare providers and state immunization programs to improve pneumococcal vaccination delivery systems for patients under their care so that national vaccine coverage increases.
• Guidance on Vaccine Product Development and Approval (U.S. Food and Drug Administration)
  View draft guidance, publications, and other information from the FDA about vaccine development and the product approval process.
• Questions and Answers: H5N1 Avian Flu Vaccine Trials (National Institute of Allergy and Infectious Diseases)
  
  Questions and answers about testing and evaluating potential avian flu vaccines for people.
• Antiviral Response in Pandemic Influenza Viruses (Centers for Disease Control and Prevention)
  
  Read about viral proteins and their possible role in human pandemics.
• Initiative for Vaccine Research (World Health Organization)
  
  Read about WHO's actions to guide, support, and facilitate the development, clinical evaluation, and world-wide access to safe, effective and affordable vaccines against infectious diseases.
• Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases (U.S. Food and Drug Administration)
  Read draft guidance from the FDA to facilitate manufacturers in the development and availability of safe and effective vaccines, including those to address emerging and pandemic threats.

Clinical Trials

Avian Influenza Clinical Trials (ClinicalTrials.gov)
Learn about current avian flu clinical trials.

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