Vaccines, Vaccine Allocation and Vaccine Research

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Vaccination is one of the most effective ways to minimize suffering and death from influenza. Research efforts have led to the development of a vaccine for one of the two known strains of the H5N1 influenza virus in humans.

The U.S. Government is working to expand domestic influenza 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 draft “Guidance on Allocating and Targeting Pandemic Influenza Vaccine” which prioritizes the allocation of limited supplies of vaccine, and describes the scientific and ethical framework for how this guidance was developed.

As part of the guidance, a tiered allocation for vaccines in severe pandemics is being proposed with the following objectives considered to be 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.

Vaccines

Two Contracts Awarded to Expand Domestic Vaccine Manufacturing Capacity (U.S. Department of Health and Human Services)
The two cost-reimbursable contracts totaling $132.5 million over five years are to retrofit existing domestic vaccine manufacturing facilities on a cost-sharing basis and to provide warm-base operations for manufacturing pandemic influenza vaccines. In warm-base operations, the contractor does not shut down the facility.

FDA Finalizes Guidances for Manufacturers of Pandemic and Seasonal Flu Vaccines (Food and Drug Administration)

Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants). The guidances describe conventional and accelerated approval pathways to vaccine licensure.

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.

Pandemic Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act (PREP)

claration to provide targeted liability protections for H5N1 vaccine.

Public Readiness and Emergency Preparedness Act (PREP Act) for Pandemic Influenza Medical Countermeasures Utilization Protocol & Decision Tools
This document details the protocol and decision tools for medical countermeasures to implement liability protections and compensation, as authorized by the PREP Act.

Global pandemic influenza action plan to increase vaccine supply

(World Health Organization)
The Plan addresses specific activities – for the short, medium and long term – designed to increase influenza vaccine production and surge- capacity, to identify key obstacles and driving forces, and to estimate funding needs; and to strengthen the engagement and collaboration of key partners and stakeholders.

Antigenic and genetic characteristics of H5N1 viruses and candidate H5N1 vaccine viruses developed for potential use as pre-pandemic vaccines (World Health Organization)

Provides guidance for national authorities and vaccine companies on the selection of candidate viruses for use in vaccine development.

Vaccine Production in Cells

Provides background on a new method of producing vaccines and current efforts to develop cell-based vaccines for influenza.

Making Better Influenza Virus Vaccines? (Centers for Disease Control and Prevention)

The article discusses how new technologies could be used to develop live vaccines that would be safe and cross-protective against variant strains, and require less virus per dose than conventional vaccines.

Vaccines and Antiviral Drugs in Pandemic Preparedness (Centers for Disease Control and Prevention)

Discover why research studies in vaccines and antiviral drugs can help prepare us for a pandemic.

Vaccine Distribution and Use (U.S. Department of Health & Human Services)

Read a summary of public health roles and responsibilities for vaccine distribution and use.

Vaccines for Pandemic Influenza (Centers for Disease Control and Prevention)

Learn about possible vaccines to be developed for an outbreak of pandemic influenza.

Request for Proposal (RFP) for Retrofitting Manufacturing Facilities for Production of Pandemic Influenza Vaccines
This RFP is to support the expansion of the surge capacity to manufacture pandemic influenza vaccines for the United States.

Vaccine Allocation

Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine

, October 23, 2007
The Department of Health and Human Services (HHS) requests input from the public on a draft document that provides guidance on which individuals and parties should be given priority for vaccinations in the event of a pandemic. Follow this link for more detailed information and to submit comments.

Request for Information (RFI): Guidance for Prioritization of Pre-pandemic and Pandemic Influenza Vaccine

, December 13, 2006
With this RFI, the Department of Health and Human Services (HHS) requests input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre-pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Follow this link for more detailed information, including instructions on how to submit comments.

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.

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.

FDA Draft Guidance to Industry for Development of Cell-Based Viral Vaccines (PDF)

(354KB) (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

NIAID DNA Vaccine for H5N1 Avian Influenza Enters Human Trial (National Institute of Allergy and Infectious Diseases)

With the spread of avian influenza virus, new strains have emerged, including clade II viruses in Indonesia and elsewhere that have drifted genetically from the initial strains detected in Southeast Asia. With this study, the investigators hope to learn whether new technologies, such as DNA vaccines, can provide protection against such viruses.

H5N1 Avian Flu Virus Vaccine Induces Immune Responses (National Institute of Allergy and Infectious Diseases)

Learn the results of an experimental vaccine clinical trial.

Safety and Immunogenicity of an Inactivated Subvirion Influenza A (H5N1) Vaccine (The New England Journal of Medicine)

Read an article that describes the results of a clinical trial in which an experimental H5N1 avian influenza vaccine induced immune responses in healthy adults.

Avian Influenza Clinical Trials (ClinicalTrials.gov)

Learn about current avian flu clinical trials.

Development of a Clinical Trial Plan for Pandemic Influenza Vaccines (National Institute of Allergy and Infectious Diseases)

Read meeting notes from September 2003 concerning pandemic influenza and clinical trials.

Adjuvants

NIAID Taps Chiron to Develop Vaccine Against H9N2 Avian Influenza
The biotech company Chiron is testing a proprietary adjuvant called MF59 under contract to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services.