| | Vaccines, Vaccine Allocation and Vaccine ResearchTopics on this Page
Overview 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 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 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. - 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.
- 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.
- 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.
- Declaration 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. - (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. Provides guidance for national authorities and vaccine companies on the selection of candidate viruses for use in vaccine development. Provides background on a new method of producing vaccines and current efforts to develop cell-based vaccines for influenza. 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. Discover why research studies in vaccines and antiviral drugs can help prepare us for a pandemic. Read a summary of public health roles and responsibilities for vaccine distribution and use. 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.
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Vaccine Allocation - , 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.
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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. - View draft guidance, publications, and other information from the FDA about vaccine development and the product approval process.
Questions and answers about testing and evaluating potential avian flu vaccines for people. Read about viral proteins and their possible role in human pandemics. 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.- (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.
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Clinical Trials - 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.
Learn the results of an experimental vaccine clinical trial. 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. Learn about current avian flu clinical trials. Read meeting notes from September 2003 concerning pandemic influenza and clinical trials.
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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.
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