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Activities on Influenza
Influenza viruses are a major cause of serious illness and death around the world. In the United States, influenza causes an annual average of 36,000 excess deaths, ranking 7th among all causes of death. Annual U.S. influenza morbidity figures are also significant, resulting in high numbers of hospitalizations (200,000), work-loss days (70 million), and restricted activity days (346 million), causing significant economic impact. Although people of all ages are susceptible to influenza, children and the elderly are particularly vulnerable.
For general information on influenza vaccines see www.cdc.gov/flu/
For key facts on protecting yourself from influenza, including recommendations for vaccination see http://www.cdc.gov/flu/protect/keyfacts.htm.
A series of questions and answers regarding Tamiflu can be found at http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm.
For information on avian (bird) influenza (flu), including background information, recent outbreaks, the viruses, and the risk to human health see http://www.cdc.gov/flu/avian/index.htm.
See also www.hhs.gov/flu
The National Vaccine Program Office (NVPO)
The National Vaccine Program Office (NVPO) has responsibility for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. NVPO is supporting a new initiative to provide $100 million for activities designed to ensure year round influenza vaccine capacity and to incentivize the accelerated development, licensing and domestic production of cell-culture influenza
A contract for egg surge capacity worth about $10 million has already been awarded.
For more information see RFP RFP 2004-N-01101A Egg-Based Pandemic Influenza Vaccine Solicitations
Negotiations are currently underway for tissue culture vaccine research and development contracts. See RFP 2004-N-01102 Cell-Based Pandemic Influenza Vaccine Solicitations
NVPO has overseen a review of the influenza industry with the goal of developing a range of options that might be considered to accelerate the development and US licensure of a cell culture influenza vaccine manufactured in the US, stabilize the influenza vaccine industry, and expand the number of US manufacturers. A report is forthcoming.
The HHS National Vaccine Advisory Committee (NVAC) has recently issued a report to the Assistant Secretary for Health with recommendations and guidance for enhancing the U.S. influenza vaccine system and including supply, demand, and financing issues. See report at NVAC Influenza Vaccine Working Group [DOC - 64 KB]
An earlier report in 2003 outlined steps necessary to shore up the nation’s vaccination supply, including increasing financial incentives for research, development and production; streamlining the regulatory process; using vaccine stockpiles; and studying liability issues. See http://www.hhs.gov/nvpo/bulletins/nvac-vsr.htm
The Centers for Disease Control and Prevention (CDC) – The CDC is the lead federal agency for protecting the health and safety of people by providing credible information to enhance health decisions, and promoting health through strong partnerships. CDC serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the people of the United States.
The Food and Drug Administration (FDA)- The FDA is responsible for overseeing product development, evaluation and regulation of vaccines. Each spring the FDA’s Vaccines and Biologics Advisory Committee selects the virus strains to be used in the influenza vaccine for the following season. For additional information see
NIH – The National Institute of Health supports both basic and applied research on infectious diseases and the development of new and improved vaccines
NIH is conducting research to develop new influenza vaccines that are highly efficacious, are easier to administer, or that are directed against a constant portion of the influenza virus and thus potentially avoiding the need to develop a new vaccine every year to match the predominant viral strains that are most likely to cause disease. NIAID supports research in the following areas:
Additional information on NIAID influenza research can be found at www.niaid.nih.gov/dmid/influenza
NIAID also sponsored a workshop, “Development of a Clinical Trial Plan for Pandemic Influenza Vaccines,” on September 22 and 23, 2003, as part of its contribution to influenza pandemic preparedness and response. Participants attending this workshop included individuals from HHS, FDA, CDC, USDA, WHO and representatives from Industry. The goal of this meeting was to frame a research plan for the development and clinical evaluation of pandemic influenza vaccines. Discussion included options for preclinical and clinical evaluation of pandemic vaccine candidates, considerations in prioritizing these strains, and issues in clinical trial design
See http://www.niaid.nih.gov/dmid/meetings/fluvaccine.htm for a summary of the meeting.
The Centers for Medicaid and Medicare (CMS)
The CMS Adult Immunization Project focuses on increasing rates of preventive vaccination against influenza and pneumococcal disease for Medicare beneficiaries across all health settings. Pneumonia and influenza are the fifth leading causes of death in adults age 65 years and older in the United States. Despite the fact that influenza and pneumococcal vaccines are clinically effective, cost-effective, and are Medicare Part B covered benefits, they remain underutilized. Healthy People 2010 target rates are 90% for influenza and pneumococcal vaccination for adults aged 65 years and older
For additional information on influenza vaccination and coverage through CMS see http://www.cms.hhs.gov/preventiveservices/2.asp
See also the Administration on Aging website at www.aoa.gov
Last revised: November 30, 2006