Gert van der Hoek
In Memoriam - Editor, Senior Moderator
U.S. Department of Health and Human Services
Pandemic Planning Update V
A Report from Secretary Michael O. Leavitt
March 17, 2008
Since the HHS Pandemic Influenza Plan went into effect in November 2005, the Department has advanced the nation?s pandemic preparedness in a broad range of activities. HHS has worked to expand and diversify domestic vaccine production and surge capacity, enlarge H5N1 pre-pandemic vaccine and antiviral drug stockpiles, support advanced development of cell culture and antigen-sparing influenza vaccines and new antiviral drugs, support advanced development of point-of-care clinical diagnostics, and stockpile medical supplies, ventilators, and personal protective equipment such as facemasks and respirators. HHS is also building a robust and comprehensive portfolio leading to a broad array of medical countermeasures ? vaccines, antivirals, and diagnostic tools.
Vaccines and Vaccine Production Capacity
A flu pandemic poses unique public health challenges. A novel influenza virus means that everyone in the world is susceptible, and the entire population should be vaccinated for optimal protection. Our investments in science and vaccine research will help bring about a new generation of influenza vaccines that could take the threat of a pandemic off the table. But our current approach requires that production of a pandemic vaccine can only start once that virus appears ? after the flu pandemic begins ? and we will be challenged to allocate a limited supply of vaccine early in a pandemic. We are taking steps now to address these challenges.
Vaccine Production
One of HHS? highest priorities, in concert with an array of leading pharmaceutical companies, is to enhance and expand U.S.-based production capacity to the point that it can generate 600 million doses of a pandemic influenza vaccine (two doses for every American) within six months of the time that a reference strain of the actual pandemic virus is developed. When this initiative began just over two years ago, the U.S. had only a small fraction of this target capacity. Only two domestic manufacturers of approved influenza vaccine existed, and only one of those had a product that was licensed for use in all appropriate age groups.
Today, with HHS funding, six companies are in various stages of implementing commercial-scale production cell culture methods and/or expanding their capacity for conventional manufacturing using chicken eggs. The target date for achieving the 600 million dose target is 2011. The work is on schedule.
The driving motivation to build this target production capacity within the U.S. is to ensure that we can provide pandemic influenza vaccine for every American without having to purchase and import it from foreign-based manufacturing facilities. A condition of HHS? funding for the participating companies is that their manufacturing facilities be located within the United States.
No one can say with certainty when new technologies such as recombinant DNA vaccines will take center stage for influenza vaccine manufacturing. But HHS is committed to accelerating the maturation of DNA vaccines and other emerging technologies, funding important research on DNA vaccines against influenza viruses and soliciting contract proposals for advanced development of a DNA vaccine. This latter initiative is a critical milestone on the path from the laboratory bench to the manufacturing floor.
http://www.pandemicflu.gov/plan/pdf/panflureport5.pdf
Pandemic Planning Update V
A Report from Secretary Michael O. Leavitt
March 17, 2008
Since the HHS Pandemic Influenza Plan went into effect in November 2005, the Department has advanced the nation?s pandemic preparedness in a broad range of activities. HHS has worked to expand and diversify domestic vaccine production and surge capacity, enlarge H5N1 pre-pandemic vaccine and antiviral drug stockpiles, support advanced development of cell culture and antigen-sparing influenza vaccines and new antiviral drugs, support advanced development of point-of-care clinical diagnostics, and stockpile medical supplies, ventilators, and personal protective equipment such as facemasks and respirators. HHS is also building a robust and comprehensive portfolio leading to a broad array of medical countermeasures ? vaccines, antivirals, and diagnostic tools.
Vaccines and Vaccine Production Capacity
A flu pandemic poses unique public health challenges. A novel influenza virus means that everyone in the world is susceptible, and the entire population should be vaccinated for optimal protection. Our investments in science and vaccine research will help bring about a new generation of influenza vaccines that could take the threat of a pandemic off the table. But our current approach requires that production of a pandemic vaccine can only start once that virus appears ? after the flu pandemic begins ? and we will be challenged to allocate a limited supply of vaccine early in a pandemic. We are taking steps now to address these challenges.
Vaccine Production
One of HHS? highest priorities, in concert with an array of leading pharmaceutical companies, is to enhance and expand U.S.-based production capacity to the point that it can generate 600 million doses of a pandemic influenza vaccine (two doses for every American) within six months of the time that a reference strain of the actual pandemic virus is developed. When this initiative began just over two years ago, the U.S. had only a small fraction of this target capacity. Only two domestic manufacturers of approved influenza vaccine existed, and only one of those had a product that was licensed for use in all appropriate age groups.
Today, with HHS funding, six companies are in various stages of implementing commercial-scale production cell culture methods and/or expanding their capacity for conventional manufacturing using chicken eggs. The target date for achieving the 600 million dose target is 2011. The work is on schedule.
The driving motivation to build this target production capacity within the U.S. is to ensure that we can provide pandemic influenza vaccine for every American without having to purchase and import it from foreign-based manufacturing facilities. A condition of HHS? funding for the participating companies is that their manufacturing facilities be located within the United States.
No one can say with certainty when new technologies such as recombinant DNA vaccines will take center stage for influenza vaccine manufacturing. But HHS is committed to accelerating the maturation of DNA vaccines and other emerging technologies, funding important research on DNA vaccines against influenza viruses and soliciting contract proposals for advanced development of a DNA vaccine. This latter initiative is a critical milestone on the path from the laboratory bench to the manufacturing floor.
http://www.pandemicflu.gov/plan/pdf/panflureport5.pdf