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BIOSECURITY AND BIOTERRORISM: BIODEFENSE STRATEGY, PRACTICE, AND SCIENCE
Volume 4, Number 1, 2006
? Mary Ann Liebert, Inc.
Universal Influenza Vaccination: The Time to Act Is Now
MICHAEL MAIR, ROBERT W. GROW, JULIE SAMIA MAIR, and LEWIS J. RADONOVICH, JR.
[snip]
CURRENT INFLUENZA VACCINE PRODUCTION CAPABILITY
In the U.S. influenza vaccine production is a private sector enterprise driven largely by market forces wherein manufacturers attempt to produce enough vaccine to meet expected demand and generate an optimal return on their investment.113,114 This system has fostered an influenza vaccine production capacity of roughly 80?100 million doses/year, 50?60 million doses of which can be produced domestically.93,94,115,116
The high costs associated with producing vaccines (e.g., costs from research and development, clinical trials, achieving and maintaining regulatory approval, manufacturing) in combination with uncertain demand and low profits have resulted in a reduction in the number of influenza manufacturers for the U.S. market.114,117,118 For the 2005?06 influenza season, four manufacturers are expected to produce approximately 71?97 million doses of vaccine for the U.S. market, although most of the vaccine (60 million doses) will be produced by one manufacturer.119,120
One consequence of this dearth of manufacturers is a fragile production capacity that is unable to handle an unexpected production problem or unanticipated surge in demand. For example, the U.S.?s influenza vaccine shortage in the 2004?05 season was the result of contamination problems with one of the three manufacturers who were expected to produce vaccine for the U.S. market that season, cutting the amount of available vaccine
nearly in half.92,114
ANNUAL INFLUENZA EPIDEMICS: INDICATIVE OF LARGER PROBLEMS
The burden of annual influenza epidemics and the fragility and instability of the capacity to respond to them underscore the U.S.?s ongoing inability to adequately respond to an influenza pandemic. There have been three influenza pandemics in the past 87 years, and, while it is uncertain when the next one will occur, another pandemic is widely viewed as inevitable.121,122
The ongoing avian influenza outbreak in Asia has raised great concern that the next influenza pandemic may be close at hand.123,124 Influenza pandemics result when a major change occurs in the proteins on the surface of an influenza virus strain?a process known as antigenic shift?which results in a new influenza strain for which there is little or no existing immunity.18 Influenza pandemics are marked by high attack rates and increased mortality.19 One analysis estimates that, in the U.S. alone, the next pandemic could result in 20?47 million illnesses, 18?42 million outpatient visits, 314,000?734,000 hospitalizations, and 89,000?207,000 deaths.125 Another analysis estimates that an influenza pandemic in the U.S. could result in from 786,000 to 4.7 million hospitalizations and 180,000 to 1 million deaths.126
The current U.S. influenza vaccine production, procurement, and delivery system is insufficient to supply enough vaccine for the entire U.S. population quickly in the event of a pandemic.17,94,115 It is estimated that the U.S.?s domestic influenza vaccine production capacity of 60 million doses would be able to produce enough pandemic vaccine to vaccinate only 30?90 million people.115
Results from an ongoing clinical trial of a candidate pandemic vaccine suggest that those estimates may be optimistic (see Appendix 4).127
And it is unlikely that the U.S. would be able to import pandemic vaccine from one of the few countries with a production capacity until those countries meet their own needs.115 It also is unlikely that the current U.S. influenza vaccine procurement and delivery system?a noncentralized, largely private- sector undertaking?could adequately handle thedemand for vaccine that a pandemic would create, given that the current system has had great difficulty managing vaccine shortages in nonpandemic years.93,94
The federal government has recently taken major steps to foster pandemic preparedness, including releasing the National Strategy for Pandemic Influenza, the HHS Pandemic Influenza Plan, and checklists for state and local health departments, businesses, community organizations, and families and individuals to aid pandemic preparedness efforts; implementing a federal-state influenza-pandemic planning process; and appropriating approximately $3.8 billion for pandemic preparedness activities for FY06. The HHS Pandemic Influenza Plan, intended to serve as a ?blueprint for all HHS pandemic influenza preparedness planning and response activities,? is not specific on issues such as pandemic vaccine production, purchase, and distribution.128?130 Part 3 of the plan, HHS Agencies? Operational Plans, is ?currently under development? and will ?elaborate on coordination, command and control, logistics, and planning, as well as financial and administration considerations.?128 Until HHS?s operational plans are released, states?which bear most of the responsibility for pandemic preparedness and response?will find it difficult to fully integrate their plans with the federal plan and to effectively operationalize their pandemic response plans. In addition, not all states have a pandemic response plan, existing state response plans remain inadequately tested, federal performance measures for evaluating the quality of state plans do not yet exist, and many weaknesses remain in response scenarios.131,132 For example, the resources and infrastructure necessary to vaccinate the U.S. population are not in place.133?136
The U.S.?s ongoing vulnerability to annual influenza epidemics and pandemics also highlights weaknesses in public health emergency preparedness and response efforts. One weakness is the inability to vaccinate large numbers of people after a biological attack.137?139 For example, the ability to vaccinate entire communities within ?a short period of time (e.g., within 5?10 days)?140 after a confirmed case of smallpox is a critical component of smallpox preparedness planning, yet few communities are fully prepared to do this.131,141?144 While response plans exist on paper, few communities have successfully identified a sufficient number of healthcare workers to staff their planned smallpox vaccination clinics, vaccinated and trained those healthcare workers, or adequately exercised their vaccination plans.132,141,142,144
A 2005 survey found that ?[o]nly seven states and two cities? are ?recognized by the U.S. Centers for Disease Control and Prevention as [being] adequately prepared to administer and distribute vaccines and antidotes [from the Strategic National Stockpile] in the event of an emergency.? 132
[snip]
Volume 4, Number 1, 2006
? Mary Ann Liebert, Inc.
Universal Influenza Vaccination: The Time to Act Is Now
MICHAEL MAIR, ROBERT W. GROW, JULIE SAMIA MAIR, and LEWIS J. RADONOVICH, JR.
[snip]
CURRENT INFLUENZA VACCINE PRODUCTION CAPABILITY
In the U.S. influenza vaccine production is a private sector enterprise driven largely by market forces wherein manufacturers attempt to produce enough vaccine to meet expected demand and generate an optimal return on their investment.113,114 This system has fostered an influenza vaccine production capacity of roughly 80?100 million doses/year, 50?60 million doses of which can be produced domestically.93,94,115,116
The high costs associated with producing vaccines (e.g., costs from research and development, clinical trials, achieving and maintaining regulatory approval, manufacturing) in combination with uncertain demand and low profits have resulted in a reduction in the number of influenza manufacturers for the U.S. market.114,117,118 For the 2005?06 influenza season, four manufacturers are expected to produce approximately 71?97 million doses of vaccine for the U.S. market, although most of the vaccine (60 million doses) will be produced by one manufacturer.119,120
One consequence of this dearth of manufacturers is a fragile production capacity that is unable to handle an unexpected production problem or unanticipated surge in demand. For example, the U.S.?s influenza vaccine shortage in the 2004?05 season was the result of contamination problems with one of the three manufacturers who were expected to produce vaccine for the U.S. market that season, cutting the amount of available vaccine
nearly in half.92,114
ANNUAL INFLUENZA EPIDEMICS: INDICATIVE OF LARGER PROBLEMS
The burden of annual influenza epidemics and the fragility and instability of the capacity to respond to them underscore the U.S.?s ongoing inability to adequately respond to an influenza pandemic. There have been three influenza pandemics in the past 87 years, and, while it is uncertain when the next one will occur, another pandemic is widely viewed as inevitable.121,122
The ongoing avian influenza outbreak in Asia has raised great concern that the next influenza pandemic may be close at hand.123,124 Influenza pandemics result when a major change occurs in the proteins on the surface of an influenza virus strain?a process known as antigenic shift?which results in a new influenza strain for which there is little or no existing immunity.18 Influenza pandemics are marked by high attack rates and increased mortality.19 One analysis estimates that, in the U.S. alone, the next pandemic could result in 20?47 million illnesses, 18?42 million outpatient visits, 314,000?734,000 hospitalizations, and 89,000?207,000 deaths.125 Another analysis estimates that an influenza pandemic in the U.S. could result in from 786,000 to 4.7 million hospitalizations and 180,000 to 1 million deaths.126
The current U.S. influenza vaccine production, procurement, and delivery system is insufficient to supply enough vaccine for the entire U.S. population quickly in the event of a pandemic.17,94,115 It is estimated that the U.S.?s domestic influenza vaccine production capacity of 60 million doses would be able to produce enough pandemic vaccine to vaccinate only 30?90 million people.115
Results from an ongoing clinical trial of a candidate pandemic vaccine suggest that those estimates may be optimistic (see Appendix 4).127
And it is unlikely that the U.S. would be able to import pandemic vaccine from one of the few countries with a production capacity until those countries meet their own needs.115 It also is unlikely that the current U.S. influenza vaccine procurement and delivery system?a noncentralized, largely private- sector undertaking?could adequately handle thedemand for vaccine that a pandemic would create, given that the current system has had great difficulty managing vaccine shortages in nonpandemic years.93,94
The federal government has recently taken major steps to foster pandemic preparedness, including releasing the National Strategy for Pandemic Influenza, the HHS Pandemic Influenza Plan, and checklists for state and local health departments, businesses, community organizations, and families and individuals to aid pandemic preparedness efforts; implementing a federal-state influenza-pandemic planning process; and appropriating approximately $3.8 billion for pandemic preparedness activities for FY06. The HHS Pandemic Influenza Plan, intended to serve as a ?blueprint for all HHS pandemic influenza preparedness planning and response activities,? is not specific on issues such as pandemic vaccine production, purchase, and distribution.128?130 Part 3 of the plan, HHS Agencies? Operational Plans, is ?currently under development? and will ?elaborate on coordination, command and control, logistics, and planning, as well as financial and administration considerations.?128 Until HHS?s operational plans are released, states?which bear most of the responsibility for pandemic preparedness and response?will find it difficult to fully integrate their plans with the federal plan and to effectively operationalize their pandemic response plans. In addition, not all states have a pandemic response plan, existing state response plans remain inadequately tested, federal performance measures for evaluating the quality of state plans do not yet exist, and many weaknesses remain in response scenarios.131,132 For example, the resources and infrastructure necessary to vaccinate the U.S. population are not in place.133?136
The U.S.?s ongoing vulnerability to annual influenza epidemics and pandemics also highlights weaknesses in public health emergency preparedness and response efforts. One weakness is the inability to vaccinate large numbers of people after a biological attack.137?139 For example, the ability to vaccinate entire communities within ?a short period of time (e.g., within 5?10 days)?140 after a confirmed case of smallpox is a critical component of smallpox preparedness planning, yet few communities are fully prepared to do this.131,141?144 While response plans exist on paper, few communities have successfully identified a sufficient number of healthcare workers to staff their planned smallpox vaccination clinics, vaccinated and trained those healthcare workers, or adequately exercised their vaccination plans.132,141,142,144
A 2005 survey found that ?[o]nly seven states and two cities? are ?recognized by the U.S. Centers for Disease Control and Prevention as [being] adequately prepared to administer and distribute vaccines and antidotes [from the Strategic National Stockpile] in the event of an emergency.? 132
[snip]