October 26, 2004 - ASM Comments on the Department of Health and Human Services Pandemic Influenza Plan

Pandemic Plan
National Vaccine Program Office
200 Independence Avenue, SW.
Washington, DC 20201

The 2003 Institute of Medicine (IOM) Report on Microbial Threats to Health cautioned that infectious disease public health needs have been and will continue to increase. The IOM reported that experts agree that an influenza pandemic is predicted during this century and that the public health infrastructure is unprepared. The capacity to produce vaccines is decreasing, antiviral drugs are inadequate and bacterial resistance to antibiotics threatens our ability to treat secondary infections which commonly cause deaths from influenza. The time for planning and responding to public health infrastructure and research needs is urgent and immediate. 

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the Draft Pandemic Influenza Preparedness and Response Plan prepared by the National Vaccine Program Office (NVPO), Department of Health and Human Services (DHHS), which was announced in the Federal Registeron August 27, 2004.

The ASM applauds the DHHS and the NVPO for drafting a plan to guide national preparedness and response to an influenza pandemic. The ASM recognizes that significant investment will be required to enhance efforts to address the threat of pandemic influenza by developing a newer generation of influenza vaccine that can be quickly produced and deployed to strengthen the public heath infrastructure on state and local levels, and to ensure that needed vaccines, antivirals and antibiotics are readily available. The ASM recommends that DHHS assess the needs for resources to address pandemic influenza within the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). The ASM also recommends that DHHS develop an aggressive timeline and framework for addressing issues and concerns raised in this statement as well as in response to the comments on this draft Plan from other interested stakeholders. A comprehensive plan and full response should be given the highest priority. The draft Plan will require modification over time in response to scientific and other changes. Discussions should be fostered between the public health sector, government and industry to better address many of the issues to achieve a successful pandemic influenza plan.

Specific Comments on the Plan

In general, the draft Pandemic Influenza Preparedness and Response Plan provides state-of-the-art information and lays out many issues that need to be addressed before and during an influenza pandemic. However, significant issues are in need of further development and strengthening as DHHS works towards a comprehensive plan.

ASM recognizes that some issues will need to be addressed largely at the state level and other issues cannot be well defined in the absence of epidemiology to understand the groups at highest risk of complications. Yet, some issues related to prioritization of available vaccine supply can be anticipated. For example, how will the vaccine and drug supply be divided between the federal government and the states? Public-private partnerships are needed and should be identified to address the prioritization of influenza vaccine supply. Decisions need to be harmonized between states and the federal government. Finally, more discussion regarding liability issues involving manufacturers and vaccinators should take place.

A major strategy for prevention of influenza is adequate vaccination. However, federal government strategies to increase demand and encourage vaccine production in inter-pandemic periods has been a relatively passive approach and is subject to the problem that the United States has little capacity to assure the availability of a vaccine supply. The IOM and others have repeatedly stated that the US government must confront the challenge of assuring vaccine supply as a matter of national security. Yet, shortages of routine vaccines continue to occur. Although the Plan recommends enhancements to the current system, it does not lay out a specific plan of action to change the vaccine development and production infrastructure to increase overall supply.

The ASM stresses the urgent need for the development and licensing of influenza vaccines produced in cell cultures. Such vaccines have the potential for shortening the time necessary for large-scale vaccine production. A further potential advantage is that vaccines can be produced in the same influenza season should a new strain of virus emerge. An emerging pandemic should be controlled with a rapidly produced, strain specific vaccine. More support should be provided for this technology. It is essential to encourage biomedical approaches using innovative vaccine technologies and to focus on research priorities for pandemic influenza preparedness and response.

It may take several years to develop, license and provide adequate production capabilities for a new cell culture vaccine. Based on this country’s history of influenza vaccine shortages and the research and time involved in developing new cell culture vaccine, it will be necessary to include steps to adequately prepare and respond to different pandemic scenarios, depending on the amount of influenza vaccine available, if available at all.

The document states that efforts to prevent transmission of influenza viruses in the community are likely to have limited effectiveness. It would be helpful to provide a constructive statement sharing what measures are likely to have some beneficial impact on prevention or delay of transmission in a community, particularly if vaccines and antiviral drugs are not readily available. ASM encourages attention to health care system challenges, including capacity concerns, as addressed in Annex 2 (Health Care System Guidance).

Annex 10 (Pandemic Influenza Research) notes the importance of early detection of influenza outbreaks with diagnostics that have more sensitivity and specificity than those utilized today. ASM supports research by the NIH to develop more reliable diagnostics for the rapid detection of influenza. ASM notes, however, that the Plan falls short of providing steps to handle an anticipated and increased demand for influenza testing by health professionals, especially if a shortage of reagents occurs. A sudden demand for testing can quickly exhaust available reagents.

Inclusion of antivirals in the strategic national stockpile is stated, but no detail is provided in the Plan, except that analyses are ongoing to determine quantities to be secured. Also of concern is the Plan’s failure to encourage development of additional antiviral agents. Although antiviral agents cannot be relied upon as a primary strategy for control of pandemics, they can be effective in ameliorating severe disease in high-risk patients. It would be useful to provide information both on shelf-life and on the amount of antiviral medication that is currently stockpiled or planned to be stockpiled in the immediate future, noting that this could change based on the results of ongoing analyses or pandemic spread. Furthermore, it would be useful if the federal government would provide more detailed guidance for the states to define target priority groups for antivirals.

A comprehensive plan for the supply and distribution of antibiotics for the treatment of bacterial co-respiratory infections in influenza patients is also needed. In addition, a plan for surge capacity for the production of antibiotics (many of which are generic and may be in short supply) as well as treatment guidelines are needed to provide, for example, the most up-to-date data on antibiotic resistance to the most common respiratory pathogens likely to be encountered in a pandemic event.

ASM notes the Plan’s attention to international coordination, including the need for enhanced global disease detection and surveillance, but more planning is needed in this area. How does the US plan fit with an international response and what will be the role of the US to a world wide pandemic situation?

The Plan states that DHHS is responsible for coordinating the overall public health and medical emergency response across all federal departments and agencies if the DHHS Secretary declares an emergency, and, federal and state roles are outlined in Annex 1 (Planning Guidance for State and Local Health Departments). However, the document does not discuss if and how the Plan changes when various responsibilities are delegated to the states. Furthermore, the Plan does not address how the biosafety level will be determined for the virus.

Finally, US surveillance efforts should be strengthened for the estimation of morbidity and mortality. Currently, it would be difficult to determine with accuracy, the number of deaths from influenza in otherwise healthy adults.

ASM appreciates the opportunity to comment on the draft Plan and offers its assistance as further planning occurs.

Sincerely,

Ruth L. Berkelman, M.D., Chair, Public and Scientific Affairs Board
James M. Tiedje, Ph.D., President, ASM
Michael T. Osterholm, Ph.D., M.P.H., Chair, Committee on Public Health

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