National Vaccine Advisory Committee (nvac)

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NVAC Pandemic Influenza Working Group - Working Group Comments on draft HHS Pandemic Influenza Preparedness and Response Plan - Dr. Alan Hinman

Dr. Hinman noted that at Dr. Helms requested that a small working group (Dr. Hinman, Ms. Koslap-Petraco, Dr. Raymond, and Dr. Schaffner) review the proposed pandemic plan and propose some NVAC comments on it. They individually read through the plan and then had a conference call to discuss their primary observations.

He commented that the plan is an extraordinarily well-written document that outlines all of the issues that need to be considered at national, state, local, and institutional levels in addressing pandemic flu. However, it is incomplete in that it does not make specific recommendations for action. This is because several key policy decisions need to be made well in advance of the pandemic (i.e., now). These issues need to be addressed now, since we do not know when the next pandemic might occur.

They need to precipitate a discussion that is widespread, involves the public, and gets into the ethics. In addition, there needs to be something more active than publishing it in the Federal Register for public comment. Although recommendations may ultimately be given to the Department, the final decisions will be made in the political arena. If there is a commitment to purchase vaccine that is going to require legislative appropriation and if there is going to be indemnification that is going to require legislation, they must be prepared for the discussion to take place in public in the political arena.

Dr. Hinman then discussed the key policy decisions that need to be made now. First, the role of the Federal government in purchasing and distributing vaccine needs to be addressed, and they must take as implicit the role of the government in indemnifying vaccine manufacturers and providing protection for liability. The identification of priority groups for vaccination needs to be addressed, particularly during the early phases of the program when there is going to be a limited supply of vaccine and great demand. The potential need for stockpiling syringes and needles to support a mass immunization program should also be addressed. Policy decisions also need to be made regarding the role of the Federal government in purchasing and distributing antiviral drugs and how they should be used, and identifying priority groups for antivirals, prophylaxis, or treatment.

In the inter-pandemic period, the emphasis is on the individual protection of those at highest risk of complication or of transmission to those at highest risk of complication. However, in a pandemic situation, priorities may shift to trying to assure the protection and maintenance of the essential services of society (e.g., health services, fire, police). This is a major shift in attitude and will require extensive discussion. He noted that they may want to consider annual, universal influenza immunization as a means of reducing the impact of influenza and its transmission and as means to establishing a manufacturing capacity adequate to meet national needs for a pandemic. They currently only produce about one-third of the vaccine that would be needed of a trivalent vaccine.

There will be state-to-state variations in the approaches that will be taken, but it is essential that national guidance is outlined now. States need to know what priorities will be taken at the national level. He commented that the plan would be greatly strengthened if there were specific examples of plans that have been developed for each level of activity.

Dr. Hinman noted that though it is not highly likely that there would be a vaccine supply produced in other countries, it is possible and a reason to take aggressive steps towards regulatory harmonization to ease importation of vaccines manufactured abroad. FDA should review the legislative and regulatory changes that would be required to streamline the process without compromising safety, and make recommendations regarding these changes.

Finally, the pandemic plan needs to identify “go/no go” decision points and who would make the decisions. For example, with respect to whether to continue should there be no transmission after the first outbreak needs to be considered. Points at which to review and make decisions about whether to continue and who will make these decisions needs to be identified.

Dr. Hinman then discussed the Working Group recommendations based on these observations. The most important thing NVAC should do is propose a mechanism for full discussion of key policy and priority issues so decisions can be made before a pandemic occurs, and the discussion should include a wide range of stakeholders. Since we cannot predict when a pandemic will occur, the process should begin immediately and a target date should be set for making specific policy recommendations. This should be the role of the Federal government in purchasing vaccines by June 30, 2005. The NVPO staff should explore possible models for the kind of stakeholder involvement required to arrive at these recommendations and present options for this today.

Dr. Helms noted that it appeared that they have the makings of a statement and that the NVAC suggestion should be taken as independent of the response to the actual document. He saw two things: what would be a response to a request for input on the document (down to the last paragraph) and then a suggestion that NVAC consider a role to play in this.

Dr. Hinman responded that they might perhaps volunteer to play that role, but that the comments should go to the Federal Register or NVPO. He highlighted indemnification and liability to clarify that this is a key policy issue.

Potential Strategies for Stakeholder Input into the Pandemic Plan - Dr. Benjamin Schwartz

Stakeholder input is critical to contribute to decisions that increase the specificity of the plan and to assure that proposed strategies are optimal and feasible. Dr. Schwartz discussed strategies to obtain short-term input on the pandemic plan. In addition to soliciting public and organizational comments during the 60-day comment period, he has been making presentations to a number of stakeholder groups, including ASTHO, ACIP, and AAP.

One option for obtaining longer term and ongoing comments on the pandemic plan, is possibly a series of NVAC-sponsored stakeholder or town hall meetings. There could be ad hoc issue-specific meetings or working groups. Another option could be the consideration of relevant issues by existing advisory committees (e.g., ACIP can consider vaccine priorities for a pandemic).

Dr. Schwartz discussed some of the possible aspects of a proposed pandemic influenza committee. The membership might include representation from key public and private sector stakeholder organizations and perhaps representatives from the various advisory committees that are involved. The objectives might include obtaining broad stakeholder input and developing recommendations on important issues that could then be shared with the Department. The committee could also review progress and offer advice on preparedness activities. In terms of organizational possibilities, there could be an NVAC working group that may include non-NVAC consultants. There is an advantage to linking this with NVAC because NVAC has a role in the Department and a channel of communication with the Assistant Secretaries.

Dr. Hinman noted that notion of establishing a body to address the issue and formalizing it is important. With respect to the organizational aspects, a working group under NVAC is appealing in that they could very quickly get moving.

Dr. Arvin commented that this is a very persuasive argument to keep the working group connected with an existing, authorized advisory group.

Dr. Schwartz noted that the really important issues are that this can happen quickly, and second, that this can be something that gets the attention of the Department where decisions ultimately will be made. Third, it should include the key stakeholders, a number of which are Federal agencies. For example, CDC is exploring how to operationalized different components of the plan and to add the specifics that it is currently lacking. A working group from NVAC would be able to take that broad government stakeholder involvement and combine it with the private sector involvement and put that out there for the Department to look at.

Dr. Guerra commented on the steps that would need to be taken to more closely connect this to overall efforts for preparedness. Many resources are being invested, staff are being trained, and capacity is being built (e.g., laboratory capacity). He was unsure whether in the overall preparedness planning effort, they were trying to link it to local and state health departments. He suggested that while recognizing that there is separate funding, there may a more efficient way to apply these resources in state and local health departments.

Dr. Schwartz responded that it would be helpful to add this to NVAC’s comments – a focus for pandemic preparedness that brings these different streams together.

Dr. Hinman then asked about next steps. He could add to the list of points (indemnification and link to preparedness) and have a version to consider for submission by the next morning.

Dr. Helms questioned whether this was pushing them further than they needed to go and whether the group would be willing to take the recommendations of the group with the additions that Dr. Hinman noted. He questioned whether they should take Dr. Hinman’s presentation down to the last paragraph to go in there as comments.

Dr. Hinman noted that he would appreciate this, but that a natural consequence of their comments is a statement that they volunteer to form a working group to undertake discussion of these tasks, the preparation of priority decisions, and recommendations for these decisions by June 30, 2005 as part of their comments. He suggested that it would be better to recommend that these things be done and note that the group is prepared to do it, rather than merely making the recommendations.

Dr. Helms commented that they could appoint a working group and have the report ready in June or July.

Dr. Hinman agreed and noted that he would put some language together for the next morning.

Welcome from the Acting Assistant Secretary for Health - Dr. Cristina Beato

Dr. Beato welcomed NVAC and the meeting attendees. She had been briefed on the committee’s activities and thanked everyone for their hard work and continuing efforts. She commended NVAC specifically for their work in responding to her request in February to make a critical assessment of the national influenza program. She looked forward to seeing the draft and to the ongoing discussion with the committees. The information is incredibly timely as the influenza season begins, and she assured the committee that the information would be carefully reviewed by her and others in the department to advise the Secretary. She was very interested to hear the committee’s assessment of the Pandemic Influenza Preparedness and Response Plan released for public comment in August. While they have already received some comments, they were eager for more critical feedback, particularly from NVAC. The events in Asia are concerning and reinforce the importance of the plan – it will be a central tool in assisting the department in preparing for a pandemic, should one occur. NVAC’s comments, as experts in the field, are greatly appreciated.

Although she was unable to hear the Committee’s comments from that morning, Dr. Gellin had updated her. She recognized the people at NVPO and the departmental agencies for their work and their commitment. They have not had a pandemic influenza plan for over 25 years, and that it was long overdue. She was very glad that they took on this mission, and they were very proud of the product. One of the key components is to share it with fellow state and territorial representatives and experts such as those in NVAC to try to incorporate the best possible feedback.

NVAC Influenza Working Group—Report and Recommendations - Dr. Charles Helms

Dr. Helms noted that the Influenza Working Group had worked very hard and completed a report in response to Dr. Beato’s request. The report had been circulated to NVAC in advance of this meeting, and the committee had a draft report worthy of discussion within the timeframe requested by Dr. Beato.

Dr. Helms noted that he would give a brief outline of the report and then would open the floor to discussion, questions, and comments. He began with background on the reasons for the effort and the report. This was the agenda of the February NVAC meeting, which was largely built around the National Influenza Immunization Program. There were insightful and helpful presentations from key players in the complex and multidisciplinary efforts who reviewed the previous year’s influenza experience and cited lessons learned. They learned much about the strengths and weaknesses of the system from that conference. Stimulated by that meeting, Dr. Beato requested NVAC to take a step back and look at NIP as a whole for ways to overcome hurdles and to improve it. She specifically asked that NVAC consult with NVPO, HHS agencies, and their advisory committees, as appropriate, in review of the program and in the preparation of the recommendations.

In response, Dr. Georges Peter put together a NVAC Influenza Working Group to evaluate the strategies and capabilities for reducing influenza disease impacts in the United States and to make recommendations for how to substantially improve prevention and reduce disease burden. Dr. Peter asked Dr. Helms to chair the working group. After input from NVPO and other agency staff, the working group was divided into three subgroups in order to better focus on and address the key issues. Members of NVAC and NVPO were assigned to the three subgroups. The Influenza Vaccine Research, Development and Production subgroup was chaired by Dr. Arvin and staffed by Dr. Gellin. The Vaccine Delivery, Financing and Demand subgroup was chaired by Dr. Guerra and staffed by Sarah Landry. The Influenza Vaccine Recommendations and Strategies subgroup was chaired by Dr. Klein staffed by Dr. Schwartz.

Dr. Helms discussed the accomplishments thus far. The working group and subgroups have met at least 10 times in discussions and coordinative efforts, particularly around drafting. The working group made a presentation at the Influenza Summit in April 2004 and consulted with various stakeholders. They have had discussions with HHS agencies, advisory committees, industry, healthcare providers, and others. They had a preliminary report in June 2004 and subgroup reports were drafted after that. The subgroup reports were then assembled into a consensus that would be presented at this meeting.

Dr. Helms discussed the recommendations and noted that the report itself was entitled Strengthening the Nation’s Influenza Vaccination System: An NVAC Assessment.

The first recommendation was to develop a system for ensuring vaccine delivery in all settings or medical homes. Time and resources often limit the ability of providers to use office visits for immunizing adults. For example, the adult providers must often deliver care for acute and chronic conditions in an office visit. There may, as a result, be no opportunity for immunizations or other preventive services. For adults, as with children, it has long been recognized that contact with the healthcare system should be used as an opportunity to vaccinate. This has perhaps been less recognized with adults, but any contact should be seen as an opportunity. Alternative vaccination sites (e.g., emergency rooms, work site, pharmacies, shopping malls, detention centers) not always connected to the traditional medical home (e.g., office, hospital) where people can receive influenza vaccine under delegated standing orders need to be further expanded.

The second recommendation was to work with payers to make influenza vaccine purchase less of a burden and less of a financial risk for providers. Studies have shown that providers have concerns regarding the costs of administering vaccines and reimbursement for vaccine purchases. Health plan payment rates do not always adequately compensate for these costs, and for many providers, influenza vaccination is a financial loss. In addition, the current system requires that the provider order and purchase vaccine in advance and does not allow for return or reimbursement of unused vaccine. The provider, thus, has to assume the cost risk of unused vaccine. This is a good incentive to reduce waste, but is not an incentive to aggressively increase immunization rates.

The third recommendation was to consider expanded influenza recommendations. The current burden of influenza-related deaths and questions about the effectiveness and impact of the influenza immunization program have led to an evaluation of influenza prevention strategies and the possible need to expand vaccination recommendations. In February 2004, the ACIP influenza working group began an evaluation of whether influenza vaccination recommendations should be expanded. Expanding vaccination recommendations raises important issues, such as: the capability of our immunization system to implement a broader program and actually achieve high vaccination coverage; the capability of our vaccination supply system to reliably produce the increased doses necessary; and, the nation’s ability to finance vaccination and achieve equitable implementation among the economically disadvantaged. NVAC will continue to work closely with the ACIP anticipating that such issues will surface as ACIP considers influenza vaccine recommendations.

The fourth recommendation was to explore options for supporting comprehensive vaccination programs for adults. Financial barriers may prevent the successful implementation of expanded influenza vaccination recommendations in adults. For example, while the VFC program supports costs associated with vaccination of low-income, uninsured children and Medicare pays for vaccination of all persons over the age of 65 years, only Medicaid, which almost never covers all the costs of influenza vaccination, finances vaccination for poor, uninsured, or disabled adults between the ages of 18 and 65. Financing options that will improve program effectiveness need to be considered. Any changes in the financing will have to balance the nation’s public health goals with industry’s need for adequate pricing to ensure a rate of return that will encourage continued investment in vaccine research and development.

The fifth recommendation was to better understand the burden of influenza illness in the United States. Annual vaccine use in the United States has reached about 80 million doses per year. Despite this, influenza continues to cause 36,000 deaths and over 200,000 hospitalizations per year. Efforts to accurately characterize the impact of the vaccination program on influenza disease and death are hampered by several factors: annual variations in influenza disease severity, which make tracking of disease trends difficult; the absence of a uniquely identified influenza syndrome; and, lack of an etiological diagnosis in most persons with febrile or respiratory illness. It is a concern, when trying to accurately estimate the contribution of influenza on exacerbating non-respiratory illnesses, such a acute myocardial infarction and congestive heart failure. Because of these factors, disease burden has generally been estimated using mathematical models that identify excess rates of specific illnesses during the influenza season. More precise metrics are needed to better estimate program impacts and vaccine effectiveness.

The sixth recommendation was to implement new surveillance systems to better assess program impacts and vaccine effectiveness on an ongoing basis. Influenza surveillance systems in the United States have been developed to monitor the annual spread, causative strains, and population burden of influenza disease. Defining overall program impacts and assessing annual vaccine effectiveness have not been primary objectives. New surveillance systems should be implemented to help fill the gap. A pilot program using this approach in children has been implemented in three metropolitan areas. Surveillance of pediatric populations is particularly important as new recommendations for universal vaccination of children between 6 and 23 months of age were adopted in 2004. Further expansions of the vaccination program are currently being considered.

The seventh recommendation was to reinforce the importance of influenza vaccination for healthcare workers. Although most patients and healthcare providers are aware of the value of influenza vaccine, many healthcare workers choose not to get vaccinated. According to the National Health Interview Survey for healthcare workers, only 38 percent of healthcare providers in this country receive influenza vaccines, annually. DHHS should work with professional medical organizations to strengthen influenza vaccination efforts among all healthcare workers.

The eighth and final recommendation was to conduct a comprehensive review of the influenza research program and identify gaps and areas for additional support. A wide range of influenza disease and prevention-related research is being supported and conducted by multiple agencies in the public and private sectors. An influenza research program review that describes ongoing activities, defines key objectives, and identifies gaps in the research portfolio is an important first step in strengthening the program and in assuring that innovations will occur in the future that will prevent the most common and the most deadly of all vaccine-preventable diseases in the United States.

Dr. Helms noted that this completed the report. He thanked the individuals who participated in this effort and asked any members of the working group who have caught errors to bring it to their attention now and to participate in the discussion.

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