10
Research and Planning

Despite the challenges associated with tracking vaccine administration, a tremendous amount of data was collected during the 2009 H1N1 response. Many noted that harvesting and evaluating these data would significantly expand the evidence base that could be used to improve future emergency vaccination campaigns. Participants suggested research questions across all the areas discussed so far in this summary, including distribution and administration, data collection, communications, and funding and payment.

Across all three workshops, many participants said that it would be extremely valuable to systematically evaluate state and county implementation processes and immunization infrastructures to understand associations between coverage rates and immunization policy, programs, and practices. Participants noted substantial variability by state in the percentages of the population vaccinated and the percentage of target group members vaccinated. Vaccination rates for ACIP target groups ranged from 19.4 to 57.5 percent (CDC, 2010a). Adults with high-risk conditions averaged 25.2 percent, but ranged from 10.4 to 47.2 percent across jurisdictions. Participants asked, given the per capita distribution of vaccine across the country, what the underlying reasons were behind the variability seen in vaccine uptake rates from region to region and among targeted groups. Workshop participants speculated that this could stem from many different factors, including differences in the state and local public health infrastructure and vaccination processes, differences in the healthcare providers who participated and their attitudes toward vaccination, varying attitudes toward vaccination by the public, communication methods, and disease burden when vaccine became available.



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10 Research and Planning Despite the challenges associated with tracking vaccine administra- tion, a tremendous amount of data was collected during the 2009 H1N1 response. Many noted that harvesting and evaluating these data would significantly expand the evidence base that could be used to improve fu- ture emergency vaccination campaigns. Participants suggested research questions across all the areas discussed so far in this summary, including distribution and administration, data collection, communications, and funding and payment. Across all three workshops, many participants said that it would be extremely valuable to systematically evaluate state and county imple- mentation processes and immunization infrastructures to understand as- sociations between coverage rates and immunization policy, programs, and practices. Participants noted substantial variability by state in the percentages of the population vaccinated and the percentage of target group members vaccinated. Vaccination rates for ACIP target groups ranged from 19.4 to 57.5 percent (CDC, 2010a). Adults with high-risk conditions averaged 25.2 percent, but ranged from 10.4 to 47.2 percent across jurisdictions. Participants asked, given the per capita distribution of vaccine across the country, what the underlying reasons were behind the variability seen in vaccine uptake rates from region to region and among targeted groups. Workshop participants speculated that this could stem from many different factors, including differences in the state and local public health infrastructure and vaccination processes, differences in the healthcare providers who participated and their attitudes toward vaccination, varying attitudes toward vaccination by the public, commu- nication methods, and disease burden when vaccine became available. 91

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92 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN They noted that local circumstances, such as publicized deaths due to 2009 H1N1, tended to increase demand. Participants suggested that ex- amining state-level data would be helpful in addressing these issues. In addition, although county-level data are not available for all counties, where available they should also be analyzed because the factors in ques- tion may vary significantly by county within a state. Several additional research questions are described below. In addition to the research questions suggested, participants dis- cussed two particular overarching areas where they said that research, combined with expert review and, potentially, modeling, could be used to develop useful planning tools and enhance processes and procedures in the future. These overarching planning areas were suggested in addi- tion to the many other suggestions for improvements to programs, proc- esses, and tools that run throughout this workshop summary. First, as discussed in the section on vaccine supply above, partici- pants noted that it was extremely challenging to switch from distribution and administration plans focused on rapidly distributing large quantities of vaccine to plans focused on equitably distributing a limited quantity of vaccine. Participants also said it was challenging to switch from plans that assumed a disease with slow transmission but high mortality, H5N1, to a disease with high transmission but lower severity, H1N1. Through- out the workshops, they discussed how different strategies may be most appropriate in different situations. Participants suggested that it would be valuable to harvest data from the 2009 H1N1 response and, in conjunc- tion with expert review and, potentially, modeling, develop a planning tool that outlines which distribution and administration strategies best ensure equitability and fairness and provide the most effective use of re- sources according to the characteristics of the situation. In particular, they noted that the planning tool should contain considerations for situa- tions of shortage versus ample vaccine supply, and also recommenda- tions regarding effective strategies according to the severity of the disease. A second recurring workshop theme was that many processes in- volved in the vaccination campaign could have been simplified, systema- tized, and automated. This would have made the campaign more efficient and reduced error rates, they said. Participants suggested that it would be useful to examine the entire response system for ways to simplify, sys- tematize, and automate processes and develop practices that take into

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93 RESEARCH AND PLANNING account human factors in order to increase vaccination rates, reduce er- rors, and increase efficiency. Particular examples are given below. Research Opportunities Individual suggestions for research areas are compiled below as part of the factual summary of the workshops and should not be con- strued as reflecting consensus or endorsement by the workshops, the Preparedness Forum, or The National Academies. Investigating details about the feasibility and implementation of these ideas was beyond the scope of the workshops. Vaccine Distribution and Administration There were several individual suggestions for research related to vaccine distribution and administration. These included • Systematically evaluate state and county implementation processes and immunization infrastructures to understand associations between coverage rates and immunization pol- icy, programs, and practices. • Assess the optimal balance of flexibility and standardization (proscription) in the ACIP guidelines, including considera- tion of whether/how this balance should shift according to the situation. This would include assessing where flexibility is or is not warranted and considering processes that could be put into place to begin to weed out flexibility where it is not benefi- cial to the overall response. • Examine the impact that the timing of vaccine distribution to the general public had on vaccine uptake and leftover vac- cine. What is the difference of vaccine uptake and leftover vac- cine among states that opened vaccinations to the general public earlier, compared to those that opened later? • Explore data on school vaccination campaigns and second- dose rates. In West Virginia, data on second-dose coverage show wide variations by county, ranging from 11 to 86 percent. One county enacted a second-dose campaign in schools, while

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94 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN another did not. There were also variations in the number of healthcare providers and who were reporting. Research on Data Collection Systems There were several individual suggestions for research on data col- lection systems. These included • Examine differences in data collected between states that had registries and those that did not. Did provider enrollment in the 2009 H1N1 vaccination campaign differ? Did coverage lev- els differ? Are there differences between states that required data entry in registries and those that had registries but did not require data entry? • Examine the VFC reporting systems in states that had good reporting rates using such systems to determine the underlying causes. What are the operational systems that support healthcare providers in providing good data to the system? Can they be dis- seminated across the nation? • Examine the links among epidemiological data, disease, and vaccine program activity. How were the data collected by the CDC shared? When were the data robust enough to share with part- ners, and when with the public? How should the data shape our vaccine programs, and at what point in vaccination campaigns? Research on Communications There were several individual suggestions for research on topics re- lated to communications. These included • Research effective methodologies for reaching different populations with risk communications and vaccine messag- ing. This would include both a retrospective evaluation of the ef- fectiveness of communications efforts during the 2009 H1N1 response and research to develop and test new messaging strategies.

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95 RESEARCH AND PLANNING • Explore the reasons why people choose to get vaccinated, why they choose not to get vaccinated, and how the messages they receive impact this decision. Research on Funding and Payment There were several individual suggestions for research on issues re- lated to funding and payment. These included • Evaluate the 2009 H1N1 response to develop a better under- standing of the full cost of the response and what portion is borne by each stakeholder (e.g., taxpayers, physicians, pa- tients, health plans, employers). Planning Opportunities Individual suggestions for areas in which research, combined with expert review and, potentially, modeling, could be used to develop better planning tools and enhanced processes and procedures are compiled below as part of the factual summary of the workshops and should not be construed as reflecting consensus or endorsement by the workshops, the Preparedness Forum, or The National Academies. Investigating details about the feasibility and implementation of these ideas was beyond the scope of the workshops. They are as follows: • Harvest data from the 2009 H1N1 response (in conjunction with expert review and, potentially, modeling) to develop a planning tool that outlines which distribution and admini- stration strategies best ensure equitability and fairness and provide the most effective use of resources according to the characteristics of the situation, including o Shortage versus ample vaccine supply. o Severity and timing of disease. For example, when and how should different routes of vaccine administration be used (e.g., mass clinics, private healthcare pro- viders, pharmacies), what messaging is most effective in each

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96 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN situation, and when is it most effective to pursue herd immunity versus targeted protection of people with the highest risk? • Examine the entire response system for ways to simplify, sys- tematize, and automate processes and develop practices that take into account human factors in order to increase vaccina- tion rates, reduce errors, and increase efficiency. Examples include o Simplify the provider registration system, o Reduce the complexity of the vaccine formulary, o Implement electronic standing orders and automatic “best practice” in electronic medical records, o Bar code and color code vaccine, o Develop systems so that information in electronic medical records and practice management systems can be automati- cally shared with systems for tracking vaccine administra- tion, and o Simplify data collection and reporting requirements.