VACCINE SUPPLY AND DEMAND

Vaccine production delays led to a slower than expected supply of vaccine, and many workshop participants said that vaccine shortage, in combination with limited information about upcoming supply, was 1 of the main challenges of the response. Initially optimistic projections of vaccine supply focused much of the planning efforts on the logistics of mass distribution and administration rather than on planning for administration of a scarce public health resource. The first doses of vaccine were administered to the public on October 5, 2009, but the supply of vaccine during the first 2 months of the program was not sufficient to cover the target groups for whom vaccination was recommended by the ACIP. Most jurisdictions, therefore, did not make vaccine available to the general population until December, after the number of cases had already declined in most areas of the United States. During the early months demand far outstripped supply, and in the later months supply far exceeded demand. Participants described the challenges of equitably and fairly distributing a “trickle” of vaccine.

During the summer of 2009, state and local public health authorities planned vaccination programs based on robust federal vaccine supply forecasts. When the production schedule fell significantly short of predictions, large-scale changes were needed in planned vaccine distribution strategies. Speaking to federal authorities and other entities involved in early planning and communications, many workshop participants urged the implementation of a policy of “underpromise, overdeliver” in future emergency countermeasure programs. Some participants recommended that federal authorities develop a stronger and more formal partnership with vaccine producers to ensure they have the most up to date information on production and inventory and can generate more accurate supply projections. Planning for a range of vaccine supply scenarios was encouraged when supply is uncertain.

Several participants also emphasized the need to develop better systems for tracking distribution and administration to ensure improved situational awareness. Participants suggested further integrating existing systems and technologies such as barcoding and electronic tracking to improve the ability to track vaccine throughout the distribution and administration system. The inability to fully track vaccine throughout the distribution and administration system, after it had been shipped by the distributor, exacerbated the challenges posed by vaccine shortage and complicated efforts to efficiently and equitably distribute and administer vaccine and, particularly, to communicate effectively with the public regarding local vaccine availability.

Finally, many participants reported that federal and state messaging encouraging vaccination increased public demand while the vaccine was in short supply and was profoundly challenging for state and local health officials and health care providers. Participants noted that message timing and content would be improved through using the additional situational awareness and real-time data gained from a stronger relationship between federal authorities and vaccine producers and the development of better systems for tracking distribution and allocation, as discussed above.

STATE AND LOCAL IMPLEMENTATION OF ACIP RECOMMENDATIONS

The ACIP recommended a set of 5 target groups as the focus of initial vaccination efforts and a subset of those groups for prioritization if vaccine supplies were insufficient to cover the initial target groups, which did turn out to be the case.2 The specific implementation strategy for these recommendations was left to state and local jurisdictions. A variety of strategies were used, including both sequential and simultaneous vaccination of target population groups. When supplies were limited, some jurisdictions restricted vaccine initially to an ACIP subset for vaccination, such as children and health care workers, whereas other jurisdictions also made vaccine available to larger target population groups, such as adults 18 to 64 years old with underlying health conditions. In general, public health officials at the workshops reported that they valued the flexibility in implementing ACIP recommendations, despite the associated challenges. State public health officials also valued the flexibility to implement their own distribution plans in accordance with their existing infrastructure and the needs of their states. However, variability across state and county lines was challenging for state and local public health officials: Jurisdictions that decided to maintain consistency with neighboring jurisdictions were concerned that their approach was not optimized for their population; jurisdictions that pursued their own plans found it harder to effectively communicate to the public.

In contrast, many representatives from multijurisdictional health care systems, large chain pharmacies, large companies with occupational health programs, and tribal authorities whose reservations crossed multiple state boundaries said that having different strategies in different jurisdictions was problematic for them. Several participants suggested that further consideration about the appropriate balance between flexibility and standardization would be valuable.

Among the specific concerns mentioned relating to the ACIP recommendations, the exclusion of tribal elders was thought to have reduced vaccination rates in some American Indian communities because elders are highly respected role models in their communities. Tribal participants requested flexibility to vaccinate elders in future programs to improve vaccination rates throughout their communities.

VACCINE FORMULATIONS AND PRIORITY GROUPS

The variety of vaccine formulations from several manufacturers and the inability to predict the time frame during which the various formulations would be available and in what quantities was extremely challenging for public health authorities and health care providers. The 2009 H1N1 vaccine was manufactured in 4 formulations (adult-dose prefilled syringes, pediatric-dose prefilled syringes, multidose vials, and prefilled single-dose intranasal sprayers) produced by 5 manufacturers, each with different age indications and labeling. Participants noted that it was particularly challenging when almost all of the initial vaccine was live attenuated vaccine, which was not indicated for many people in the target groups. Health care providers reported being unable to vaccinate their patients at highest risk until later in the campaign because they initially received primarily or only live attenuated vaccine. Pediatricians noted that this issue was even more complicated for their practices, relative to vaccinating adults, because of the large number of different age indications among the various products. This complicated their efforts to schedule patients for vaccinations and added additional challenges to communicating with parents about whether vaccine was available for their children.

OPPORTUNITIES FOR DEVELOPING PARTNERSHIPS

Workshop participants acknowledged the value of the federal VFC childhood immunization program and distribution system in providing the underlying framework for the 2009 H1N1 distribution system. For the 2009 H1N1 program, it was particularly important to recruit supplemental partners not only to expand vaccine availability to children but also to reach adult populations. There is no existing national program for adult vaccination with linkages to the public health system that is analogous to the VFC program.

Existing and new partnerships played a crucial role in the vaccination campaigns. At the workshops there was general excitement and pride in how new partners had been integrated into the response, and many participants said that these partnerships should be further developed and leveraged in the future. Important partners included health care providers, pharmacies and pharmacists, health plans, large companies with occupational health programs, community organizations, emergency medical services, school systems, colleges and universities, contract nurses, Medical Reserve Corps, and federal agencies and programs providing clinical services, including the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. In light of the erosion of funding for public health infrastructure, state and local public health authorities are highly concerned about how to sustain and capitalize on the infrastructure improvements, partnerships, and other capacities built.67 They also expressed concern about the absence of an ongoing adult vaccination program.

Health care providers played an integral role in the distribution and administration plans of this emergency vaccination campaign. Workshop speakers included obstetrician-gynecologists, pediatricians, and family practice physicians. Describing their experience with the 2009 H1N1 vaccination efforts, they mentioned a number of challenges that were similar to those faced by the public health officials discussed above, including the lack of vaccine relative to the number of their patients who met target group criteria, the large number of formulations and indications, the mismatch between available formulations and target groups, and the lack of information about upcoming supply. The minimum order size of 100 doses was also reported to have created a barrier for some health care providers. The private practice providers and commercial vaccinators also faced significant challenges resulting from uncompensated costs associated with participation in the 2009 H1N1 vaccination campaign. They noted, in particular, the costs that were associated with additional staff needed to handle the large volume of telephone calls and the logistical requirements of receiving and administering vaccine.

Pharmacies and pharmacists were also integrated into the response much more deeply than ever before. The integration of pharmacies into the distribution and administration system was viewed as a success by both public health and pharmacy participants, and pharmacists reported adherence to the target groups, despite potential business implications. Participants did report, however, that some health care providers objected to pharmacies receiving vaccine when health care providers did not have adequate supplies. Many participants encouraged public health authorities to continue to engage with pharmacies and integrate them into vaccine and other countermeasure distribution and administration systems. Efforts should continue to address issues such as payment, legal and regulatory barriers, and interstate variability in age restrictions about who a pharmacist can vaccinate. Another important issue discussed at the workshops was how public health authorities should balance distribution through private health care providers and pharmacies with equitability and ensure that people without a medical home are not left out. Several participants believed that additional research and consideration is needed to determine the appropriate balance and timing for using private and public mechanisms to distribute vaccine.

Health plans can play a role in all of the stages of planning and response, reported several health plan representatives at the workshops. They reminded participants that large integrated health care systems may already have systems set up specifically for vaccinating their members. Health plans already have systems for communicating with health care providers, employers, and members, including call centers and targeted communications and reminders based on electronic records. Finally, they have data and other resources to contribute. One health plan participant suggested convening a national meeting for large health plans, both public and private, to discuss the lessons learned during the 2009 H1N1 response, their role in future emergency responses, and how to address issues such as reimbursement, funding, and information sharing so that health plans can be more fully integrated into the response system.

The challenge of dealing with multiple state and local jurisdictions and their different distribution and administration schemes was noted by several stakeholder groups, including large chain pharmacies, health plans, large companies with occupational health programs, and tribal governments on American Indian reservations that cross state boundaries.

OPPORTUNITIES TO INCREASE VACCINATION RATES

Individual workshop participants identified several “low-hanging fruit” opportunities to increase vaccination rates. Specifically, they said that concrete steps could be taken to increase vaccination rates for pregnant women, increase acceptance of live attenuated nasal spray vaccine, and increase vaccination rates for health care workers. These are discussed in more detail below.

Pregnant women emerged as 1 of the groups at highest risk of developing serious complications.Reference Jamieson, Honein and Rasmussen8 Public health authorities, medical associations, and the obstetrician-gynecologist provider community should work together, participants said, to improve vaccination rates for pregnant women by ensuring that influenza vaccine is routinely recommended for pregnant women and “institutionalizing” access to vaccine where obstetrical care is provided. Three concrete suggestions were made, as follows:

• 1. Use electronic standing orders (“opt out”) and automatic best practice alerts in electronic medical records for pregnant women.

• 2. Increase education for health care providers regarding safety and importance of vaccinating pregnant women so that the providers are more likely to encourage their patients to be vaccinated.

• 3. Increase the number of obstetrician-gynecologists that provide seasonal influenza vaccine to their patients, making vaccination a regular part of their practice.

Increasing acceptance of live attenuated nasal spray vaccine was also identified by workshop participants as a “low-hanging fruit” opportunity. Participants reported that uptake of live attenuated influenza vaccine was low among eligible health care providers and the public, often because of unfounded concerns about transmission to patients in health care settings and vaccine efficacy. Participants suggested educating health care providers and the public about the safety of the nasal spray vaccine. Several participants noted that some members of the public may lack understanding of live attenuated influenza vaccine and this may lead them to decline vaccine in this format; participants suggested instead that it should be referred to as “nasal spray vaccine.” Several participants also reported that they had found it helpful for clinics and health care providers to adopt the attitude that nasal spray vaccine will be given unless contraindicated.

Finally, many participants discussed the importance of taking steps to increase vaccination among health care workers. They discussed developing incentives for health care provider immunization and education regarding safety and importance so that they will be more likely to be vaccinated and to advise patients to be vaccinated.

STANDARDIZATION OF IMMUNIZATION INFORMATION MANAGEMENT SYSTEMS

In general, utilization reporting was considered to be poor in most areas, making it difficult for public health authorities and health care providers to determine in real time, or near real time, whether their efforts were successful. There was a high level of variability in information management systems for tracking administration of vaccine across state and local public health systems. This caused problems, particularly for partners who had to interact with multiple public health jurisdictions and/or also report to their own internal systems, such as the Department of Veterans Affairs and large pharmacy chains. Several participants suggested that it would be useful to explore standardization of information management systems and data reporting requirements and to analyze current immunization registries and other systems to assess where variability is not warranted.

OPPORTUNITIES TO SIMPLIFY, SYSTEMATIZE, AND AUTOMATE PROCESSES AND PRACTICES

Several workshop participants highlighted the benefits that could be gleaned from examining the entire response system for ways to simplify, systematize, and automate processes and develop practices that take into account human factors to increase vaccination rates, reduce errors, and increase efficiency. Throughout the 3 workshops, many participants suggested ideas for accomplishing this at federal, state, and local levels and in health care providers' offices, including streamline/simplify provider registration, reduce the complexity of the vaccine formulary, and implement electronic standing orders and automatic best practice alerts in electronic medical records. In particular, many suggestions were made about ways to facilitate data collection and improve the functionality of immunization registries to enable real-time tracking of vaccine administration, including barcoding and color-coding vaccine, automatically sharing information from electronic medical records and practice management systems with systems for tracking vaccine administration, and simplifying data collection and reporting requirements.

RESEARCH OPPORTUNITIES AND NEEDS

Identifying research opportunities and needs was not a primary focus of the workshop design. Nevertheless, the plethora of potential research opportunities afforded by the 2009 H1N1 response and the need for additional research to guide improvements for future distribution and administration of countermeasures emerged as a strong theme. On the basis of workshop presentations and discussions, a range of opportunities and needs were identified:

• • Systematically evaluate state and county implementation processes and immunization infrastructures to understand associations between coverage rates (where data from the 2009 H1N1 response is available) and immunization policy, programs, and practices.

• • Assess the optimal balance of flexibility and standardization (proscription) in the ACIP guidelines, including consideration of whether/how this balance should shift according to the characteristics of the situation. Assess where flexibility is or is not warranted, and consider processes that could be put into place to begin to weed out flexibility where it is not beneficial to the overall response.

• • Evaluate the 2009 H1N1 response to develop a better understanding of the full cost of the response and what portion is borne by each stakeholder (eg, taxpayers, physicians, patients, health plans, employers).

• • 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 administration strategies best ensure equitability and fairness and provide the most effective use of resources according to the characteristics of the situation, including shortage vs ample vaccine supply and severity and timing of disease. For example, when and how should different routes of vaccine administration be used (eg, mass clinics, private health care providers, pharmacies); what messaging is most effective in each situation?

• • Research effective methodologies for reaching different populations with risk communications and vaccine messaging. This activity would include both a retrospective evaluation of the effectiveness of communications efforts during the 2009 H1N1 response and research to develop and test new messaging strategies.

This is not a complete list, and investigating details about the feasibility and implementation of these ideas was beyond the scope of the workshops. The list of ideas does, however, highlight the rich diversity of possible directions for future research.

SUMMARY

The IOM Preparedness Forum's regional workshop series was 1 of several efforts to examine the 2009 H1N1 vaccination campaign, discuss lessons learned, and identify promising practices. A particular contribution of these workshops was the special emphasis placed on including partners from across the vaccine dispensing and administration system in all of the workshops. The workshops provided an opportunity for federal, tribal, state, and local public health officials, health care providers, emergency medical services providers, health care administrators, representatives from the private sector, journalists, and community leaders, among others, to learn about each other's roles and experiences during the campaign. Most important, it was a venue for them to join together to discuss strategies to sustain and leverage progress made during the past year, identify opportunities and areas for further work, and continue to improve the nation's ability to respond to public health threats.

APPENDIX

Planning committee membership: Jay C. Butler, co-chair (formerly CDC, currently Alaska Native Tribal Health Consortium), Jeffrey S. Duchin, co-chair (Public Health–Seattle & King County and University of Washington), Teresa Bates (Tarrant County Public Health, TX), Beth P. Bell (CDC), Pam Blackwell (Cobb & Douglas Public Health, Georgia), James S. Blumenstock (Association of State and Territorial Health Officials), Brooke Courtney (Center for Biosecurity of University of Pittsburgh Medical Center), Jack Herrmann (National Association of County and City Health Officials), B. Tilman Jolly (Department of Homeland Security), Lisa Koonin (CDC), David L. Lakey (Texas Department of State Health Services), and Cathy Slemp (West Virginia Department of Health and Human Resources).