Mass Vaccination for the 2009 H1N1 Pandemic: Approaches, Challenges, and Recommendations PDF image

Kunal J. Rambhia, Matthew Watson, Tara Kirk Sell, Richard Waldhorn, and Eric Toner

Biosecurity and Bioterrorism: Volume 8, Number 3, 2010. © Mary Ann Liebert, Inc. DOI: 10.1089/bsp.2010.0043

 

Introduction: The 2009 H1N1 pandemic stimulated a nationwide response that included a mass vaccination effort coordinated at the federal, state, and local levels. This article examines a sampling of state and local efforts during the pandemic in order to better prepare for future public health emergencies involving mass distribution, dispensing, and administration of medical countermeasures. In this analysis, the authors interviewed national, state, and local leaders to gain a better understanding of the accomplishments and challenges of H1N1 vaccination programs during the 2009-10 influenza season. State and local health departments distributed and administered H1N1 vaccine using a combination of public and private efforts. Challenges encountered during the vaccination campaign included the supply of and demand for vaccine, prioritization strategies, and local logistics. To improve the response capabilities to deal with infectious disease emergencies, the authors recommend investing in technologies that will assure a more timely availability of the needed quantities of vaccine, developing local public health capacity and relationships with healthcare providers, and enhancing federal support of state and local activities. The authors support in principle the CDC recommendation to vaccinate annually all Americans over 6 months of age against seasonal influenza to establish a standard of practice on which to expand the ability to vaccinate during a pandemic. However, expanding seasonal influenza vaccination efforts will be an expensive and long-term investment that will need to be weighed against anticipated benefits and other public health needs. Such investments in public health infrastructure could be important for building capacity and practice for distributing, dispensing, and administering countermeasures in response to a future pandemic or biological weapons attack.

Sections: Background | Methodology | Findings | Recommendations | Conclusion | Acknowledgments | References


On April 24, 2009, the World Health Organization (WHO) reported that public health authorities in Mexico and the United States had detected and reported an unusual increase in the number of cases presenting with influenzalike illness and pneumonia.1 Laboratory diagnostics performed in the U.S. and Canada identified the causative agent as a novel influenza A/H1N1 virus. Subsequently, the virus spread globally through efficient and sustained human-to-human transmission. Evidence from serological surveys indicated a widespread lack of preexisting immunity against the 2009 H1N1 influenza virus in the general population. On April 25, 2009, the WHO Director-General determined H1N1 to be the firstever public health emergency of international concern under the revised International Health Regulations, and on June 11, WHO officially declared the first influenza pandemic in more than 4 decades.2,3

The U.S. Centers for Disease Control and Prevention (CDC) responded to the emerging threat by initiating a suite of preplanned mitigation efforts. Chief among these was supporting the manufacture, distribution, and administration of a safe, effective vaccine. By July 9, the Secretary of the U.S. Department of Health and Human Services (DHHS), Kathleen Sebelius, announced that a mass vaccination campaign would be undertaken in order to prevent cases and deaths.4

The goals of this analysis are to (1) describe how state and local public health authorities chose to distribute and administer H1N1 vaccine during the 2009 H1N1 pandemic, (2) outline the practical challenges that were encountered during implementation of the mass vaccination campaign, and (3) make recommendations that would enhance the public health response to a future infectious disease emergency.

Background

Manufacture of H1N1 Vaccine

The manufacture of large quantities of influenza vaccine is a complex process that includes formulation, production, clinical trials, licensure, and fill-and-finish. The process takes 6 to 9 months to complete.5 In order to provide supplies of inactivated vaccine sufficient to immunize the entire U.S. population, the federal government contracted with GlaxoSmithKline, Novartis, CSL, Inc., and Sanofi Pasteur. A fifth company, MedImmune, supplied a live attenuated influenza vaccine (LAIV), which is administered via nasal inhalation. Three separate purchases of vaccines were made by the Biological Advanced Research and Development Authority (BARDA) on May 22, July 9, and September 21, 2009, that totaled more than $1.5 billion.6 Vaccines purchased by the federal government were provided free of charge to state and local health departments.7

H1N1 Vaccine Distribution

To ensure a prompt and effective distribution of vaccine to state and local health departments, CDC contracted with a logistics company, McKesson, to establish a centralized distribution network that would fill orders placed by state and local health departments.Officials believed that this approach would allow for equitable distribution of vaccine supplies. McKesson had prior experience with centralized vaccine distribution from its involvement with CDC vaccination programs, including the Vaccines for Children program.8 This approach differed from the distribution of seasonal influenza vaccine, which is focused on private sector administration of vaccine (ie, vaccines are sent directly to healthcare providers). Initially, health departments were informed that they could expect to receive shipments of vaccine in advance of the fall ‘‘wave’’; however, various technical issues delayed vaccine manufacture.9 Vaccine did not begin to arrive in local communities until mid-October, when the influenza epidemic was just reaching its peak. Mass vaccination was nevertheless pursued in anticipation of additional waves of disease continuing throughout the winter influenza season.

ACIP Recommendations

The CDC Advisory Committee on Immunization Practice (ACIP) formulates guidance regarding vaccine usage. ACIP met on July 29 to develop the guidance for the first mass vaccination campaign in more than 3 decades. Recommendations were based on available clinical and epidemiologic data, as well as input from the general public. ACIP assumed that approximately 120 million doses of vaccine would be available by mid-October and that individuals would require 2 doses of vaccine to be fully immunized.10 As data from clinical trials became available in the fall, CDC ultimately recommended that a single dose would be sufficient to protect people 10 years and older. Children under 10 years of age would require 2 doses.

ACIP published its findings on August 21, 2009.11 It ultimately recommended 2 sets of priority groups (Table 1), consisting of an estimated 159 million Americans. In the event that supplies of vaccine were limited, ACIP recommended that a subset of the primary priority group—estimated at 62 million Americans—receive the highest priority.
 

Table 1. ACIP Recommendations for H1N1 Vaccination11
Primary Priority GroupsSubset of Priority Groups During
Limited Vaccine Availability

Pregnant women

Pregnant women

People who live with or provide care for infants aged <6 months

People who live with or provide care for infants aged <6 months

Healthcare and emergency medical services personnel

Healthcare and emergency medical services personnel who have direct contact with patients or infectious material

People aged 6 months to 24 years

Children aged 6 months to 4 years

People aged 25 to 64 who have medical conditions that put them at higher risk for influenza-related complications

Children and adolescents aged 5 to 18 years who have medical conditions that put them at higher risk for influenza-related complications

Total: 159 million

Total: 62 million

 

Local Implementation of ACIP Guidance

While the purchase and distribution of vaccine was a federal responsibility, organizing and implementing populationwide immunization campaigns was primarily delegated to state and local health departments. Because ACIP guidance was nonbinding, health departments were free to adapt the guidance to local conditions.

The mass vaccination campaign started in October 2009,12 with most localities focusing on limited vulnerable populations. The campaign was expanded as vaccine became available and continued into the spring of 2010. Figure 1 illustrates the number of doses of vaccine that were allocated to, ordered by, and shipped to states over the course of the pandemic through the end of January 2010.
   

Figure 1. Doses of H1N1 Vaccine Ordered, Allocated, and Shipped.12

Figure 1. Doses of H1N1 Vaccine Ordered, Allocated, and Shipped.

  

Coverage for 2009 H1N1 Vaccine Campaign

To assess the performance of the mass vaccination campaign, CDC performed and published 2 analyses of population coverage.13,14 These estimates used data from 2 telephone surveys designed to assess health-related behaviors. The first, the Behavioral Risk Factor Surveillance System, was used to query the vaccination status of approximately 400,000 Americans in 49 states, the District of Columbia, and 2 territories. The second, the National 2009 H1N1 Flu Survey, was established specifically to assess the impact of the vaccination campaign. It consisted of approximately 6,000 randomly selected interviews per month. At the time this article was written, the most recent findings based on these surveys indicated that approximately 23.9% of Americans were vaccinated against the 2009 H1N1 influenza virus. The vaccine coverage in the initial ACIP target groups, and in those aged 6 months to 18 years, is estimated at 33.2% and 36.8%, respectively. An additional analysis determined that approximately 34.7% of healthcare workers were vaccinated against the 2009 H1N1 virus (Table 2).15
  

Table 2. 2009 H1N1 Vaccine Coverage of
Primary Priority Groups (159 million)
% CoverageThrough
December 2009
13
Through
January 201014
Total population20.3%23.9%
Initial ACIP priority group27.9%33.2%
Pediatric population29.4%36.8%

  

Methodology

Between February and May 2010, researchers at the Center for Biosecurity conducted 1-hour, qualitative telephone interviews with public health and medical leaders directly involved in the response to the 2009 H1N1 pandemic to better understand and discuss the implementation of the national mass vaccination program. In all, 19 leaders from 11 institutions were interviewed: 10 were leaders at local and county health departments, 3 at state health departments, 5 at national organizations, and 1 at a multistate healthcare provider. The interview subjects were selected as a convenience sample, based on professional contacts with national, state, and local experts and practitioners.

Interview questions, which were developed by Center for Biosecurity staff, were informed by pandemic influenza planning literature, the response to the 2009 pandemic, and a 1-day conference, The 2009 H1N1 Experience: Policy Implications for Future Infectious Disease Emergencies, hosted by the Center.16 All interviews were conducted on a not-for-attribution basis. Because of the semistructured nature of the interviews, project participants focused on different aspects of their response to the pandemic, which may have introduced some bias in reporting. Selecting participants by convenience sample also may have resulted in bias of reporting. This analysis is not representative of the entire country, nor is it intended to achieve statistical significance.

Findings

Wide Variety of Approaches

There is no single, formal system by which federal, state, and local governments administer vaccine to the entire population. During the 2009 H1N1 pandemic, states and local communities employed a variety of different methods, some of which are described below, to distribute and administer vaccine.

Study participants also noted that these methods were improved or aided by preexisting relationships. Most communities used a combination of different methods, depending on local conditions, and additional avenues were used as more vaccine became available. Public service announcements encouraged the public to be vaccinated, while state and local advertising efforts provided information on when and where to receive vaccine.

Distribution of vaccine through the healthcare system

Some communities reported that they promoted distribution of vaccine through the healthcare system, to practitioners in hospitals, doctors’ offices, and health clinics (Table 3). Health departments increased, or in some cases initiated, communication with healthcare providers of priority group individuals—especially practitioners who cared for pregnant women.

Some health departments categorized providers into tiers to guide decision making on distributing limited vaccine to high-priority providers. For example, obstetricians were placed in a tier above pharmacies. Other health departments worked to build and expand registries of those that served high-priority individuals. These registries often included an online component that allowed providers to order vaccine and communicate with the health departments. However, some health departments felt that the financial and time commitments required for healthcare provider–based vaccination made recruitment difficult and, instead, conducted larger mass vaccination clinics.
  

Table 3. Reported Local Strategies to Vaccinate
Through the Healthcare System During 2009 H1N1
StrategyNotes
Increased communication with healthcare providersLocal health departments built ties to health providers, especially those most likely to come in contact with individuals in the priority groups, including obstetricians, pediatricians, and other health providers.
Use of a tiered approach for vaccine distribution to health providersPediatricians, obstetricians, community health clinics, and providers serving larger numbers of priority group individuals were the first to receive vaccine. Other providers, including pharmacies, were given vaccine as supplies from manufacturers increased.
Targeted communicationsFederal, state, and local communications targeted obstetricians and women who were pregnant. As vaccine supplies increased, communications expanded to the general public.
Registries of providersLocal providers participated in an immunization registry, organized by local and state health departments, to order vaccine, communicate with health officials, and maintain immunization records.
  
Mass vaccination clinics

Mass vaccination clinics were often used to deliver vaccine quickly and efficiently (Table 4). The clinics were generally positioned at a site that would allow hundreds to thousands of people to be vaccinated. These clinics were organized, staffed, and administered in a variety of different ways and were located in different locations within a community. Clinics were staffed and administered by health departments, non-health city personnel such as department of emergency management staff, contract healthcare providers, nursing and graduate students in public health programs, private providers, and others. School-based clinics targeted children in the education setting. Provider-based or public health– supported mass vaccination clinics were open to some or all members of the priority groups.

The efficiency of mass vaccination clinics and the number of people vaccinated in them varied and often depended on the available supply of vaccine as well as organizers’ prior experience with mass vaccination clinics. Several health departments activated points of dispensing to facilitate mass administration of the vaccine. This approach was originally designed to aid in the mass dispensing of postexposure prophylaxis by public health authorities in the event of a biological weapons attack. Participants noted that though some research has occurred on points of dispensing,17 more must be done to increase their throughput and utility. Local leaders said that points of dispensing and other public health department-led efforts were necessary to reach those without a medical home.

Pharmacy participation

Pharmacists have assumed an increasing role in vaccine administration over the past 15 years.18-20 As the H1N1 vaccination campaign continued into December 2009, a growing number of states used pharmacists to administer vaccine.21 Pharmacists began administering vaccine to priority group members, and, as states and local jurisdictions recommended expanded vaccination beyond the initial target groups, pharmacies provided vaccine to the general public.22 Several study participants emphasized that the use of pharmacists, given their experience in vaccinating and their ability to adhere to public health guidance, was important to implementing mass vaccination programs.

Preexisting local relationships

Whether programs were based in schools, in public health departments, or with healthcare providers, the most successful vaccination initiatives were built on preexisting relationships. Close relationships between health departments in neighboring jurisdictions helped to coordinate the response within a region. Local nursing and public health school programs provided additional staff. Some vaccination clinics were aided by previous seasonal influenza clinics, relationships formed through these experiences, and public familiarity with vaccination. Some participants noted that joint conference calls among providers, health departments, and government officials facilitated information sharing and vaccine sharing between jurisdictions. Other interviewees emphasized the value of years of planning with schools and community members to run effective schoolbased clinics.
  

Table 4. Reported Local Mass Vaccination Strategies During 2009 H1N1
StrategyNotes
SchoolsPublic health staff and hired contract healthcare providers organized and staffed clinics that were targeted at children in the education setting.
ProvidersHospitals and large provider groups hosted mass vaccination clinics. In these clinics, public health departments facilitated but did not administer vaccine. Initially, target groups, including healthcare workers, were emphasized.
Public health departmentsPublic health departments hosted mass vaccination clinics, implementing points of dispensing, drive-through clinics, and other approaches.
PharmaciesPharmacies played a role in administering vaccine to priority groups and the general public; their major contribution occurred later in the vaccine campaign as vaccine supplies increased and vaccine became available to members of the general public.
Occupational and institutional clinicsSome occupational and institutional clinics offered vaccine to priority group members in businesses, prisons, and hospital systems.
   
Supply and Demand Challenges

Study participants articulated several common challenges in their response to the H1N1 pandemic. Among these were difficulties related to the vaccine, including supply shortages, decline in demand, and confusion on the part of the public and healthcare providers caused by multiple vaccine formulations.

Early shortages, delays in mass vaccination

During the summer, DHHS anticipated having 120 million doses by mid-October 2009. In mid-September CDC projected that only 40 million doses of vaccine would be available by mid- to late October. Yet, by October 30 only 23.2 million doses were available for distribution.23,24 Uncertain and changing forecasts of vaccine availability caused significant disruptions of local plans, with consequent frustration of public health staff and loss of public confidence in the vaccine program.

Because of uncertainties in vaccine distribution, health departments were challenged in communicating effectively with healthcare providers who served target populations. Often vaccinators would receive only a small percentage of the number of doses they were scheduled to receive and would have only a few days’ notice as to when vaccine would be shipped to them. The vaccine was available only in batches of 100 doses, but many providers did not require that many doses for their patient populations. Further complicating the vaccination program was the mismatch between the formulations of vaccine that were available and the priority groups for vaccination. For example, pregnant women were prioritized to receive vaccine, but LAIV, the first vaccine to become widely available, was contraindicated in this population.

Increasing supplies, decreasing demand

While early vaccine supplies did not meet public demand, the supply soon outstripped demand for vaccine, ultimately resulting in unused vaccine. In April 2010, CDC reported that between 81 and 91 million doses of vaccine had been used through mid-February 2010, far short of the 162.5 million doses that were available.25 Several interviewees suggested that unused vaccine may have been the result of missed opportunities earlier in the season to vaccinate high-risk individuals when they sought medical care for noninfluenza-related issues.

Some interviewees felt that the public perception of the severity of H1N1 was a primary motivating factor when individuals were deciding whether they should get vaccine for themselves and their family. However, the presence and fear of the disease was most keenly felt early in the influenza season when little vaccine was available. Between July and October 2009, when limited amounts of vaccine became available, between 46% and 57% of the public said they expected to get the vaccine.26 Participants reported queues forming at midnight on the day that vaccination clinics were held and lines snaking around buildings. However, by mid-January 2010, when vaccine was widely available, the disease was seen to be much milder than had been publicized. Only 21% of adults had received the vaccine, and only 16% of adults said that they planned to get it by the end of February.26

Confusion about multiple formulations

Some study participants noted that, with the many formulations available, it was difficult and confusing to run the vaccination programs. Many people, and some healthcare providers, were not clear about who should or could receive each different formulation. With seasonal influenza vaccine available concurrently, people were also confused about which vaccine they should get or if they should try to get vaccinated with both seasonal and H1N1 vaccines. Additionally, some states have laws prohibiting the administration of vaccines with thimerosal to pregnant women. This required that the laws be temporarily waived, serving to increase public anxiety regarding vaccine safety.

LAIV was the first vaccine to become widely available.27 But many individuals, including hospital workers, were concerned about the possibility that vaccinated individuals might transmit the LAIV virus to high-risk contacts, so some refused the vaccine. Many vaccine recipients requested the inactivated vaccine formulation, but in the early stages of vaccine distribution, nearly all available vaccine was the LAIV formulation. Because of the greater availability of LAIV, plans to vaccinate high-risk individuals were changed to vaccinate people who could receive the LAIV, such as children, healthcare workers, and public safety workers. This resulted in confusion among priority populations and the public.

Challenges of Priority Group Implementation

Although health departments appreciated flexibility in planning and implementing their local response, they were challenged in developing and adjusting priorities for vaccination. Additionally, the inclusion of children in priority groups was controversial among study participants. Once target groups were determined, health departments faced further challenges in locating these populations.

Difficulty determining priority groups

During its summer planning meetings, ACIP recommended a target group that included an estimated 159 million Americans, of which 62 million were designated to be the highest priority should vaccine supplies be inadequate. Decisions as to how to implement the vaccine programs were left to the state and local levels. As only 23.2 million doses had been shipped by October 30, 2009, communities had to make decisions quickly on how to further break down priority groups and to communicate these decisions to vaccinators and to the public. Vaccinators were challenged with determining whether to turn away individuals who sought vaccine but did not fall into priority or ‘‘sub-priority’’ groups. Health departments struggled to decide when it was appropriate to invite larger parts of the population to get vaccinated. And different communities made different decisions, which led to a confusing public cacophony of recommendations.

Children as a priority group controversial

ACIP’s decision to include healthy children in the priority groups was based on several factors. Early epidemiologic data indicated that the incidence of pandemic influenza appeared to be highest in younger adults and children.28 ACIP also took WHO’s guidance into consideration, which included prioritizing healthy children for vaccination. Furthermore, during public engagement activities in 2005 and 2008, the U.S. Interagency Work Group discussed protecting children as a priority for a pandemic vaccine program,10 but unanimity of opinion was not reached.

Similarly, study participants were divided on the wisdom of including children in priority groups, with some citing the importance of vaccinating high-risk adults first, while others considered vaccinating children as a key aspect of the response. Some study participants doubted that a high enough level of herd immunity could be achieved to slow the spread of the virus. Others supported early vaccination of children based on available vaccine formulations and continued clinical evidence of their higher risk of serious illness.

Locating and identifying individuals

Currently, there is no system by which health departments or providers can identify and locate target patients, such as pregnant women. A common theme from the H1N1 experience was that health departments had to develop special relationships with healthcare providers, obstetricians, pediatricians, and other potential vaccinators very quickly to prepare for the fall vaccination program. However, it was often difficult to identify high-risk individuals as they moved through the healthcare system. Federally qualified health centers were key partners in reaching underserved populations, such as marginalized populations or those without insurance or a medical home.

Logistical Challenges

Logistical aspects of the response also presented difficulties for health departments. Communication was a key factor in successful vaccination efforts, and poor communication hindered the response. Staffing demands often required health departments to seek outside help. Finally, the use of occupational health clinics presented challenges.

Communication critically important

Local leaders considered flexibility of response depending on local conditions to be a positive aspect of mass vaccination efforts, and they noted the importance of communication among CDC, state health departments, local health departments, practitioners, and professional organizations. This communication often took place on conference calls and was necessary for basic information, consistency of message, and specific guidance. Some project participants reported good communication with state health departments and CDC, while others pointed out occasional disconnects between state and local expectations and information.

In some instances, poor communication between government agencies and clinicians, unavailable information, and administrative delays hindered the H1N1 response. Project participants noted that poor communication about the availability of vaccine contributed to a lack of credibility that would later hinder public engagement efforts when adequate vaccine became available.

More timely and basic guidance was needed. For example, CDC information sheets should be provided on an annual basis to obtain parental consent for vaccinating school-aged children. Study participants noted that these information sheets were too long and came too late for effective school-based vaccination programs.

Public health departments under stress

Project participants reported that local public health departments were stressed by the H1N1 response, often to the point of being unable to continue some or much of their normal work. In one community, the local emergency management agency provided resources and coordinated the response because of the lack of public health resources and personnel. In another, public employees from outside of the health department helped staff schoolbased clinics and mass vaccination sites. Some health departments hired contract nurses or temporarily expanded scopes of practice of certain practitioners (eg, paramedics) to staff mass vaccination clinics, and some cities reassigned nonhealth personnel to support health departments in the H1N1 response, including staffing points of dispensing. While some costs were defrayed by public funding, many were not.

Criticism of occupational health clinics

In early November 2009, Wall Street companies and other large corporations received doses of then-scarce H1N1 vaccine and were portrayed in the media as having obtained an unfair distribution of a limited, life-saving vaccine.29 In implementing the vaccination program, some local health departments distributed vaccine to occupational health clinics as one of many methods designed to reach high-priority individuals. This was consistent with federal, state, and local public health efforts to engage the private sector in the response to public health emergencies. Such clinics were in a good position to identify high-priority individuals in their workforce, such as pregnant women and adults with underlying health conditions.

Recommendations

Based on our findings, we recommend the following actions to improve future mass vaccination efforts in response to an influenza pandemic or other public health emergency.

Improve Vaccine Supply and Manufacture

The 2009-10 mass vaccination campaign was a substantial effort by local, state, and federal health officials and leaders that was severely challenged by inadequate supplies of vaccine. Although we did not directly evaluate influenza vaccine technologies or manufacturing processes, it is clear that the early availability of vaccine would have substantially minimized or eliminated many of the challenges outlined here. ACIP decisions were informed by and dependent on projected supplies of vaccine. Local and state plans were developed based on expectations of abundant vaccine.

The H1N1 experience showed that with present vaccine manufacturing capabilities, it is essentially impossible to produce sufficient supplies of the needed influenza vaccine in the interval between the discovery of the new virus and the onset of the pandemic. Thus, in anticipation of another pandemic, it is critical that the federal government invest in new influenza vaccine technologies that may increase the availability of a suitable vaccine early in a pandemic.

Recognize Challenges of Priority Group Decisions

In a future public health emergency, accurate information about the severity and epidemiology of the disease is likely to be lacking, yet federal leaders will have to make decisions about priority groups as they did in 2009. Choosing priority groups is an inherently difficult task. It may not be possible to appropriately match the supply of vaccine with the goals of a program and public demand for vaccine in the midst of an evolving public health emergency. The ACIP recommendations were based on best judgments of this group’s experience with pandemic planning as well as available epidemiologic data and projected vaccine supply. Their conclusions had significant implications for local vaccination efforts.

The H1N1 experience highlighted the realities of mounting a large-scale vaccination program within a health structure that has had no experience in implementing such a program. An understanding of the challenges involved with local implementation will be critical to improving federal guidance. The logistical, practical, and financial realities at the local level should be emphasized as ACIP and their federal partners deliberate what should and can be accomplished in a mass vaccination campaign.

Build and Support Local Capacity

Ultimately, ACIP recommended a large set of priority groups, totaling 159 million individuals, to ensure that vaccine did not go unused and that opportunities to vaccinate were not missed. ACIP cited the 2004 influenza season as a recent experience of recommending much smaller priority groups, which resulted in missed opportunities and unused vaccine. For the 2009 H1N1 pandemic, they instead chose broad groups, emphasizing the need for state and local leaders to determine how best to distribute vaccine.

Mass vaccination planning should focus on building capacity at the state and local levels that takes into account local variation of resources. In advance of a future pandemic, health departments should build additional relationships and expand their ability to distribute vaccine in a number of ways. Specifically, health departments should expand relationships with potential vaccinators and vaccination sites, such as schools, to increase the avenues by which target groups and the general population can be reached. The roles of hospitals and the private sector also will need to be expanded. Contingency plans should be made at the state and local levels to augment federal guidance concerning the prioritization of scarce vaccine.

Going forward, key steps will include expanding relationships with specialists (eg, obstetricians) who serve target populations and with occupational health clinics, developing protocols for expanding scopes of practice of certain practitioners to administer vaccine, and improving the efficiency of points of dispensing. Plans should be developed using existing structures and relationships within communities and knowledge of local demographics. Finally, community members should be engaged in decision making regarding response issues, including further breakdown of priority groups and the use of schools as point-of-dispensing sites.

Provide Timely Information and Guidance

The federal role should support the activities listed above by appropriating funds, communicating critical information, and helping develop guidance. HHS should partner with the National Association of County and City Health Officials (NACCHO) and the Association of State and Territorial Health Officials (ASTHO) to help develop basic guidance on decision making in case of scarcity. The Food and Drug Administration (FDA) should aid in the development and distribution of guidance on the appropriate use of LAIV as well as other vaccine formulations. The federal government should be able to obtain more accurate and timely estimates of how much vaccine to expect from manufacturers and communicate this to state and local partners. During a public health emergency, federal guidance should be concise and easy to understand.

Build on Universal Seasonal Flu Immunization Recommendation

In February 2010, ACIP expanded its recommendations for seasonal influenza vaccine to include all Americans aged 6 months and older. But health departments are underfunded, and most lack the capacity to undertake an effort comparable to the H1N1 pandemic response annually. One way to improve the capacity of health departments to execute successful mass vaccination campaigns would be to focus on developing a permanent program to meet ACIP’s expanded recommendations for annual seasonal influenza vaccination. To build such a program would be costly and would require significantly increased federal, state, and local funds. Additionally, the effort needed to persuade all citizens to have a vaccination against influenza every year should not be underestimated. However, it is difficult to imagine a pandemic scenario for which the U.S. government would not recommend that everyone in the country be vaccinated. Building the capacity around seasonal influenza vaccine programs would serve a dual purpose: providing protection against seasonal influenza and preparing the country for a future severe influenza pandemic.

Conclusion

The challenges of fairly and efficiently allocating, distributing, and administering vaccine during an influenza pandemic are profound. If the U.S. government is to make the decision to offer vaccination to the entire country in a future pandemic, it will need to invest in new technologies that will produce sufficient quantities of vaccine and in local and state public health infrastructure and personnel. The limited supplies of vaccine during the 2009 pandemic resulted in an array of complex decision-making and logistical dilemmas, many of which would not have arisen if sufficient quantities of vaccine had been available. Of particular interest, vaccines targeting antigens that are common to all or most influenza viruses, often called ‘‘universal’’ or ‘‘conserved antigen’’ influenza vaccines, could reduce the frequency of vaccination needed against influenza and potentially reduce the number of individuals susceptible to a future pandemic strain.30 These are large long-term investments that will be critical to protecting American lives during a future influenza pandemic.

Even if ample quantities of vaccine are available, the challenges associated with vaccinating the entire U.S. population are significant. Despite important successes and the tremendous efforts undertaken by federal, state, and local health officials during the 2009 pandemic, we still do not have an infrastructure and plans, nor have we exercised protocols that would permit the successful vaccination of the entire U.S. population in a short period of time. The timing of the next pandemic is unpredictable. It is possible that several decades could pass before another influenza virus develops a pandemic potential. Meanwhile, we should take the opportunity to strengthen federal, state, and local strategies and capacities to respond.

Acknowledgments

The authors thank D. A. Henderson, MD, MPH, and Brooke Courtney, JD, MPH, for their guidance and contributions to the preparation of this manuscript.

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