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Introduction1

In response to the 2009 H1N1 influenza pandemic, public health authorities launched an ambitious vaccination campaign to protect tens of millions of Americans from the virus. The goal was to ensure that everyone who wanted to be vaccinated was able to be vaccinated. Providing one dose of vaccine to everyone in groups considered to be at high risk for serious complications would have required 159 million doses, a far greater undertaking than reaching the approximately 85 million people who are vaccinated annually for seasonal influenza (CDC/ACIP, 2009; Medlock and Galvani, 2009). Launched in October 2009, the nationwide campaign was made possible through collaboration among a wide range of stakeholders, including federal, state, tribal, territorial, and local governments; healthcare providers; health systems; pharmacies; community organizations; and health insurers, among others. Despite challenges stemming from delays in supply, the identification of priority groups to receive the initial supply of vaccine, and associated messaging complexities, 61 million Americans—about a quarter of the U.S. population—were vaccinated in the first 3 months of the program (CDC, 2010a).

In April and May 2010, the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted three regional workshops on the 2009 H1N1 influenza vaccina-

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The workshop was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshops. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Preparedness Forum or The National Academies and should not be construed as reflecting any group consensus.



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1 Introduction1 In response to the 2009 H1N1 influenza pandemic, public health au- thorities launched an ambitious vaccination campaign to protect tens of millions of Americans from the virus. The goal was to ensure that every- one who wanted to be vaccinated was able to be vaccinated. Providing one dose of vaccine to everyone in groups considered to be at high risk for serious complications would have required 159 million doses, a far greater undertaking than reaching the approximately 85 million people who are vaccinated annually for seasonal influenza (CDC/ACIP, 2009; Medlock and Galvani, 2009). Launched in October 2009, the nationwide campaign was made possible through collaboration among a wide range of stakeholders, including federal, state, tribal, territorial, and local gov- ernments; healthcare providers; health systems; pharmacies; community organizations; and health insurers, among others. Despite challenges stemming from delays in supply, the identification of priority groups to receive the initial supply of vaccine, and associated messaging complexi- ties, 61 million Americans—about a quarter of the U.S. population— were vaccinated in the first 3 months of the program (CDC, 2010a). In April and May 2010, the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted three regional workshops on the 2009 H1N1 influenza vaccina- 1 The workshop was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was pre- pared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshops. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or veri- fied by the Preparedness Forum or The National Academies and should not be construed as reflecting any group consensus. 1

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2 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN tion campaign. Participants from across the nation met in Raleigh, North Carolina; Austin, Texas; and Seattle, Washington, to review, evaluate, and learn from their experiences during the vaccination campaign. The 2009 H1N1 vaccination campaign was one of the biggest public health initiatives in U.S. history, and a thorough and critical evaluation of the campaign presents an important opportunity to examine the nation’s re- sponse to a public health threat and to identify useful lessons, promising practices, and other strategies to improve future emergency vaccination campaigns. Background: Preparing for the Vaccination Campaign In April 2009, the first cases of a new strain of influenza A—referred to as the 2009 H1N1 influenza—were detected in California. Because of the potentially severe health consequences of a pandemic influenza, the detection of these cases set off a coordinated wave of activity across the public health system to minimize public health consequences.2 Each year in the United States, between 5 and 20 percent of the population is in- fected with the seasonal flu, and on average approximately 24,000 people die of flu-related causes (range 3,300 to 48,600) (CDC, 2010c). How- ever, in a pandemic, the infection rate and death toll can be much higher. The pandemic of 1918 killed an estimated 50 million people worldwide (about 3 percent of the global population) and approximately 675,000 people in the United States alone (CDC, 2010d). Pandemics also oc- curred in 1957 and 1968, although they were less severe. Adding to the sense of urgency, previous pandemic response plan- ning efforts had largely focused on influenza A virus subtype H5N1. Unlike 2009 H1N1, H5N1 has a low human-to-human transmission rate but a very high mortality rate; more than half of humans known to have been infected with the current Asian strain of H5N1 avian influenza died from it (WHO, 2006). The surveillance and laboratory systems devel- oped by the Centers for Disease Control and Prevention (CDC) as part of these planning efforts were responsible for the early detection of 2009 2 According to the Centers for Disease Control and Prevention, “An influenza pandemic occurs when a new influenza A virus emerges for which there is little or no immunity in the human population, begins to cause serious illness, and then spreads easily person-to- person worldwide. A pandemic is determined by spread of disease, not its ability to cause death” (CDC, 2010b).

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3 INTRODUCTION H1N1 in the United States. However, because the characteristics of the 2009 H1N1 influenza pandemic were different from those of H5N1—in the severity, timing, and geographic origin of the disease—significant modifications were needed to the existing pandemic influenza plans. A detailed account of the CDC’s activities in response to the 2009 H1N1 influenza virus is available on the CDC website (CDC, 2010e). A time- line of the 2009 H1N1 disease incidence and vaccination campaign is also available on the CDC website (CDC, 2010f). By June 11, 2009, the virus had spread so extensively around the world that the World Health Organization declared that a global pan- demic was under way (WHO, 2009). This declaration reflected the fact that the virus had spread throughout multiple parts of the world, but was not indicative of the severity of the illness in those infected. Most people in the United States who became ill from 2009 H1N1 influenza recov- ered without hospitalization and, in many cases, without medical treat- ment. However, the pattern of those who did become seriously ill and required hospitalization was different from seasonal influenza, which usually has the greatest impact on older adults. Data from the initial wave of influenza in the spring showed that the highest rate of hospitali- zation was in children under age 5, followed by young people ages 5 to 24. Data also showed that pregnant women, along with people with un- derlying chronic medical conditions, were at particularly high risk for hospitalization and death (CDC, 2009a). Efforts to produce a vaccine for the 2009 H1N1 virus began within days of detection of the first cases in the United States. The CDC imme- diately began to develop a high-yield vaccine virus that would be effec- tive against the new virus. Once developed, it was sent to the vaccine manufacturers to begin production, even though at that point the U.S. government had not yet determined whether the vaccination campaign would be implemented. Over the summer, the National Institutes of Health (NIH) conducted clinical trials on pilot lots of the vaccine and the Food and Drug Administration (FDA) developed a plan for licensing the vaccine. Meanwhile, in parallel to the process of developing, licensing, and producing the vaccine, federal, state, tribal, territorial, and local public health officials worked to plan an ambitious vaccination program. The CDC’s Advisory Committee on Immunization Practices (ACIP) met in July to develop recommendations on who should receive the 2009 H1N1 vaccine. On the basis of the epidemiological data from the spring 2009

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4 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN wave of influenza, ACIP recommended that vaccination efforts focus on five initial target groups: • Pregnant women, • People who lived with or cared for infants younger than age 6 months, • Healthcare and emergency medical services (EMS) personnel, • Infants ages 6 months and older through young adults age 24; and • Adults ages 25 through 64 who were at higher risk for complications because of chronic health disorders or compromised immune systems (CDC/ACIP, 2009). At the time the ACIP recommendations were developed, it was not yet known how many doses of vaccine would be required to provide suf- ficient immunity. Providing one dose of vaccine to everyone in these groups would have required 159 million doses (CDC/ACIP, 2009). Later clinical testing revealed that one dose was sufficient for most people, with children under 9 requiring two doses to achieve sufficient immunity and children under 3 requiring two half-doses. These recommendations are discussed in more detail below. The prototype of the national vaccine distribution strategy was the federal Vaccines for Children (VFC) program, through which healthcare providers routinely work with their state and local health departments to provide recommended pediatric vaccines to eligible children. In prepara- tion for the vaccination campaign, the CDC expanded its contract with McKesson Corporation for the VFC program, to enable centralized dis- tribution of the 2009 H1N1 vaccine. Funded by the federal government, vaccine was allocated to states in proportion to their population. State health departments, in turn, worked with local health departments and other partners to develop plans to distribute and administer vaccine within the state. Because of the scope and short time frame of the cam- paign, unprecedented efforts were made to strengthen existing vaccine distribution partnerships and to integrate new partners into the distribu- tion and administration system, particularly for vaccination of pregnant women, other high-risk adults, and children. These partners included healthcare providers, health systems, pharmacies, community organiza- tions, health insurers, and large companies with occupational health clin- ics, among others. The distribution and administration systems used by

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5 INTRODUCTION jurisdictions, as well as the partnerships that were important in the re- sponse, are discussed in greater detail in subsequent sections. In September 2009, the NIH announced that results of the clinical trials indicated the vaccine was safe and effective. The FDA approved four of the 2009 H1N1 influenza vaccines (a fifth was later approved in November), and the CDC had organized a centralized distribution system for shipping the vaccine to public and private provider vaccination sites based on orders placed by the states. Manufacturers had some vaccine available for use, although in much smaller quantities than had been pre- dicted throughout the summer months. This caused significant problems throughout all aspects of the vaccination campaign during the first months, as described in detail below. With these pieces in place, the na- tional vaccination campaign was launched at the beginning of October. Workshop Goals and Objectives In spring 2010, the IOM’s Preparedness Forum organized three workshops to discuss and examine the vaccination campaign. The work- shops were held in Raleigh, North Carolina (April 15); Austin, Texas (April 27); and Seattle, Washington (May 11). They were organized by a planning committee that included representatives from relevant federal agencies and state and local public health authorities and associations. The workshops were designed to facilitate a series of conversations fo- cused on the following objectives: • Examine innovative efforts used to distribute and administer vaccine and discuss how they may inform future efforts; • Examine how jurisdictions and providers interpreted and applied the CDC/ACIP recommendations for use of 2009 H1N1 vaccine; • Highlight successful approaches used by jurisdictions to develop and use innovative partnerships with traditional and non- traditional partners, such as community groups and the private sector; and • Discuss strategies used to collect, monitor, evaluate, and use data during the 2009 H1N1 vaccination campaigns. For each area, participants discussed lessons learned and challenges that arose during the vaccination campaigns and identified strategies to

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6 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN address these challenges for future emergency vaccination programs and other medical countermeasures dispensing campaigns. Participants and attendees included federal, state, tribal, and local public health officials; national healthcare providers’ associations and healthcare pro- viders (including pediatricians, family physicians, obstetricians/gynecologists [OB/GYNs], nurses, EMS providers, and healthcare administrators); pri- vate-sector representatives, including pharmacies and health insurers; journalists; and representatives from community organizations. Partici- pants came from across the nation, not just from states where the work- shops were held. The workshop agendas are in Appendix B, and a list of the speakers and registered attendees is in Appendix C. About This Summary This document is intended to highlight and summarize the presenta- tions and discussions at the three workshops, including participants’ suc- cess stories, challenges faced, and lessons learned. The summary also highlights opportunities and areas for further work that participants sug- gested to help improve future vaccination programs and other medical countermeasures dispensing campaigns. Whenever possible, unique ideas or concepts presented at the workshop are attributed to the individual who first advanced those concepts. In situations where many participants made similar points, the recurring themes are identified. Any opinions, conclusions, or recommendations discussed in this workshop summary are solely those of the individual participants and should not be con- strued as reflecting consensus or endorsement by the workshop, the Fo- rum on Medical and Public Health Preparedness for Catastrophic Events, or The National Academies.