.
Requirements: Identify the question you decide to answer at the top of your post. Prompt responses should answer the question and elaborate in a meaningful way using 2 of the weekly class readings (250 words of original content). Do not quote the readings, paraphrase and cite them using APA style in text citations. You can only use ONE multimedia source for your minimum 2 sources each week. The readings must be from the current week. The more sources you use, the more convincing your argument. Include a reference list in APA style at the end of your post, does not count towards minimum word content.
Select ONE of the following:
1) Why is influenza such a complex virus to deal with? How do agencies deal with this challenge? What are the lessons learned from the H1N1 US experience?
2) Compare the Mitigation, Preparedness and Response actions of the H1N1 pandemic and the Coronavirus Pandemic in the US. Use class readings for the H1N1 and ONLY academic and official sources about the coronavirus. No news outlets or blogs or non academic sources allowed.
Commentary
CDC’s Evolving Approach to Emergency Response
Stephen C. Redd and Thomas R. Frieden
The Centers for Disease Control and Prevention (CDC) transformed its approach to preparing for and responding to
public health emergencies following the anthrax attacks of 2001. The Office of Public Health Preparedness and Re-
sponse, an organizational home for emergency response at CDC, was established, and 4 programs were created or greatly
expanded after the anthrax attacks: (1) an emergency management program, including an Emergency Operations Center;
(2) increased support of state and local health department efforts to prepare for emergencies; (3) a greatly enlarged
Strategic National Stockpile of medicines, vaccines, and medical equipment; and (4) a regulatory program to assure that
work done on the most dangerous pathogens and toxins is done as safely and securely as possible. Following these
changes, CDC led responses to 3 major public health emergencies: the 2009-10 H1N1 influenza pandemic, the 2014-16
Ebola epidemic in West Africa, and the ongoing Zika epidemic. This article reviews the programs of CDC’s Office of
Public Health Preparedness, the major responses, and how these responses have resulted in changes in CDC’s approach
to responding to public health emergencies.
The Centers for Disease Control and Prevention(CDC) was established in 1946 with the primary purpose of supporting state and local public health agen- cies, particularly in responding to disasters and infectious disease outbreaks.1 The capacity to respond to health emergencies in order to protect the public has remained an essential function of CDC. Over the decades, disease out- break investigations have evolved to include larger and more complex events, and CDC’s role has remained that of providing support to state and local health departments while sometimes taking a leadership or coordination role with complex or interstate investigations. For international investigations, CDC has worked with ministries of health that requested assistance as well as with the World Health Organization.2
Within weeks of the 9/11 World Trade Center attack, CDC responded to a biological attack with anthrax in- volving numerous domestic jurisdictions. The anthrax at- tack required CDC to provide the public with frequent updates on the progress of the investigation. The volume of information and the expectations of the public created a need for CDC to operate at an unprecedented scale and tempo.3 To meet the challenges identified in the response to the anthrax attacks, CDC created a new organizational unit and approach to respond to large, complex public health emergencies, whether naturally occurring, inten- tional, or accidental. CDC’s approach to emergency re- sponse continues to evolve.
In addition to the potential for bioterror attacks, such as the anthrax attack, 2 global trends required that CDC
Stephen C. Redd, MD, is Director, Office of Public Health Preparedness and Response, and Thomas R. Frieden, MD, MPH, is CDC Director, both at the Centers for Disease Control and Prevention, Atlanta, Georgia. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention or the Department of Health and Human Services.
Health Security Volume 15, Number 1, 2017 ª Mary Ann Liebert, Inc. DOI: 10.1089/hs.2017.0006
41
develop an expanded capability to respond at speed and scale to future emergencies.4 First, the speed and volume of long-distance travel have increased substantially. Over the past 75 years, the widespread availability of air travel has reduced the time for intercontinental travel from weeks to hours.5 Along with shorter travel times, the volume of in- tercontinental travel has increased exponentially. With in- creased and faster global travel, the opportunity for a person infected with a pathogen to travel to another part of the world within hours has become increasingly likely.6 Sec- ond, global population increases concentrated in Africa, the Indian subcontinent, and East Asia have resulted in a dra- matic increase in the number of cities with populations over 10 million.7 Ease of travel and urbanization, particularly the concentration of poverty in urban areas, is creating the opportunity for an increasing number of large infectious disease epidemics affecting multiple urban areas.
Technological advances in medicine and public health have created new tools to diagnose and quickly respond to public health emergencies. Rapid and specific diagnostic methods, vastly improved communication systems, and evolving therapeutic and vaccine technologies create oppor- tunities to detect and respond to health emergencies that were unimaginable in the past. Unfortunately, these same scientific and technologic advances allow the possibility to create more deadly or transmissible pathogens that could be released, intentionally or not, into the community.8
In this article we describe how CDC’s emergency re- sponse preparations and execution have evolved with these changing realities and expectations, with a particular focus on changes beginning with the 2009 H1N1 pandemic.
Creation of the Office of Public
Health Preparedness and Response
After the 2001 anthrax attacks, the nation readied itself for additional bioterror attacks. Government policy- makers and public health officials created lists of mi- croorganisms and chemical and biological toxins that could be used as terror agents. Government funding created a scientific-medical-production enterprise to de- velop medical countermeasures—diagnostics, vaccines, and therapeutics—to address these threats.9
The concerns and activities following the 2001 attacks were similar to those that led to the 1951 creation of the CDC Epidemic Intelligence Service, a 2-year training program in field epidemiology, as part of a response to fears of an attack with bioweapons during the Cold War.1 In 2002 CDC created a new organization—the Office of Terrorism Preparedness and Emergency Response, later the Coordinating Office for Terrorism Preparedness and Emergency Response, predecessors to the current Office of Public Health Preparedness and Response (OPHPR)— with responsibility for preparing for large-scale emergen- cies, including terrorism attacks. The office combined 3
smaller existing programs: support of state and local emer- gency preparedness activities, the Strategic National Stock- pile, and the regulatory program for select agents and toxins. In addition, the Bernie Marcus Foundation, through the CDC Foundation, funded renovations and equipment pro- curement for CDC’s first Emergency Operations Center.10
Each division or program in the Office of Public Health Preparedness and Response has specific responsibilities to as- sure that CDC and the nation’s public health system is as ready as possible to respond to future health threats (Table 1).
Regulatory Program on Select Agents and Toxins The mission of the Division of Select Agents and Toxins (DSAT) is to assure that work done with dangerous path- ogens and toxins in the United States is done as safely and securely as possible (Table 1). The Federal Select Agent Program consists of CDC’s DSAT and the US Department of Agriculture’s Agriculture Select Agent Services Program. Examples of select agents and toxins include the organisms that cause anthrax, smallpox, and bubonic plague, as well as the toxins ricin and botulinum neurotoxin. The program has an enabling mission: to assure that laboratories working with select agents and toxins are able to do their work, to create new knowledge to detect and respond to the threats these pathogens and toxins could cause.11 As of November 2016, 279 laboratories were registered with the Federal Select Agent Program (a decrease from a high of 336 lab- oratories in 2006); 241 are registered with CDC’s Select Agent and Toxins program and 38 with USDA’s Agri- culture Select Agent Services Program. The CDC Select Agent Program conducted 183 inspections in 2015, in- cluding 72 unannounced inspections. Since its inception, the program has denied 361 individuals access to select agent laboratories through the Security Risk Assessment process, which includes background investigations con- ducted by the FBI.
The underlying challenge for the Federal Select Agent Program is to balance competing priorities: (1) transpar- ency to the public regarding the work and safety of the laboratories registered with the program with the need to protect information about the work from those that might use such information to cause harm; (2) the regulatory burden necessary to assure safety and security with fostering an environment where the greatest scientific output is possible; and (3) ultimately, assuring that the benefits of the research justify its inherent risks. Even the most stringent regulations cannot ensure that work with select agents and toxins has zero risk; the program works to keep risk to the minimum possible. Determining whether potential benefit outweighs irreducible risks is complex and requires recon- ciling numerous points of view.
Within the purview of the regulatory program, work continues to improve in the following areas: (1)
CDC’S EVOLVING APPROACH TO EMERGENCY RESPONSE
42 Health Security
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Volume 15, Number 1, 2017 43
T ab
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. (C
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ti n
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)
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o rt
in g
sy st
em s
44 Health Security
standardizing the inspection process through ongoing ef- forts to improve training of inspectors, (2) improving the science of biosafety and biosecurity, and (3) preparing for biosafety and biosecurity risks of the future as a result of the ongoing revolution in biology. These ongoing advances in biology, including sequencing technologies and synthetic biology, will make regulation and oversight in these areas increasingly complex.
Emergency Operations at CDC The Division of Emergency Operations manages CDC’s Emergency Operations Center (EOC). The division’s mission is to serve as a hub for communication, decision making, and operations during emergency activations and to plan and train for that function. When activated, the EOC serves as a tempo- rary home for responders: scientists, communication specialists, laboratory experts, and program managers from throughout CDC who are deployed to respond to a specific emergency. Since April 2009, the start of the H1N1 pandemic response, CDC’s EOC has been activated over 91% of the time.12
By activating the EOC, CDC is able to perform many of the functions it was not able to carry out during the 2001 anthrax attack: managing a scalable system for travel and shipping of equipment; recruiting and managing volunteer responders; assuring a uniform system of deployment, including pre- deployment, during deployment, and postdeployment activi- ties; and providing software tools to visualize data, thereby improving situational awareness. Although the health and safety of deployed staff have always been of concern during responses, the risks in the Ebola response led to the creation of a Deployment Risk Mitigation Unit, which provided a focal point for assuring a standard approach to safety and security training for staff deployed in responses.
The division has taken on an important new activity: training future incident commanders to lead CDC emer- gency responses. The training is based on the real-world experiences of large emergency responses in which CDC has played a leading role. The intent is to provide a setting for experiential learning in initiating a response, making recommendations or decisions, and understanding the needs of senior leaders during a large emergency response and how to meet those needs.
Improving emergency response capacity globally is a sec- ond, related function the division has undertaken as part of the Global Health Security Agenda.13 CDC staff have led emergency management training sessions in 40 countries since 2014. This training has been put to use in 6 countries in 2015 and 2016, where ministry of health officials have acti- vated their emergency operations centers 11 times to respond to emergencies ranging from cholera and influenza outbreaks to a train derailment. The training sessions and establishment of emergency operations centers have resulted in earlier and more effective responses to health emergencies. For those emergencies that have the potential to spread, more effective responses overseas protect Americans.
The Strategic National Stockpile The Strategic National Stockpile’s purpose is to assure that medical material needed to respond to a public health emergency is available when, where, and in the quantity needed to respond effectively. The stockpile’s inventory includes vaccines, medications, chemical antidotes, ancillary supplies needed to administer the countermeasures, me- chanical ventilators, respirators, and other medical equip- ment. The stockpile is a part of the Public Health Emergency Medical Countermeasure Enterprise, an interagency com- mittee led by the Department of Health and Human Ser- vices’ (HHS) Assistant Secretary of Preparedness and Response. The Public Health Emergency Management Countermeasure Enterprise is charged with developing and implementing the medical countermeasure strategy from basic science, to product development, licensing, stock- piling, distribution, and dispensing.14 As of November 2016, the stockpile contains material worth approximately $7 billion, with annual funding of $575 million in 2016.
State and Local Readiness The Division of State and Local Readiness is responsible for assuring that state, local, tribal, and territorial health de- partments are as ready as possible to respond to any health emergency. The division manages the Public Health and Emergency Preparedness cooperative agreement and pro- gram, with annual funding of $660 million in 2016. This cooperative agreement funds personnel in state and local jurisdictions responsible for emergency response, planning and exercising, and costs associated with small-scale re- sponses (as a means of testing and improving systems that would be needed in larger responses). Through this pro- gram, state and local health departments have become part of the emergency response structure in their jurisdictions. This functionality includes the ability to rapidly mobilize for an event that requires a large-scale response. The co- operative agreement also supports the Laboratory Response Network, which has the capability to detect pathogens that might be used in a bioterror attack. The network has proved adaptable in quickly adding diagnostic tests to de- tect novel infectious diseases. Risk communication staff are now available in state and local health departments to assure that the public is informed about emerging health threats.
Experience in Responding
to Large-Scale Emergencies
In the years since the restructuring of emergency response at CDC, public health emergencies have become in- creasingly frequent. Since 2001, CDC has mounted major responses to the SARS epidemic, Hurricane Ka- trina, and more recently to the H1N1 influenza pan- demic and Ebola and Zika virus epidemics (Table 2).15
REDD AND FRIEDEN
Volume 15, Number 1, 2017 45
T ab
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46 Health Security
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Volume 15, Number 1, 2017 47
Since 2009, CDC has activated its Emergency Opera- tions Center 17 times (Tables 2 and 3). The median duration of activation has been 85 days, and most have been for infectious disease emergencies, frequently be- ginning overseas but with the potential to spread to the United States.15 Natural threats, rather than accidental or intentional events, have predominated. Brief summaries help to understand the results and lessons of these re- sponses (Tables 2 and 3).
2009 H1N1 Pandemic In mid-April 2009, CDC confirmed several human in- fections with a novel H1N1 influenza virus. When cases of severe respiratory illness in Mexico, including deaths, were confirmed to be caused by the same virus, CDC activated its Emergency Operations Center to the highest response level.16 Within weeks, CDC had developed and distributed a PCR diagnostic test to state health depart- ment laboratories and influenza laboratories throughout the world. The Biomedical Advanced Research and De- velopment Authority (BARDA), operating in the HHS Office of the Assistant Secretary of Health for Pre- paredness and Response, worked with vaccine manufac- turers to produce monovalent H1N1 vaccine. CDC coordinated the distribution of 126.9 million doses of monovalent H1N1 vaccine in 330,000 separate ship- ments to more than 72,000 providers using the same system that is used to distribute childhood vaccines through the Vaccines for Children’s Program. Even- tually, an estimated 81 million US residents were vacci- nated against the pandemic strain of H1N1 influenza.17
CDC distributed 12 million treatment courses of anti- viral drugs to treat influenza, approximately one-quarter of the quantity stockpiled. To keep the public informed, CDC conducted 39 press conferences and 21 telebrief- ings and convened a pandemic influenza ‘‘boot camp’’ for media in August 2009. CDC coordinated closely with state and local health departments, other federal depart- ments, and clinician organizations.
In a public opinion poll conducted in January 2010 re- garding the federal government response to H1N1, 59% of respondents rated the government response as good or ex- cellent.18 Despite delayed production of vaccine, produced and procured through contracts managed by BARDA, CDC’s work to rapidly distribute vaccine as soon as it be- came available and encourage use of antiviral medications prevented at least 1 million cases of influenza, 18,000 hospitalizations, and 600 deaths.19,20 Public Health Emergency Preparedness grantees were able to track cases of H1N1 disease and mobilize planning and communication efforts for the vaccination campaign because of investments in these capabilities before the pandemic. Similarly, the investments and training in CDC’s Emergency Operations Center facilitated CDC’s uniform and prioritized approach to the response.
The West African Ebola Epidemic In March 2014, the global public health community was alerted to an outbreak of Ebola in West Africa. First identified in a remote area of Guinea bordering Liberia and Sierra Leone, this was the first Ebola outbreak in West Africa.21 Over the next 8 weeks, cases were identified in Conakry, Guinea’s capital, and in Liberia. When measures to identify suspect cases, isolate them to prevent transmis- sion, and conduct laboratory testing to distinguish cases from non-cases were implemented in March and April 2014, initial reports indicated a fall in incidence. The global public health response largely demobilized, allowing transmission to continue and leading to the world’s first Ebola epidemic.21 The epidemic ultimately involved more than 28,000 cases and more than 11,000 deaths in Guinea, Sierra Leone, and Liberia—the 3 most highly affected countries—with imported cases and limited transmission in 3 neighboring countries (Nigeria, Mali, and Senegal) and more than a dozen medical evacuations and single genera- tions of transmission in developed countries (Spain and the United States). The outbreak was not brought fully under control until March 2016.22
Severe as the epidemic was, rapid response to a cluster of cases in Lagos, Nigeria, as well as effective work to end the epidemic in West Africa prevented a catastrophe that could have resulted in hundreds of thousands of deaths and wide- spread dissemination of Ebola.23,24 Two cases were diagnosed in the United States in returning travelers; Public Health Emergency Preparedness grantees implemented a system to track returning travelers from Guinea, Sierra Leone, and Li- beria to quickly identify people with possible Ebola.
The epidemic serves as a vivid example of the conse- quences of the ease of travel to and from any location in the world and has spurred efforts to assure that every country has the ability to detect and respond to disease outbreaks, the goal of the Global Health Security Agenda.25 In addition to local capability, the West Africa Ebola epidemic showed the need for the global community to have the resources and training in place to be able to support local response efforts rapidly anywhere in the world when the need arises.
The Zika Epidemic Even before the response to the Ebola epidemic was over, a new disease had emerged requiring a global response. Zika virus was little more than an arboviral curiosity until the fall of 2015.26 The mosquito-transmitted virus was first iden- tified in the late 1940s and was recognized as causing only mild symptoms among the 1 in 5 human infections who had any symptoms.26,27 In May 2015, a large outbreak was reported in Brazil, similar epidemiologically to outbreaks that had occurred in the Western Pacific in the preceding decade.28 In November 2015, investigators in Brazil re- ported an unexpected finding: an association between the Zika virus epidemic and large numbers of babies born with
48 Health Security
CDC’S EVOLVING APPROACH TO EMERGENCY RESPONSE
microcephaly.29 Over the next several months, epidemio- logic and pathologic evidence mounted that Zika virus was the cause of this severe and previously extremely rare birth defect.30 Protecting pregnant women from Zika virus in- fection became a high priority. In addition to mosquito- borne transmission and the association with birth defects, the Zika virus epidemic differed from the Ebola epidemic or H1N1 pandemic; in those earlier events, there was a good understanding of the pathophysiology of the disease and the effectiveness of control measures. In the case of Zika virus, new knowledge continues to emerge. For ex- ample, sexual transmission of Zika virus infection, though documented previously, is not a characteristic known to be shared with other arboviruses.31
The public health community in the continental United States has little recent experience in controlling diseases spread by Aedes mosquitoes. In addition, the eventual public health burden of the epidemic has been challenging to communicate because the disease is most often asymp- tomatic and the severe consequences occur in babies, months after infection of pregnant women.
The Zika virus epidemic has required an unprecedented scientific, operational, and communication response. Above all, the outbreak has shown the need to be able to respond rapidly to an event that was unpredictable. The response has required expertise in reproductive health, vector biology, arbovirology, birth defects, sexually trans- mitted diseases, laboratory test development, risk commu- nication, and community engagement.
Major Observations from Responses
Several observations emerge from the experience over the past 15 years using the CDC Emergency Operations Center to respond to large, complex health events. The first is that experience, whether acquired through plans and exercises or through real-life response, pays dividends. CDC’s response to the H1N1 pandemic was based on plans and exercises to prepare for a severe influenza pandemic emerging overseas.32 The rapid spread of H5N1 in wild birds and poultry and the high mortality rate among hu- man H5N1 cases in 2005 and 2006 provided an urgency to this preparation.33 The work to plan and exercise for a response to H5N1 was put to the test in the 2009 H1N1 influenza pandemic response. The plans and exercises to prepare for a severe influenza pandemic established a framework to understand and respond to the H1N1 pan- demic, even though it was less severe than assumptions in H5N1 planning scenarios. The involvement of state and local public health and emergency response staff, many federal agencies, and the private sector in planning for an influenza pandemic also helped create a shared sense of expectations for what was important in the response. The Ebola and Zika responses benefited from the experience gained during the H1N1 response.T
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Volume 15, Number 1, 2017 49
REDD AND FRIEDEN
The second observation is that public health systems used routinely—everyday systems—form the basis for emergency response; these systems are easier to scale than systems not in everyday use. CDC adapted the Vaccines for Children system, the system that ships more than half of all childhood vaccines in the United States to providers, to distribute monovalent H1N1 vaccine in the H1N1 pan- demic. CDC also scaled up routine vaccine coverage sur- veys to measure vaccine uptake weekly.34 In contrast, CDC shipped antiviral drugs to state health departments, where distribution plans differed widely. It remains unclear how many patients with influenza received antiviral drugs from the Strategic National Stockpile, but treatment of more patients could have led to improved outcomes.
The third observation is that naturally occurring emer- gencies are more frequent than bioterror attacks.35 This has implications for ensuring that these more frequent re- sponses, especially aspects of the response that need to be improved, are used to plan for scenarios that require near instantaneous response—such as low-likelihood, high- consequence terrorist attacks. Large-scale natural disasters, such as hurricanes, earthquakes, and tornadoes, will con- tinue to occur, and these events require dedicated plans and exercises. However, of the 3 major emergency responses in the past 10 years, only the H1N1 influenza pandemic was anticipated. Plans and the experience from exercises and real-life events have to be adapted to respond to un- predicted and unexpected emergencies.
The fourth major observation, evident in all large emergency responses, is that the best responses adapt quickly to changing circumstances. Unlike responses to natural disasters, in which the course of events is somewhat predictable based on the magnitude and location of the event, an effective response to a public health emergency depends on rapid collection and analysis of complex information and adaptive response based on both epidemiologic trends and the documented impact of program interventions. The ability to receive new, sometimes unexpected, information and to change the objectives and operations of the response is critical. Effective emergency re- sponse is similar to effective public health action generally— using data to improve performance rapidly. In both emergency responses and in public health programs, policymakers need to use all available facts and base decisions on scientifically valid principles in order to optimally protect the public. As the full extent of the Ebola epidemic in Liberia became apparent in the summer of 2014, it became clear that resources were insuffi- cient to implement all control measures widely. Efforts to es- tablish clinical care for Ebola patients that met established minimal standards and assuring safe and dignified burial for people who died of Ebola took priority. Later, when action to reduce transmission from burials and ill patients led to a de- crease in cases, the emphasis shifted to rapid laboratory con- firmation of cases, case isolation, and contract tracing.
Another example of this adaptation occurred during the Ebola response following the domestic diagnosis of the first case of Ebola virus disease and the subsequent confirmation
of the disease in 2 nurses who had cared for the initial patient. Within days, CDC and DHS’s Customs and Border Protection established procedures for screening at 5 airports where almost all travelers from the highly affected countries entered the United States; CDC revised and re- leased more specific guidance for personal protective equipment and established a system to track travelers from highly affected countries through their potential incubation period.36 This tracking system used data collected during airport screening and relied on state and local health de- partments to make contact with travelers on a daily basis.
The fifth observation is that public communication is a crucial response function. The need for a massive communi- cation response—the need to respond to media and public inquiries orders of magnitude greater than baseline—might serve as the definition of a public health emergency. Ef- fective risk communication cannot change bad outcomes or decisions, but poor communication can lead to confusion or lack of confidence and erosion of trust. Basic risk com- mination principles include explaining what is known and not known, what is being done to better understand the situation and to intervene, and what individuals can do to reduce their health risks.37 Setting realistic expectations is key but may be difficult, depending on the situation. For large emergencies, the media act as an amplifier of public opinion, but also offer a platform to assure that people have the most up-to-date information and are sufficiently in- formed so that they can take action. This spotlight of at- tention is linked with the next finding.
Sixth, large emergency responses require the ability to co- ordinate response actions with many groups external to CDC. CDC has a close relationship with state and local health de- partments, but events frequently require a broader set of partners. Providing timely and essential information, not only to the public, but also to political leaders, is important in order to avoid misunderstanding and unproductive work and to identify areas where higher level intervention and assistance is necessary. For example, during the Ebola response, the dis- position of medical waste in the United States became a major challenge. The Pipeline and Hazardous Materials Safety Ad- ministration with the Department of Transportation has the responsibility to regulate the transportation of medical waste.38
Within 48 hours of becoming involved, that office had issued guidance to hospitals for contracts with medical waste trans- porters on how to package and transport medical waste.
The final observation, perhaps also implicit in the defi- nition of an emergency, is that a sense of urgency is inherent in the event. Unlike public health programs that address diseases in which the disease burden changes slowly, in an emergency, events can and do change quickly. Response leaders need to remember that every decision and im- plementation action has to be accomplished within a timeframe—often a very short timeframe. Understanding that timeframe, when a decision or action has to be initiated or completed, means that some decisions have to be made with incomplete information or analysis.
CDC’S EVOLVING APPROACH TO EMERGENCY RESPONSE
50 Health Security
Recurrent Issues and Next Steps
Since 2001, CDC and the nation’s public health system have continued to improve capabilities to respond to emergencies. We have accomplished this improvement through ongoing adjustments and refinements to internal procedures and guidance to state and local health depart- ments. Despite this progress, more work remains. The current preparedness and response program represents ef- forts to develop, improve, and sustain response capabilities. Without sustained funding and leadership support, these gains would quickly erode.
Resources are always scarce at the beginning of a large- scale public health response, and at the outset the ultimate scale of an emergency and response cannot be known. An emergency public health response fund, set up along the same lines as FEMA’s Disaster Relief Fund, could alleviate much of this challenge. Such a response fund would include established triggers, authorities, and reporting require- ments. Because the scale of public health emergencies varies by orders of magnitude, the resources needed to respond also vary. Even with a response fund, large responses would require a supplemental appropriation or replenishment to a response fund to assure the best response, as is done to fund response and recovery efforts to large-scale natural disasters. Congress appropriated $2.1 billion to CDC for the 2009 H1N1 response and $1.8 billion for the Ebola response. Even when funds are available, public health programs (federal, state, and local) need to have expedited means of contracting, hiring, and otherwise bringing available re- sources to bear quickly. For CDC, emergency authorities to distribute funds to states quickly would alleviate delays associated with usual grant procedures.
Assuring that trained and experienced staff are available is a further challenge. At CDC, a system of identifying personnel needs and requesting staff with specific skills and training has been established. Being able to recruit retired staff and staff from other agencies and rapidly hire are additional means of shoring up the workforce.
Every emergency CDC has responded to since 2001 has been a natural event—either an emerging infectious disease or natural disaster.39 Although the strategies and structures put in place after the attacks of September 2001 have shown their value in responding to these natural events, the orig- inal motivation for these systems was to be better prepared for bioterror attacks. By their nature, bioterror attacks will be unannounced and will require responders to mobilize countermeasures quickly; resources have to be in place before the attack. A difficult policy decision for the future requires balancing the resources devoted to everyday, nat- urally occurring emergencies with resources to procure countermeasures and plan and train for their distribution and dispensing in a bioterror attack.
Emergency response—protecting the public from health emergencies—has always been a bedrock function of public health. The planning, training, staffing, and experience of
the past 15 years to prepare for and respond to public health emergencies has expanded the scope of emergency pre- paredness and response as a discipline in public health.
Acknowledgments
The authors thank the following people for their review, editorial assistance, and advice: Dan M. Sosin, Jeffery Bryant, Christine A. Kosmos, Samuel S. Edwin, Roberto Henry, and Cara Rivera.
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15. Centers for Disease Control and Prevention. Public health responses supported by CDC’s Emergency Operations Center (EOC). CDC website. Update June 29, 2016. http://www. cdc.gov/phpr/eoc_responses.htm. Accessed January 12, 2017.
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17. Centers for Disease Control and Prevention. Final estimates for 2009-10 seasonal influenza and influenza A (H1N1) 2009 monovalent vaccination coverage—United States, August 2009 through May 2010. CDC website. Updated May 13, 2011. https://www.cdc.gov/flu/fluvaxview/coverage_ 0910estimates.htm. Accessed January 12, 2017.
18. SteelFisher GK, Blendon RJ, Bekheit MM, Lubell K. The public’s response to the 2009 H1N1 influenza pandemic. N Engl J Med 2010;362(22):e65.
19. Borse RH, Shrestha SS, Fiore AE, et al. Effects of vaccine program against pandemic influenza A(H1N1) virus, United States, 2009–2010. Emerg Infect Dis 2013;19(3):439-448.
20. Atkins CY, Patel A, Taylor TH, et al. Estimating effect of antiviral drug use during pandemic (H1N1) 2009 outbreak, United States. Emerg Infect Dis 2011;17(9):1591-1598.
21. Dixon MG, Schafer IJ. Ebola viral disease outbreak—West Africa, 2014. MMWR Morb Mortal Wkly Rep 2014;63(25): 548-551.
22. Centers for Disease Control and Prevention. 2014 Ebola outbreak in West Africa—case counts. CDC website. Up- dated April 13, 2014. http://www.cdc.gov/vhf/ebola/ outbreaks/2014-west-africa/case-counts.html. Accessed Jan- uary 12, 2017.
23. Shuaib F, Gunnala R, Musa EO, et al. Ebola virus disease outbreak—Nigeria, July-September 2014. MMWR Morb Mortal Wkly Rep 2014;63(39):867-872.
24. Meltzer MI, Atkins CY, Santibanez S, et al. Estimating the future number of cases in the Ebola epidemic—Liberia and Sierra Leone, 2014-2015. MMWR Suppl 2014;63(3):1-14.
25. Inglesby T, Fischer JE. Moving ahead on the Global Health Security Agenda. Biosecur Bioterror 2014;12(2):63-65.
26. Duffy MR, Chen TH, Hancock WT, et al. Zika Virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med 2009;360(24):2536-2543.
27. Petersen LR, Jamieson DJ, Powers AM, Honein MA. Zika virus. N Engl J Med 2016;374(16):1552-1563.
28. Hennessey M, Fischer M, Staples JE. Zika virus spreads to new areas—region of the Americas, May 2015-January 2016. MMWR Morb Mortal Wkly Rep 2016;65(3):55-58.
29. Schuler-Faccini L, Ribeiro EM, Feitosa IM, et al. Possible asso- ciation between Zika virus infection and microcephaly—Brazil, 2015. MMWR Morb Mortal Wkly Rep 2016;65(3):59-62.
30. Rasmussen SA, Jamieson DJ, Honein MA, Petersen LR. Zika virus and birth defects—reviewing the evidence for causality. N Engl J Med 2016;374(20):1981-1987.
31. D’Ortenzio E, Matheron S, de Lamballerie X, et al. Evidence of sexual transmission of Zika virus. N Engl J Med 2016;374(22):2195-2198.
32. Singleton CM, DeBastiani S, Rose D, Kahn EB. An analysis of root cause identification and continuous quality im-
provement in public health H1N1 after-action reports. J Public Health Manag Pract 2014;20(2):197-204.
33. World Health Organization. Cumulative number of confirmed human cases for avian influenza A(H5N1) reported to WHO, 2003-2011. Geneva: World Health Organization; 2011. http:// www.who.int/influenza/human_animal_interface/EN_GIP_ LatestCumulativeNumberH5N1cases.pdf. Accessed January 12, 2017.
34. H1N1 Preparedness: An Overview of Vaccine Production and Distribution: Hearing before the Committee on Energy and Commerce, U.S. House of Representatives, November 18, 2009. https://www.gpo.gov/fdsys/pkg/CHRG-111hhrg74853/ pdf/CHRG-111hhrg74853.pdf. Accessed January 12, 2017.
35. Centers for Disease Control and Prevention. CDC’s emer- gency management program activities—worldwide, 2003- 2012. MMWR Morb Mortal Wkly Rep 2013;62(35):709-713.
36. Brown CM, Aranas AE, Benenson GA, et al. Airport exit and entry screening for Ebola—August-November 10, 2014. MMWR Morb Mortal Wkly Rep 2014;63(49):1163-1167.
37. Reynolds B, Crawford S, Deitch S, et al. Crisis and emer- gency risk communication: pandemic influenza. Reynolds B, Crawford S, Deitch S, et al., eds. Atlanta, GA: Centers for Disease Control and Prevention; 2007.
38. Corse T, Thomas K, Broderick J, et al. Using Ebola as a lens to examine medical waste sterilization. World Medical & Health Policy 2015;7(4):402-411.
39. Centers for Disease Control and Prevention. Public Health Preparedness: Strengthening CDC’s Emergency Response. Atlanta, GA: Centers for Disease Control and Prevention; 2009. https://www.cdc.gov/phpr/publications/2009/phprep_ report_2009.pdf. Accessed January 12, 2017.
40. Dawood FS, Iuliano AD, Reed C, et al. Estimated global mortality associated with the first 12 months of 2009 pan- demic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis 2012;12(9):687-695.
41. ArboNET. Centers for Disease Control and Prevention. 2016. https://www.cdc.gov/westnile/resourcepages/survresources. html. Accessed January 12, 2017.
42. Cronberg S, Cronberg E. First description of a small epi- demic of poliomyelitis (1808) with an extensive case report from 1807. J Hist Med Allied Sci 1965;20(1):33-37.
43. Global Polio Eradication Initiative. Polio this week as of 2 November 2016. Geneva: World Health Organization; 2016. http://polioeradication.org/polio-today/polio-now/ this-week/. Accessed January 12, 2017.
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Address correspondence to: Stephen C. Redd, MD
Centers for Disease Control and Prevention 1600 Clifton Rd., MS A48
Atlanta, GA 30329
E-mail: [email protected]
CDC’S EVOLVING APPROACH TO EMERGENCY RESPONSE
52 Health Security
,
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review article
global health
Pandemic Preparedness and Response — Lessons from the H1N1 Influenza of 2009
Harvey V. Fineberg, M.D., Ph.D.
From the Institute of Medicine, Washing- ton, DC. Address reprint requests to Dr. Fineberg at the Institute of Medicine, 500 Fifth St. NW, Washington, DC 20001-2721, or at [email protected].
This article was updated on December 22, 2014, at NEJM.org.
N Engl J Med 2014;370:1335-42. DOI: 10.1056/NEJMra1208802 Copyright © 2014 Massachusetts Medical Society.
A number of viruses have pandemic potential. For example, the coronavirus responsible for the severe acute respiratory syndrome (SARS), which first appeared in southern China in November 2002, caused 8096 cases and 774 deaths in 26 countries before coming to a halt by July 2003 mainly owing to isolation and quarantine.1 In terms of persistence, versatility, potential severity, and speed of spread, however, few viruses rival influenza virus. Endemic in a number of species, including humans, birds, and pigs, influenza virus causes annual outbreaks punctuated by occasional worldwide pandemics, which are char- acterized by sustained community spread in multiple regions of the world.
Beyond spread, the degree to which a pandemic is defined according to the severity of the disease, or whether it may be simply described as often producing many illnesses and deaths, remains ambiguous.2 At its worst, pandemic influenza can be catastrophic: the great influenza pandemic of 1918–1919 is estimated to have infected 500 million persons worldwide and to have killed 50 to 100 million persons.3 In a typical year of seasonal outbreaks in the Northern and Southern Hemispheres, influenza virus causes as many as 5 million cases of severe illness in humans and 500,000 deaths.4
Over the past decade, sporadic cases of severe influenza and deaths in humans have been caused by a number of avian influenza A viruses, including the H5N1 virus, first detected in 1997, and the H7N9 and H10N8 viruses, first reported in 2013. Such sporadic cases may be harbingers of a gathering pandemic, but the likelihood is difficult to judge because it is not known how frequently similar zoo- notic episodes occurred silently in the past, when surveillance was more limited, and did not cause pandemics.
The most recent global pandemic was caused by the influenza A (H1N1) strain, which was first detected in North America in 2009 (influenza A[H1N1]pdm09). This event prompted the first activation of provisions under the 2005 Interna- tional Health Regulations (IHR), which went into effect in 2007.5 Deliberations that led to the 2005 IHR revisions were shaped by experience in the SARS outbreak of 2003. The regulations delineate the responsibilities of individual countries and the leadership role of the World Health Organization (WHO) in declaring and managing a public health emergency of international concern.
The 2009 H1N1 pandemic presented a public health emergency of uncertain scope, duration, and effect. The experience exposed strengths of the newly imple- mented IHR as well as a number of deficiencies and defects, including vulnerabil- ities in global, national, and local public health capacities; limitations of scien- tific knowledge; difficulties in decision making under conditions of uncertainty; complexities in international cooperation; and challenges in communication among experts, policymakers, and the public.
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At the request of the WHO, an international committee, which I chaired, reviewed the experi- ence of the pandemic, with special attention given to the function of the 2005 IHR and the performance of the WHO.6 Since this was the first time that the 2005 IHR was tested in a real- world situation, it was inevitable that aspects of the response to the series of outbreaks and sub- sequent pandemic could have been improved. Even though there were areas of outstanding performance, such as the timely identification of the pathogen, the development of sensitive and specific diagnostics, and the creation of highly interactive networks of public health officials, the most fundamental conclusion of the committee, which applies today, is not reassuring: “The world is ill prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public-health emergency.”6
In this article, I focus on lessons from the global response to the 2009 H1N1 pandemic. I identify some of the key successes and short- comings in the global response, on the basis of the findings and conclusions of the review com- mittee. The article concludes by pointing to steps that can improve global readiness to deal with future pandemics.
T I M E C O U R S E O F T H E 2 0 0 9 H 1 N1 PA N D E M I C
The first laboratory-confirmed cases of H1N1 influenza appeared in Mexico in February and March of 2009. Cases that were detected in Cali- fornia in late March were laboratory-confirmed by mid-April. By the end of April, cases had been reported in a number of U.S. states and in coun- tries on various continents, including Canada, Spain, the United Kingdom, New Zealand, Israel, and Germany. On April 25, invoking its authority under the 2005 IHR, the WHO declared a public health emergency of international concern and convened the emergency committee called for in the regulations. The WHO also established a dedicated internal group to coordinate the re- sponse to the widening outbreaks. As of June 9, 2009, a total of 73 countries had reported more than 26,000 laboratory-confirmed cases, and the WHO declared on June 11 that the situation met the criteria for phase 6 — that is, a full-fledged pandemic (Table 1). By the time the pandemic had waned, in August 2010, virtually all coun- tries had reported laboratory-confirmed cases
(Fig. 1). An interactive graphic showing the time- line of the 2009 H1N1 pandemic is available with the full text of this article at NEJM.org.
Evidence from the first outbreak in Mexico was alarming. An observational study of 899 hospitalized patients showed that 58 (6.5%) be- came critically ill, and of those, 41% died.7 Dur- ing the course of the pandemic, mortality among children, young adults, and pregnant women was much higher than in a typical inf luenza season, and there was substantial variation in severity among different regions of the world.8 In general, older adults fared relatively well, and the total number of inf luenza-related deaths worldwide (estimated ranges of 123,000 to 203,000 deaths8 and 105,700 to 395,600 deaths9) proved similar to the number in a relatively mild year of seasonal influenza. However, because of the proportionately higher mortality among chil- dren and young adults, the severity in terms of years of life lost was greater than in a typical year of seasonal influenza.10
2005 INTERNATIONAL HEALTH REGULATIONS
A number of provisions of the 2005 IHR proved helpful in dealing with the 2009 H1N1 pandemic. For example, the 2005 IHR established system- atic approaches to surveillance, early-warning systems, and response in member states and pro- moted technical cooperation and sharing of logis- tic support. Communication among countries and the WHO was strengthened by the establishment in each member state of National Focal Points — national offices that would be responsible for rapid collection and dissemination of emerging data and guidance.
A static and potentially outdated list of notifi- able diseases in previous regulations was replaced by a more flexible flow diagram and decision tool that identified conditions warranting public health action. The 2005 IHR required, for the first time, that member states implementing uni- lateral measures that interfere with international traffic and trade inform the WHO and that they also provide a public health rationale and scien- tific justification for those measures. Most im- portant, the 2005 IHR formally assigned to the WHO the authority to declare a public health emergency of international concern and take a leading role in the global response.
Despite these positive features, many member states did not have in place the capacities called for in the IHR, nor were they on a path to meet
An interactive timeline of the
2009 H1N1 influenza pandemic
is available at NEJM.org
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their obligations by the 2012 deadline specified in the document. Of the 194 eligible states, 128 (66%) responded to a WHO questionnaire on their state of progress in 2011. Only 58% of the responding member states reported having de- veloped national plans to meet their core capac- ity requirements, and only 10% claimed to have fully established the capacities called for in the IHR.6
The IHR fails to specify a basis for virus shar- ing and vaccine sharing. This has been partially ameliorated in a framework for pandemic-influ- enza preparedness, adopted in 2011, that calls on member states to encourage vaccine manu- facturers to set aside a fraction of their pandem- ic-vaccine production for donation and for dis- counted pricing in developing countries.11 A glaring gap in the IHR, which has not been remedied, is its lack of enforceable sanctions. For example, if a country fails to explain why it restricted trade or travel, no financial penalties
or punitive trade sanctions are called for under the 2005 IHR.
WORLD HEALTH ORGANIZATION
The WHO is an indispensable global resource for leading and coordinating the response to a pan- demic. In the 2009 H1N1 pandemic, the WHO had many notable achievements. The organization provided guidance to inform national influenza- preparedness plans, which were in place in 74% of countries at the time of the first outbreak in North America, and helped countries monitor their development of IHR core capacities. The WHO Global Influenza Surveillance Network de- tected, identified, and characterized the virus in a timely manner and monitored the course of the pandemic.
Within 48 hours after the activation of provi- sions in the 2005 IHR, the WHO convened the first meeting of the emergency committee of ex- perts who would advise the WHO on the status
Table 1. World Health Organization (WHO) Pandemic-Phase Descriptions and Main Actions According to Phase.
Phase Estimated Probability
of Pandemic Description Main Actions in Affected
Countries Main Actions in Nonaffected
Countries
1 Uncertain No animal influenza virus circulating among animals has been reported to cause infection in humans
Developing and implementing na- tional pandemic-influenza pre- paredness and response plans and harmonizing them with national emergency prepared- ness and response plans
Same as in affected countries
2 Uncertain An animal influenza virus circulating in domesticated or wild animals is known to have caused infection in humans and is therefore considered a specific potential pandemic threat
Same as phase 1 Same as phase 1
3 Uncertain An animal or human–animal influenza reassortant virus has caused spo- radic cases or small clusters of dis- ease in people but has not resulted in a level of human-to-human transmission sufficient to sustain community-level outbreaks
Same as phase 1 Same as phase 1
4 Medium to high Human-to-human transmission of an animal or human–animal influenza reassortant virus that is able to sus- tain community-level outbreaks has been verified
Rapid containment Readiness for pandemic response
5 High to certain The same identified virus has caused sustained community-level out- breaks in at least two countries in one WHO region
Pandemic response: each country implements the actions called for in its national plans
Readiness for imminent pandemic response
6 Pandemic in progress
In addition to the criteria for phase 5, the same virus has caused sus- tained community-level outbreaks in at least one other country in an- other WHO region
Same as phase 5 Same as phase 5
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of the pandemic. Within 32 days after the WHO had declared a public health emergency of inter- national concern, the first candidate reassortant vaccine viruses were developed, and vaccine seed
strains and control reagents were made available within a few weeks. The Strategic Advisory Group of Experts on immunization at the WHO provided early recommendations on vaccine target groups
Extent of H1N1 Influenza Worldwide by Late April 2009 A
Extent of H1N1 Influenza by Late July 2010B
Number of cumulative positive H1N1 samples by country
0 1–24,999 25,000–49,999
50,000–74,999 75,000–99,999 ≥100,000
Not available
Figure 1. H1N1 Inf luenza Pandemic.
Data are from the World Health Organization and http://fluNet.org.
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and dose. The WHO provided prompt and valu- able field assistance to affected countries and efficiently distributed more than 3 million cours- es of antiviral drugs to 72 countries.
Against this backdrop of accomplishment, the WHO confronted systemic difficulties and made a number of missteps in the course of cop- ing with the unfolding pandemic. Although the WHO is the only global agency with legitimate authority to lead the response to a pandemic, it is burdened by a number of structural impediments. First, the WHO is simultaneously the moral voice for health in the world and the servant of its member states, which authorize the overall pro- gram and budget. National interests may con- flict with a mandate to equitably protect the health of every person on the planet. Second, the budget of the WHO is incommensurate with the scope of its responsibilities. Only approxi- mately one quarter of the budget comes from member-state assessments, and the rest depends on specific project support from countries and foundations. These budget realities and the per- sonnel-management requirements inherent in be- ing a United Nations agency constrain flexibility.
Third, the WHO is better designed to respond to focal, short-term emergencies, such as investi- gating an outbreak of hemorrhagic fever in sub- Saharan Africa, or to manage a multiyear, steady- state disease-control program than to mount and sustain the kind of intensive, global response that is required to deal with a rapidly unfolding pandemic. Finally, the regional WHO offices are autonomous, with member states of the region responsible for the election of the regional direc- tor, budget, and program. Although this system allows for regional variation to suit local condi- tions, the arrangement limits the ability of the WHO to direct a globally coherent and coordi- nated response during a global health emergency.
In anticipation of a possible pandemic before 2009, public health authorities had focused on the threat of avian H5N1 influenza, and a signal feature among recognized cases of H5N1 influ- enza in humans was mortality exceeding 50%.12 Hence, it was expected that a newly emerging pandemic virus would cause many deaths as well as widespread disease, and the WHO said as much on its website on pandemic preparedness in advance of the 2009 H1N1 pandemic.
The prospects of a pandemic depend on the transmissibility and virulence of the virus and on the susceptibility of the population, which
may vary according to age and past exposure to influenza viruses. Although a catastrophic pan- demic probably depends on the emergence of a new antigenic type of influenza virus, it does not follow that every newly emerging influenza virus will produce an especially severe burden of influenza. For example, in the 40 years between the mid-1930s and mid-1970s, the 5 years of greatest excess mortality from influenza in the United States were 1937, 1943, 1953, 1957, and 1960, but among these years, only 1957 was marked by a new antigenic type (H2N2), and 1968 (the year when H3N2 appeared) did not rank in the top five for severity.13 The expecta- tion of a very severe pandemic was understand- able in the context of H5N1 but not necessarily for every new antigenic type.
Since the formal criteria for advancing from one phase to the next higher phase in an emerg- ing pandemic were based entirely on the extent of spread and not on severity, this led to public confusion about exactly what the WHO meant by a pandemic. The WHO lacked a consistent, mea- surable, and understandable depiction of the severity of a pandemic. This situation was prob- lematic because, regardless of the definition of a pandemic, the decisions about response logi- cally depend on both spread and severity. In addition, the defining phase structure that was based on spread was needlessly complex in that it defined more stages than there were differen- tiated responses, and the structure that seemed suitable for planning proved less suited to op- erational management.
The weekly requests by the WHO for data were overwhelming for some countries, particu- larly those with limited epidemiologic and labo- ratory capacity. As the epidemic progressed, it was not always evident to country officials that the data they submitted were being analyzed and used. Rather than focus on laboratory-confirmed cases, a surveillance model that relied on syn- dromic surveillance and selective, systematic viro- logic testing might have been more revealing.14 Public health officials in some countries, such as the U.K. Health Protection Agency, produced weekly summaries that tracked domestic indica- tors of influenza spread and severity while not- ing pertinent global influenza activity, and this approach could hold lessons for other countries as well as for the WHO.15
When the WHO convened an expert group, typically for a 1- or 2-day consultation, the prac-
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tice of the organization was not to disclose the identities of the experts until the consultation was concluded. Similarly, the WHO kept confi- dential the identities of emergency-committee members convened under the provisions of the IHR, who would advise the WHO on the status of the emerging pandemic. Although the intent was to shield the experts from commercial or political influences, the effect was to stoke sus- picions about the potential links between indi- vidual members of the emergency committee and industry.16 Although the review committee uncovered no evidence of inappropriate influence on the emergency committee, the decision to keep the members’ identities secret fostered sus- picions about WHO decision making, which were exacerbated by the failure to apply systematic and open procedures for disclosing, recognizing, and managing conflicts of interest. A practice of confidentiality that was arguably fitting for a 1-day consultation was ill-suited to an advisory function that extended over a period of months.
The failure to acknowledge legitimate criti- cisms, such as inconsistent descriptions of the meaning of a pandemic and the lack of timely and open disclosure of potential conflicts of interest, undermined the ability of the WHO to respond effectively to unfounded criticisms. For example, the WHO was wrongly accused of rushing to declare phase 6, or a full-fledged pandemic, because such action would trigger vaccine orders sought by manufacturers. This kind of suspicion proved hard for the WHO to dispel, despite the fact that the declaration of phase 6 was delayed until the sustained com- munity spread in multiple countries in multiple WHO regions was incontrovertible.
The WHO made a number of operational mis- steps, including conferring with only a subset of the emergency committee, rather than inviting input from the full group, at a crucial point of deciding to declare progression from phase 4 to phase 5. Throughout the pandemic period, the WHO generated an unmanageable number of documents from multiple technical units within the organization and lacked a cohesive, over- arching set of procedures and priorities for pro- ducing consistent and timely technical guidance. In addition, after the declaration of phase 6, a time when public awareness of the evolving pan- demic was especially important, the WHO chose to diminish proactive communication with the
media by discontinuing routine press conferences on the pandemic.
The most serious operational shortcoming, however, was the failure to distribute enough inf luenza vaccine in a timely way. Ultimately, 78 million doses of vaccine were sent to 77 coun- tries, but mainly long after they would have done the most good. At its root, this reflected a short- fall in global vaccine-production capacity and technical delays due to reliance on viral egg cultures for production, as well as distributional problems. Among the latter were variation among wealthier countries and manufacturers in their willingness to donate vaccine, concerns about liability, complex negotiations over legal agree- ments with both manufacturers and recipient countries, a lack of procedures to bypass national regulatory requirements for imported vaccine, and limited national and local capacities to trans- port, store, and administer vaccines. Some re- cipient countries thought that the WHO did not adequately explain that the liability provisions included in their recipient agreements were the same as the provisions accepted by purchasing countries.
L O O K I N G A H E A D
In light of these structural impediments and op- erational deficiencies, the world was very fortu- nate that the 2009 H1N1 influenza pandemic was not more severe. On the basis of its analysis, the review committee offered 15 recommenda- tions to the WHO and the member states (Table 2). The report and recommendations were endorsed by the member states at the 64th World Health Assembly in May 2011, and the relevant WHO departments incorporated the recommendations into their biennial work plans.17 Some recom- mendations, such as improved protocols for vac- cine sharing, have been carried out, some are within the power of the WHO to implement, and others depend on the actions and resources of the member states, which have yet to be commit- ted to this purpose.
Beyond institutional, political, and manage- rial difficulties, the most fundamental con- straints on pandemic preparedness are the lim- its of scientific understanding and technical capacity. Perhaps because only three or four in- fluenza pandemics tend to occur each century, at least in recent centuries, the annals of influ-
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enza are filled with overly confident predictions based on insufficient evidence.18 Studies de- signed to select for avian-origin viruses that can be transmitted more readily than the original virus in mammalian species (gain-of-function studies) may arguably help predict the pandemic potential of naturally occurring viruses but have raised concerns about the possibilities of inten- tional misuse and unintended consequences.19,20 In the current state of scientific knowledge, however, no one can predict with confidence which influenza virus will become dangerous to human health and to what degree. The only way, potentially, to reduce this uncertainty is through a deeper biologic and epidemiologic understanding.
Disease detection, surveillance, and labora- tory capacity are improving in many countries. The new techniques of Web-based field reports and analysis of Web-based search patterns can yield valuable intelligence that can give the world a head start on the next emerging pandemic.21
In addition to superior surveillance and agree- ments on virus and vaccine sharing, the world needs better antiviral agents and more effective influenza vaccines, greater production capacity, and faster throughput. One comprehensive as- sessment showed that the effectiveness of cur- rent influenza vaccines in practice is lower than is typically asserted, especially among elderly persons.22 The traditional methods of influenza- vaccine production, which rely on egg cultures, are often too slow to keep up with a first wave of pandemic spread, and in total, the annual capacity of influenza-vaccine production covers less than one third of the global population.
In early 2013, the Food and Drug Administra- tion approved the first trivalent influenza vac- cine produced with the use of recombinant technology,23 and other production methods are under active research and development. At least four lower-income countries have their own influenza-vaccine manufacturing facilities, and more are on the way. Most important, if research could yield a universal (non–strain-specific), long-lasting, safe, and effective vaccine against inf luenza, the annual frenzy of action against inf luenza would be transformed into a proac- tive, long-term prevention program.24,25
In the meantime, influenza outbreaks and pandemics will continue to challenge policy- makers and public health leaders to make deci- sions under conditions of stress and uncertainty.
Pandemics will challenge national authorities and the WHO to function more efficiently and effectively with insufficient resources. Prepara- tion beyond planning, with advance protocols and agreements, the commitment of ready reserves of public health experts and a financial line of credit, and the fulfillment of the IHR require- ments can all help. Whenever the next influenza pandemic arises, many more lives may be at risk. By heeding the lessons from the 2009 H1N1 pandemic, the international community will be able to cope more successfully the next time.
The views expressed in this article are those of the author and do not necessarily represent the views of the Institute of Medicine.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org.
Members of the World Health Organization committee for the review of the 2009 H1N1 pandemic and 2005 International Health Regulations, on whose work this article is largely based, include Preben Aavitsland (Norway), Tjandra Y. Aditama (Indonesia), Sil- via Bino (Albania), Eduardo Hage Carmo (Brazil), Martin Cetron (United States), Omar El Menzhi (Morocco), Yuri Fedorov (Russia), Andrew Forsyth (New Zealand), Claudia Gonzalez (Chile), Moham- mad Mehdi Gouya (Iran), Amr Mohamed Kandeel (Egypt), Arlene King (Canada), Abdulsalami Nasidi (Nigeria), Paul Odehouri- Koudou (Ivory Coast), Nobuhiko Okabe (Japan), Mahmudur Rahman (Bangladesh), Palliri Ravindran (India), José Ignacio
Table 2. Recommendations of the WHO Review Committee on the Functioning of the 2005 International Health Regulations (IHR) in Relation to the 2009 H1N1 Influenza Pandemic.
Accelerate the implementation of the core capacities required by the IHR
Enhance the WHO Event Information Site*
Reinforce evidence-based decisions on international travel and trade
Ensure necessary authority and resources for all National Focal Points†
Strengthen the internal capacity of the WHO for sustained response
Improve practices for the appointment of an emergency committee
Revise pandemic-preparedness guidance
Develop and apply measures to assess the severity of a pandemic
Streamline the management of guidance documents
Develop and implement a strategic, organization-wide communications policy
Encourage advance agreements for vaccine distribution and delivery
Establish a more extensive public health reserve workforce globally
Create a contingency fund for public health emergencies
Reach an agreement on the sharing of viruses, access to vaccines, and other benefits
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Pursue a comprehensive influenza research and evaluation program
* The Event Information Site is a WHO website that, in the event of a pandemic, would serve as an authoritative resource to disseminate reliable, up-to-date, and readily accessible information related to the pandemic.
† National Focal Points are national offices that are responsible for the rapid collection and dissemination of emerging data and guidance.
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Santos (Mexico), Palanitina Tupuimatagi Toelupe (Samoa), Patri- cia Ann Troop (United Kingdom), Kumnuan Ungchusak (Thai- land), Kuku Voyi (South Africa), Yu Wang (China), and Sam Zaramba (Uganda). The committee secretariat was led by Nick Drager and included Dominique Metais, Faith McLellan, Mary
Chamberland, Nadia Day, Alice Ghent, Sue Horsfall, Janet Kin- caid, Phillip Lambach, Linda Larsson, Fabienne Maertens, Joan Ntabadde, Les Olson, Magdalena Rabini, Sarah Ramsay, Mick Reid, Chastine Rodriguez, Alexandra Rosado-Miguel, and Na- tasha Shapovalova.
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Video lecture
Welcome to disasters from shock to recovery. The past disasters that we have studied in this class had mostly to do with atmospheric disturbances are natural processes. This week we'll look into an entirely different hazard. Pandemic influenza are case study focuses on the response in the US during the 2009 H1N1 influenza pandemic. But let's take a couple of steps back in time to understand how the Center for Disease Control prepare for the event in 2009. The first human case of H5 N1 or avian influenza was detected in China in 1997. At the time there was an alarm as to how it was transmitted and how to stop it spread.Scientists discovered that it wasn't very efficient at at transmitting from person to person. And thus direct animal exposure was to be blamed for most infections. At the time avian influenza did not turn into our world wall pandemic but scientists and policymakers were willing to invest time money and effort to prepare for such an eventuality. H5 N1 made its appearance again in 20052006. Spreading rapidly not only in South East Asia but also in Africa Europe and the Middle East. Public health officials officials in the US were aware of the potential threat of this virus and we're preparing for the worst think something like the great influenza pandemic of 1918 that cost nearly a 100 million deaths and 500 million infections worldwide. Us public health officials also use experiences from the Severe Acute Respiratory Syndrome. Sars outbreak of 2003 to prepare for the pandemic in 2009. This was a potential worldwide pandemic. So the World Health Organization on several member countries created international health regulations in 2005 as well. Officials were fearful and willing to prepare because of the uncertainty associated with the scope duration and effects of this kind of outbreaks. So a lot of the planning in the US and the world was based on the H5N1 outbreak the sars outbreak among other small ones. But H1 N1 in the US will bring its own challenges to the CDC. The H1N1 outbreak in the US was different than anything they had planned for before. The initial outbreak started in Mexico and rapidly arrive in the US. Most scenarios where a plan for overseas outbreaks that slowly spread. They had planned for a specific strings like i stronger strain of avian influenza or sars Influenza common but ever changing virus which makes Korean vaccines less effective. People will not take-the initial symptoms seriously. It's just a call right. Other viruses like Ebola had much more noticeable an alarming symptoms.Finally H1N1 is efficiently transmitted from human to human but also from animals to humans because this was a type a string. So there was a higher chance of contamination and the virus could mutate easily. Think about a commons needs that reaches six feet away from the infected person. On April 2009 the first two cases of H1N1 where identify all thanks to good timing from the CDC who had just developed a testing kit that included this one string h one. The two children infected had initially tested positive for influenza type a but it wasn't clear what strain. The CDC test came just in time but he brought more questions that identify strain was swine H1 type a but they couldn't find a connection between patients and any contact with peaks or among themselves. With any Type a influenza the CDC was already on high alert launching investigations on warnings as more and more cases started to show up. The CDC immediately activated its emergency operation center and was quick to identify priority areas to be vaccinated while more vaccines were produced. They also provided guidelines that reduce chaos or more infections They had to act quickly with constantly flowing information whatever new information they had was communicated to keep local state and federal officials and other nations as well. By June 2009 H1N1 pandemic affecting 73 countries. The CDC in the US coordinate the distribution of almost 126.9 million doses of H1N1 vaccine manufacturer only weeks after the first cases. 81 million of those were for US citizens at risk. And the rest for foreign countries suffering outbreaks. Some of the most important lessons learn during the H1N1 pandemic are the following. This need to plan for more general outbreak scenarios. Partnerships between public health officials local state health departments school and businesses are crucial for speedy response. Preparedness pays off existence seasonal influenza surveillance systems were useful as they just needed to be scaled up for a larger event but the knowledge was there Surveillance systems help information gathering decision-making on forecasting. Pandemic exercises are a pain in the neck but they provide a helpful information with processes and procedures regardless of the type of the virus. Moving forward the CDC is also focusing on developing more efficient impact assessment frameworks that looks at measures of transmission and measures of severity. This means that the health officials will have these estimates available earlier than previous measures-and is designed to accept multiple inputs. Better ways to visualize data using military inspire mapping and communications in the flu view website. And management of data for better understanding and compiling of lessons learned.Even though the US has a well-funded and efficient systemH1N1 brought its own challenges and the people in charge of the emergency. We're capable of using existing resources to service communities affected. Novel influenza strains keep scientists and public health officials on the move constantly updating and reviewing systems. But how do you think other countries Less resources may have fair. Could some of these practices be replicated abroad.
