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Homeland Security

REPORT TO THE PRESIDENT ON U.S. PREPARATIONS FOR 2009-H1N1 INFLUENZA



V. Responding to the Pandemic


CHAPTER SUMMARY

The impact of influenza epidemics can be mitigated by four methods: vaccination, administration of anti-viral drugs, symptomatic medical care, and non-medical interventions that reduce viral transmis­ sion. Decisions to implement these approaches depend on a variety of factors, especially the nature and course of the epidemic and the availability of materials, personnel, and delivery systems.

Because the influenza virus spreads rapidly and often efficiently, little time is generally available to respond once medically significant outbreaks occur. It is thus critical that scenario-based plans be made in advance for each of these interventions. It is equally important that a well-defined process for decision making be established, with clear assignments of responsibility and logical, agreed-upon guidelines for evidence-based decision making.

The Working Group was impressed with the very active engagement by many highly competent people in multiple Federal agencies who are thinking about the decisions that need to be made. However, as the fall resurgence nears it is especially important to be certain the roles and responsibilities of these individuals in decision making, as well as the processes used to arrive at decisions, are clear. The Working Group believes that it would be valuable to (1) clarify decision-making authorities and processes, and (2) adopt a more structured decision-making framework for certain key decisions.

We recommend that the Homeland Security Advisor assume responsibility for identifying the people, agencies, and processes for making decisions in the next phases of the 2009-H1N1 pandemic; for guar­ anteeing that all necessary decisions are made in a timely fashion; and for presenting recommended courses of action to the President.

In addition, we examine critical issues in each of the four areas of intervention and make specific rec­ ommendations about the processes and information required for decision making in those areas. In particular, we encourage the responsible agencies to focus immediately on decisions that could reduce severe disease and death in especially vulnerable populations by accelerating the delivery and use of vaccines, increasing the appropriate use of anti-viral drugs, and ensuring access to intensive care facilities.

Finally, we comment on the ways in which decisions made to mitigate disease in the United States might affect the many other countries likely to be affected by the 2009-H1N1 pandemic.

Introduction

Influenza epidemics cannot be prevented with currently available tools, but four categories of methods are available to mitigate the effects of an epidemic:

1. Vaccines to prevent infection. For seasonal influenza, vaccines reduce the risk of serious disease in infants and children, pregnant women, older adults, people who have chronic medical con­ ditions, or those who might infect high-risk people through their work or household contact.


  • Antiviral drugs to decrease the likelihood of infection or severe disease in uninfected individu­ als (usually those with known or suspected exposure); to reduce the severity and duration of disease in patients already infected and ill; and to lower the rate of virus shedding in infected individuals, thereby decreasing the likelihood of transmission to others.
  • Medical care to manage clinical illness, which may range from mild to extreme, delivered at home, in out-patient clinics, hospitals, and intensive care units.
  • Non-medical mitigation practices, including isolation of infected individuals, hand washing, and several forms of social distancing such as school closures, cancellation of sporting events, etc., to lower the chances of person-to-person transmission of virus.

Because the influenza virus spreads rapidly and often efficiently, little time is generally available to respond once surveillance methods reveal medically significant information. For this reason, it is critical that plans be made in advance for the production, acquisition, and delivery of medical interventions, such as vaccines and drugs; the provision of facilities and materials for patient care; the mobilization of necessary health personnel; and the communication of information about both medical and non­medical mitigation strategies. In addition, a well-defined process for decision making needs to be established well in advance, with clear assignments of responsibility and logical, agreed-upon guidelines for decision making.

Responding to the anticipated 2009-H1N1 influenza epidemic in the coming months will require com­plex coordination—across different agencies of the Federal Government, vertically across the various levels of government (Federal, state, local), between public officials and health professions and insti­ tutions, and between the public and private sectors. “Coordination” across agencies and participants can be wasteful and frustrating if there are ambiguous responsibilities and unclear lines of authority. Rather than focusing on coordination per se, it is more productive to emphasize clarity about leadership, responsibilities, roles, and communication.

The Working Group has been impressed by the active engagement by many highly competent people in multiple Federal agencies who are thinking about the decisions that need to be made about efforts to mitigate the effects of the spread of 2009-H1N1 influenza virus in the United States this fall and winter.

The Working Group has some concerns, based on conversations with representatives of the various agencies involved, that decision-making authorities and processes may not be completely clear in all cases. Primary Federal responsibilities for response to an epidemic are lodged in two departments (DHHS and DHS), with significant involvement of others (Education, Defense, State, Agriculture, Labor), and coordination by White House staff. While the National Strategy for Pandemic Influenza Implementation Plan provides a comprehensive list of assignments for a multitude of offices, agencies, and departments involved in the Federal planning process, the large number of tasks and responsible units tends to obscure the primary seat of responsibility. (See www.pandemicflu.gov/plan/federal/pandemic-influenza­ implementation.pdf.) The Working Group believes it would be valuable to clarify these matters before events accelerate in September and assign to the Homeland Security Advisor the responsibility for ensuring that all of the important decisions are made in a timely fashion and with appropriate consul­ tation with the President.

In addition to clarifying authorities, the Working Group believes it would be valuable to adopt structured frameworks for making certain key decisions. At the time of our study, agencies had not yet formalized decision frameworks but were moving to do so. We strongly endorse these efforts. We urge that they attempt to be as precise as practical with respect to overall goals, scenario-based assumptions, required data elements, quantitative trigger points, expected benefits, and expected costs. It would be valuable to circulate these analyses within the government. Where feasible, it could also be desirable to share them publicly through an appropriate channel to gain the benefit of expertise outside government; this would be consistent with the Administration’s commitment to open government.


MAIN RECOMMENDATION (CHAPTER 5)

As the fall resurgence nears, important decisions will have to be made rapidly and based on limited data. It is important to be certain that roles and responsibilities in decision making, as well as the processes used to arrive at key decisions, are clear. The Working Group believes that the White House is best positioned to ensure that these systems are in place, building upon the strong coor­ dination role it is already playing.

We recommend that the White House designate an individual, preferably the Homeland Security Advisor, to be responsible for coordinating all policy development for the 2009-H1N1 response; identifying the people, agencies, and processes for making key decisions; guaranteeing that all necessary decisions are made in a timely manner; and presenting recommended courses of action to the President.

Concerning decision-making authority, it will be important to identify the individual(s) responsible for organizing the decision-making processes for each of the mitigation measures. For most key decisions discussed in this Chapter, the responsible individual should be the Secretary of DHHS.

Concerning decision-making processes, it would be valuable to employ structured decision frame­ works incorporating scenarios—including an assessment of required data, specific trigger points for action, and a forecast of benefits (e.g., decreased morbidity and mortality, decreased trans­ mission) and costs (e.g., financial loss and social disruption). We are aware of and endorse efforts already underway to create such structured analyses. Such documents should be shared within government and, where feasible, shared with experts outside government.

The most urgent attention should be given to the priority decisions necessary to support vaccine and antiviral allocation and deployment, the national medical response, and the implementation of non-medical mitigation strategies, as described below.

In the sections that follow, we discuss specific issues that should be addressed in making decisions about each of the categories of mitigation methods, and we offer specific recommendations about how to approach those issues.

Vaccines and Antiviral Drugs

The two main medical lines of defense are vaccination and antiviral drugs. Vaccination constitutes the best defense against an epidemic, but its effectiveness depends on timing and coverage of the popula­ tion. Both inactivated and live attenuated influenza vaccines are approved for use. (See Box 5A ) Antiviral drugs can provide a powerful tool for prophylaxis for exposed individuals and for treatment, especially if used within 48 hours of the appearance of symptoms, but with possible benefits for treatment of severe cases thereafter. Two inhibitors of influenza neuraminidase, oseltamivir and zanamivir, are approved and effective against 2009-H1N1 virus. (See Box 5B )


BOX 5A: INFLUENZA VIRUS VACCINES

Two types of vaccines are FDA-approved, recommended for seasonal influenza among the elderly and young children, and now being manufactured at five pharmaceutical companies in response to orders from the Federal government for use in the 2009-H1N1 influenza pandemic.

Inactivated vaccines are the most widely used. They are prepared by growing viruses in embryo­ nated chicken eggs and then inactivating them by treatment with ethyl ethers or detergents. Inactivated vaccines contain all the viral structural proteins and are administered via injection, usu­ally in a single 15 microgram dose that is made available in multi-dose vials or single-dose syringes.

Live attenuated vaccines are made from cold-sensitive variants of the virus that are also produced in chicken eggs, partly purified, and administered to the nasal mucosa, usually with a nasal spray device.

Other approaches to making influenza vaccines by growth of virus in cell culture or by recombinant DNA methods are being studied and are described in Chapter 8. In addition, it may be possible to augment the effectiveness of influenza vaccines through the use of adjuvants, substances that stimulate the immune response to viral proteins. Use of adjuvants with influenza vaccines has not yet been approved by the FDA, but is permitted in Europe . Depending on the outcome of clinical tests, adjuvants could be added to 2009-H1N1 vaccines under the terms of an Emergency Use Authorization (EUA) from the FDA.

BOX 5B: ANTIVIRAL DRUGS FOR INFLUENZA

Two classes of antiviral drugs have been developed and approved for use in the treatment of influenza.

One class, the amantadines , blocks the virus life cycle by interfering with a small viral protein called M2. This class of drug is not effective in the treatment of either 2009-H1N1 virus or the cur­ rent seasonal influenza viruses and is thus not considered further here.

The second class, the neuraminidase inhibitors , includes two agents— oseltamivir (TamiFlu, taken orally) and zanamivir (Relenza, inhaled)—that are FDA-approved and widely used as pro­ phylaxis against disease (among those known or likely to be exposed to infected individuals) and as treatment (for patients diagnosed with influenza). Treatment is most successful when begun soon after infection; the agents also reduce the amount of infectious virus produced by infected individuals. The drugs are often used in the management of severe influenza, but intravenous delivery of these two agents, or of a third agent ( peramivir ), in advanced stages of development, has not yet been approved by the FDA. Resistance to these agents, especially oseltamivir, as a result of viral mutation or genetic recombination, can be a major factor limiting antiviral effectiveness; seasonal influenza viruses increasingly show resistance to oseltamivir, but thus far only a few of the many isolates of 2009-H1N1 virus have shown resistance to oseltamivir.

The Working Group has identified several important decisions that need to be taken—immediately in some cases, rapidly in all cases—if these two mitigation measures are to be employed to maximum effect this fall:

(1) Accelerate vaccine production . The expected timing of vaccine availability poses significant chal­ lenges, as seen from the following considerations:

  • Although revisions of the schedule are under consideration by DHHS, plans announced in July by the HHS Secretary would provide the first significant quantities of 2009-H1N1 vaccine in mid-October; an effective immune response would take another 2 to 4 weeks to develop after vaccination. Under the model scenario described in Chapter 3, the resurgence of the epidemic would start in September and peak in mid-October. If this model is approximately correct with respect to timing, a vaccination campaign would not begin to protect vaccinees until well after the epidemic had peaked.

  • Certain groups are already known or suspected to be at high risk for serious complications and death from 2009-H1N1, and are likely to account for a significant minority of serious morbidity and mortality. Based on current information, groups at relatively high risk include pregnant women, individuals with certain neurological impairments, asthmatics, and others (see Chapter 3). In addition, high numbers of severe cases and deaths were observed among children and young adults. These groups would disproportionately benefit from early access to vaccine.

Given these circumstances, it is important to consider options for accelerating the availability of vac­ cine supplies, at least for individuals at elevated risk, estimated to represent nearly 40 million in the U.S. Currently, vaccine availability is gated by results of clinical studies concerning safety and optimal dose (expected in mid-September), after which manufacturers can “fill and finish” the vaccines at the appro­priate doses (which requires another 3–4 weeks). Inactivated vaccine for seasonal influenza is usually administered at a dosage of 15 micrograms; a similar dosage is expected to work for the 2009-H1N1 vaccine, but this will not be known with certainty until results from clinical studies are available.


RECOMMENDATION 5-1: ACCELERATING VACCINE AVAILABILITY FOR HIGH-RISK GROUPS

We recommend that DHHS accelerate the availability of a portion of the vaccine supply to mid- September by having manufacturers begin to “fill and finish” a subset of the bulk vaccine product at 15 micrograms. Such a decision would need to be taken almost immediately.

We thus recommend a “hedged” strategy in which an initial amount of product is packaged “on risk,” assuming a 15 microgram dosage, and the remainder is packaged when dosing and safety information becomes available in mid-September following the first results of clinical trials conducted by the NIH and industry. The risks of this course of action appear to be relatively low: some vaccine product could be wasted by filling vials at sub-optimal doses. If a somewhat larger dose is required, however, physicians can administer additional vaccine (e.g., a second dose of 15 micrograms to achieve 30 micrograms). The optimal amount of vaccine will need to be determined from immunological responses in clinical tests and an appropriate decision analysis. However, it seems clear that filling and finishing up to 40 million doses could have a substantial effect on the incidence of disease and death in these vulnerable populations.

The Working Group recognizes that there are important considerations for manufacturers as they con­ template reconfiguring their “fill and finish” operations to meet accelerated deadlines. If DHHS elects to follow this approach, a highly knowledgeable Federal decision-maker would need to work promptly with one or more of the pharmaceutical companies already contracted to produce vaccine to execute this strategy.

We note that the National Biodefense Science Board has also encouraged accelerated production and that the strategy is under consideration by the relevant DHHS agencies.

(2) Focus on protecting those at highest risk . Because the most severe outcomes appear to be con­ centrated in certain groups, based on data thus far with 2009-H1N1, it is logical to assume that focus­ ing mitigation efforts on those groups will have disproportionate public health benefits. In addition to accelerating the availability of vaccine, it is important to develop clear guidance about the means of access and appropriate use of vaccines and anti-viral drugs for these groups and to communicate that guidance to them and their health care providers promptly and effectively (discussed in Chapter 7). We note that the complex and distributed nature of the U.S. healthcare system poses logistical challenges in accomplishing these goals, which will require considerable planning.

This strategy will require attention to important questions about the specific recommended interven­tions, both medical and non-medical. To cite just one example, what guidance concerning antiviral prophylaxis should be given to a pregnant schoolteacher whose class has two students who are at home after contracting symptoms of 2009-H1N1 influenza?


RECOMMENDATION 5-2: PROTECTING HIGH-RISK GROUPS

We recommend that DHHS undertake a focused program to identify and maximize protection of individuals at high risk of severe outcomes if infected with 2009-H1N1.
 
This process should include:

    A. reviewing existing knowledge about nH1N1 hospitalizations, ICU admissions and deaths to strengthen the list of groups at highest risk for these events;

    B. developing plans to mobilize these groups (and their health care providers), generate guidance

    for members of these groups to follow in deciding when to use such medication, and dispense antiviral drugs when indicated;

    C. using these mobilization strategies to reach the same groups for vaccination, and begin offering vaccine as soon as supplies become available; and

    D. considering plans to offer existing vaccines against other respiratory pathogens to members of such groups (severe consequences of influenza virus infection often result from secondary infection, such as pneumococcal pneumonia).

(3) Manage anti-viral stockpiles . The United States currently has Federal and state stockpiles of approxi­ mately 90 million courses of antivirals (consisting of roughly 80 percent oseltamivir and 20 percent zanamivir). Each course represents one week of treatment; an individual taking prophylaxis for three months would thus consume 12 courses. There is little or no additional supply available for purchase through the end of 2009. The existing stockpile must thus be used prudently.

The Working Group has heard concerns expressed that there is a risk of depleting the stockpile if it is not managed properly (for example, if used for widespread and prolonged prophylaxis of health care workers or the general public). It is important that antiviral drugs be available for treatment and for prophylaxis for those at greatest risk of serious illness (prioritized groups directly exposed to virus). Once antiviral drugs are released from the national stockpile, the states and localities control their use. Still, CDC has an important influence through its guidelines on the use of these drugs. The Working Group heard con­ cerns that the existing CDC guidelines may not be sufficiently strong and clear to promote optimal use.


RECOMMENDATION 5-3: ANTIVIRAL DRUGS

We recommend that CDC clarify and strengthen its guidelines for use of antiviral drugs, including for treatment, pre-exposure, and post-exposure prophylaxis, and contingency plans for the devel­opment of drug resistance. These guidelines and plans, and their rationales (including preservation of limited supply for those in greatest need), should be clearly communicated to state and local health departments, health care practitioners, and the public. State and Federal supplies of antiviral drugs should be monitored on a frequent basis.

(4) Intravenous antivirals . Severely ill patients may benefit from the intravenous use of neuraminidase inhibitors. (For example, in the model scenario described in Table 3-1, as many as 300,000 patients are envisioned to require treatment in an ICU). However, no antiviral drugs have been approved by FDA for intravenous use. There are some initial clinical data on intravenous use of the approved drugs oseltamivir and zanamivir and more advanced clinical data for peramivir, a new drug with a somewhat different resistance profile than oseltamivir. The Working Group urges FDA to work with drug manufacturers to determine whether these drugs can be used intravenously as a result of accelerated approval or under the terms of an Emergency Use Authorization (EUA).


RECOMMENDATION 5-4: INTRAVENOUS ANTIVIRALS

We recommend that FDA accelerate a decision about the availability of antiviral drugs (peramivir, zanamivir, or oseltamivir) for intravenous use.

(5) Trigger for using adjuvant. The effectiveness of vaccines can often be increased by co-administra­ tion with adjuvants, substances that can amplify an immune response when mixed with an appropriate antigen, allowing the dosage of antigen to be decreased. Thus a given amount of antigen can be used to immunize more individuals. This strategy may be important if a vaccine is poorly immunogenic (and thus requires a large quantity of antigen) or if vaccine supplies are insufficient to fill an urgent national need. A supply of one adjuvant (MF59) has been ordered and stockpiled for possible use with the 2009- H1N1 vaccine.

Adjuvants are not currently approved for use with influenza vaccines in the United States , although they have been approved and are being used with influenza vaccines in Europe . Accordingly, the use of adjuvants would require an EUA by the FDA. Given these circumstances, there is reluctance to use adjuvants unless they are clearly necessary to extend the vaccine supply.

The Working Group encourages DHHS to develop quantitative criteria (vaccine efficacy, severity of epidemic) that would trigger a decision to use adjuvants and to ensure that sufficient data are available for the FDA to grant an EUA.

(6) Plan for a national vaccination campaign. A decision to vaccinate portions or the entirety of the U.S. population against influenza virus is an important step, but the public health consequences of that decision depend heavily on the manner in which the decision is announced, the recommendations that are made about who should receive vaccine, and the system(s) chosen to distribute and deliver the vaccine. Without those additional steps, actual use of the vaccine may be low or the vaccine may be used inappropriately. The Working Group encourages DHHS to accelerate the planning required for an effective campaign, taking into consideration some of the recommendations about commu­ nication practices offered in Chapter 6. The ACIP has already proposed to CDC that up to 160 million people should be considered preferentially for vaccination against 2009-H1N1 virus, and a subset of those individuals should be prioritized according to criteria mentioned earlier in this chapter. Plans for a national campaign will need to incorporate appropriately those priorities and target messages about the vaccine. The complex and distributed nature of the U.S. healthcare system makes a coordinated national effort particularly challenging; considerable attention will need to be focused on the many logistical challenges.

(7) Surveillance of vaccine effectiveness and vaccine-associated adverse events. Clinical testing of an influenza vaccine allows scientists to determine whether that vaccine produces a measurable immune response that has been correlated with some degree of clinical protection. However, it does not directly determine whether the vaccine elicits protective immunity against infection that is a conclusion that can only be firmly drawn by studying groups of vaccinated and control individuals over longer periods of time. Furthermore, initial clinical tests usually are conducted with small groups of healthy individuals, so rare adverse events and complications associated with pre-existing medical conditions are unlikely to be encountered. In view of these circumstances, it will be important that CDC, FDA, and NIH develop a collaborative plan to monitor appropriately designated groups of vaccinees, based on age, location, or pre-existing conditions, to assess the effectiveness of the vaccines and study any adverse reactions. These observations will be especially useful if a virus closely related to 2009-H1N1 returns in future years

Medical Response

As discussed in earlier chapters, even in the absence of changes in the characteristics of the 2009-H1N1 virus, the capacity of some communities to provide an appropriate medical response to ill patients is likely to be strained and possibly overwhelmed at the peak of the anticipated fall outbreak. It is impos­ sible to predict where and when this will happen, so it is important that all communities be prepared for this possibility. During spring and summer 2009, the 2009-H1N1 pandemic has stressed the health care system in several countries, including parts of the United States , Argentina , Canada , Chile , and Mexico , and this has provided an opportunity to learn from the health system response in these places.

Given the structure of the U.S. health care system, the response to these “surge” requirements will be addressed at the local, state, and regional levels, with the majority of capacity coming from private and non-profit facilities that are outside of government. Nevertheless, the Federal Government will play a critical supporting role in this response—by providing guidance to communities on strategies that address the medical requirements; by relaxing legal and regulatory constraints; by mobilizing Federal personnel to assist in the response; and, in some cases, by providing medical materiel from the Strategic National Stockpile. Furthermore, while the Working Group recognizes that the potential inadequacy of the Nation’s medical “surge” capacity cannot be closed in the immediate future, we believe that use of existing capacity can be improved and made more equitable by expanded monitoring and allocation of scarce resources (such as ICU beds and ventilators) used to care for the most critically ill patients, as described in Chapter 4 (see Recommendation 4-4) and by the development of procedures to mobilize equipment, personnel, or patients.


RECOMMENDATION 5-5: MEDICAL RESPONSE

In its efforts to prepare the Nation’s complex health care system for the likely increase in cases of severe 2009-H1N1 influenza, we recommend that DHHS emphasize the following approaches:

    A. Using planning scenarios, forecast requirements for hospital beds, ICU beds, personnel, equipment, and medical materiel to inform state and local authorities in their planning efforts. Special attention should be given to the capacity to care for critically ill infants and children, as most adult ICU facilities are not fully equipped to handle these patients, and potentially high-risk populations for whom the Federal Government has specific responsibilities,
    such as American Indians/Alaska Natives. Guidance should be offered on (1) strategies and best practices to close critical gaps, and (2) Federal resources available to assist in this effort (e.g., through the Strategic National Stockpile).
    B. Use national surveillance systems, in collaboration with state health authorities, to maintain up-to-date situational awareness of the medical response across the country, as recommended
    in Chapter 4 (see Recommendation 4-4). These efforts should aim to determine which locations are under the greatest duress; track clinical presentation of infection and effectiveness of interventions; and understand which medical surge strategies are most effective.
    C. Determine the authorities, protections, and guidelines necessary to maximize a community’s ability to allocate scarce resources in the most appropriate, ethical, and just manner, without fear of inappropriate penalties. The intent is to ensure uniformity in the allocation of scarce and perhaps life-saving medical resources, such as ventilators, across communities.
    D. Consult with relevant professional societies and health care organizations to ensure that guidance for protection of health care workers from the effects of 2009-H1N1 is supported by the evidence, feasible to implement, and is harmonized among multiple sources. Relevant societies include the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and, where recommendations concern children, the American Academy of Pediatrics (AAP).
    E. Work closely with state and local health personnel to prepare the public to self-triage and manage illness at home or at alternative care facilities when appropriate, using scalable solutions such as national toll-free phone lines and web-based instructions where appropriate (as discussed further in Chapter 6).

Non-medical Mitigation Measures

The Federal Government’s planned response to a pandemic virus includes community mitigation measures, including “social distancing,” cancellation of public gatherings, voluntary home quarantine, and school closure. Implementation of these measures has been linked to the severity of the pandemic, which the Federal Government has codified through a “Pandemic Severity Index” or PSI . The PSI for the 2009-H1N1 pandemic proved to be very difficult to assign early in its course in North America : the PSI depends primarily on the “case fatality rate,” which cannot be calculated with certainty when the total number of infected persons is unknown. Implementation of the more significant interventions, such as school closure, has proved to be controversial, due to a perceived imbalance between the negative finan­cial and social consequences of the intervention relative to the perceived mildness of the pandemic virus.

Valuable lessons about community mitigation have been learned in the United States , the United Kingdom , Japan , Mexico , and elsewhere since the emergence of the 2009-H1N1 virus, and have also been gleaned from historical accounts of past epidemics. The Working Group believes it is essential to capitalize on these lessons and ensure that communities are prepared to implement appropriate com­ munity mitigation measures depending on the course of the pandemic this fall.

The importance of such preparations is underscored by the following observations: (a) it is possible that the virulence of the virus could increase in subsequent waves, as happened in 1918–19; (b) even at the current level of virulence, the demand on the health care system in some communities is likely to exceed available capacity, necessitating measures to slow the spread of the virus; (c) the sheer number of cases in a given community, along with concern among the public, may lead to unplanned school closure and absenteeism in the workplace; and (d) it is unlikely that significant proportions of the population will have vaccine-mediated immunity at the time the 2009-H1N1 virus returns to a given community this fall.

The Working Group recognizes that many components of the Federal Government, including DHHS/ CDC, NSC , and the Departments of Labor, Homeland Security, State, and Defense are engaged in discus­ sions of non-medical mitigation methods and that national guidance is being developed. We suggest that adequately resolving these issues will require a greater quantitative specificity, in particular, of the trade-offs between the medical benefit gained and social disruption caused by school or institu­ tional closure. The costs and benefits of these measures have not, to our knowledge, been adequately weighed in quantitative terms. For example: although there is significant evidence, as well as logic, to support the idea that school closure (and presumably similar social distancing actions) can reduce virus transmission, clear analyses are needed of what specific effects on the spread of infection in different types of communities are likely to result from school closures at different infection prevalence. Even more difficult to assess are the economic and social costs of implementing such measures. Although evidence-based estimates of such costs are difficult to make and inherently imprecise, they can help to advance the rationality of the debates, especially if performed in the context of specific scenarios for the severity of an epidemic.

Finally, we note that there currently appears to be no value in using border closures or travel restric­ tions as social mitigation measures, as the H1N1 influenza virus is already well-established in the U.S. This situation could change if a more virulent or drug-resistant variant of 2009 H1N1 in another country became a serious threat.


RECOMMENDATION 5-6: NON-MEDICAL INTERVENTIONS

We encourage CDC, working with other components of DHHS, the Departments of Education, Homeland Security, Commerce, Labor, and others as appropriate, to prepare a document that provides general guidance on non-medical interventions to mitigate the predicted recurrence of the 2009-H1N1 pandemic in the United States. This document could be the basis for communication of key messages to several different constituencies, including local governments, school officials, leaders of institutions and businesses with high concentrations of personnel, and organizers of various kinds of public events, and it should include several important components:

  • A description of the lessons that have been learned about community mitigation measures as a result of the experience in the United States, Japan, Mexico, and other places where these measures were implemented during the 2009-H1N1 pandemic, as well as a summary of lessons from earlier epidemics.

  • An account of the second- and third-order consequences of measures such as closure of schools and other institutions or cancellation of public events, and strategies to limit their impact.

  • An articulation of the goals of community mitigation measures if implemented (e.g., reduc­ tion in community-wide transmission, reduction in peak burden on health care system, pro­tection of those most at risk for severe complications, reactive in response to absenteeism) under various scenarios, and the impact this would have on implementation.

  • Triggers for implementation and adjustment of community mitigation strategies, based on data that are likely to be readily available to decision-makers. These plans should include strategies for communicating the recommendations to the public and state and local stake­ holders, as discussed in Chapter 6.

  • Methods for monitoring the effectiveness or ineffectiveness of these interventions during the expected fall outbreak, both to guide continued use in the fall and to gather knowledge for use in future influenza outbreaks.

International Considerations Presented by the Pandemic

In preparing for the resurgence of the 2009-H1N1 epidemic, protecting the U.S population is the Federal Government’s primary responsibility. In addition, the Federal Government is concerned about the impact of the pandemic on other countries in terms of health effects (diseases spread rapidly across borders and epidemics do not end until they subside everywhere); economic consequences (pandemics can disrupt the global economy, trade, tourism, political stability, and foreign policy); and, importantly, humanitarian reasons (rooted in deeply held national values).

There is reason to believe that under-resourced countries may be at special risk during influenza epidemics. For instance, a recent study projected that, if a 1918–19-like pandemic were to happen today, 96 percent of the deaths would occur in the developing world. Given the relatively young demographic profile, the widespread prevalence of co-morbidities such as malnutrition, HIV/AIDS, and tuberculosis, and the fact that many of these countries do not have functional health systems, the 2009-H1N1 pan­demic could have a devastating impact on developing nations. Serious outbreaks already have been observed in underserved populations in the developed world. For example, aboriginal populations of Manitoba, which represent 10 percent of the population, appear to have accounted for 30 percent of cases of 2009-H1N1 influenza in the province so far and the majority of 2009-H1N1-infected patients requiring intubation in ICUs in Winnipeg.

While recognizing that issues with basic health infrastructure in developing countries cannot be rem­ edied in the short run, the availability of materials—including 2009-H1N1 vaccine, antiviral medications, antibiotics, personal protective equipment, and other essential medical materials—may help mitigate the impact of the epidemic. Unfortunately, global supplies of the most important of these items—vac­ cines and antiviral medications—are expensive and severely constrained; thus, large quantities are unlikely to be readily available to developing nations. The vast majority of production capacity for 2009- H1N1 vaccine, for instance, already has been reserved by industrialized countries.

Since 2005, the United States has taken a number of steps, often in conjunction with WHO, to support global pandemic preparedness, including the open sharing of information about novel influenza viruses and establishing capacity in developing countries to rapidly detect and respond to influenza viruses with pandemic potential (see Box 5C).


BOX 5C: SAMPLING OF U.S. ACTIONS TO SUPPORT GLOBAL PANDEMIC PREPAREDNESS

  • Sharing viral isolates, sequence information, and technical expertise with WHO and regional and national laboratories;
  • Providing technical assistance to support country-level pandemic planning over the past several years, including adaptation of community mitigation strategies to developing world contexts;

  • Providing technical assistance to support in-country public health and medical responses,, including adaptation of clinical guidelines and implementation of medical surge plans;

  • Providing resources to WHO, as well as personnel and technical assistance;

  • Supporting the WHO Global Access Plan to establish vaccine production capacity in developing countries and the WHO-managed stockpile of antiviral medications;

  • Providing extensive support of in-country laboratory and surveillance efforts; and

  • Supporting the response to 2009-H1N1 influenza in Mexico this spring, including a donation of 400,000 courses of oseltamivir.

Mindful of the urgency of protecting the U.S. population, the Working Group nonetheless believes that the United States can play an important role in efforts to reduce the impact of the 2009-H1N1 pandemic in developing countries, both independently and in collaboration with other countries and WHO. We recognize that the current lack of a U.S. Agency for International Development (USAID) Administrator and a Director of the Office of Global Health Affairs at DHHS has limited the institutional capacity to work on these issues. Nonetheless, we believe these issues should be addressed.


RECOMMENDATION 5-7: THREE ACTIVITIES TO REDUCE THE IMPACT OF THE EPIDEMIC ON DEVELOPING COUNTRIES

A. Take action to produce, purchase, or redirect vaccines, antiviral drugs, antibiotics, and medical materiel to developing countries in need of such support;

B. Use the influence of the United States, in collaboration with WHO, to convince other developed nations to pay close attention to the needs of developing countries during the pandemic and to encourage manufacturers to make vaccines and drugs available under donation and/or tiered-pricing schemes to those developing countries that have the plans and the capacity to use them effectively, and in the same time frame as these materials are made available to developed countries;

C. Incorporate the international consequences of mitigation plans into Federal decision-making processes for the pandemic—for example, by recognizing that efforts to conserve antigen by use of adjuvants in vaccines or to conserve antiviral drugs by restriction on inappropriate use could liberate valuable materials for use in poor countries severely affected by the epidemic

An Improbable Scenario Requiring More Stringent Non-Medical Measures

The 1918–19 pandemic was characterized by a relatively mild first wave of illness in spring 1918, fol­ lowed by much more severe second and third waves. This pattern could conceivably be repeated with the 2009-H1N1 virus, leading to a far greater strain on communities than described in Chapter 3 or cur­ rently anticipated by the Federal Government. While the Working Group views this specter as highly unlikely and inappropriate as a driver of Federal preparedness efforts, the possibility of such a “step change” in the severity of the pandemic (e.g., to “Category 5” in the current Pandemic Severity Index) cannot be entirely ignored. If it should occur, the Federal Government would be confronted with a national crisis and the prospect of hundreds of thousands of deaths, millions of hospitalizations, and a dramatic impact on the functioning of communities due to school closure, workplace absenteeism, and fear-driven changes in people’s behavior.

Such an event would stress the Federal Government in ways that are not discussed in this report. The Federal Government may be unable to respond to the number and scope of requests for Federal assistance from state and local authorities, whether for support of the healthcare infrastructure or the preservation of law and order. Communities may be unable to provide medical care to everyone in need, raising the prospect of rationing of services and mortality that would otherwise be preventable.

Federal, state, and local authorities may take unilateral action such as border closure, seizure of essential commodities, or curtailment of individual freedoms, out of fear or as a result of public pressure.

Under these circumstances, it would be necessary for the Federal Government to have streamlined mechanisms for decision making and coordination of the national response. The capability for such coordination extends well beyond the processes described earlier in this chapter, and falls into the realm of “national incident management.” The Federal Government has spent a great deal of time develop­ing systems for such coordination; the National Response Framework and associated documents are the result of that work. But these systems have never been tested by an event of the scope and scale described here. For this reason, it is essential that the Administration examine these systems of coor­ dination and the roles and responsibilities of all players—particularly the Departments of Homeland Security, Health and Human Services, Justice, Defense, State, and Education—to ensure that the Federal response can be scaled to the magnitude of the health crisis as warranted by the circumstances.

 



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