Published on: August 19, 2024
PLEASE READ THE ARTICLE FIRST.
ABSTRACT
Production of a vaccine would take a minimum of six months after isolation of the circulating strain and given the capacity of all the current international vaccine manufacturers, supplies during those next six months would be limited to fewer than a billion monovalent doses. Since two doses may be required for protection, we could vaccinate fewer than 500 million people -- approximately 14 percent of the world's population.
FULL TEXT
Annual influenza epidemics are like Minnesota winters -- all are challenges, but some are worse than others. No matter how well we prepare, some blizzards take quite a toll. Each year, despite our efforts to increase the rates of influenza vaccination in our most vulnerable populations, unpredictable factors largely determine the burden of influenza disease and related deaths. During a typical year in the United States, 30,000 to 50,000 persons die as a result of influenza virus infection, and the global death toll is about 20 to 30 times as high as the toll in this country. We usually accept this outcome as part of the cycle of life. Only when a vaccine shortage occurs, or young children die suddenly does the public demand that someone step forward to change the course of the epidemic. Unfortunately, the fragile and limited production capacity of our 1950s egg-based technology for producing influenza vaccine and the lack of a national commitment to universal annual influenza vaccination mean that influenza epidemics will continue to present a substantial public health challenge for the foreseeable future.
An influenza pandemic has always been a great global infectious-disease threat. There have been 10 pandemics of influenza A in the past 300 years. A recent analysis showed that the pandemic of 1918 and 1919 killed 50 million to 100 million people,1 and although its severity is often considered anomalous, the pandemic of 1830 through 1832 was similarly severe -- it simply occurred when the world's population was smaller. Today, with a world population of 6.5 billion -- more than three times that in 1918 -- even a relatively ""mild"" pandemic could kill many millions of people.
Influenza experts recognize the inevitability of another pandemic. When will it begin? Will it be caused by H5N1, the avian influenza virus strain currently circulating in Asia? Will its effect rival that of 1918 or be more muted, as was the case in the pandemics of 1957 and 1968? Nobody knows.
So how can we prepare? One key step is to rapidly ramp up research related to the production of an effective vaccine, as the Department of Health and Human Services is doing. In addition to clinical research on the immunogenicity of influenza vaccines, urgent needs include basic research on the ecology and biology of influenza viruses, studies of the epidemiologic role of various animal and bird species, and work on early interventions and risk assessment.2 Equally urgent is the development of cell-culture technology for production of vaccine that can replace our egg-based manufacturing process. Today, making the 300 million doses of influenza vaccine needed annually worldwide requires more than 350 million chicken eggs and six or more months; a cell-culture approach may produce much higher antigen yields and be faster. After such a process was developed, we would also need assured industrial capacity to produce sufficient vaccine for the world's population during the earliest days of an emerging pandemic.
Beyond research and development, we need a public health approach that includes far more than drafting of general plans, as several countries and states have done. We need a detailed operational blueprint of the best way to get through 12 to 24 months of a pandemic.
What if the next pandemic were to start tonight? If it were determined that several cities in Vietnam had major outbreaks of H5N1 infection associated with high mortality, there would be a scramble to stop the virus from entering other countries by greatly reducing or even prohibiting foreign travel and trade. The global economy would come to a halt, and since we could not expect appropriate vaccines to be available for many months and we have very limited stockpiles of antiviral drugs, we would be facing a 1918-like scenario.
Production of a vaccine would take a minimum of six months after isolation of the circulating strain and given the capacity of all the current international vaccine manufacturers, supplies during those next six months would be limited to fewer than a billion monovalent doses. Since two doses may be required for protection, we could vaccinate fewer than 500 million people -- approximately 14 percent of the world's population. And owing to our global ""just-in-time delivery"" economy, we would have no surge capacity for health care, food supplies, and many other products and services. For example, in the United States today, we have only 105,000 mechanical ventilators, 75,000 to 80,000 of which are in use at any given time for everyday medical care; during a garden-variety influenza season, more than 100,000 are required. In a pandemic, most patients with influenza who needed ventilation would not have access to it.
We have no detailed plans for staffing the temporary hospitals that would have to be set up in high-school gymnasiums and community centers -- and that might need to remain in operation for one or two years. Health care workers would become ill and die at rates similar to, or even higher than, those in the general public. Judging by our experience with the severe acute respiratory syndrome (SARS), some health care workers would not show up for duty. How would communities train and use volunteers? If the pandemic wave were spreading slowly enough, could immune survivors of an early wave, particularly health care workers, become the primary response corps?
Health care delivery systems and managed-care organizations have done little planning for such a scenario. Who, for instance, would receive the extremely limited antiviral agents that will be available? We need to develop a national, and even an international, consensus on the priorities for the use of antiviral drugs well before the pandemic begins. In addition, we have no way of urgently increasing production of critical items such as antiviral drugs, masks for respiratory protection, or antibiotics for the treatment of secondary bacterial infections. Even under today's relatively stable operating conditions, eight different anti-infective agents are in short supply because of manufacturing problems. Nor do we have detailed plans for handling the massive number of dead bodies that would soon exceed our ability to cope with them.
What if an H5N1 influenza pandemic began not now but a year from now? We would still need to plan with fervor for local nonmedical as well as medical preparedness. Planning for a pandemic must be on the agenda of every public health agency, school board, manufacturing plant, investment firm, mortuary, state legislature, and food distributor. Health professionals must become much more proficient in ""risk communication,"" so that they can effectively provide the facts -- and acknowledge the unknowns -- to a frightened population.3
With another year of lead time, vaccine might have a more central role in our response. Although the manufacturing capacity would still be limited, strategies such as developing antigen-sparing formulations -- that is, intradermal formulations that take advantage of copious numbers of dendritic cells for antigen processing or formulations including adjuvants to boost the immune response -- might extend the vaccine supply. Urgent planning efforts are required to ensure that we have the syringes and other essential equipment, as well as the workforce, for effective delivery. Finally, a detailed plan for vaccine allocation will be needed -- before the crisis, not during it.
What if the pandemic were 10 years away and we embarked today on a worldwide influenza Manhattan Project aimed at producing and delivering a pandemic vaccine for everyone in the world soon after the onset of sustained human-to-human transmission? In this scenario, we just might make a real difference.
The current system of producing and distributing influenza vaccine is broken, both technically and financially. The belief that we can greatly advance manufacturing technology and expand capacity in the normal course of increasing our annual vaccination coverage is flawed. At our current pace, it will take generations for meaningful advances to be made. Our goal should be to develop a new cell-culture-based vaccine that includes antigens that are present in all subtypes of influenza virus, that do not change from year to year, and that can be made available to the entire world population. We need an international approach to public funding that will pay for the excess production capacity required during a pandemic.
Today, public health experts and infectious-disease scientists do not know whether H5N1 avian influenza virus threatens an imminent pandemic. Most indications, however, suggest that it is just a matter of time: witness the increasing number of H5N1 infections in humans and animals, the documentation of additional small clusters of cases suggestive of near misses with respect to sustained human-to-human transmission, the ongoing genetic changes in the H5N1 Z genotype that have increased its pathogenicity, and the existence in Asia of a genetic-reassortment laboratory -- the mix of an unprecedented number of people, pigs, and poultry.
It is sobering to realize that in 1968, when the most recent influenza pandemic occurred, the virus emerged in a China that had a human population of 790 million, a pig population of 5.2 million, and a poultry population of 12.3 million; today, these populations number 1.3 billion, 508 million, and 13 billion, respectively. Similar changes have occurred in the human and animal populations of other Asian countries, creating an incredible mixing vessel for viruses. Given this reality, as well as the exponential growth in foreign travel during the past 50 years, we must accept that a pandemic is coming -- although whether it will be caused by H5N1 or by another novel strain remains to be seen.
Should H5N1 become the next pandemic strain, the resultant morbidity and mortality could rival those of 1918, when more than half the deaths occurred among largely healthy people between 18 and 40 years of age and were caused by a virus-induced cytokine storm (see diagram ) that led to the acute respiratory distress syndrome (ARDS).4 The ARDS-related morbidity and mortality in the pandemic of 1918 was on a different scale from those of 1957 and 1968 -- a fact that highlights the importance of the virulence of the virus subtype or genotype. Clinical, epidemiologic, and laboratory evidence suggests that a pandemic caused by the current H5N1 strain would be more likely to mimic the 1918 pandemic than those that occurred more recently.5 If we translate the rate of death associated with the 1918 influenza virus to that in the current population, there could be 1.7 million deaths in the United States and 180 million to 360 million deaths globally. We have an extremely limited armamentarium with which to handle millions of cases of ARDS -- one not much different from that available to the front-line medical corps in 1918.
Is there anything we can do to avoid this course? The answer is a qualified yes that depends on how everyone, from world leaders to local elected officials, decides to respond. We need bold and timely leadership at the highest levels of the governments in the developed world; these governments must recognize the economic, security, and health threats posed by the next influenza pandemic and invest accordingly. The resources needed must be considered in the light of the eventual costs of failing to invest in such an effort. The loss of human life even in a mild pandemic will be devastating, and the cost of a world economy in shambles for several years can only be imagined.
An interview with Dr. Osterholm can be heard at www.nejm.org.
References
1. Johnson NP, Mueller J Updating the account lobal mortality of the 1918-1920 ""Spanish"" influenza pandemic. Bull Hist Med 2002;76:105-115
2. Stohr K Avian influenza and pandemics--research needs and opportunities. N Engl J Med 2005;352:405-407
3. Sandman PM, Lanard J. Pandemic influenza risk communication:the teachable moment. 2005. (Accessed April 14, 2005, at http://www.psandman.com/col/pandemic.htm.)
4. Kobasa D, Takada A, Shinya K, Enhanced virulence of influenza A viruses with haemagglutinin of the 1918 pandemic virus. Nature 2004;431:703-707
5. Peiris JS, Yu WC, Leung CW, Re-emergence of fatal human influenza A subtype H5N1 disease. Lancet 2004;363:617-619
In the article by Osterholm, the author presents a possibility of another pandemic. Consider your leadership perspective during a pandemic influenza outbreak in the United States
As the Director of FEMA, how would you respond during this outbreak?
Use a systems approach to work with Director, CDC, Governor of an afflicted state, Incident Response Commander, Response Leader, American Red Cross (or other non-governmental organization) to establish immediate response in preventing another pandemic.
Based on the leadership role as Director, FEMA, include the following:
A summary of the leadership challenges this leader would face in assuring the system changes necessary to be prepared for the next pandemic.
An explanation of how your leadership challenges as Director, FEMA relate to challenges of the other leaders listed above.
An explanation of how transformational and transactional leaders might influence outcomes within this case
A summary of how poor leadership might affect the outcome of the case"
The following is the FEMA Director’s Action Plan in Response to a Pandemic Influenza Outbreak:
Summary of Leadership Challenges
As the Director of FEMA, responding to a pandemic influenza outbreak involves several key challenges:When it comes to dealing with the outbreak of a pandemic influenza as the Director of FEMA the following key challenges can be identified.
Coordinating with Multiple Agencies: Ensuring that the CDC, state governors, Incident Response Commanders and NGOs such as the America Red Cross is in sync. This requires the well stated channels of communication and also the cooperation agreements on the division of labor.
Resource Allocation: Functioning in the management of limited resources such as vaccines and antiviral drugs formulations and other related medical products. These are issues such as those that pertain to enhancing the production and distribution Spurs in the shortest time possible.
Public Communication: To enlighten the public and reduce their fear by telling them the right information and also to encourage them to follow the health standards. It also entails discrediting myths and myths and pacifying communities.
Planning and Preparedness: The measures include; developing and implementing formal plans to combat the pandemic, setting up of thora hospitals, training of more personnel in the health sector as well as ensuring that health facilities have the capacity to handle more patients.
Political and Public Pressure: When it comes to meeting the demands of the political class and the society which is increasingly impatient and demanding.
The relationship between Leadership Challenges and Other Leaders
Director, CDC: There is no intersection between CDC’s core objectives that are research, vaccines, and epidemiology and FEMA’s core tasks of logistics and coordination. It is essential for both the leaders to make sure that their strategies are not contradictory and the resources are optimally used.
Governor of an Afflicted State: He has to do with matters to do with the state policy and co-ordination of the state’s power. To this end, helping in the coordination with FEMA and other federal agencies for the state level implementation of the strategies is crucial.
Incident Response Commander: This leader is in charge of probably the on ground response and the emergency operations. Some of the functions are to put into practice the plans that FEMA and other entities develop, coordination of the local activities, and improvement of the overall systems.
Response Leader: It is often from an NGO and may encompass community mobilisation and support services. They are intended to address current requirements and provide support in the activities of FEMA and other organizations.
The Impact of Transformational and Transactional Leadership
Transformational Leadership:
Vision and Inspiration: The transformational leaders would make sure that the teams are motivated, to this end, they would describe what the response entails and encourage creativity.
Change Management: It would give the leadership to effect the system change necessary for the management of the pandemic, for instance, to set new processes or to acquire new technologies for vaccine delivery.
Empowerment: This type of leadership foster cooperation and enable all the employees at all the level hence enhancing their performance during the management of the outbreak.
Transactional Leadership:
Task and Process Focus: Transactional leadership would be appropriate in the case of the following, for instance, supplying of materials or following the laid down health measures.
Efficiency: This is useful in ensuring that the needs of the moment are served and that the responses given are within the normal scheme of things which is quite handy in managing a crisis.
Performance Monitoring: They would be very watchful over the performance and would ensure that the goals that have been set are met, any deviation from the plan being corrected immediately.
Impact of Poor Leadership
Poor leadership could severely impact the outcome of the pandemic response in the following ways:If poor leadership is entertained, the following may happen in the course of handling the pandemic:
Ineffective Coordination: It has been realized that non-effective communication and co-ordination leads to delayed action, repetition of action, overlap and/or void in action.
Resource Mismanagement: It means that if resources are not properly used in the system, then what may transpire is that the scarce resource will be absent where it is most needed and hence the situation will be compounded.
Public Mistrust: This would mean that there would be no trust, non-adherence to the set measures and cross infections.
Operational Failures: Failure to plan for management and lack of flexibility to changes means that the response interventions may not be effective and lead to more morbidity and mortality.
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