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The Rationing of Vaccines against Pandemic Influenza In recent years, the world has confronted the possibility of pandemic influenza, or “bird flu.” As history has shown, outbreaks of new variants of the influenza virus can have catastrophic consequences worldwide. In light of this threat, governments around the world have committed significant resources toward planning for a possible pandemic. Such plans must make difficult assessments amid great uncertainty regarding how, or even if, a pandemic will occur. Not surprisingly, the content of these reports from international agencies, national governments, states, and other groups have generated significant discussion and occasional criticism. A particularly complex debate has centered on the provision of vaccines during an influenza pandemic, particularly in the early stages of a pandemic, when vaccine supply will be extremely limited. As National Institutes of Health (NIH) researchers Ezekiel Emanuel and Alan Wertheimer write, “Doubtless, any principle of rationing will offend many.”1 While some are indeed likely to be offended by such discussion, others debate the appropriate prioritization of groups that ought to receive the scarce supply of vaccine. Even though significant questions exist over the availability and value of vaccines produced prior to the start of an influenza pandemic, there is no shortage of opinion on how such vaccines should be allocated. Public Policy on Pandemic Influenza It has been estimated that in the first year of a bird flu pandemic, only one in 10 Americans will be vaccinated given the current levels of vaccine production.2 It is widely accepted that it will take at least six months after an outbreak begins to produce an effective vaccine, due to factors such as the need to identify the precise pandemic strain and the current capacity for production.3 Clearly, if pandemic influenza arrives in the United States, the nation will have to face important rationing issues. In 2006, the Advisory Committee on Immunization Practices (ACIP), a CDC advisory body, and the National Vaccine Advisory Committee (NVAC) released their recommendations for vaccine allocation in the event of a global flu pandemic. They advised first immunizing the elderly, patients with at least two high-risk conditions (such as heart disease), and those with a history of severe pneumonia. First responders, key leaders in government, healthy senior citizens, and those with one risk factor would receive the vaccine next, followed by employees of the utility, transportation, and telecommunications industries. Jon Abramson, the chair of one of the two federal advisory panels, explained that equity was the primary principle used in the formulation of these guidelines, and that members of the panels “strongly felt [that] you cannot prioritize on the basis of age or gender or race.”4 Shortly after the NVAC/ACIP recommendations were made public, criticism arose. As Washington Post staff writer Ceci Connolly reported, “Already federal agencies are sparring over who is ‘critical,’ posing no-win dilemmas such as: air traffic controllers or border patrol officers?”5 Researchers Emanuel and Wertheimer at NIH came up with an alternate plan, published in the journal Science.6 They wrote, “The NVAC and ACIP approach is inadequate on both ethical and practical accounts.” They strove to develop an alternative to the two primary principles in vaccine allocation: saving the most lives by prioritizing the elderly and a pure life-cycle approach, which aims at saving the most life years by prioritizing infants, and instead advocated what they termed an “investment refinement of life-cycle principle including public order” (IRPOP).7, 8 Both the NVAC/ACIP and IRPOP approaches agree that vaccines should be distributed to front-line medical staff and first responders first, as well as the military, which may be needed to impose order and uphold authority in a time of chaos.9 The IRPOP then gives priority to 13- to 40-year-olds, including healthy members of these groups. A key principle guiding Emanuel and Wertheimer’s model is saving the most “life-years” rather than the most lives. They explain: “A 20-year-old has had great investment that is largely unfulfilled, while a 2-year-old has had minimal investment and a 65-year-old has had great investment that is largely fulfilled.... There is a good ethical argument that even if vaccinating the elderly saved the most life years, one should prefer the young over the old because the young have more unfulfilled life.”10 Younger children do not receive the highest priority because they can be protected by social isolation, which involves taking measures such as closing schools and community centers. The IRPOP model was met with a mix of support and criticism. Many agree that vaccinating those who are predicted to have the highest risk of hospitalization and dying is not the most appropriate method of rationing in a global pandemic.11 Rationing decisions should be made after taking factors such as risk severity, risk likelihood, transmissibility, and vaccine effectiveness into consideration, advocates of this view argue.12 In 2006, a study found that the elderly may reap less benefit from influenza vaccines because the antibody response in those aged 65 and older is less than half that of young adults. The elderly are also less likely to transmit the disease because, in general, they spend less time in high-density areas such as schools and offices.13 Critiques of the IRPOP model noted that children under age 13 were not included among the top priority groups. They also pointed to its failure to consider possible differential mortality rates with age and its potential to perpetuate existing injustices. The vaccination of children has been suggested by others as a way to limit the overall size of the pandemic and provide protection to older populations. Children have been deemed “most responsible for initiating and perpetuating epidemics” of influenza, and epidemiological and simulation studies have demonstrated that influenza vaccination targeted at children dramatically reduces community-wide disease transmission.14 Another critique of the IRPOP model states that it may not actually save the most life-years. For example, a 60-year-old with a life expectancy of 19 years and an expected mortality of 10% may have 1.9 years of life on average saved with vaccination. A healthy 80-year-old with a life expectancy of 7 years and an expected mortality of 50% would gain 3.5 years of life on average.15 As a result, vaccinating healthy 80-year-olds rather than healthy 60-year-olds may save more life-years. Conclusion As this very brief survey of some prominent proposals has shown, there are no easy solutions to rationing in the event of an influenza pandemic. The situation is complicated by the fact that scientists and government officials will have difficulty assessing who is at the greatest risk during a pandemic, data that will only become clear after it has concluded. In the 1918 pandemic, often referred to as a model for contemporary planning, 20- to 40-year-olds and children under the age of five experienced the highest mortality rates. However, in the flu pandemics of 1957 and 1968, the very young and the very old were more susceptible.16 As of May 10, 2007, the U.S. Department of Health and Human Services website for its Pandemic Influenza Plan retains support for and includes the document on the NVAC/ACIP Recommendations on Use of Vaccines. -- By Jessica Ho, University of Pennsylvania (yjho@sas.upenn.edu) For More Information • Information on vaccine allocation principles in HHS Pandemic Influenza Plan: http://www.hhs.gov/pandemicflu/plan/appendixd.html
1 Emanuel, Ezekiel J and Alan Wertheimer. “Response to: Deciding Who Should Get the Flu Vaccine.” Science 314(2006):1539. |
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