Pandemic H1N1 Influenza Vaccination Issues in the United States

The current H1N1 influenza pandemic is here. H1N1, also known as swine flu or Influenza A, is a highly contagious acute respiratory disease caused by a new virus that is affecting humans. A pandemic is an epidemic or disease that is spread out over a large geographic area and affects a large part of the population. Vaccination is considered one of the best ways of dealing with an influenza pandemic, but the new influenza vaccinations cannot be made quickly enough to vaccinate the whole population immediately. This causes legal and ethical issues as governments have to choose who gets vaccinated first, while also trying to keep up with the safety of the vaccinations themselves.

In a statement to the press on June 11, 2009, World Health Organization (WHO) Director-General Dr Margaret Chan declared the start of the 2009 H1N1 ("swine flu") influenza pandemic with these words: "On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met. I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6. The world is now at the start of the 2009 influenza pandemic" (Chan, 2009). The media reports that this new virus has infected at least a million Americans and has killed more than 400 people globally since it emerged in March (Fox, 2009).

Vaccination is considered to be one of the most cost-effective interventions in an influenza pandemic (AFP, 2009; Fauci, 2006; Kotali, 2005; Lister, 2005). However, a pandemic influenza vaccine most likely would not be available for at least six months (Fauci, 2006; French & Raymond, 2009). This six-month period allows for "the time needed to collect the virus, decipher its genetic makeup, develop a prototypic vaccine, and manufacture the final vaccine product, which must be evaluated by the Food and Drug Administration for use" (French & Raymond, 2009, p. 824). Under currently existing capabilities for manufacturing pandemic influenza vaccines, there is a good chance that "more than 90% of the U.S. population will not be vaccinated in the first year" (Emanuel & Wertheimer, 2007, p.24). The World Health Organization predicts that the H1N1 influenza pandemic will peak in October, when most people will have not yet received the vaccination, and they have also warned of a possible H1N1 vaccine shortage as winter approaches in the northern hemisphere (AFP, 2009).

Even ten years ago, scientists accurately predicted that should an influenza pandemic occur, there may be a limited supply of influenza vaccine (Meltzer, Cox, & Fukuda, 1999). In addition, once there is asufficient supply of vaccine to vaccinate the entire United States population, it will still take more time to administer the vaccine to everyone, especially if two doses are needed for adequate immune response (Meltzer, Cox, & Fukuda, 1999). These factors raise the question of how to prioritize those who will receive vaccinations (French & Raymond, 2009; Meltzer, Cox, & Fukuda, 1999).

The World Health Organization reports that when the pandemic influenza vaccine first becomes available, they anticipate that the demand will be greater than the supply (2009). While they predict that the gap will narrow as more vaccine becomes available over time (WHO, 2009), pandemics generally occur in waves and last for at least eighteen months (French & Raymond, 2009). Authors and political scientists, French and Raymond (2009) assert that "government officials must be prepared to face the first wave without an effective vaccine" (p. 823). While the federal government will provide broad guidelines for state and local governments, the state and local governments will have to make difficult decisions regarding vaccine prioritization and monitoring at the local level; these decisions "may have unprecedented legal and ethical implications" (French & Raymond, 2009, p. 823). Such crucial levels of responsibility and intergovernmental management present challenges to many state and local governments as they work to prioritize vaccine administration and distribution and ensure the safety of their jurisdictions.

Two federal advisory committees, the Advisory Committee on Immunization Practices (ACIP) and the National Vaccine Advisory Committee (NVAC) invoked what Emanuel and Wertheimer (2007) refer to as the "save-the-most-lives principle" of vaccine prioritization. This principle justifies giving top priority to health care workers and workers engaged in vaccine production and distribution to ensure that "maximal life-saving vaccine is produced and so that health care is provided to the sick" (Emanuel & Wertheimer, 2007, p. 16). In contrast, the Investment-Refinement Principle (IRP) "gives priority to people between early adolescence and middle age on the basis of the amount the person invested in his or her life balanced by the amount left to live"-that is, young adults are more valued than babies because they have more developed goals and dreams that are as yet unrealized (Emanuel & Wertheimer, 2007, p. 18). Another prioritization principle, the public-order principle, focuses on the importance of protecting the safety of individuals and the provision of food, fuel, and other basic necessities (Emanuel & Wertheimer, 2007).

Emanuel and Wertheimer (2007) believe "the investment refinement combined with the public-order principle (IRPOP) should be the ultimate objective of all pandemic response measures, including priority ranking for vaccines...These two principles should inform decisions at the start of an epidemic when the shape of the risk curves for morbidity and mortality are largely uncertain" (p. 18). The IRPOP ranking gives high priority to vaccine workers and direct-care health workers, but instead of prioritization for the sick elderly and infants, IRPOP emphasizes people between 13 and 40 years of age. Worldwide, swine flu is killing mostly people in their 20s, 30s and 40s (AFP, 2009), so this plan seems most relevant to the current strain of influenza. IRPOP prioritizes those age cohorts at highest risk during the devastating 1918 pandemic, compared to the NVAC and ACIP ranking which matches well with those most at risk during the milder 1957 and 1968 pandemics (Emanuel & Wertheimer, 2007). In addition, some mathematical models suggest that "following IRPOP propriety ranking could save the most lives" (Emanuel & Wertheimer, 2007, p. 18). Metzer, Cox, and Fukuda (1999) acknowledge that health care workers and essential service providers should likely be among the first to be vaccinated. However , they point out that "the logic behind using essential services as 'the' criteria for setting priorities will not cover the majority of the population" (Meltzer et al., 1999).

In the United States, most state and local governments look to the US Department of Health and Human Services (DHSS) for guidelines on vaccination prioritization during the event of an influenza pandemic (French & Raymond, 2009). The DHHS guidelines detail a tiered system for vaccine prioritization in the face of an influenza pandemic. The top tier is comprised of individuals providing essential health care services; the second tier includes those "at high risk of influenza complications"; the third, fourth, and fifth include public health emergency response workers, skilled nursing facility workers, and those individuals essential to critical infrastructure sectors; the sixth tier is comprised of individuals who are severely immune-compromised; and the last tier of infants younger than six months of age (DHHS, 2005). French and Raymond (2009) point out that "[t]his prioritization policy considers medically high-risk and at-risk individuals to be of higher priority, based on their position within the system, than some individuals who would ensure the preservation of social continuance" (p. 826).

While theDHHS has published and updated their recommended guidelines for vaccine prioritization, state and local governments have the freedom to tailor their vaccination distribution prioritization policy to their own plans (French & Raymond, 2009) and are not bound by hierarchical constraints from the DHHS's federal recommendations. However, government officials at all levels in this democracy must be conscientious of the personal values of individuals in society who oppose vaccinations for religious, medical, or philosophical reasons, while carefully balancing that consideration with the importance of preventing harm to the overall population. Public health officials have the legal authority to require vaccinations, but there must be "a reasonable relationship between the public health intervention and the demonstrable threat to the community" (French & Raymond, 2009, p. 826). Prioritization plans for pandemic vaccinations and the treatment of those who refuse vaccinations both raise ethical and legal concerns (French & Raymond, 2009). Addressing these concerns needs to be a priority of a responsible government, at federal, state, and local levels.

According to media reports, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said clinical trials would likely begin in August to make sure the new H1N1 vaccines are safe, and to see which dose will be best. "All of this seems to be pretty much on schedule but when you are dealing with vaccines, anything can happen," Fauci said in an interview (Fox, 2009). In addition, the President's Council of Advisors on Science and Technology (PCAST)-"an advisory group of the nation's leading scientists and engineers-recommended an accelerated "productionof an initial quantity of finished vaccineas early as mid-September, to allow vaccination of up to 40 million people, with emphasis on the most vulnerable age and disease groups, as soon as initial data are available on safety and immunogenicity" (2009, p. 35). Recent reports quote HHS vaccine expert Dr. Bruce Gellin as asserting, "At mid-October we might have as much as 100 million doses of vaccine" (Fox, 2009). As predicted by the aforementioned authors, researchers, and bureaucracies, the creation and distribution of the H1N1 influenza vaccine is lagging behind the need for it.

The operational pandemic vaccination plans f some local governments also show both strengths and weaknesses. French and Raymond (2009) evaluated the pandemic influenza policies of eight large cities across the United States to determine whether and how the DHHS recommendations have been incorporated into local government preparedness plans. They determined that in regard to vaccine distribution and use, all eight cities had state-based plans for distribution, use, and monitoring of vaccinations (French & Raymond, 2009). In addition, most of the plans specified guidelines for "the procurement, storage, security, distribution, and monitoring of actions to ensure access to the treatments during a pandemic" (French & Raymond, 2009, p. 827). Six of the plans referenced procedures for tracking vaccine recipients, the training requirements of involved personnel, and the distribution plan for specific locations in the community (French & Raymond, 2009). Unfortunately, only two of the plans "actually included information for citizens in advance about where they would be vaccinated" (French & Raymond, 2009, p. 827). This oversight appears to be a failure in communication in shared planning between public and private organizations-the local governments and the operators of the public and private facilities where vaccinations could take place. Clearly intergovernmental management is important as federal, state, and local governments address the allocation and management of funds and other resources across jurisdictions when dealing with this influenza pandemic and the resulting vaccination issues.

French and Raymond offer the following key recommendations for vaccine distribution and use to local governments:

• Work with health care partners "to develop state-based plans for vaccine distribution, use, and monitoring";

• Implement an operational plan that focuses on "the procurement, storage, security, distribution, and monitoring actions necessary to ensure access to this product during a pandemic";

• Ensure that the operational plan outlines procedures for "tracking the number and priority of vaccine recipients, where and by whom vaccinations will be given, a distribution plan for ensuring that vaccine and necessary equipment and supplies are available at all points of distribution in the community, the security and logistical support for the points of distribution, and the training requirements for involved personnel";

• Include plans for security issues, transport and storage issues, and biohazardous waste issues connected with vaccines;

• Plan ways to meet the needs of "vulnerable and hard-to-reach populations";

• And "[i]nform citizens in advance about where they will be vaccinated" (French & Raymond, 2009, p. 828).

With federal, state, and local governments urging priority groups to receive influenza vaccinations, accountability is crucial. Many Americans have expressed concerns about the safety of rapidly manufactured new vaccines, and Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, reassures the public: "H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and over, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust" (2009). The numbers of individuals who will eventually be vaccinated cannot be known until scientists determine whether one or two doses of the vaccine will be needed to achieve protection (WHO, 2009).

In the face of the H1N1 influenza pandemic, governments at all levels are confronted with many legal and ethical issues as they try to determine who will receive limited influenza vaccinations, while also considering the stances of those against vaccinations, and weighing the benefits and safety of the vaccinations with the risks. Various tiered-prioritizations systems have been proposed to determine who most needs the influenza vaccines, but not all are in agreement. While the federal government has issues guidelines to those state and local governments, design and implementation of operations vaccination plans is on the shoulders of the state and local jurisdictions themselves. The complicated issues with pandemic influenza vaccination have been known for years, but there is still no simple solution.

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