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Biosecurity Briefing
Federal Government Issues Draft Guidance for Allocating Pandemic Vaccine, Seeks Public Comments By Jennifer Nuzzo, October 26, 2007 On October 23, 2007, the U.S. government released Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. Anticipating limited supplies of vaccine during an influenza pandemic, the federal government developed the draft document to provide states and communities with guidance “on who should be vaccinated earlier during the pandemic to best protect our people, communities and country.”1 The new draft guidance, which is dated October 17, 2007, is an update from an earlier prioritization scheme that was based on 2005 guidance from the National Vaccine Advisory Council and the Advisory Committee on Immunization Practice. The guidance document was “drafted by a Federal interagency working group whose members represent all sectors of the government.” According to the document, “information considered by the working group included rigorous scientific assessment of pandemics and pandemic vaccines, national and homeland security issues, essential community services and the infrastructures and workforces critical to maintaining them, and the perspectives of the state and local public health and homeland security experts” as well as a historical analysis of past pandemics and the perspectives of professional ethicists. In addition, the working group considered input from “meetings with the public and stakeholders including business and community organizations.” A detailed description of the draft guidance development process is contained in Appendix A of the document. According to the document, “one of the important findings of the working group analysis, and the strongest message from the public and stakeholder meetings, was that there is no single, overriding objective for pandemic vaccination and no single target group to protect at the exclusion of others.” Rather, the working group found that “there are several important objectives and, thus, vaccine should be allocated simultaneously to several groups.” To that end, the deliberative process identified that the most important objectives of the U.S. pandemic vaccination program should be to protect the following individuals during a pandemic:
In addition to these four objectives, the “working group discussions highlighted the important Federal objective of maintaining homeland and national security.”1 With those objectives in mind, the working group vaccine prioritization guidance divides the U.S. population into target groups, categories, levels, and tiers. Target groups are “defined by a common occupation, type of service, age group, or risk level.” Pandemic vaccination target groups are then “clustered into four broad categories (homeland and national security, health care and critical support services, critical infrastructures, and the general population),” which are defined in order to help meet the above “major objectives of the pandemic vaccination program.” Everyone in the U.S. is included in at least one of these four categories. In the event that an individual falls under more than one category, he/she “would be targeted for vaccination with the earliest group in which they are included.” Within categories, vaccination target groups are further clustered into levels, and then tiers, which vary depending on the severity of the pandemic. Tiers may be further subdivided if vaccine is in extremely short supply. The following graphic is an illustration of how vaccine will be prioritized according to this tiered system during a severe pandemic (pandemic severity index 4 or 5): Figure 1. Vaccination tiers and target groups for a severe pandemic. This figure illustrates how vaccination is administered by tiers until the entire U.S. population has had the opportunity to be vaccinated, and how tiers integrate target groups across the four categories balancing vaccine allocation to occupationally defined groups and the general population.1
Source: Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. http://www.pandemicflu.gov/vaccine/prioritization.html. Accessed October 26, 2007. Tier 1 represents the groups that would be assigned highest priority for vaccine during a pandemic. The document states that vaccine allocation to the states will be based on population. While states should follow national guidance, they “will have some flexibility in defining the target groups and implementing the guidance to best fit their local situations.” To that end, “a small portion of each State’s vaccine allocation may be maintained at the State level for distribution based on the specific needs of that jurisdiction.”1 The document stresses that “public and stakeholder input…will be crucial as the guidance is finalized.” “Comments on the draft document will be solicited through:
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