Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine

Excerpt, please click on the title for the whole document.

Introduction

Effective allocation of vaccines will play a critical role in preventing influenza and reducing its effects on health and society when a pandemic arrives. The specific type of influenza that causes a pandemic will not be known until it occurs. Developing a new vaccine in response will take several months and pandemic vaccine may not be available when cases first occur in the United States. Moreover, once vaccine production begins, it will not be possible to make enough new vaccine to protect everyone in the early stages of a pandemic.

The U.S. Government is taking steps to minimize the need to make vaccine allocation decisions by supporting efforts to increase domestic influenza vaccine production capacity. Significant funding is being provided to develop new vaccine technologies that allow production of enough pandemic influenza vaccine for any person in the United States who wants to be vaccinated within six months of a pandemic declaration. Until this goal is met, Federal, State, local and tribal governments, communities, and the private sector will need guidance on who should be vaccinated earlier during the pandemic to best protect our people, communities, and country.

Issues to consider in drafting guidance on pandemic influenza vaccination are different and more complex than in developing recommendations for vaccination against annual influenza. In contrast with annual influenza, during a pandemic nobody in the population is likely to have immunity to the virus, many more people will become ill, and rates of severe illness, complications and death are likely to be much higher and more widely distributed throughout the population. The greater frequency and severity of disease will increase the burden on health care providers and institutions and may disrupt critical products and services in health care and other sectors. National and homeland security could be threatened if illness among military and other critical personnel undermines their capabilities. Because the needs that must be addressed by pandemic vaccination differ from annual influenza vaccination, the guidance on vaccination differs as well.

This draft guidance is intended to provide strong advice to support planning an effective and consistent pandemic response by States and communities. Nevertheless, it is important that plans are flexible as the guidance may be modified based on the status of vaccine technology, the characteristics of pandemic illness, and risk groups for severe disease – factors that will remain unknown until a pandemic actually occurs.

The Federal Government has embarked on a rigorous and collaborative process that seeks input from all interested parties in developing this strategy. Hearing opinions from persons and organizations with a wide variety of interests and concerns is the best way to ensure that allocation of vaccine in the early stages of a pandemic is fair and provides the best chance for our country to emerge from a pandemic with minimal levels of illness, death, and disruption to our society and economy.

Public and stakeholder input have been central to the development of this draft guidance and will continue to be crucial as the guidance is finalized. Comments received on this draft guidance will be considered by a Federal Government working group made up of members of various U.S. Government agencies, and will contribute to a final guidance document. Comments on this draft strategy will be solicited through:

• Public meetings,
• Stakeholders meetings,
• Web-based public dialogue, and
• A request for comments posted at www.pandemicflu.gov and in the Federal Register.

Vaccination will be only one of several tools that can be used to fight the spread of influenza when a pandemic emerges. Other approaches include public health measures in communities, businesses, and households to reduce and slow the spread of infection; using antiviral medications for treatment and prevention; and washing hands and covering coughs and sneezes. These strategies will be the initial mainstay of a pandemic response before vaccine is available and continue to have important effects as vaccination availability progresses. Guidance around vaccine use is meant to be applied in conjunction with and in the context of these other pandemic response efforts. More information about pandemic planning and response measures is provided at www.pandemicflu.gov.

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