Testimony

Statement by
Bruce Gellin, M.D., M.P.H.
Director
National Vaccine Program Office
U.S. Department of Health and Human Services

on
Avian Influenza: Preparing for a Possible Influenza Pandemic

before
Committee on Appropriations
Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
United States House of Representatives

Thursday, March 30, 2006

Introduction
I am Dr. Bruce Gellin, Director of the National Vaccine Program Office within the Department of Health and Human Services. Mr. Chairman, Ms. DeLauro, and members of the Subcommittee, I am honored to be here today to describe for you how the Department of Health and Human Services (HHS) is working to improve preparedness for a potential human influenza pandemic. Dr. Jesse Goodman, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) joins me today. We are pleased to appear today with Secretary Johanns and Dr. Ron DeHaven of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). USDA is one of our frontline partners in this effort to monitor, prepare for, and respond to a potential pandemic.

Working to Meet the Existing threat
On November 1, 2005, President Bush released the National Strategy for Pandemic Influenza, which outlines the roles of the Federal government, State and local governments, private and international partners, and individual citizens in preparing for and responding to an influenza pandemic. The following day, Secretary Leavitt announced the HHS Pandemic Influenza Plan-a blueprint for all HHS pandemic influenza preparedness and response planning. The HHS Plan provides guidance to national, State, and local policy makers and health departments with the goal of achieving national readiness and the ability to respond quickly and effectively to a pandemic. The HHS plan also includes an outline of key roles and responsibilities during a pandemic. In the event of a pandemic and the activation of the National Response Plan, HHS has a critical role to play managing the public health and medical response and supporting the Department of Homeland Security in its role of overall domestic incident management and Federal coordination.

As you know, the President requested $7.1 billion in emergency funding for the National Strategy for Pandemic Influenza, of which $6.7 billion was requested for HHS. Congress appropriated $3.8 billion as the first installment of the President's request to begin these priority activities, and of this amount, $3.3 billion was provided to HHS. We appreciate the action of Congress on this appropriation as it takes us an essential step forward to becoming the first generation in history to be prepared for a possible pandemic.

As you are also aware, the potential for a human influenza pandemic is a current public health concern with an immense potential impact. Pandemics are not new. There were three in the 20th century, the worst of which was the Spanish flu epidemic in 1918-1919 that is estimated to have killed over one half million people in the U.S. and 50 million worldwide. While we are focusing today on the impact of a possible pandemic of avian flu, many of the policy issues and preparedness measures that arise for avian flu apply as well to pandemics of other types of influenza, other emerging infectious disease outbreaks and public health emergencies. To put the impact of a pandemic in context, the seasonal influenza that we have today causes an average of 36,000 deaths each year in the United States, mostly among the elderly, and adds more than 200,000 hospitalizations.

Scientists cannot accurately predict the severity and impact of an influenza pandemic, whether from the H5N1 virus currently circulating in birds in Asia and Europe, or the emergence of another influenza virus of pandemic potential. However, it is still useful to model possible scenarios based on analysis of past pandemics. In a report released in December 2005, the Congressional Budget Office presents the results of modeling a severe pandemic scenario similar to the 1918 Spanish flu outbreak and a more moderate outbreak resembling the flu pandemics of 1957 and 1968. In the severe scenario, roughly 90 million people become ill and 2 million die in the United States and the impact on the real Gross Domestic Product [GDP] is about a 5 percent reduction in the year following the outbreak. While there is substantial uncertainty associated with these estimates, they illustrate the enormous public health threat of an influenza pandemic and the need for effective access to vaccines, treatments, and a robust public health infrastructure to meet the challenge.

There are several important points to note about an influenza pandemic:

  • A pandemic could occur anytime during the year and is unlikely to behave like a typical seasonal influenza. Rather, past pandemics have occurred in "waves" of infection and could persist in the world for over a year.
  • The capacity to prevent or control transmission of the virus once it gains the ability to be efficiently transmitted from person to person will be limited.
  • Right now, the H5N1 avian influenza strain that is circulating in Asia and Europe among birds is considered the leading candidate to cause the next pandemic. However, influenza viruses rapidly evolve and have the potential to spark a pandemic. Therefore, it is possible that another influenza virus, which could originate anywhere in the world, could cause the next pandemic. This uncertainty is one of the reasons why we need to maintain year-round surveillance of influenza viruses to be able to determine if there are genetic changes that may signal a potential pandemic, to develop reference viruses that can be used to develop pandemic vaccines, and to assess whether influenza viruses have developed resistance to antiviral drugs. As is the case with the H5N1 that is currently in birds around the world, pandemic influenza viruses often emerge in animals. Like other viruses, they tend to remain within a species, however, as we have seen already in the 186 documented cases of human infection confirmed by the World Health Organization, they do have the ability to infect humans who have high levels of exposure to infected birds. Of greatest concern for human health is the question of whether the viruses will develop the ability to readily infect people and whether these viruses will be able to transmit efficiently from person to person as is the case with seasonal flu. For all of these reasons, it is critical to maintain constant surveillance of viruses worldwide affecting animal populations and that can potentially be transmitted to humans.
  • We often look to history in an effort to understand the impact that a new pandemic might have, and how to intervene most effectively. However, there have been many changes in society since the "great influenza" of 1918, including dramatic changes in population and social structures, medical and technological advances, and a significant increase in international travel. Some of these changes have increased our ability to plan for and respond to pandemics, but other changes have made us more vulnerable.

HHS Preparations for Pandemic Influenza
In FY 2006, the President announced an emergency budget request of $7.1 billion, of which $6.7 billion was for HHS pandemic influenza activities. The goal of this funding was to:

  1. Produce a course of pandemic influenza vaccine for every American within six months of an outbreak;
  2. Provide enough antiviral drugs and other medicals supplies to treat 25 percent of the U.S. population; and
  3. Ensure a domestic and international public health capacity to detect and respond to a potential pandemic.

While not tied to the $7.1 billon request, a collateral goal was to stockpile enough pre-pandemic influenza vaccine for 20 million persons.

In December 2005, Congress appropriated $3.8 billion to help the Nation prepare for pandemic influenza preparedness activities. Of that total, Congress allocated $3.3 billion to HHS for the first year of funding of the HHS Pandemic Influenza Plan, including $20 million for the FDA. HHS will use these emergency funds to help achieve five primary objectives:

  1. Monitoring disease spread to support rapid response;
  2. Developing vaccines and vaccine production capacity;
  3. Stockpiling antivirals and other countermeasures;
  4. Coordinating Federal, State and local preparation; and
  5. Enhancing outreach and communications planning.

HHS is working both domestically and internationally to monitor the spread of H5N1 and other possible pandemic viruses. Through collaborations with the World Health Organization (WHO), the United Nations Food and Agriculture Organization, the World Organization for Animal Health, the Institute Pasteur, and numerous national governments, HHS is working to build capacity in other countries to detect outbreaks early and to contain the spread of the virus. On the domestic front, CDC is strengthening local laboratory capacity and capability, and accelerating implementation of the national BioSense program to enhance our ability to detect an outbreak early.

In the event of a pandemic, movement restriction, social distancing measures, and antiviral drugs will be the first line of defense before a vaccine is available and could delay the spread of the pandemic. On March 22, Secretary Leavitt announced the purchase of additional antiviral drugs that could be used in the event of a potential influenza pandemic. With the FY 2006 emergency funding, HHS has ordered a total of 3.95 million treatment courses of antiviral drug Relenza and 16.2 million treatment courses of Tamiflu. With these purchases, the Strategic National Stockpile will have 26 million treatment courses of antiviral drugs that will be available to the States when an influenza pandemic is imminent.

The cornerstone of the HHS Pandemic Influenza Plan is to create domestic manufacturing capacity sufficient to produce 300 million vaccine courses within 6 months of the onset of a pandemic outbreak, and to maintain a stockpile of pre-pandemic vaccine. The FY 2006 funding will increase vaccine production capacity by accelerating cell-based manufacturing technology, increasing egg-based vaccine production capacity, and supporting the advanced development for antigen sparing technologies that could extend the vaccine supply by decreasing the amount of antigen needed to protect each individual.

Pandemic influenza preparedness requires the active planning and participation of States and local communities. If a pandemic was to occur in the U.S., it would likely affect thousands of communities at the same time over the course of many weeks. The Federal Government is working to provide guidance regarding how state, local, and tribal governments can develop pandemic preparedness plans and respond in the event of a pandemic. As part of the Administration's effort to enhance State and local pandemic preparedness, HHS has held pandemic influenza summits in 26 States and the District of Columbia. As part of the Administration's goal to enhance State and local pandemic preparedness, HHS has held pandemic influenza summits in 26 States and the District of Columbia. These summits have brought together State and local officials, public health, schools, businesses, and other stakeholders to discuss pandemic preparedness. With the FY 2006 emergency funding, HHS has awarded $100 million of the $350 million allocated for State preparedness for pandemic influenza preparedness planning activities. The remaining portion of these funds will be awarded based on benchmarks that will measure States' progress.

Effective communications and outreach are essential to pandemic preparedness. President Bush called for the development of a single, comprehensive web site to be the official Federal source of pandemic and avian influenza information. This web site, www.PandemicFlu.gov, includes a wide range of information on pandemic influenza and preparedness activities. In addition, HHS has developed checklists for State and local planning, businesses, health care providers, community organizations, and individuals and families.

FDA Activities under the Emergency Supplemental
Congress appropriated $20 million for FDA in the FY 2006 Emergency Supplemental Appropriations Act. FDA is using these funds to address one of the five HHS priorities - developing vaccines and vaccine production capacity. These resources will significantly enhance the existing FDA programs to facilitate development of pandemic vaccines and increase manufacturing capacity using both new and existing egg-based technologies. Specific activities include:

  • In conjunction with HHS, developing and launching a comprehensive FDA pandemic influenza preparedness strategy and emergency response plan.
  • Assessing and fostering development of new technologies and novel adjuvants and systems for antigen sparing.
  • Facilitating the availability of vaccines made with these new technologies for use under Investigational New Drugs applications, Emergency Use Authorization, and as licensed vaccines.
  • Monitoring the safety and effectiveness of pandemic influenza vaccines administered to patients using modern analytic tools to identify vaccine safety signals.
  • Providing robust outreach and training in manufacturing quality.
  • Conducting timely and efficient inspections of manufacturing facilities to assure product quality and prevent problems that threaten product safety or availability.

Through these activities, FDA's goal is to support the efforts of manufacturers and others to produce pandemic influenza vaccine in the shortest possible time, and to protect the greatest number of people, using a vaccine that is safe, effective, and easy to deliver.

FDA is already hard at work to meet these goals. In the early part of this month, CBER released two draft guidance documents for pandemic and seasonal influenza vaccines, which provide manufacturers with recommendations on obtaining and submitting clinical data to show safety and effectiveness for new vaccines, as well as outlining the approach of accelerated approval for both seasonal and influenza vaccine.

The President's FY 2007 Budget Request for FDA
The President's Budget request seeks to strengthen FDA's base pandemic influenza program by expanding it to a total program level of $55.3 million for FY 2007, an increase of $30.5 million above FY 2006.

This increase will allow FDA to conduct additional vaccine-related work that is critical to preparedness and to enhance food and animal health programs to address the challenge of an influenza pandemic. With the additional FY 2007 resources, FDA's vaccine program will:

  • Engage in public-private partnerships to select, prepare, and test pandemic seed strains of variants of the H5N1 virus.
  • Develop reagents that are essential for influenza vaccine manufacturing.
  • Evaluate and license influenza vaccines that rely on current egg-based technology as well as encouraging development of new culture-based and recombinant approaches.
  • Provide essential technical support to vaccine manufacturers throughout the vaccine development process.

In FY 2007, FDA's Foods program will focus new resources on those foods that may require surveillance to ensure that the virus is not present in food. In addition, FDA's Animal Drugs and Feeds program will focus new resources on developing a method to detect antiviral drug residues in poultry and on educating the feed industry and others about the proper techniques for disposal of contaminated animal feed. Both the Foods program and the Animal Drugs and Feed program will develop best practices and provide technical assistance on biosecurity measures for the rendering, animal feed, and human food industries. FDA's Office of Crisis Management will develop and exercise an FDA response plan for animal and food issues and quarantine contingency plans and will integrate such plans into Agency preparedness planning.

These resources comprise nearly half of the requested $30 million pandemic influenza increase in FY 2007 and include activities such as developing tests for antiviral residues in poultry and coordinating with USDA and the Bureau of Customs and Border Protection on sampling and testing of imported poultry products for antiviral residues. The FDA will also develop and implement plans to contain and dispose of animal feed that has been or may be contaminated with avian flu agents and provide technical support to USDA and the States on quarantine, culling, disposal, decontamination, and species-to-species transmission. Other activities include developing and integrating avian influenza response plans, in coordination with USDA and sister HHS agencies, and conducting research on possible transmission of pandemic influenza through food.

The resources requested in FY 2007 are essential to allow FDA to maintain public confidence and perform its vital public health responsibility for medical products, food, and animal health in the face of the threat of avian influenza.

Conclusion
FDA plays a unique and central role in working with HHS to prepare the Nation for an influenza pandemic. Although we have seen important achievements in recent months that improve our pandemic preparedness, additional work remains. With the support of this Subcommittee for the FY 2007 President's Budget request, HHS and FDA will continue implementing its dynamic program to safeguard Americans from the dangers of pandemic influenza.

Thank you for the opportunity to share this information with you. I am happy to answer any questions.

FDA Roles and Timetable for Production of Licensed Egg-Based Pandemic Vaccine from Newly Emerging Strain [PPT - 53KB]
FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability: Activities Involving FDA Assistance, Research & Review [PPT - 46KB]

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Last Revised: March 31, 2006