U.S. Policy Regarding Pandemic-Influenza Vaccines
September 2008
Unless otherwise indicated, all years refer to fiscal years. Numbers in the text and tables may not add up to totals because of rounding.
On the cover: Top, transmission electron micrograph of a small grouping of influenza A virions; image courtesy of the Centers for Disease Control and Prevention, Public Health Image Library. Bottom right, eggs are inoculated to produce vaccine; photo by Peggy Greb; image courtesy of the Department of Agriculture, Agriculture Research Service, News & Events Image Gallery. Bottom left: Vaccine production, photo by A. Grillet; image courtesy of Marcy l’Etiole France V4, copyright 2006 Sanofi Pasteur.
Preface
The possibility of an influenza pandemic is cause for concern among policymakers, public health experts, and the world’s populations. Against that prospect, in 2005, the Department of Health and Human Services (HHS) published a plan that includes a series of measures, first to monitor the spread of disease in the event of a worldwide outbreak and then to facilitate a rapid response. That second step includes developing influenza vaccines and expanding the nation’s capacity for producing influenza vaccine; creating stockpiles of antiviral drugs and other medical supplies (to avert an influenza pandemic or minimize its effects); coordinating federal, state, and local preparations; and planning for public outreach and communications.
HHS’s plan has two specific goals that relate to vaccines. The first goal is to have in place by 2011 domestic production capacity sufficient to supply vaccine to the entire U.S. population within six months of the onset of a pandemic. The second goal is to stockpile enough doses of vaccine to inoculate 20 million people as soon as possible after the onset of a pandemic.
This Congressional Budget Office (CBO) paper, which was prepared at the request of the Senate Majority Leader, focuses on the government’s role in the vaccine market that stems from HHS’s plan. It provides information on the current state of readiness, the additional expenditures likely to be necessary to achieve HHS’s vaccine-related goals, the expenditures that are likely to be needed to maintain preparedness, and the approaches of other countries as they too face the prospect of an influenza pandemic. In keeping with CBO’s mandate to provide objective, nonpartisan analysis, this paper makes no recommendations.
The report was written by Julie Somers and Philip Webre of CBO’s MicroeconomicStudies Division under the supervision of Joseph Kile and David Moore. Bob Arnold, David Auerbach, Bob Dennis, Keith Fontenot, Renee Fox, Carla Tighe-Murray, and Jeanne De Sa (formerly of CBO) provided thoughtful comments on drafts.
Helpful comments also came from outside CBO. Thanks go to David Fedson, M.D.; Christopher Adams, Federal Trade Commission; Peter Dunnill, University College London; Robert Giffin and Margaret Hamburg, Institute of Medicine; Sarah Lister, Congressional Research Service; Peter Khoury, Baxter BioScience; the Food and Drug Administration’s (FDA’s) Immediate Office of the Director, Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research; the FDA’s Office of Compliance and Biologics Quality; the FDA’s Office of Counter-Terrorism and Emerging Threats; the Biomedical Advanced Research and Development Authority; and the National Vaccine Program Office in HHS. (The assistance of external reviewers implies no responsibility for the final product, which rests solely with CBO.)
Angela McCollough prepared the tables for publication. Kate Kelly edited the manuscript, and Loretta Lettner proofread the paper. Maureen Costantino prepared the figures for publication and designed the cover. Lenny Skutnik produced the printed copies, Linda Schimmel coordinated the print distribution, and Simone Thomas produced the electronic version for CBO’s Web site
Contents
The Market for Seasonal-Influenza Vaccine and the Challenge of Providing Vaccine in a Pandemic
The Market for Seasonal-Influenza Vaccine
Supplying Vaccine in a Pandemic
Risks Associated with HHS’s Plan
Additional Public Health Questions
International Efforts at Funding the Development of Vaccines
Investing in New Capacity for Production
Egg-Based Manufacturing Capacity
Cell-Based Manufacturing Capacity
International Efforts to Build Capacity
Cost to Complete and Maintain the Stockpile
International Efforts to Stockpile Vaccine
Options for Modifying HHS’s Plan
Adjuvanted Vaccines and Adequate Capacity
1-1. HHS’s Funding for Influenza Preparedness, 2004 to 2008
1-2. Supplemental Funding for HHS’s Pandemic-Influenza Plan, 2006
1-3. HHS’s Obligations for Pandemic-Influenza Vaccine Projects
1-4. Domestic Production Capacity for Seasonal- and Pandemic-Influenza Vaccine
2-1. Egg-Based Pandemic-Influenza Vaccines, With and Without Adjuvants
2-2. HHS’s Contract Awards and Development Status for Cell-Based Influenza Vaccines
3-1. HHS’s Funding for Capacity to Produce Influenza Vaccine
4-1. U.S. Stockpile of H5N1 Vaccine, by Year of Purchase
1-1. Vaccine Production for the 2006–2007 Influenza Season in the United States
1-2. Seasonal-Influenza Vaccine for the U.S. Market
2-1. Vaccine Development: Typical Time and Cost
2-2. What Constitutes the Next Generation of Influenza Vaccines?
