Tuesday, September 16, 2008


IWS Documented News Service
Institute for Workplace Studies----------------- Professor Samuel B. Bacharach
School of Industrial & Labor Relations
-------- Director, Institute for Workplace Studies
Cornell University
16 East 34th Street, 4th floor
---------------------- Stuart Basefsky
New York, NY 10016
-------------------------------Director, IWS News Bureau

Congressional Budget Office (CBO)
A CBO Paper

U.S. Policy Regarding Pandemic-Influenza Vaccines [15 September 2008]
September 2008
[full-text, 56 pages]

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.


Summary ix
1 The Market for Seasonal-Influenza Vaccine and the
Challenge of Providing Vaccine in a Pandemic 1
The Market for Seasonal-Influenza Vaccine 3
Supplying Vaccine in a Pandemic 5
Overview of HHS's Plan 5
Risks Associated with HHS's Plan 7
Additional Public Health Questions 7

2 Developing New Vaccines 9
Adjuvanted Vaccines 9
Cell-Based Vaccines 13
Next-Generation Vaccines 15
International Efforts at Funding the Development of Vaccines 17

3 Investing in New Capacity for Production 19
Egg-Based Manufacturing Capacity 19
Cell-Based Manufacturing Capacity 20
International Efforts to Build Capacity 22

4 Stockpiling Vaccine 25
Cost to Complete and Maintain the Stockpile 25
International Efforts to Stockpile Vaccine 27

5 Options for Modifying HHS's Plan 29
Adjuvanted Vaccines and Adequate Capacity 29
Next-Generation Vaccines 30
Advance Supply Agreements 30
The Size of the Stockpile 31
References 33

1-1. HHS's Funding for Influenza Preparedness, 2004 to 2008 2
1-2. Supplemental Funding for HHS's Pandemic-Influenza Plan, 2006 3
1-3. HHS's Obligations for Pandemic-Influenza Vaccine Projects 3
1-4. Domestic Production Capacity for Seasonal- and Pandemic-Influenza Vaccine 6
2-1. Egg-Based Pandemic-Influenza Vaccines, With and Without Adjuvants 12
2-2. HHS's Contract Awards and Development Status for Cell-Based Influenza Vaccines 14
3-1. HHS's Funding for Capacity to Produce Influenza Vaccine 20
4-1. U.S. Stockpile of H5N1 Vaccine, by Year of Purchase 26

1-1. Vaccine Production for the 2006­2007 Influenza Season in the United States 4
1-2. Seasonal-Influenza Vaccine for the U.S. Market 4

2-1. Vaccine Development: Typical Time and Cost 10
2-2. What Constitutes the Next Generation of Influenza Vaccines? 16
This information is provided to subscribers, friends, faculty, students and alumni of the School of Industrial & Labor Relations (ILR). It is a service of the Institute for Workplace Studies (IWS) in New York City. Stuart Basefsky is responsible for the selection of the contents which is intended to keep researchers, companies, workers, and governments aware of the latest information related to ILR disciplines as it becomes available for the purposes of research, understanding and debate. The content does not reflect the opinions or positions of Cornell University, the School of Industrial & Labor Relations, or that of Mr. Basefsky and should not be construed as such. The service is unique in that it provides the original source documentation, via links, behind the news and research of the day. Use of the information provided is unrestricted. However, it is requested that users acknowledge that the information was found via the IWS Documented News Service.

Stuart Basefsky                   
Director, IWS News Bureau                
Institute for Workplace Studies 
Cornell/ILR School                        
16 E. 34th Street, 4th Floor             
New York, NY 10016                        
Telephone: (607) 255-2703                
Fax: (607) 255-9641                       
E-mail: smb6@cornell.edu                  

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