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National Vaccine Program Office

DHHS Reports



National Immunization Program Strategic Plan

Protecting the Nation's Health in an Era of Globalization: CDC's Global Infectious Disease Strategy


Federal Register Notice; Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - 5/29/2001 - (PDF), (Text)

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines - 3/12/2001 - (PDF), (Text)

Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000 - (PDF), (Text)

Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications - 9/8/2000 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order - 5/15/2000
(PDF), (Text)

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product - 1/5/1999 - (PDF), (Text)

Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) - 9/8/1998 - (PDF), (Text)

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies - 4/10/1997 - (PDF), (Text)

Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications - 12/27/1996
(PDF), (Text)

Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations - December 2 - 3, 2002

Transcripts -

12/2/02 - (292 pages) (PDF), (Text)
12/3/02 - (282 pages) (PDF), (Text)

Workshop on Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development - September 7 - 10, 1999

Handout - A Defined-Risks Approach to the Regulatory Assessment of the Use of Neoplastic Cells as Substrates for Viral Vaccine Manufacture (PDF)

Transcripts -

09/07/99 - (87 Pages) (Text)
09/08/99 - (316 Pages) (Text)
09/09/99 - (399 Pages) (Text)
09/10/99 - (259 Pages) (Text)

FDA-NCI Workshop on Tumor Vaccines - December 10 and 11, 1998

Transcript -

12/10/98 - (PDF)
12/11/98 - (PDF)

Simian Virus 40: A Possible Human Polyomavirus Workshop - January 27 & 28, 1997
(All files are in text format)

January 27 - Transcript Part 1 (170 pages)
January 27 - Transcript Part 2 (173 pages)
January 28 - Transcript (351 pages)
Bibliography (7 pages)
List of participants (26 pages)
List of speakers (4 pages)


Jordan Report 20th Anniversary: Accelerated Development of Vaccines 2002

Vaccine Research Center Strategic Plan

GAO Reports

Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges, September 2002

IOM Reports

Calling the Shots:  Immunization Finance Policies and Practice, June 16, 2000

Financing Vaccines in the 21st Century: Assuring Access and Availability, August 4, 2003

Scientific and Policy Implications in Developing Smallpox Immunization Options

IOM Setting the Course Series

Following the publication of Calling the Shots, IOM convened three regional workshops and one national workshop to review the findings and recommendations of the report and to identify areas of consensus as well as unresolved concerns that require future attention by public and private officials in strengthening the national immunization system. The workshops were designed not only to foster awareness about the Calling the Shots report, but also to strengthen interactions among public- and private-sector health officials to build consensus about immunization initiatives, and to identify unresolved public health and health finance issues and concerns at the regional, state, and local levels that require further attention from public and private policymakers. The regional workshops were held in Chicago, Austin, and Los Angeles; summaries of each workshop are available.

Setting the Course, A Strategic Vision for Immunization Finance, The Chicago Workshop, January 2001

Setting the Course: A Strategic Vision for Immunization. Part 2 Summary of the Austin Workshop
September 20, 2002

Setting the Course:  A Strategic Vision for Immunization Part 3:  Summary of the Los Angeles Workshop, February 2003

Setting the Course:  A Strategic Vision for Immunization Part 4:  Summary of the Washington DC Workshop, November, 2003

Immunization Safety Review

Immunization Safety Review: Influenza Vaccines and Neurological Complications, October 6, 2003

Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy March 12, 2003

Immunization Safety Review:  SV40 Contamination of Polio Vaccine, October 22, 2002

Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders   May 30, 2002

Immunization Safety Review: Multiple Immunizations and Immune Dysfunction, February 20, 2002

Immunization Safety Review:  Thimerosal Containing Vaccines and Neurodevelopmental Disorders, October 1, 2001

Immunization Safety Review:  Measles-Mumps-Rubella Vaccine and Autism, April 23, 2001

Risk Communication

Science and Risk Communication: A mini-symposium sponsored by the EHSRT


Assessing New Vaccines for National Immunization Programmes (PDF) (274KB)

NVAC Reports and Documents

Last revised: November 8, 2005


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