Vaccine Safety > Research
Vaccine Safety and Development 
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Vaccine Safety
National Immunization Program
January 2000

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Note: This publication is presented for information purposes only, and no claims of accuracy are made. Mention of trade names, commercial products, or organizations does not constitute endorsement by the National Immunization Program (NIP) or the Centers for Disease Control and Prevention (CDC).

Introduction
This guide was produced by the National Immunization Program, Vaccine Safety and Development Activity, part of the Centers for Disease Control and Prevention, to help individuals research issues surrounding vaccine safety. A large portion of this guide is devoted to identifying search tools and resources that are available electronically over the Internet. This document also contains descriptions of selected vaccine-related publications, government agencies involved in national immunization efforts and vaccine control, and organizations that can provide pertinent information or assistance.

The Internet is a valuable, ever growing resource of health-related information. Before you start searching the Internet, you should be aware that not all information posted on the Web is valuable or accurate, and it is not always possible to determine the credibility of every Web site. You can use the following Web sites as starting points that provide useful information and/or links to many other sites of interest:

National Immunization Program
Web site: www.cdc.gov/nip
Web site on vaccine safety: www.cdc.gov/nip/vacsafe

National Immunization Information Hotline
(800) 232-2522 (English), (800) 232-0233 (Spanish)

Healthfinder
Web site: www.healthfinder.gov

A gateway to consumer health-related information available on the Internet maintained by the U.S. Department of Health and Human Services, this site links to online publications, clearinghouses, databases, Web sites, and support and self-help groups, as well as government agencies and non-profit organizations.

The Immunization Gateway: Your Vaccine Fact-Finder
Web site: www.immunofacts.com

This site is an online vaccine/immunization fact finder that links to many of the latest resources on vaccines. It is produced by Facts and Comparisons, a commercial publisher of drug-related information.

Medscape
Web site: www.medscape.com

Medscape has a combination of information from clinical journals, medical news providers, medical education programs, and materials created expressly for Medscape. Access to Medscape is free, but requires a one-time membership registration.

The Vaccine Page
Web site: vaccines.com/index.html

This page contains up-to-date information about immunizations for several distinct audiences including parents, practitioners, and researcher. Vaccine related online journals are also available. This site is produced by UniScience News Net, producer of a daily science news page.

National Library of Medicine Resources
Web site: www.nlm.nih.gov
Service Desk: (888) FIND-NLM

Comprehensive medical and health information through MEDLARS (Medical Literature Analysis and Retrieval System) and MEDLINE. These resources can generally be accessed at medical or university libraries. They are also available at no cost through Internet Grateful Med and Pub Med.

Internet Grateful Med
Web site: igm.nlm.nih.gov

Internet Grateful Med offers assisted searching of MEDLINE and other NLM databases, including HealthSTAR (non-clinical planning and health care delivery citations) and HSRPROJ (detailed descriptions of ongoing health research projects).

PubMed
Web site: www.ncbi.nlm.nih.gov/pubmed

PubMed also accesses MEDLINE with the enhanced abilities to combine more than one search and to automatically retrieve related items. When conducting a database search in MEDLINE, it is helpful to be familiar with the subject terms, officially called the Medical Subject Headings (MeSH), consistently used throughout the database. If you use a MeSH term, your search will be more precise, retrieving more relevant records and eliminating "false hits" or records that are not really relevant. To retrieve vaccine-related information use the terms vaccination, specific adverse events (e.g. arthritis, SIDS) and specific vaccine-preventable diseases of interest (e.g. chickenpox, diphtheria).

National Immunization Program
Web site: www.cdc.gov/nip
Vaccine safety web site: www.cdc.gov/nip/vacsafe

National Immunization Information Hotline
(800) 232-2522 (English), (800) 232-0233 (Spanish)

What Would Happen If we Stopped Vaccinations (fact sheet)
Web site document: www.cdc.gov/nip/vacsafe/fs/valuefs.htm

Six Common Misconceptions About Vaccination and How to Respond to Them (1996)
National Immunization Program
Information and Distribution Center
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS E-34
Atlanta, GA 30333
(800) 232-2522
FAX (404) 639-8828
Web site: www.cdc.gov/nip/publications/default.htm

Risk Communication and Vaccination: Workshop Summary (1997)
National Academy Press
2101 Constitution Avenue, NW
P.O. Box 285
Washington, DC 20055
(800) 624-6242 or (202) 334-3313
Web site: http://www.nap.edu/readingroom/enter2.cgi?
0309057906.html

Vaccines: What Every Parent Should Know (1999, revised edition)
Authors: Paul A. Offit, MD and Louis M. Bell, MD
IDG Books World Wide, Inc
New York, New York

Vaccine Safety: What Parents Need to Know (pamphlet)
Michigan Department of Community Health
Information & Education Coordinator
Division of Immunization
3423 N. M.L. King Blvd, PO Box 30195
Lansing, Michigan 48909
1-888-76-SHOTS

What if You Don’t Immunize Your Child? (pamphlet)
California Department of Health Services
Immunization Branch
2151 Berkeley Way, Room 712
Berkeley, CA 94704

Plain Talk About Childhood Immunizations (booklet)
Washington Department of Health
Immunization Program
New Market Industrial Campus, Bldg. 1
PO Box 47843
Olympia, WA 98504-7843

State of Alaska, Section of Epidemiology
Immunization Program
3601 C Street, Suite 540
Anchorage, Alaska 99503
(907) 269-8000

Other State Immunization Programs (Appendix G) may have materials they developed to address myths and misinformation regarding vaccines.

Journal Articles that provide important information to address myths and misinformation:

Gangarosa EJ, Galazka AM, Wolfe CR, Phillips LM, Gangarosa RE, Miller E, Chen RT. Impact of the anti-vaccine movements on pertussis control: the untold story. Lancet 1998;351:356-61.

Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, Chen RT. Health consequences of religious and philosophical exemptions from immunization laws: individual and societal risk of measles. J Am Med Assoc 1999;282:47-53.

Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (1994)

National Academy Press
2101 Constitution Avenue, NW
P.O. Box 285
Washington, DC 20055
(800) 624-6242 or (202) 334-3313
Web site: www.nap.edu

This volume provides a literature review about common childhood vaccines for tetanus, diphtheria, measles, mumps, polio, Hib, and hepatitis B. It presents findings in tables and narrative, discusses approaches to evidence and causality, and examines the possible adverse effects, including neurologic and immunologic disorders and death. Helpful background information on the development of vaccines, detailed case reports, clinical trials, and other evidence associating each vaccine with specific disorders are included.
  

Adverse Effects of Pertussis and Rubella Vaccines (1991)

National Academy Press
2101 Constitution Avenue, NW
P.O. Box 285
Washington, DC 20055
(800) 624-6242 or (202) 334-3313
Web site: www.nap.edu

This book examines the relationship of rubella and pertussis vaccines to a number of serious adverse events based on an extensive review of evidence from epidemiologic studies, case histories, studies in animals, and other sources of information.

Epidemiology and Prevention of Vaccine-Preventable Diseases (8th edition, 2004) UPDATED!

Produced by the National Immunization Program, Centers for Disease Control and Prevention

Published and distributed by the Public Health Foundation
(877) 252-1200
$29 + S/H
Web site: http://bookstore.phf.org/cat5.htm

This book provides an overview of vaccine-preventable infectious diseases and the corresponding vaccines.
  

Immunofacts

Facts and Comparisons, Inc.
111 West Port Plaza, Suite 400
St. Louis, MO 63146-3098
(800) 223-0554
FAX (314) 878-5563

This book provides comprehensive, technical information on specific vaccines, indications, product availability, dosage, safety and a glossary of terms.
  

Parents Guide to Childhood Immunization (2001)

National Immunization Program
Information and Distribution Center
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS E-34
Atlanta GA 30333
(800) 232-2522
FAX (404) 639-8828

Web site: www.cdc.gov/nip/publications/default.htm

This booklet, available in English and Spanish, is designed for parents and discusses vaccines, vaccine-preventable diseases, and possible vaccine side effects.
  

Risk Communication and Vaccination: Workshop Summary (1997)

National Academy Press
2101 Constitution Avenue, NW
P.O. Box 285
Washington, DC 20055
(800) 624-6242 or (202) 334-3313
Web site: http://www.nap.edu/readingroom/enter2.cgi
?0309057906.html

In 1995, the Institute of Medicine (IOM) established the Vaccine Safety Forum to examine issues relating to vaccine safety. On May 13, 1996, the forum held a work shop on risk communication and vaccination. The topics included key concepts in risk communication, current practices, vaccine risks versus disease risks and vaccine failure. This document summarizes the workshop.
  

Six Common Misconceptions About Vaccination and How to Respond to Them (1996)

National Immunization Program
Information and Distribution Center
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS E-34
Atlanta GA 30333
(800) 232-2522
FAX (404) 639-8828
Web site: www.cdc.gov/nip/publications/default.htm

This booklet discusses six misconceptions about vaccination often cited by parents as reasons they question the need to have their children immunized. Each misconception is refuted based on scientific information and research findings. The misconceptions include (1) diseases already began to disappear before vaccines were introduced because of better hygiene and sanitation; (2) the majority of people who get a disease have been vaccinated; (3) so-called "hot lots" of vaccines have been associated with more adverse events and deaths than others, and parents should identify the numbers of these lots and not allow their children to receive vaccines from them; (4) vaccines cause harmful side effects, illnesses, and even death; (5) vaccine-preventable diseases have been virtually eliminated in the United States, so there is no need for vaccination; and (6) giving a child multiple vaccinations for different diseases at the same time increases the risk of harmful side effects and can overload the immune system.
  

Understanding the Immune System (1993)

National Institutes of Health
National Institute of Allergy and Infectious Diseases
NIH Publication No. 93-529
NIAID Office of Communications and Public Liaison
Building 31, Room 7A-50
31 Center Drive MSC 2520
Bethesda, MD 20892-2520
http://rex.nic.nih.gov/PATIENTS/INFO_TEACHER/
bookshelf/NIH_immune/index.html

This booklet provides information on the anatomy of the immune system, natural and acquired immunity, and disorders of the immune system.
   

Understanding Vaccines (1998)

National Institutes of Health
National Institute of Allergy and Infectious Diseases
NIH Publication No. 98-4219
NIAID Office of Communications and Public Liaison
Building 31, Room 7A-50
31 Center Drive MSC 2520
Bethesda, MD 20892-2520
http://www.niaid.nih.gov/publications/vaccine/
undvacc.htm

This booklet provides a general overview of the immune system, the different types of vaccines, the development phase, FDA licensure and vaccines of the future.
  

Vaccine Safety Forum: Summaries of Two Workshops (1997)

Board on Health Promotion and Disease Prevention, Institute of Medicine
National Academy Press, 2101 Constitution Ave., NW
P.O. Box 285
Washington DC 20055
(800) 624-6242
FAX (202) 334-3313
Web site: www.nap.edu

This report summarizes the proceedings of the following two workshops: (1) Detecting and Responding to Adverse Events Following Vaccination, which was held on November 6, 1995, and (2) Research to Identify Risks for Adverse Events Following Vaccination: Mechanisms and Possible Means of Prevention, which was conducted on April 1, 1996. Topics of the first workshop included difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. The second workshop addressed immunologic and genetic factors that might influence individual vaccine responses, current research to identify which populations are at increased risk for experiencing adverse events from vaccines, and research needs.
  

CW Henderson Customer Service
P.O. Box 830409
Birmingham AL 35283-0409
(800) 633-4931
FAX (205) 995-1588

This weekly newsletter contains the latest information available on vaccine-related research around the world. Topics include therapeutic vaccines for AIDS and other diseases, efficacy and safety trials, FDA approvals, and much more. Other vaccine-related newsletters include: Hepatitis Weekly, Immunotherapy Weekly, and Tuberculosis and Airborne Disease Weekly. A partial glimpse is available weekly via the Internet at: www.homepage.holowww.com.
  

Vaccines (1999) Chen, RT. Safety of Vaccines. Chapter 49, page 1144-63.

Authors: Plotkin SA, Orenstein WA, eds.
W.B. Saunders Company
P.O. Box 628239
Orlando FL 32862-8239
(800) 545-2522
FAX (800) 874-6418

Web site: customerservice.wbsaunders.com
wbsbcs@harcourtbrace.com

This book discusses specific vaccines and related issues. Of particular interest are chapters covering the following topics: safety of vaccines; regulation and testing of vaccines; public health considerations; US law, and the National Vaccine Injury Compensation Program.
  

Vaccines and Related Biological Products Advisory Committee: (Open Session) Post-Marketing Surveillance of Vaccine Safety, August 24, 1994

Food and Drug Administration (FDA)
Freedom of Information
5600 Fishers Lane, HFI-35
Rockville, MD 20857
(301) 827-2000
FAX (301) 443-1726

This document is an edited transcript of the proceedings of the Vaccine and Related Biological Products meeting held in Bethesda, MD, on August 24, 1994. It contains the portions of the proceedings covering vaccine safety. Topics include: (1) Introduction to Vaccine Safety Issues; (2) Summary of the Institute of Medicine Reports; (3) Scientific Background on Vaccine Safety; (4) Vaccine Adverse Events Reporting System (VAERS); (5) Interpretation of VAERS Data; (6) Using VAERS to Monitor Vaccine Safety; (7) Methodological Approaches to Assessing Vaccine Safety; (8) CDC Activities Related to Vaccine Safety; and (9) Large-Linked Database Project.

Vaccines: What Every Parent Should Know (1999, revised edition)

Authors: Paul A. Offit, MD and Louis M. Bell, MD
IDG Books World Wide, Inc
New York, New York

This book provides the answers to questions that parents frequently ask their pediatrician about vaccines. Topics include, safety, including vaccine additives such as Thimerosal; myths about vaccines; routinely recommended immunizations, and vaccines used in special situations (travel, etc). This publication provides parents with the information they require to make well-informed decisions about their child's health.

CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37:197-200.

CDC. Update: Vaccine side effects, adverse reactions, contraindications and precautions. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

Chen RT and Hibbs B. Vaccine safety: current and future challenges. Ped Annals 1998;27:445-64.

Chen RT et al. The Vaccine Adverse Event Reporting System (VAERS). (1994) Vaccine 12(6): 542-548.

Chen RT, Glasser J, Rhodes P, Davis RL, Barlow WE, Thompson RS, Mullooly JP, Black SB, Shinefield HR, Vadheim CM, Marcy SM, Ward JI, Wise RP, Wassilak SG, Hadler SC. The Vaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States. Pediatrics 1997;99:765-73.

Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12:542-50.

Chen RT. Special methodological issues in pharmacoepidemiology studies of vaccine safety. In: Strom BL, ed. Pharmacoepidemiology. Sussex: John Wiley & Sons, 1994

Chen RT. Safety of Vaccines. Ch. 49 In: Plotkin SA, Orenstein WA, eds. Vaccines. Philadelphia: WB Saunders, 1999:1144-63.

Chen RT. Vaccine risks: real, perceived, and unknown. Vaccine 1999; 17: S41-6.

Chen RT and Orenstein WA. Epidemiologic Methods in Immunization Programs. (1996) Epidemiologic Reviews 18(2):99-117.

Ellenberg SS and Chen RT. The complicated task of monitoring vaccine safety. Public Health Reports 1997;112:10-20.

Gangarosa EJ, Galazka AM, Wolfe CR, Phillips LM, Gangarosa RE, Miller E, Chen RT. Impact of the anti-vaccine movements on pertussis control: the untold story. Lancet 1998;351:356-61.

Grabenstein JD. Clinical Management of Hypersensitivities to Vaccine Components.(1997) Hospital Pharmacy 32(1):77-87.

Grabenstein JD. Immunologic Necessities: Diluents, Adjuvants, and Excipients. (1996) Hospital Pharmacy 31(13):1387-1401.

Institute of Medicine. Adverse effects of pertussis and rubella vaccines. Washington, D.C.: National Academy Press, 1991.

Institute of Medicine. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington, D.C.: National Academy Press, 1994.

Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, Chen RT. Health consequences of religious and philosophical exemptions from immunization laws: individual and societal risk of measles. J Am Med Assoc 1999;282:47-53.

Stehlin IB. How FDA Works to Ensure Vaccine Safety.(December 1995) FDA Consumer 29(10):6-10.

The National Chilhood Vaccine Injury Act of 1986, at Section 2125 of the Public Health Service Act as codified at 42 U.S.C. 300aa-Supp 1987.

Prevention Guidelines:
The following federal guidelines are available from:

The Centers for Disease Control and Prevention
MMWR Series
1600 Clifton Road, MS C-08
Atlanta, GA 30333
Web site: www.cdc.gov/epo/mmwr/mmwr.html.

General Recommendations on Immunization. January 28, 1994, MMWR, Vol. 43, No. RR-1.

Immunization of Adolescents. November 22, 1996, MMWR, Vol. 45, No. RR-13.

Immunization of Health Care Workers. December 26, 1997, MMWR, Vol. 46, No. RR-18.

Update on Adult Immunization. November 15, 1991, MMWR, Vol. 40, No. RR-12.

Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence. April 9, 1993, MMWR, Vol. 42, No. RR-4.

Vaccines Recommended for Routine Use in the United States

Diphtheria, Tetanus, Pertussis: Recommendations for Vaccine Use and Other Preventative Measures. August 8, 1991, MMWR, Vol. 40, No. RR-10.

Pertussis Vaccination: Use of Acellular Pertussis Vaccine Among Infants and Young Children, March 28, 1997, MMWR, Vol. 46, No. RR-7.

Prevention of Hepatitis A Through Active or Passive Immunization. MMWR 1999, Vol. 48, RR-12.

Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination. November 22, 1991, MMWR, Vol. 40, No. RR-13.

Haemophilus b Conjugate Vaccines for Prevention of Haemophilus Influenzae Type b Disease Among Infants and Children Two Months of Age and Older. January 11, 1991, MMWR, Vol. 40, No. RR-1.

Recommendations for Use of Haemophilus b Conjugate Vaccines and a Combined Diphtheria, Tetanus, Pertussis, and Haemophilus b Vaccine. September 17, 1993, MMWR, Vol. 42, No. RR-13.

Prevention and Control of Influenza. April 30, 1999, MMWR, Vol. 48, No. RR-4.

Measles, Mumps, and Rubella-Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps. May 23, 1998, MMWR, Vol. 47, No. RR-8.

Prevention of Pneumococcal Disease. April 4, 1997, MMWR, Vol. 46, No. RR-8.

Poliomyelitis Prevention in the United States: Introduction of a Sequential Vaccination Schedule of Inactivated Poliovirus Vaccine Followed by Oral Poliovirus Vaccine. January 24, 1997, MMWR, Vol. 46, No. RR-3.

Prevention of Varicella. July 12, 1996, MMWR, Vol. 45, No. RR-11.

The Role of BCG Vaccine in the Prevention and Control of Tuberculosis in the United States. April 26, 1996, MMWR, Vol. 45, No. RR-4.

Cholera Vaccine. October 14, 1988, MMWR, Vol. 37, No. 40.

Inactivated Japanese Encephalitis Virus Vaccine. January 8, 1993, MMWR, Vol. 42, No. RR-1.

Recommendations for the use of Lyme Disease Vaccine. June 4, 1999. MMWR, Vol. 48, No. RR-7.

Control and Prevention of Meningococcal Disease and Control and Prevention of Serogroup C Meningococcal Disease: Evaluation and Management of Suspected Outbreaks. February 14, 1997, MMWR, Vol. 46, No. RR-5.

Prevention of Plague. December 13, 1996, MMWR, Vol. 45, No. RR-14.

Human Rabies Prevention-United States, 1999. January 8, 1999, MMWR, Vol. 48, No. RR-1.

Typhoid Immunization. December 9, 1994, MMWR, Vol. 43, No. RR-14.

Vaccinia (Smallpox) Vaccine. December 13, 1991, MMWR, Vol. 40, No. RR-14.

Yellow Fever Vaccine. May 4, 1990, MMWR, Vol. 39, No. RR-6.

Programmatic Strategies to Increase Vaccination Coverage by Age 2 Years-Linkage of Vaccination and WIC Services. March 15, 1996, MMWR, Vol. 45, No. 10, pp. 217-218.

Programmatic Strategies to Increase Vaccination Rates - Assessment and Feedback of Provider-Based Vaccination Coverage Information. March 15, 1996, MMWR, Vol. 45, No. 10, 219-220.

Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions. September 6, 1996, MMWR, Vol. 45, No. RR-12.

For general information on immunization, vaccine safety, clinics administering vaccines and school-entry requirements, contact your state or local health department.

State Health Departments On-line: www.cdc.gov/epo/mmwr/medassn.html#states

Immunization Grantees (National Immunization Program), Program Managers - see Appendix G.

Centers for Disease Control and Prevention (CDC)
National Immunization Program (NIP)

1600 Clifton Road, NE, MS E-05
Atlanta, GA 30333
E-mail: nipinfo@cdc.gov
Web site: www.cdc.gov/nip
Web site-Vaccine Safety: www.cdc.gov/nip/vacsafe

Find immunization clinics near you and answers to questions about immunization -- (800) 232-2522

Spanish hotline providing materials and referral services to callers who have questions about immunization -- (800) 232-0233 

Travelers' hotline (24 hours a day, 7 days a week) information on requirements and recommendations for the international traveler -- (877) 394-0747
Web site: www.cdc.gov/travel/index.htm.

NIP provides leadership for the planning, coordination, and implementation of immunization activities nationwide. The program helps monitor the safety and efficacy of vaccines by linking vaccine administration information with adverse event reporting and disease outbreak patterns. Through its toll-free telephone numbers and Web site, NIP answers frequently asked questions about vaccines, provides immunization schedules, and distributes vaccine-related publications. It also produces the Immunization Action News Memorandum, a bi-weekly newsletter that contains the latest news and information concerning vaccinations.

1600 Clifton Road, NE, Mailstop E-62
Atlanta, GA 30333
(800) 799-7062
FAX (404) 639-8548
E-mail: siisclear@cdc.gov
Web site: www.cdc.gov/nip/registry

The Immunization Registry Clearinghouse gathers wide-ranging information on immunization registry development and implementation, shares immunization strategies that work, and fosters communication and data sharing between local and state immunization registries. It promotes using immunization registry information for action through reminder/recall functions, coverage assessments, and provider evaluations.

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research
1401 Rockville Pike, HSM 99
Rockville, MD 20852
(800) 835-4709 or (301) 827-1800 (voice information system)
FAX (888) CBER-FAX (fax information system)
E-mail: OCTMA@CBER.FDA.GOV
Web site: www.fda.gov or www.fda.gov/cber

This FDA office maintains a consumer information hotline to answer questions on vaccine safety and regulations. It also distributes materials such as guidelines, Points to Consider, and informational letters to manufacturers. Its Web site contains current vaccine information, including recalls and withdrawals of vaccine products.

FDA Freedom of Information Staff, HFI-35

5600 Fishers Lane
Rockville, MD 20857
(301) 443-2414
FAX (301) 443-1726
Web site:  www.fda.gov/foi/foia2.htm

Under the National Childhood Vaccine Injury Act of 1986 (NCVIA), consumers are entitled to information from reports describing specific adverse events subsequent to administration of vaccines outlined within the NCVIA. If more information on specific Vaccine Adverse Events Reporting System (VAERS) reports is desired, consumers make a Freedom of Information Act (FOIA) request using the unique VAERS Report Identification Numbers contained within the enclosed data set. Items of information that are not disclosable, such as personal identifiers, will be purged before the request for additional information is fulfilled. Charges for search time and copying will be made in accordance with HHS regulations.

National Vaccine Injury Compensation Program

Parklawn Building, Room 8A-35
5600 Fishers Lane
Rockville, MD 20857
(800) 338-2382
(301) 443-6593
FAX (301) 443-8196
Web site: www.hrsa.gov/osp/vicp

Congress passed the National Childhood Vaccine Injury Act (NCVIA) to help ensure vaccine safety and availability, and to compensate people injured by vaccines. The act established the National Vaccine Injury Compensation Program (VICP) to compensate those who suffer certain vaccine-related injuries or death. VICP also protects doctors and manufacturers from lawsuits while providing compensation for those injured from vaccines. The program office distributes an information package detailing how to file a claim, criteria for eligibility, and what documentation is required.

Vaccine Adverse Event Reporting System (VAERS)

P.O. Box 1100
Rockville, MD 20849-1100
(800) 822-7967 (24 hours)
Web site: www.fda.gov/cber/vaers.html or www.cdc.gov/nip/vaers.htm

VAERS is a reporting system created by the FDA and the CDC to receive and analyze reports about adverse events that may be associated with vaccines under the National Childhood Vaccine Injury Act (NCVIA) of 1986. VAERS encourages the reporting of all clinically significant adverse events following any vaccine, whether or not the vaccine is believed to be the cause of the event. Both the CDC and the FDA routinely review data reported to VAERS. The FDA monitors reports to determine whether any vaccine lot has a higher than expected reporting rate of adverse events. The report of an adverse event to VAERS is not a documentation that a vaccine has caused the event and does not enter a person into the vaccine injury compensation process. Because it is difficult to distinguish a coincidental event from one truly caused by a vaccine, the VAERS database contains events of both types. Anyone (health care providers or consumers) can report an adverse event 24 hours a day.

National Vaccine Program Office (NVPO)

Centers for Disease Control and Prevention
1600 Clifton Road, NE, MS A-11
Atlanta, GA 30333
(404) 639-4450
FAX (404) 639-3036
E-mail: NVPO@cdc.gov
Web site: www.cdc.gov/od/nvpo

The National Vaccine Program Office (NVPO) was created in 1986 to coordinate immunization-related activities between all federal agencies including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health and the Health Resources and Services Administration.

World Health Organization (WHO)
Department of Vaccines and Other Biologicals

Avenue Appia 20
1211 Geneva 27, Switzerland
(+41 22) 791 2111
FAX (+41 22) 791 0746
E-mail: info@who.ch
Web site: www.who.int/gpv 
              or www.who.int/gpv-safety

The Department of Vaccines and Other Biologicals was established by the World Health Organization with the goal of protecting all people at risk against vaccine-preventable diseases. The program is comprised of three units: (1) Expanded Programme on Immunization; (2) Vaccine Research and Development; and (3) Vaccine Supply and Quality.

Pan American Health Organization (PAHO)
Special Program for Vaccines and Immunization (SVI)

525 23rd Street, NW
Washington, DC 20037
(202) 974-3766
FAX (202) 974-3635
E-mail: SVI@PAHO.ORG
Web site: www.paho.org/english/svihome.htm
EPI Newsletter Web site: www.paho.org/english/svi/svipubf.htm

The Special Program for Vaccine and Immunization (SVI) was established in 1995 to complement the existing Expanded Programme on Immunization and the Regional System for Vaccines; to strengthen the activities of vaccine research development, production, quality control; and to control/eradicate vaccine preventable diseases in the Americas. It produces the EPI Newsletter, which facilitates the exchange of ideas and information concerning immunization programs in the Region.

All Kids Count

750 Commerce Drive, Suite 400
Decatur, GA 30030
(404) 687-5615
FAX (404) 371-0415
E-mail: Info@allkidscount.org
Web site: www.allkidscount.org

A program developed to monitor and follow-up systems for preschool children, All Kids Count works closely with the Centers for Disease Control and Prevention to ensure that immunization information, when combined with other local, state, and federal efforts, will help increase immunization rates and the overall health of preschool children. It produces a quarterly newsletter that is available at no cost.

American Academy of Pediatrics (AAP)

National Headquarters
141 Northwest Point Boulevard
Elk Grove Village, IL 60007-1098 USA
(847) 228-5005
FAX (847) 228-5097
E-mail: kidsdoc@aap.org
Web site: www.aap.org

The American Academy of Pediatrics is an organization of 45,000 pediatricians dedicated to the health, safety and well-being of infants, children, adolescents, and young adults.

American Pharmaceutical Association (APhA)

2215 Constitution Avenue, NW
Washington DC 20037-2985
(202) 628-4410
FAX (202) 783-2351
Web site: www2.aphanet.org

The American Pharmaceutical Association is an organization of 50,000 pharmacists and allied health professionals involved in on-going efforts to educate the public about pharmaceutical products, including vaccines.

American Public Health Association (APHA)

1015 15th Street, NW
Washington DC 20005-2605
(202) 789-5600
FAX (202) 789-5661
E-mail: comments@apha.org
Web site: www.apha.org

The American Public Heath Association is comprised of over 50,000 members from more than 50 health-related occupations. APHA serves health care providers and the general public through its scientific and research programs, publications, annual meeting, educational services and advocacy efforts.

Association of State and Territorial Health Officials (ASTHO)

1275 K Street NW, Suite 800
Washington DC 20005-4006
(202) 371-9090
FAX (202) 371-9797
E-mail: Sturner@astho.org
Web site: www.astho.org/index.html

The Association of State and Territorial Health Officials is an organization that represents public health agencies across the country and in U.S. territories. The Association is involved in many legislative, educational, scientific, research and programmatic issues having to do with public health.

Every Child By Two (ECBT)

666 11^th St. NW
Washington, DC 20001
(202) 783-7035
E-mail: ecbt@ana.org
Web site: www.ecbt.org

A program of the American Nurses Foundation, ECBT attempts to raise awareness of the critical need for timely immunization and fosters putting in place a systematic way to immunize all of America's children by the age of two. Their Web site includes the latest immunization research and schedules, immunization contacts, related periodicals, a nationwide calendar of events, a plan for action, the ECBT Newsletter, and a list of current activities.

Immunization Action Coalition (IAC)

1573 Selby Avenue
Saint Paul, MN 55104
(651) 647-9009
FAX (651) 647-9131
E-mail: admin@immunize.org
Web site: www.immunize.org

The Immunization Action Coalition is a nonprofit organization working to boost immunization rates. It promotes physician, community, and family awareness of, and responsibility for, appropriate immunization of people of all ages against vaccine-preventable diseases. The Hepatitis B Coalition promotes hepatitis B vaccination for all infants, children, and adolescents and HbsAg screening for all pregnant women. Other services includes testing and vaccination for high-risk groups and education and treatment for hepatitis B carriers. A semi-annual newsletter containing valuable resources and news is available.

Infectious Disease Society of America (IDSA)

99 Canal Center Plaza, Suite 210
Alexandria, VA 22314
(703) 299-0200
FAX (703) 299-0204
E-mail: info@idsociety.org
Web site: www.idsociety.org

The Infectious Disease Society of America seeks to provide comprehensive information on disease prevention to health care providers and the general public. Recently, IDSA began the Vaccine Initiative to communicate the benefits of routine immunization.

Institute for Vaccine Safety

Johns Hopkins School of Public Health
615 North Wolfe Street, Suite W5515
Baltimore, MD 21207
(410) 955-2955
FAX (410) 502-6733
E-mail: info@vaccinesafety.edu
Web site: www.vaccinesafety.edu

The purpose of the Institute for Vaccine Safety is to distribute information on vaccines recommended for routine use, to investigate vaccine safety concerns and to fund relevant research projects.

National Coalition for Adult Immunization (NCAI)

Suite 750 / 4733 Bethesda Avenue
Bethesda, MD 20814-5228
(301) 656-0003
FAX (301) 907-0878
E-mail: adultimm@aol.com
Web site: www.nfid.org/ncai/

The National Coalition for Adult Immunization is composed of more than 95 professional medical and health care associations, advocacy groups, voluntary organizations, vaccine manufacturers, and government agencies. The goal of NCAI is to raise immunization levels for high-risk, adolescent, and adult target groups by increasing the awareness of physicians, other health care providers, and the general public about the need for and benefits of immunization.

National Coalition of Hispanic Health and Human Services Organization (COSSMHO)

1501 16th Street NW
Washington, DC 20036
(202) 797-4353
FAX (202) 387-5000
Web site: www.cossmho.org

COSSMHO focuses on the health, mental health, and human services needs of the diverse Hispanic Communities. COSSMHO's mission is to work with community-based organizations; universities; federal, state, and local governments; foundations; and corporations. Research shows that Hispanic children have low rates of immunization as demonstrated by the 1990 measles epidemic, during which Hispanic Children were seven times more at risk than non-Hispanic white counterparts. COSSMHO makes a concerted effort to ensure that immunizations are made readily available to the Hispanic Community and addresses barriers to immunization.

National Council of La Raza (NCLR)

Center for Health Promotion, Office Institutional Development
1111 19th Street NW
Suite 1000
Washington, DC 20036
(202) 785-1670, FAX (202) 776-1792
Web site: www.nclr.org

The largest constituency-based national Hispanic Organization serves as an advocate for Hispanic Americans as a national umbrella organization for more than 150 formerly affiliated community-based organizations which together serve Hispanics in 36 states, Puerto Rico, and the District of Columbia. The NCLR Center for Health Promotion provides technical assistance to NCLR affiliates and other national, regional, and local entities which share a commitment to health-related education and disease prevention in the Hispanic Community. NCLR disseminates and develops Spanish-language immunization materials.

This page last modified on February 3, 2004