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Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders (2002)

Chapter: Appendix C: Chronology of Important Events Regarding Vaccine Safety

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Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×

Appendix C
Chronology of Important Events Regarding Vaccine Safety

Year

Vaccine Licensure

Legislation and/or Policy Statements

IOM Reports on Vaccine Safety

1955

Inactivated poliomyelitis vaccine (IPV) available

 

1963

Oral poliomyelitis vaccine (OPV) available, replaces IPV

 

Measles vaccine available

1967

Mumps vaccine available

1969

Rubella vaccine available

1971

Measles-Mumps-Rubella (MMR) vaccine available

1977

 

Mumps vaccination recommended

Evaluation of Poliomyelitis Vaccines

1979

Current formulation of rubella vaccine available, replaces earlier versions

 

1982

Plasma-derived hepatitis B vaccine available

Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×

Year

Vaccine Licensure

Legislation and/or Policy Statements

IOM Reports on Vaccine Safety

1985

Hib vaccine licensed for children>15 months

 

1986

 

Congress passes Public Law 99–660, the National Childhood Vaccine Injury Act (introduced in 1984) calls for:

• est of NVPO

• est. of NVAC

• est. of VICP

• est. of ACCV

IOM review of 1) pertussis and rubella, 2) routine child vaccines

 

1988

 

Evaluation of Poliomyelitis Vaccine Policy Options

1990

2 Hib conjugate vaccines licensed for use beginning at 2 months

 

1991

Acellular pertussis component licensed for the 4th and 5th doses of the 5-part DTP series in ACEL-IMUNE

Hepatitis B recommended by ACIP for addition to childhood immunization schedule

Adverse Effects of Pertussis and Rubella Vaccines

ACIP recommends Hib be added to childhood immunization schedule

1992

Acellular pertussis component licensed for the 4th and 5th doses of the 5-part DTP series in Tripedia

Hepatitis B vaccine: Added universal vaccination for all infants, high-risk adolescents (e.g., IV drug users, persons with multiple sex partners)

 

1993

Combined DTP and Hib vaccine (Tetramune) licensed

 

1994

 

Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality

DPT and Chronic Nervous System Dysfunction: A New Analysis

1995

Varicella virus vaccine available (Varivax)

 

Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×

Year

Vaccine Licensure

Legislation and/or Policy Statements

IOM Reports on Vaccine Safety

1996

DTaP vaccine licensed for first three doses given in infancy (Tripedia and ACEL-IMUNE were previously licensed for only the 4th and 5th doses).

ACIP recommends using IPV for the first 2 polio vaccinations, followed by OPV for remaining doses. Intended to be a transitional schedule for 3–5 years until an all-IPV series is available

Options for Poliomyelitis Vaccinations in the United States: Workshop Summary

 

ACIP recommends children 12months–12 years receive Varicella vaccine

 

1997

Additional DTaP vaccine (Infanrix) licensed for first 4 doses of 5-part series

ACIP recommends DTaP in place of DTP

Vaccine Safety Forum: Summary of Two Workshops

 

Risk Communication and Vaccination: Workshop Summary

1998

Additional DTaP vaccine (Certiva) licensed for first 4 doses of 5-part series

ACIP updates MMR recommendation, encouraging use of the combined MMR vaccine

 

1999

 

ACIP updates varicella vaccine recommendation, requiring immunity for child care and school entry

ACIP recommends an all-IPV schedule begin January 2000 to prevent cases of vaccine-associated paralytic polio

AAP and PHS recommend removal of thimerosal from vaccines

Also recommended postponement of hepatitis B vaccine from birth to 2–6 months for infants of hepatitis B surface antigen-negative mothers

Additional supply of thimerosal-free hepatitis B vaccine made available

MMWR notifies readers of the availability of a thimerosal-free hepatitis B vaccine, enabling the resumption of the birth dose

 

2000

Pneumococcal vaccine for infants and young

ACIP recommends pneumococcal vaccination for all chil

 

Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×

Year

Vaccine Licensure

Legislation and/or Policy Statements

IOM Reports on Vaccine Safety

 

children licensed (Prevnar)

dren 2–23 months, and at-risk children 24–59 months (e.g., immunocompromised)

 

2001

 

October: ACIP drafts statement expressing a preference for use of thimerosal-free DtaP, Hib, and Hep B vaccines by March 2002

Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism

 

Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders

2002

 

Immunization Safety Review: Multiple Immunizations and Immune Dysfunction

Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×
Page 103
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×
Page 104
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×
Page 105
Suggested Citation:"Appendix C: Chronology of Important Events Regarding Vaccine Safety." Institute of Medicine. 2002. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington, DC: The National Academies Press. doi: 10.17226/10393.
×
Page 106
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Immunization to protect infants and children from vaccine-preventable diseases is one of the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.

The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001- 2003). While all of the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis (MS) and Guillain-Barré syndrome (GBS).

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