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Appendix C
Chronology of Important
Events Regarding
Vaccine Safety
Year Vaccine Licensure Legislation and/or TOM Reports on
Policy Statements Vaccine Safety
Activated poliomyelitis
vaccine (IPV) available
Oral poliomyelitis vac-
cine (OPV) available,
replaces IPV
Measles vaccine available
Mumps vaccine available
Rubella vaccine available
Measles -Mump s-Rubella
(MMR) vaccine available
Current formulation of
rubella vaccine available,
replaces earlier versions
Plasma-derived hepatitis
B vaccine available
1985 Hib vaccine licensed for
Mumps vaccination
recommended
Evaluation of
Poliomyelitis
Vaccines
98
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APPENDIX C
99
Year Vaccine Licensure
Legislation and/or TOM Reports on
Policy Statements Vaccine Safety
children >15 months
1986
1988
990
991
1992
1993
1994
Acellular pertussis com-
ponent licensed for the 4
and So doses of the S-part
DTP series in Tripedia
Combined DTP and Hib
vaccine (Tetramune)
licensed
1995 Varicella virus vaccine
available (Varivax)
Congress passes Public Law
99-660, the National Child-
hood Vaccine Injury Act (in-
troduced 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 vac-
cines
2 Hib conjugate vaccines
licensed for use begin-
ning at 2 months
Evaluation of Polio-
myelitis Vaccine
Policy Options
Acellular pertussis com- Hepatitis B recommended by Adverse Ejects of
portent licensed for the Oh ACIP for addition to childhood Pertussis and Ru-
and 5~ doses of the 5-part immunization schedule bella Vaccines
DTP series in ACEL-
IMUNE
ACIP recommends Hib be
added to childhood immuniza-
tion schedule
Hepatitis B vaccine: Added
universal vaccination for all
infants, high-risk adolescents
(e.g., IV drug users, persons
win multiple sex parmers)
Adverse Events
Associated with
Childhood Vaccines:
Evidence Bearing on
Causality
DPT and Chronic
Nervous System
Dysfunction: A New
Analysis
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I M M U N I Z A T I O N S A F E T Y R E V I E W
Year Vaccine Licensure
Legislation and/or
Policy Statements
ACIP recommends using IPV
for the first 2 polio vaccina-
tions, followed by OPV for
remaining doses. Intended to
be a transitional schedule for
3-5 years until an all-IPV
series is available
TOM Reports on
Vaccine Safety
Options for Polio-
myelitis Vaccinations
in the United States:
Workshop Summmy
996
997
998
999
DTaP vaccine licensed
for first three doses given
in infancy (Tripedia and
ACEL-IMUNE were
previously licensed for
only the 4~ and 5th
doses).
Additional DTaP vaccine
(Infanrix) licensed for
first 4 doses of 5-part
series
Additional DTaP vaccine
(Certiva) licensed for first
4 doses of 5-part
series
Additional supply of
thimerosal-free hepatitis
B vaccine made available
2000 Pneumococcal vaccine
for infants and young
ACIP recommends children
12months - 12 years receive
Varicella vaccine
ACIP recommends DTaP in
place of DTP
ACIP updates MMR recom-
mendation, encouraging use of
the combined ME vaccine
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 postpone-
ment of hepatitis B vaccine
from birth to 2-6 months for
infants of hepatitis B surface
antigen-negative mothers
MOOR notifies readers of the
availability of a thimerosal-free
hepatitis B vaccine, enabling
the resumption of the birth
dose
AC IP recommends p neumo -
coccal vaccination for all
Vaccine Safety Fo-
rum: Summary of
Two Workshops
Risk Communication
and Vaccination:
Workshop Summary
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APPENDIX C
101
Year Vaccine Licensure
Legislation
Policy Statements
and/or TOM Reports on
Vaccine Safety
2001
2002
children licensed (Prev- children 2-23 months, and at-
nar) risk children 2059 months
(e.g., immunocompromised)
October: ACIP drafts statement Immunization Safety
expressing a preference for use Review: Measles-
of thimerosal-free DTaP, Hib, Mumps-Rubella
and Hep B vaccines by March Vaccine and Autism
2002
Immunization Safety
Review: Thimerosal-
Containing Vaccines
and Neurodevelop-
mental Disorders
Immunization Safety
Review: Multiple
Immunizations and
Immune Dysfunction
Immunization Safety
Review: Hepatitis B
Vaccine and Demye-
linating Neurological
Disorders
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Representative terms from entire chapter:
vaccine safety