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. Author manuscript; available in PMC: 2015 Nov 29.
Published in final edited form as: Vaccine. 2015 Oct 1;33(0 4):D46–D54. doi: 10.1016/j.vaccine.2015.06.073

Table 2. Some highlights in the history of vaccine safety in the U.S., pre- and post- National Childhood Vaccine Injury Act (NCVIA) of 1986.

  • Pre-1986 NCVIA

    • 1902 Biologics Control Act after tetanus contamination of diphtheria antitoxin and smallpox vaccine (23)

    • 1942, hepatitis B contaminated yellow fever vaccine (129)

    • 1955 Cutter incident (130-132)

    • 1967 Publication of The Hazards of Immunization by Sir G.S. Wilson (133)

    • 1976 Swine influenza vaccine and Guillain-Barre Syndrome (GBS) (134)

  • Post-1986(NCVIA (134)

    • Hypothesis Generation

      • 1990: Vaccine Adverse Event Reporting System (VAERS) (14, 135); combining Monitoring System for Adverse Events Following Immunizations (MSAEFI) (136) and Adverse Drug Reaction (ADR) Reporting (for vaccines) (137)

      • 2001: Data mining for signal detection in VAERS (138) (55-57)

      • 2005: Using electronic medical records to enhance detection and reporting of vaccine adverse events. (51)

    • Hypothesis Strengthening

      • 2000: Brighton Collaboration standardized case definitions for AEFI's (139).

      • 2001: Clinical Immunization Safety Assessment (CISA) Network (41)

      • 2005: Rapid Cycle analysis using Maximized Sequential Probability Ratio Test of the Vaccine Safety Datalink (VSD) project (61)

    • Hypothesis Testing

      • 1989: Vaccine Safety Datalink project (140)

      • 2009: Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program: (40)

    • Risk Perception and Vaccine Acceptance/Hesitancy

      • 1998: Lessons from risk communications (141)

      • National Immunization Information Hotline (142)

    • Institute of Medicine (IOM) reviews (81, 143-146)

    • Non-US:

      • Large Linked Databases:

        • UK (147)

        • Denmark (148)

          • Genomic studies (149)

        • Europe (95)

    • Low and Middle Income Countries (LMIC)

      • Mass campaign and AEFI surveillance

      • Safe Injection Global Network (SIGN) (153)

      • Large Linked Databases (154)

    • Methods:

      • Use of VAERS as registry of rare reactions for hypothesis testing (155)

      • First use of self-control case series study design (147) ; first application in the VSD project (156)

      • Rapid Cycle analysis using Maximized Sequential Probability Ratio Test of the Vaccine Safety Datalink (VSD) project (39, 60-62)

      • Distributed Data Network Model in VSD, 2001 (60)

      • Data sharing in the VSD, 2002 (60)

      • Genomics study (157-159)