The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence, and Future Studies (2013) / Chapter Skim
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2 Determination of the Immunization Schedule
2 Determination of the Immunization Schedule
Pages 25-38
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From page 25... ...
The fundamental goal of vaccination is to prepare the immune system to defend the host against disease by intentionally exposing the body to all or part of an infectious agent in an effort to confer long-term protective immunity against future infection and to protect the most vulnerable individuals against disease. Immunity protects the body against infectious diseases mainly through the production of specialized protein molecules, known as "antibodies" or "immunoglobulins," once the immune system has been stimulated by the 25
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From page 26... ...
The immune response is largely dependent upon the properties of the antigen used to develop the vaccine and on the route of administration. Live attenuated vaccines contain viruses or bacteria that are weakened versions of the naturally occurring infectious agent, whereas inactivated vaccines contain either antigens that are grown in laboratory culture media and inactivated by the use of heat or chemicals, altered bacterial toxins (toxoids)
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From page 27... ...
. These antibodies reduce infection by blocking the interaction between the influenza virus antigen, hemagglutinin, and cell surface receptors that it will use to enter the cell (Reddy et al., 2011)
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For the major childhood infectious diseases, such as measles, mumps, rubella, chickenpox, and polio, a variety of methods have been devised to estimate R0 from longitudinal incidence reports, outbreak data, and age-stratified serology (Anderson and May, 1982, 1992; Becker, 1989; Keeling and Rohani, 2008)
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Bitmapped SOURCE: Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule.
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Figure 2-2 SOURCE: Adapted and reprinted Type is all outlines (noon the Assessment of Studies of by the Committee fonts) Health Outcomes Related to the Recommended Childhood Immunization Schedule.
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From page 31... ...
Although this process results in an evaluation of whether the observed benefits outweigh the observed risks for the new vaccine and, by extension, for the schedule, it does not include studies specifically designed to test variations in the schedule in an effort to identify the optimal schedule. Chapter 5 reviews researchers' efforts in testing variations in immunization schedules.
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From page 32... ...
If the clinical trials demonstrate that a vaccine is safe and effective, the licensing procedures begin with the submission of a Biologics License Application and a review of the immunization benefits and risk demonstrated by the clinical evidence. If FDA's Center for Biologics Evaluation and Research is convinced that the vaccine's benefits significantly outweigh potential risks for use in the general population, the vaccine is licensed and will undergo further evaluation of product safety through activities such as periodic facility inspections, as well as postmarketing clinical safety evaluation (FDA, 2010)
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. A representative from ACIP serves as a liaison on the National Vaccine Advisory Committee, which is the federal advisory committee responsible for advising the National Vaccine Program Office (NVPO)
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From page 34... ...
. PAST AND PRESENT IMMUNIZATION SCHEDULES The current schedule of recommended immunizations for infants and children from birth through age 6 years comprises vaccines that prevent 14 infectious diseases, a remarkable achievement compared with the schedule in 1948, when immunizations against only diphtheria, tetanus, pertussis, and smallpox were available and recommended for administration for protection.
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Exemptions may be medical in nature, such as exemptions for delayed or skipped immunization if the child has a condition that contraindicates immunization with the vaccine, as referenced above. Currently, every state law covering immunization requirements has a provision that allows medical exemptions.
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. The National Childhood Vaccine Injury Act also established the Vaccine Adverse Event Reporting System to track adverse events and created NVPO
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2011. The National Vaccine Injury Compensation Program.
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2011. National Vaccine Advisory Committee draft white paper on the United States vaccine safety system.
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