and approval before vaccines are made publicly available. Each new vaccine considered for inclusion in the immunization schedule is tested within the context of the existing schedule and reviewed by clinical researchers, who analyze the balance of demonstrated benefits and risks. Thus, each new vaccine is approved on the basis of a detailed evaluation of both the vaccine itself and the immunization schedule. Every year, the Centers for Disease Control and Prevention (CDC) issues guidance on the vaccines to be administered and immunization schedules for children, adolescents, and adults, based on recommendations from ACIP.
To recommend new vaccines, ACIP uses a process in which it reviews a comprehensive set of data associated with the vaccine, including illnesses and deaths associated with the disease and specific high-risk groups; the results of clinical trials, including indicators of safety, efficacy, and effectiveness; cost-effectiveness; information on vaccine use provided by the manufacturer in the product’s labeling or package insert; and the feasibility of incorporation of the vaccine into the existing immunization schedule.
Ongoing surveillance systems are the primary source of data on vaccine safety postmarketing. CDC maintains three major postmarketing surveillance systems: the Vaccine Adverse Event Reporting System, which is jointly managed with the Food and Drug Administration (FDA); the Vaccine Safety Datalink (VSD); and the Clinical Immunization Safety Assessment Network. In addition to the surveillance systems managed by CDC, FDA has established the Sentinel Initiative, a supplementary mechanism for monitoring vaccine safety.
Immunization coverage among children entering kindergarten currently exceeds 90 percent for most recommended vaccines. However, concerns about vaccine safety have contributed to increases in the delay or refusal of immunization, which have, in turn, contributed to a reemergence of vaccine-preventable illnesses. For example, measles and pertussis (whooping cough) outbreaks have occurred in areas where higher proportions of children are unimmunized.
Vaccines—like all drugs or medical interventions—are neither 100 percent risk-free nor 100 percent effective. Additionally, population-wide prevention of vaccine-preventable diseases relies on community immunity, also commonly referred to as herd immunity, which is the shared protective effect conferred on unimmunized individuals when a sufficiently large proportion of the population is immunized against infectious diseases. This phenomenon is achieved when too few people who are vulnerable to development of a disease remain in the population to maintain the chain of disease transmission. Community immunity is waning, however, in places with increasing numbers of unimmunized, incompletely immunized individuals and/or individuals with waning immunity.
Even though children are required to be immunized to enter school