The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence, and Future Studies (2013) / Chapter Skim
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3 Existing Data Sources and Systems
3 Existing Data Sources and Systems
Pages 39-58
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From page 39... ...
, and vaccine manufacturers have systems in place for postmarketing surveillance and research. CDC and FDA manage a number of postmarketing activities, including surveillance of vaccine-preventable diseases, monitoring of adverse events following immunization, tracking of vaccine coverage and issuance 39
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From page 40... ...
In addition to the surveillance systems managed by CDC, FDA has established a supplementary mechanism for monitoring vaccine safety called the Sentinel Initiative. Vaccine Adverse Event Reporting System VAERS is a passive reporting surveillance system that is jointly managed by CDC and FDA and serves as a warning system for potential adverse events and side effects from a recommended vaccine that may not have been detectable in clinical trials (NVAC, 2011)
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From page 41... ...
The VSD project was formed in the 1990s as a collaborative effort between CDC and a group of managed care organizations (MCOs) to maintain a large linked database for monitoring immunization safety and studying potential rare and serious adverse events.
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From page 42... ...
Every week, the Rapid Cycle Analysis team determines the rates of adverse events associated with newly licensed or recommended vaccines in the study population. This information allows VSD researchers to compare the rates of adverse events in similar groups of people to determine if an event is related to the vaccine.
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From page 43... ...
The fact that MCOs have different vaccination policies (after the first year of life) -- along with deviations in the immunization schedule due to variations in clinical practice, vaccine shortages, problems with access, or intentional denial of vaccine coverage -- yields differences in vaccine exposure in this large cohort (Chen et al., 1997)
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From page 44... ...
program similarly captures claims data from the Mini-Sentinel sites to establish a large cohort with which to analyze vaccine exposure and adverse events with a high degree of statistical power. This active surveillance system, which is updated quarterly, has the capacity to link claims data from collaborating health insurers to immunization registries.
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From page 45... ...
CISA investigators have performed causality assessments on reports received from VAERS, including a recent assessment of serious neurologic adverse events following immunization with the H1N1 influenza vaccine (Williams et al., 2011)
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From page 46... ...
program was developed by the NIAID in 2010 to further an understanding of the human immune system and its regulation. HIPC researchers are using innovative technologies to profile human responses and provide new biological evidence to help determine if there is a relationship between short-term adverse events following vaccination and long-term health issues (HIPC, 2012)
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From page 47... ...
children in all 50 states and selected territories and urban areas. The combined surveys produce coverage data for children in the United States by individual vaccine, as well as immunization schedule completion indicators, such as completion of the 4:3:1:3:3:1:4 seven-vaccine series (four or more doses of diphtheria-tetanus-pertussis vaccine, three or more doses of poliovirus vaccine, one or more doses of MMR vaccine, three or more doses of Haemophilus influenzae type b, vaccine, three or more doses of hepatitis B vaccine, one or more doses of varicella vaccine, and four doses of sevenvalent pneumococcal conjugate vaccine [PCV]
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From page 48... ...
. DATABASES EXAMINING ADVERSE EVENTS AFTER IMMUNIZATION FOR VACCINE-PREVENTABLE DISEASES A set of national and state databases with data on hospital discharges can be used to monitor events requiring medical attention that occur after immunization with selected vaccines.
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From page 49... ...
Analyses like these require specific diagnosis codes for the adverse events and, in addition, require a causal chain that links the adverse event to vaccines. This is the case for rotavirus and intussusception but is less frequent for adverse events with other vaccines.
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Although these systems and those in place in the United States have key differences, starting with differences in the recommended immunization schedules, other countries may be well-equipped to provide data on safety concerns with the immunization schedule identified by the committee. Descriptions of immunization data systems from three countries, including Canada, with populations similar to the population in the United States are presented below.
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From page 51... ...
The Yellow Card passive surveillance system was introduced in 1965 and is currently operated by the pharmaceutical licensing authority in the United Kingdom, the Medicines and Healthcare Products Regulatory Agency. Today, UK health care professionals and patients can also report potential adverse events electronically or by phone.
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From page 52... ...
England and Wales maintain national child health databases that routinely collect immunization records and can likewise be linked with the HES by use of an NHS number and specified approvals. This method has been used to investigate adverse event signals, such as a suspected increased risk of purpura or convulsions from the meningococcal group C conjugate vaccine and a potential association between MMR and idiopathic thrombocytopenic purpura (Andrews et al., 2007; Miller et al., 2001)
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From page 53... ...
Today, the passive surveillance system is called the Canadian Adverse Events Following Immunization Surveillance System and is maintained by the Public Health Agency of Canada. Health care professionals in Canada can submit reports of suspected adverse events to their local public health authority.
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Any suspected adverse events are reported to the vaccinee's local public health authorities and the Public Health Agency of Canada (Public Health Agency of Canada, 2006)
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From page 55... ...
2012. Vaccine Adverse Event Reporting System.
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From page 56... ...
Presentation to Meeting 1 of the Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule, Washington, DC, February 9. Hedden, E.M., A.B.
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Presentation to Meeting 3 of the Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule, Washington, DC, May 29. Miller, E., P
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From page 58... ...
2011. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.
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