White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink. (15th February 2016)

• Record Type: Journal Article
• Authors: Glanz, Jason M.; Newcomer, Sophia R.; Jackson, Michael L.; Omer, Saad B.; Bednarczyk, Robert A.; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F.; Goddard, Kristin; Panneton, Michelle; Groom, Holly; Plotkin, Stanley A.; Orenstein, Walter A.; Marcuse, Edgar K.; Brookhart, M. Alan; Kulldorff, Martin; Shimabukuro, Tom; McNeil, Michael; Gee, Julianne; Weintraub, Eric; Sukumaran, Lakshmi
• Is Part Of: Vaccine. Volume 34(2016)Supplement 1
• Page Start: A1
• Page End: A29
• Publication Date: 2016-02-15
• Subjects: ACIP Advisory Committee on Immunization Practices -- ADU average days undervaccinated -- CDC Centers for Disease Control and Prevention -- DAG Directed Acyclic Graph -- DTaP diphtheria and tetanus toxoid and acellular pertussis vaccine -- EHR electronic health record -- Hep B Hepatitis B Vaccine -- Hib Haemophilus Influenzae Type b Vaccine -- ICD-9-CM International Classification of Diseases, 9th revision, Clinical Modification -- IIS Immunization Information Systems -- IOM Institute of Medicine -- ISO Immunization Safety Office -- MCO Managed Care Organization -- MMR Measles, Mumps, and Rubella Vaccine -- PC Pneumococcal Vaccine -- PCV7 Pneumococcal 7-valent Conjugate Vaccine -- PCV13 Pneumococcal 13-valent Conjugate Vaccine -- SME Subject Matter Expert -- VDW Virtual Data Warehouse -- VSD Vaccine Safety Datalink; Vaccine safety -- Recommended immunization schedule -- Alternative immunization schedule -- Parental vaccine concerns -- Parental vaccine refusal -- Vaccine safety methods; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2015.10.082
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule.