13-Valent Pneumococcal Conjugate Vaccination (PCV13) and Kawasaki Disease

Basic Details
Date Posted
Wednesday, October 24, 2018
Status
Complete
Medical Product
13-valent pneumococcal vaccine (PCV13)
Prevnar 13
Health Outcome(s)
Kawasaki disease
Description

This project was a one-time assessment of a possible association between Prevnar 13 vaccination and Kawasaki disease. The objectives were to determine 1) the existence and magnitude of any increased risk of Kawasaki disease in the 28 days following 13-Valent pneumococcal conjugate vaccination (PCV13) and 2) the positive predictive value of an International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) code-based algorithm for identifying Kawasaki disease.  

The study population was children aged 0-23.99 months from six Sentinel Data Partners during 2010-2015. The primary analysis used an age-adjusted self-controlled risk interval design and chart-confirmed cases of Kawasaki disease. More than 6 million doses of PCV13 vaccine were administered to the study population. There were 87 confirmed cases of Kawasaki disease in the primary analysis. No evidence was found of an elevated risk of Kawasaki disease in the 4 weeks after PCV13 vaccination. These null results were robust across alternative designs, age-adjustment methods, control intervals, and levels of case confirmation. The positive predictive value of the case-finding algorithm was 68%.

The Mini-Sentinel Operations Center posted the protocol for public comment from September 11, 2015 through September 29, 2015. The public comment period is now closed. Revised versions were approved for implementation by FDA on August 9, 2016. A log of changes is included in the final version (v2).

Additional Details
FDA Center
CBER
Time Period
2010 - 2015
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
HOI Study Type
Validations Supported by Traditional Medical Chart Review
Population / Cohort
Children 0 - 23.99 months of age
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Workgroup Leader(s)

Meghan A. Baker, MD, ScD; W. Katherine Yih, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Bethany Baer, MD; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Carolyn Balsbaugh, MPH; David Cole; Sandra Feibelmann, MPH; Katherine Freitas; Robert Jin, MS; Grace M. Lee, MD, MPH; Hana Lipowicz, MPH; Lauren Zichittella, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Martin Kulldorff, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, MA
Rebecca Reindel, MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

Vinit Nair, BPharm; Mano Selvan, PhD; Yunping Zhou, MS; Comprehensive Health Insights, Humana, Miramar, FL

Laura Karslake, MS; Ling Li, MSPH; Nancy Lin, ScD; Eva Ng, MS; Judy Wong; OptumInsight LifeSciences, Inc., Boston, MA

Annemarie Kline, MS; Yihai Liu, MS; Cheryl McMahill-Walraven, MSW, PhD; Kevin Walsh, MS; Aetna, Blue Bell, PA

Jade Dinh, MPH; Kevin Haynes, PharmD; Chunfu Liu, ScD; Amanda Marshall, MBA; Lauren Parlett, PhD; HealthCore, Inc., Translational Research for Affordability and Quality, Alexandria, VA 

Marie Griffin, MD, MPH; Judy King; J. Anthony Morrow; Vanderbilt University School of Medicine, Department of Health Policy, Nashville, TN 

Kecia N. Carroll, MD, MPH; Vanderbilt University Medical Center, Nashville, TN 

James Antoon, MD, PhD, FAAP; University of Illinois at Chicago and Children’s Hospital, University of Illinois Hospital & Health Sciences System, Chicago, IL

Joseph Lazar, MD; Boston Children’s Hospital Pediatric Program at Winchester Hospital, Winchester, MA