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

Project Title 13-Valent Pneumococcal Conjugate Vaccination (PCV13) and Kawasaki Disease
Date Posted
Wednesday, October 24, 2018
Status
Complete
Deliverables
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).

Medical Product
13-valent pneumococcal vaccine (PCV13)
Prevnar 13
Health Outcome
Kawasaki disease
Population / Cohort
Children 0 - 23.99 months of age
Time Period
2010 - 2015
Assessment Type
Safety Analyses
Study Type
Protocol/Surveillance Plan
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

Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CBER