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