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Influenza Vaccines and Birth Outcomes

    Basic Details
    Date Posted
    Medical Product
    influenza vaccine
    Health Outcome(s)
    cleft lip with cleft palate
    cleft lip without cleft palate
    cleft palate without cleft lip

    This project was a one-time assessment of the association between influenza vaccination and birth outcomes (cleft lip without cleft palate, cleft palate without cleft lip, or cleft lip with cleft palate).

    Medical record review was conducted to confirm case status, confounders, and gestational age at delivery to better understand the strengths and limitations of using electronic data for surveillance. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    The Mini-Sentinel Operations Center posted this protocol for public comment from February 25, 2013, through March 11, 2013. The public comment period is now closed.  A revised version was approved for implementation by FDA on December 5, 2014 and a second revised version was approved for implementation by FDA on January 3, 2017. A log of changes is included in the revised protocol (v3).

    Additional Details
    FDA Center
    Time Period
    January 2004 - May 2012
    HOI Study Type
    Validations Supported by Traditional Medical Chart Review
    Population / Cohort
    Females 10-55 years of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD), immunization registries, and vital record registries in Colorado, Georgia, Pennsylvania, Missouri, Utah, Louisiana, Virginia, and Florida
    Workgroup Leader(s)

    Alison Kawai, ScD; Grace Lee, MD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Azadeh Shoaibi, PhD, MS, MHS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Carolyn Balsbaugh, MPH; Austin Cosgrove; Sandra Feibelmann, MPH; Katherine Freitas; Tim Glavin; Katie Haffenreffer; Margaret Johnson, MPH; Lingling Li, PhD; Madelyn Pimentel; Linda Pointon; Megan Reidy, MPH; Catherine Rogers, MPH; Robert Rosofsky, MA; Lauren Zichittella, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Susan Andrade, ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA

    Steve Anderson, PhD, Faith Barash, MD, MPH; Laura Polakowski, MD, MPH; Office of Biostatistics and Epidemiology Center for Biostatistics 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, Louisville, KY

    Michael Doherty, MS; Laura Karslake, MS; Ling Li, MSPH; Nancy Lin, ScD; Anita Loughlin, PhD; Eva Ng, MS; Rosie Prieto; Steve Roloff; Judy Wong; Li Zhou, MS; OptumInsight Inc, Waltham, MA

    Kirti Batra, MS; Smita Bhatia, MCA; Carolyn Jevit; Yihai Liu; Cheryl McMahill-Walraven, MSW, PhD; Aetna Inc, Blue Bell, PA

    Bola Ekezue, PhD; Kevin Haynes, PharmD; Chunfu Liu, ScD; Mike Mack, MS; Lauren Parlett, PhD, Nandini Selvam, PhD, MPH; Sonali Shambhu, MPH; Fang Tian, PhD; HealthCore, Inc, Alexandria, VA,

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

    Erin Longley, MD; Community Health Care, Lakewood, WA

    Tara Wenger, MD, PhD; Seattle Children’s Craniofacial Center, Seattle, WA