Rapid Surveillance Capability: 2017-18 Seasonal Influenza Vaccines Surveillance

Basic Details
Date Posted
Wednesday, May 22, 2019
Status
Complete
Description

This study conducted surveillance of influenza vaccines during the 2017-2018 influenza season, from October 2017 through May 2018; the last analysis was performed at the beginning of June 2018 with the available data up to that time.  Because influenza vaccines are administered during a relatively short period, the Sentinel Operations Center worked with select PRISM Data Partners to access sources of fresher data.

The Sentinel Operations Center posted the surveillance protocol for public comment from August 4, 2017, through August 18, 2017. The public comment period is now closed.  A revised version was approved for implementation by September 6, 2017. A log of changes is included in the revised protocol.

Additional Details
FDA Center
CBER
Time Period
2017 – 2018
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
Data Sources
Sentinel Distributed Database (SDD)
Workgroup Leader(s)

Alison Kawai, ScD; Cathy Panozzo, PhD; W. Katherine Yih, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

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

Workgroup Members

Deepa Arya MD, MPH, MBA; Kinnera Chada, PhD; Richard A. Forshee, PhD; Hector S. Izurieta, MD, MPH; Joyce Obidi, PhD; Scott Proestel, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Eric Czernizer, MPH; Tyler Jette, MPH; Lauren Zichittella, MS; James Williams, MBA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Smita Bhatia, MCA; Annemarie Kline, MS; Cheryl McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA 

Kevin Haynes, PharmD, MSCE; Lauren Parlett, PhD; HealthCore, Inc., Alexandria, VA 

Mano Selvan, PhD; Comprehensive Health Insights, Humana Inc., Louisville, KY