Developing The Infrastructure To Conduct Surveillance Of Birth Outcomes Following Maternal Vaccination: A Project Using Influenza Vaccines And Birth Outcomes As A Use Case

White paper published online at: External Link

Published March 28, 2018

Author(s): Alison Tse Kawai, Susan E Andrade, Lauren Zichittella, Robert Rosofsky, Kecia N Carroll, Erin Longley, Mano Selvan, Cheryl Walraven, Lauren E Parlett, Anita Loughlin, Tara Wenger, Megan Reidy, Sandra Feibelmann, Madelyn Pimentel, Austin Cosgrove, Azadeh Shoaibi, Steven Anderson, Grace M Lee

Abstract

To complement other post-marketing safety surveillance systems, we assessed the feasibility of conducting safety surveillance of vaccine use during pregnancy within Sentinel’s PRISM program. For this activity, we focused on developing capabilities to assess infant birth outcomes following maternal vaccination exposure during pregnancy. We assessed the feasibility of developing data infrastructure and identifying key data elements for an exposure-outcome pair selected as an example for methods development (“use case”), maternal influenza vaccination during pregnancy and cleft lip/palate in the infant. The use case was selected based on the universal recommendation for influenza vaccination in all pregnant women, and the early and relative ease of identifying cleft lip/palate at birth in the Sentinel database. The selection of cleft lip/palate as the use case was not based on any concern or evidence regarding an association between influenza vaccine and cleft lip/palate. Other malformations (e.g., cardiac defects) might not be identified until months or years following birth. We also explored the feasibility of utilizing the case-time-control study design to assess the use case association.

Funding Transparency

This work was possible through:

Tags

Analytic: common data model | case algorithm validation

Data Source: claims | mother-infant linkage | birth certificates

Research Focus: vaccines | sentinel initiative | reproductive epidemiology

Study Design: medical record review | case-time-control

Entry last updated (DMY): 24-11-2024.

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2024 Lauren Elizabeth Parlett, PhD - Epidemiologist. All rights reserved.

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