A systematic review of adverse events following immunization during pregnancy and the newborn period.

ABSTRACT: In 2013, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) requested WHO to develop a process and a plan to move the maternal immunization agenda forward in support of an increased alignment of data safety evidence, public health needs, and regulatory processes. A key challenge identified was the continued need for harmonization of maternal adverse event following immunization (AEFI) research and surveillance efforts within developing and developed country contexts. We conducted a systematic review as a preliminary step in the development of standardized AEFI definitions for use in maternal and neonatal clinical trials, post-licensure surveillance, and other vaccine studies. We documented the current extent and nature of variability in AEFI definitions and adverse event re

SUBMITTER: Fulton TR 

PROVIDER: S-EPMC8290429 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature