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Manufacturers' postmarketing safety surveillance of influenza vaccine exposure in pregnancy.

Abstract：

:Pregnant women are at increased risk for hospitalization and death with influenza infection. The limited data on safety and effectiveness of influenza immunization in pregnancy emphasizes the importance of developing new and well-designed studies and of enhancing safety surveillance in pregnant women who are vaccinated with licensed influenza vaccines. Pregnancy exposure registries aim to collect and maintain data on the effects of marketed drugs and vaccines, when prescribed in pregnancy or during breastfeeding, on the women themselves and their children. Women who are prescribed a medication or vaccine as part of their routine clinical care can be enrolled directly or through reporting health care providers on a voluntary basis. Such registries generally are established for products that are intended for use by adolescents and adults and are a key component of the safety monitoring of licensed products. This article reviews some of the pregnancy registries that have been established for US-licensed vaccines, which includes influenza vaccines, and other postlicensure safety surveillance efforts for monitoring safety in vaccinated pregnant women.

journal_name

Am J Obstet Gynecol

journal_title

American journal of obstetrics and gynecology

authors

Khromava A,Cohen CJ,Mazur M,Kanesa-thasan N,Crucitti A,Seifert H

doi

10.1016/j.ajog.2012.06.074

subject

Has Abstract

pub_date

2012-09-01 00:00:00

pages

S52-6

issue

3 Suppl

eissn

0002-9378

issn

1097-6868

pii

S0002-9378(12)00728-4

journal_volume

207

pub_type

杂志文章,评审

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