Exclusion of Reproductive-aged Women in COVID-19 Vaccination and Clinical Trials.

ABSTRACT:

Introduction

We analyzed the exclusion of pregnant and breastfeeding individuals and those capable of pregnancy in COVID-19 vaccine and clinical treatment trials.

Methods

Inclusion and exclusion criteria were extracted from all listed COVID-19 vaccine and treatment clinical trials from May 1, 2020, to October 31, 2020, using the U.S. National Library of Medicine database. We report rates of rates of exclusion for pregnant and lactating individuals and requirements for contraception for pregnancy-capable participants in COVID-19 vaccine and treatment clinical trials. The analysis included the association between clinical trial exclusion and vaccine and treatment type, study location, sponsor, and phase.

Results

Pregnant and lactating individuals were explicitly exclude

SUBMITTER: Kons KM 

PROVIDER: S-EPMC9197956 | biostudies-literature | 2022 Nov-Dec

REPOSITORIES: biostudies-literature