About the Authors

Michael J Brennan

To whom correspondence should be addressed. E-mail: Michael.Brennan@fda.hhs.gov

Uli Fruth
Julie Milstien
Rosemary Tiernan
Sergio de Andrade Nishioka
Liliana Chocarro
Developing Countries Vaccine Regulatory Network and the Ad Hoc Regulatory and TB Expert Panel

Competing Interests

MJB and RT are staff members of the United States Food and Drug Administration. UF and LC are staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy, or views of the Food and Drug Administration or the World Health Organization.

Author Contributions

Members of the Developing Countries Vaccine Regulatory Network and the Ad Hoc Regulatory and TB Expert Panel are listed in Text S1 under Supporting Information.