About the Authors

Corresponding Author

Michael.Brennan@fda.hhs.gov

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.