title: Propelling novel vaccines directed against tuberculosis through the regulatory process.
abstract: The development of novel vaccines for use in the prevention and immunotherapy of tuberculosis is an area of intense interest for scientific researchers, public health agencies and pharmaceutical manufacturers. Development of effective anti-tuberculosis vaccines for use in specific target populations will require close cooperation among several different international organizations including agencies responsible for evaluating the safety and effectiveness of new biologics for human use. In this review, the major issues that are addressed by regulatory agencies to ensure that vaccines are pure, potent, safe, and effective are discussed. It is hoped that the comments provided here will help accelerate the development of new effective vaccines for the prevention and treatment of tuberculosis.
authors.affiliation: Laboratory of Mycobacteria, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA. Brennan@cber.fda.gov
authors.forename: M J
authors.initials: MJ
authors.lastname: Brennan
authors.forename: F M
authors.initials: FM
authors.lastname: Collins
authors.forename: S L
authors.initials: SL
authors.lastname: Morris
mesh_terms: D001500:BCG Vaccine / Q000138:chemical synthesis; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D006801:Humans; D014376:Tuberculosis / Q000517:prevention & control* / Q000628:therapy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001500:BCG Vaccine