Journal Article

Challenges in the Development, Licensure, and Use of Combination Vaccines

Alicia S. Postema, Martin G. Myers and Robert F. Breiman

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue Supplement_4, pages S261-S266
Published in print December 2001 | ISSN: 1058-4838
Published online December 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/322560
Challenges in the Development, Licensure, and Use of Combination Vaccines

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Before substantial public health benefits associated with use of combination vaccines can be realized, a variety of challenges must be addressed. In February 2000, the National Vaccine Program Office convened the International Symposium on Combination Vaccines to explore solutions for barriers to development, licensure, and use of safe and effective combination vaccines. The symposium focused on the following questions: (1) What immunologic standards should be used to evaluate new combination vaccines? (2) How should correlates of protection be developed, and how should the data they provide be interpreted? (3) What sample size is adequate for prelicensure safety trials of combination vaccines? (4) Should standards for evaluation of combination vaccines containing licensed components be different from standards for evaluation of combinations containing unlicensed components? (5) How can the “great expectations” of postlicensure surveillance be realized? Available data relevant to these issues were presented, providing a foundation for furthering the science of combination vaccines.

Journal Article.  3976 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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