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Global Management of Infectious Disease After Ebola$
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Sam F. Halabi, Lawrence O. Gostin, and Jeffrey S. Crowley

Print publication date: 2016

Print ISBN-13: 9780190604882

Published to Oxford Scholarship Online: October 2016

DOI: 10.1093/acprof:oso/9780190604882.001.0001

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Evidence, Strategies, and Challenges for Assuring Vaccine Availability, Efficacy, and Safety

Evidence, Strategies, and Challenges for Assuring Vaccine Availability, Efficacy, and Safety

Chapter:
(p.223) 13 Evidence, Strategies, and Challenges for Assuring Vaccine Availability, Efficacy, and Safety
Source:
Global Management of Infectious Disease After Ebola
Author(s):

Saad B. Omer

Sam F. Halabi

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780190604882.003.0013

In chapter 13, Saad B. Omer and Sam F. Halabi examine the evidence, strategies, and challenges surrounding vaccine safety as novel technologies and expanding coverage introduce new factors to consider in maintaining the safety profile of current and new vaccines. While the fundamental principle behind vaccination remains the same, the technologies behind antigenic components have evolved. The chapter provides concrete recommendations on how the regulatory process that assures vaccine safety and efficacy may be adapted to respond to these technologies. The chapter also reviews postlicensure vaccine safety and adverse event reporting systems at both the national and the international level. It assesses weaknesses in the global system for adverse event monitoring, especially in light of advances in immunization coverage programs in low-income countries, and propose potential solutions to address those weaknesses.

Keywords:   vaccine safety, regulatory process, vaccine efficacy, adverse event reporting systems, immunization

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