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Vaccines 2018, 6(2), 24; https://doi.org/10.3390/vaccines6020024

Development and Regulation of Novel Influenza Virus Vaccines: A United States Young Scientist Perspective

Division of Viral Products, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Silver Spring, MD 20993, USA
Received: 4 April 2018 / Revised: 20 April 2018 / Accepted: 25 April 2018 / Published: 27 April 2018
Full-Text   |   PDF [199 KB, uploaded 3 May 2018]

Abstract

Vaccination against influenza is the most effective approach for reducing influenza morbidity and mortality. However, influenza vaccines are unique among all licensed vaccines as they are updated and administered annually to antigenically match the vaccine strains and currently circulating influenza strains. Vaccine efficacy of each selected influenza virus vaccine varies depending on the antigenic match between circulating strains and vaccine strains, as well as the age and health status of the vaccine recipient. Low vaccine effectiveness of seasonal influenza vaccines in recent years provides an impetus to improve current seasonal influenza vaccines, and for development of next-generation influenza vaccines that can provide broader, long-lasting protection against both matching and antigenically diverse influenza strains. This review discusses a perspective on some of the issues and formidable challenges facing the development and regulation of the next-generation influenza vaccines. View Full-Text
Keywords: influenza; vaccine; correlates; universal; next-generation; animal model; human challenge; adjuvants; vaccine safety; regulatory pathway influenza; vaccine; correlates; universal; next-generation; animal model; human challenge; adjuvants; vaccine safety; regulatory pathway
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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Khurana, S. Development and Regulation of Novel Influenza Virus Vaccines: A United States Young Scientist Perspective. Vaccines 2018, 6, 24.

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