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.
Highlights
The Food and Drug Administration (FDA) is responsible for regulating vaccines in the UnitedStates
A longer post-vaccination follow-up, typically 12 months following last vaccination is recommended to capture delayed vaccine associated serious adverse events (SAE) and new onset of medical conditions
Differential pattern recognition receptor (PRR) repertoire, husbandry, microbiome, inoculation routes, immune effector functions, and the interval between vaccination and influenza virus challenge may contribute to significant differences in immune responses and protection from viral challenge compared to humans
Summary
The Food and Drug Administration (FDA) is responsible for regulating vaccines in the United. In 1945, the first inactivated influenza vaccine (IIV) was licensed in the United States (US). The adaptation of vaccine strains to growth in eggs to increase HA yields, can result in accumulation of mutations that could impact important antigenic sites and may reduce the protective immunity against the circulating influenza strains. To overcome some of these limitations, cell-based and recombinant production technologies were developed for more rapid production of seasonal influenza vaccines that could be used in response to a pandemic threat. The first recombinant influenza vaccine based exclusively on hemagglutinin protein was licensed in 2013 by FDA. To improve vaccine immunogenicity and protection in the elderly population, the first adjuvanted seasonal influenza vaccine combined with adjuvant, MF59C.1., an oil in water emulsion of squalene, was licensed in November 2015 by FDA for adults 65 years of age and older
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