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The rationale for quadrivalent influenza vaccines.

ABSTRACT: Two antigenically distinct lineages of influenza B viruses have circulated globally since 1985. However, licensed trivalent seasonal influenza vaccines contain antigens from only a single influenza B virus and thus provide limited immunity against circulating influenza B strains of the lineage not present in the vaccine. In recent years, predictions about which B lineage will predominate in an upcoming influenza season have been no better than chance alone, correct in only 5 of the 10 seasons from 2001 to 2011. Consequently, seasonal influenza vaccines could be improved by inclusion of influenza B strains of both lineages. The resulting quadrivalent influenza vaccines would allow influenza vaccination campaigns to respond more effectively to current global influenza epidemiology. Manufacturing capacity for seasonal influenza vaccines has increased sufficiently to supply quadrivalent influenza vaccines, and methods to identify the influenza B strains to include in such vaccines are in place. Multiple manufacturers have initiated clinical studies of quadrivalent influenza vaccines. Data from those studies, taken together with epidemiologic data regarding the burden of disease caused by influenza B infections, will determine the safety, effectiveness, and benefit of utilizing quadrivalent vaccines for the prevention of seasonal influenza disease.

SUBMITTER: Ambrose CS

PROVIDER: S-EPMC3350141 | biostudies-other | 2012 Jan

REPOSITORIES: biostudies-other

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The rationale for quadrivalent influenza vaccines.

Ambrose Christopher S CS Levin Myron J MJ

Human vaccines & immunotherapeutics 20120101 1

Two antigenically distinct lineages of influenza B viruses have circulated globally since 1985. However, licensed trivalent seasonal influenza vaccines contain antigens from only a single influenza B virus and thus provide limited immunity against circulating influenza B strains of the lineage not present in the vaccine. In recent years, predictions about which B lineage will predominate in an upcoming influenza season have been no better than chance alone, correct in only 5 of the 10 seasons fr ...[more]

PMID: 22252006

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Project description:Background and aimThe majority of seasonal influenza vaccines are trivalent, containing two A virus strains (H1N1 and H3N2) and one B virus strain. The co-circulation of two distinct lineages of B viruses can lead to mismatch between the influenza B virus strain recommended for the trivalent seasonal vaccine and the circulating B virus. This has led some manufacturers to produce quadrivalent influenza vaccines containing one strain from each B lineage in addition to H1N1 and H3N2 strains. However, it is also important to know whether vaccines containing a single influenza B strain can provide cross-protectivity against viruses of the antigenically distinct lineage. The aim of this study was to assess in naïve ferrets the potential cross-protective activity of trivalent live attenuated influenza vaccine (T-LAIV) against challenge with a heterologous wild-type influenza B virus belonging to the genetically different lineage and to compare this activity with effectiveness of quadrivalent LAIV (Q-LAIV) in the ferret model.Methods and resultsFerrets were vaccinated with either one dose of trivalent LAIV containing B/Victoria or B/Yamagata lineage virus, or quadrivalent LAIV (containing both B lineages), or placebo. They were then challenged with B/Victoria or B/Yamagata lineage wild-type virus 28 days after vaccination. The ferrets were monitored for clinical signs and morbidity. Nasal swabs and lung tissue samples were analyzed for the presence of challenge virus. Antibody response to vaccination was assessed by routine hemagglutination inhibition assay. All LAIVs tested were found to be safe and effective against wild-type influenza B viruses based on clinical signs, and virological and histological data. The absence of interference between vaccine strains in trivalent and quadrivalent vaccine formulations was confirmed. Trivalent LAIVs were shown to have the potential to be cross-protective against infection with genetically different influenza B/Victoria and B/Yamagata lineages.ConclusionsIn this ferret model, quadrivalent vaccine provided higher protection to challenge against both B/Victoria and B/Yamagata lineage viruses. However, T-LAIV provided some cross-protection in the case of a mismatch between circulating and vaccine type B strains. Notably, B/Victoria-based T-LAIV was more protective compared to B/Yamagata-based T-LAIV.

Project description:IntroductionTrivalent influenza vaccines (TIVs) are currently reimbursed for subjects aged ≥ 65 years and children between 6 and 59 months of age under a national immunization program in South Korea. Quadrivalent influenza vaccines (QIVs) are expected to address the potential problem of influenza B-lineage mismatch for TIVs.ObjectiveThe objective of this analysis was to compare the cost effectiveness of QIV versus TIV in children aged 6-59 months and older adults ≥ 65 years of age in South Korea.MethodsA 1-year static population model was employed to compare the costs and outcomes of a QIV vaccination program compared with TIV in children aged 6-59 months and older adults ≥ 65 years of age in South Korea. Influenza-related parameters (probabilities, health resource use, and costs) were derived from an analysis of the National Health Insurance System claims database between 2010 and 2013 under a broad and narrow set of International Classification of Diseases, Tenth Revision (ICD-10) codes used to identify influenza. Other inputs were extracted from published literature. Incremental cost-effectiveness ratios (2016 South Korean Won [KRW] per quality-adjusted life-year [QALY] gained) were estimated using a 'limited' societal perspective as per the Korean pharmacoeconomic guidelines. QALYs lost due to premature mortality were discounted at 5% annually.ResultsFor both age groups combined, under the narrow definition of influenza, QIV is expected to prevent nearly 16,000 (2923 in children and 13,011 in older adults) medically attended influenza cases, nearly 8000 (672 in children, 7048 in older adults) cases of complications, and over 230 (0 in children, 238 in older adults) deaths annually compared with TIV. The impact of using QIV versus TIV in this setting translates into savings of KRW 24 billion (KRW 0.6 billion in children, KRW 23.4 billion in older adults) in annual medical costs, and over 2100 (18 in children, 2084 in older adults) QALYs. Under the broad definition, the corresponding results are over 190,000 (50,697 in children, 140,644 in older adults) influenza cases, over 37,000 (12,623 in children, 24,526 in older adults) complications, 270 deaths (0 in children, 270 in older adults), KRW 94.22 billion (KRW 16 billion in children, KRW 78.2 billion in older adults), and over 3500 QALYs saved (316 in children, 3260 in older adults).ConclusionThe use of QIV over TIV was estimated to not be cost effective in children 6-59 months of age, but cost saving in older adults, using the narrow definition of influenza; however, QIV use was cost saving in both age groups using the broad definition. QIV is expected to yield more benefits in older adults ≥ 65 years of age than in children aged 6-59 months due to higher influenza-related mortality and costs among the older adults. Further analyses considering the indirect effects of influenza vaccination in children are required.

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The rationale for quadrivalent influenza vaccines.

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The rationale for quadrivalent influenza vaccines.

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