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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control</title><author><name sortKey="Ray, Riju" sort="Ray, Riju" uniqKey="Ray R" first="Riju" last="Ray">Riju Ray</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Dos Santos, Gael" sort="Dos Santos, Gael" uniqKey="Dos Santos G" first="Gaël" last="Dos Santos">Gaël Dos Santos</name><affiliation><nlm:aff id="af0002"><institution>Business & Decision Life Sciences</institution>, Brussels,<country>Belgium (on behalf of GSK)</country></nlm:aff></affiliation></author><author><name sortKey="Buck, Philip O" sort="Buck, Philip O" uniqKey="Buck P" first="Philip O." last="Buck">Philip O. Buck</name><affiliation><nlm:aff id="af0003"><institution>GSK</institution>, Philadelphia, PA,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Claeys, Carine" sort="Claeys, Carine" uniqKey="Claeys C" first="Carine" last="Claeys">Carine Claeys</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Matias, Goncalo" sort="Matias, Goncalo" uniqKey="Matias G" first="Gonçalo" last="Matias">Gonçalo Matias</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L." last="Innis">Bruce L. Innis</name><affiliation><nlm:aff id="af0003"><institution>GSK</institution>, Philadelphia, PA,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Bekkat Berkani, Rafik" sort="Bekkat Berkani, Rafik" uniqKey="Bekkat Berkani R" first="Rafik" last="Bekkat-Berkani">Rafik Bekkat-Berkani</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28532276</idno><idno type="pmc">5512791</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5512791</idno><idno type="RBID">PMC:5512791</idno><idno type="doi">10.1080/21645515.2017.1313375</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">000D64</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000D64</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control</title><author><name sortKey="Ray, Riju" sort="Ray, Riju" uniqKey="Ray R" first="Riju" last="Ray">Riju Ray</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Dos Santos, Gael" sort="Dos Santos, Gael" uniqKey="Dos Santos G" first="Gaël" last="Dos Santos">Gaël Dos Santos</name><affiliation><nlm:aff id="af0002"><institution>Business & Decision Life Sciences</institution>, Brussels,<country>Belgium (on behalf of GSK)</country></nlm:aff></affiliation></author><author><name sortKey="Buck, Philip O" sort="Buck, Philip O" uniqKey="Buck P" first="Philip O." last="Buck">Philip O. Buck</name><affiliation><nlm:aff id="af0003"><institution>GSK</institution>, Philadelphia, PA,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Claeys, Carine" sort="Claeys, Carine" uniqKey="Claeys C" first="Carine" last="Claeys">Carine Claeys</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Matias, Goncalo" sort="Matias, Goncalo" uniqKey="Matias G" first="Gonçalo" last="Matias">Gonçalo Matias</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author><author><name sortKey="Innis, Bruce L" sort="Innis, Bruce L" uniqKey="Innis B" first="Bruce L." last="Innis">Bruce L. Innis</name><affiliation><nlm:aff id="af0003"><institution>GSK</institution>, Philadelphia, PA,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Bekkat Berkani, Rafik" sort="Bekkat Berkani, Rafik" uniqKey="Bekkat Berkani R" first="Rafik" last="Bekkat-Berkani">Rafik Bekkat-Berkani</name><affiliation><nlm:aff id="af0001"><institution>GSK</institution>, Wavre,<country>Belgium</country></nlm:aff></affiliation></author></analytic><series><title level="j">Human Vaccines & Immunotherapeutics</title><idno type="ISSN">2164-5515</idno><idno type="eISSN">2164-554X</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>ABSTRACT</title><p>The contribution of influenza B to the seasonal influenza burden varies from year-to-year. Although 2 antigenically distinct influenza B virus lineages have co-circulated since 2001, trivalent influenza vaccines (TIVs) contain antigens from only one influenza B virus. B-mismatch or co-circulation of both B lineages results in increased morbidity and mortality attributable to the B lineage absent from the vaccine. Quadrivalent vaccines (QIVs) contain both influenza B lineages. We reviewed currently licensed QIVs and their value by focusing on the preventable disease burden. Modeling studies support that QIVs are expected to prevent more influenza cases, hospitalisations and deaths than TIVs, although estimates of the case numbers prevented vary according to local specificities. The value of QIVs is demonstrated by their capacity to broaden the immune response and reduce the likelihood of a B-mismatched season. Some health authorities have preferentially recommended QIVs over TIVs in their influenza prevention programmes.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Mccauley, J" uniqKey="Mccauley J">J McCauley</name></author><author><name sortKey="Hongo, S" uniqKey="Hongo S">S Hongo</name></author><author><name sortKey="Kaverin, N" uniqKey="Kaverin N">N Kaverin</name></author><author><name sortKey="Kochs, G" uniqKey="Kochs G">G Kochs</name></author><author><name sortKey="Lamb, R" uniqKey="Lamb R">R Lamb</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chen, R" uniqKey="Chen R">R Chen</name></author><author><name sortKey="Holmes, Ec" uniqKey="Holmes E">EC Holmes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tan, Y" uniqKey="Tan Y">Y Tan</name></author><author><name sortKey="Guan, W" uniqKey="Guan W">W Guan</name></author><author><name sortKey="Lam, Tt Y" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id><journal-id journal-id-type="publisher-id">KHVI</journal-id><journal-id journal-id-type="publisher-id">khvi20</journal-id><journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title></journal-title-group><issn pub-type="ppub">2164-5515</issn><issn pub-type="epub">2164-554X</issn><publisher><publisher-name>Taylor & Francis</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28532276</article-id><article-id pub-id-type="pmc">5512791</article-id><article-id pub-id-type="publisher-id">1313375</article-id><article-id pub-id-type="doi">10.1080/21645515.2017.1313375</article-id><article-categories><subj-group subj-group-type="heading"><subject>Review</subject></subj-group></article-categories><title-group><article-title>A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control</article-title><alt-title alt-title-type="running-authors">R. RAY ET AL.</alt-title><alt-title alt-title-type="running-title">HUMAN VACCINES & IMMUNOTHERAPEUTICS</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Ray</surname><given-names>Riju</given-names></name><xref ref-type="aff" rid="af0001"><sup>a</sup></xref><xref ref-type="author-notes" rid="afn0001"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dos Santos</surname><given-names>Gaël</given-names></name><xref ref-type="aff" rid="af0002"><sup>b</sup></xref><xref ref-type="author-notes" rid="afn0002"><sup>‡</sup></xref></contrib><contrib contrib-type="author"><name><surname>Buck</surname><given-names>Philip O.</given-names></name><xref ref-type="aff" rid="af0003"><sup>c</sup></xref></contrib><contrib contrib-type="author"><name><surname>Claeys</surname><given-names>Carine</given-names></name><xref ref-type="aff" rid="af0001"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Matias</surname><given-names>Gonçalo</given-names></name><xref ref-type="aff" rid="af0001"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Innis</surname><given-names>Bruce L.</given-names></name><xref ref-type="aff" rid="af0003"><sup>c</sup></xref><xref ref-type="author-notes" rid="afn0003"><sup>#</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bekkat-Berkani</surname><given-names>Rafik</given-names></name><xref ref-type="aff" rid="af0001"><sup>a</sup></xref><xref ref-type="corresp" rid="an0001"></xref><xref ref-type="author-notes" rid="afn0004"><sup>**</sup></xref></contrib><aff id="af0001"><label>a</label><institution>GSK</institution>, Wavre,<country>Belgium</country></aff><aff id="af0002"><label>b</label><institution>Business & Decision Life Sciences</institution>, Brussels,<country>Belgium (on behalf of GSK)</country></aff><aff id="af0003"><label>c</label><institution>GSK</institution>, Philadelphia, PA,<country>USA</country></aff></contrib-group><author-notes><corresp id="an0001"><bold>CONTACT</bold> Rafik Bekkat-Berkani <email xlink:href="Rafik.X.Bekkat-Berkani@gsk.com">Rafik.X.Bekkat-Berkani@gsk.com</email><addr-line>5 Crescent Drive</addr-line>, Philadelphia, PA 19112, <country>USA</country></corresp><fn id="afn0001"><label>*</label><p>Current affiliation: GSK, Research Triangle Park, NC, USA.</p></fn><fn id="afn0002"><label>‡</label><p>Current affiliation: GSK, Wavre, Belgium.</p></fn><fn id="afn0003"><label>#</label><p>Current affiliation: PATH, Washington, DC, USA.</p></fn><fn id="afn0004"><label>**</label><p>Current affiliation: GSK, Philadelphia, PA, USA.</p></fn></author-notes><pub-date pub-type="collection"><month>6</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>22</day><month>5</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>22</day><month>5</month><year>2017</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>13</volume><issue>7</issue><fpage seq="23">1640</fpage><lpage>1652</lpage><history><date date-type="received"><day>31</day><month>1</month><year>2017</year></date><date date-type="rev-recd"><day>20</day><month>3</month><year>2017</year></date><date date-type="accepted"><day>25</day><month>3</month><year>2017</year></date></history><permissions><pmc-comment> © Riju Ray, Gaël Dos Santos, Philip O. Buck, Carine Claeys, Gonçalo Matias, Bruce L. Innis, and Rafik Bekkat-Berkani </pmc-comment>
<copyright-statement>© 2017 The Author(s). Published with license by Taylor & Francis</copyright-statement><copyright-year>2017</copyright-year><copyright-holder>The Author(s)</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/3.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/3.0/">http://creativecommons.org/licenses/by/3.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="khvi-13-07-1313375.pdf"></self-uri><abstract><title>ABSTRACT</title><p>The contribution of influenza B to the seasonal influenza burden varies from year-to-year. Although 2 antigenically distinct influenza B virus lineages have co-circulated since 2001, trivalent influenza vaccines (TIVs) contain antigens from only one influenza B virus. B-mismatch or co-circulation of both B lineages results in increased morbidity and mortality attributable to the B lineage absent from the vaccine. Quadrivalent vaccines (QIVs) contain both influenza B lineages. We reviewed currently licensed QIVs and their value by focusing on the preventable disease burden. Modeling studies support that QIVs are expected to prevent more influenza cases, hospitalisations and deaths than TIVs, although estimates of the case numbers prevented vary according to local specificities. The value of QIVs is demonstrated by their capacity to broaden the immune response and reduce the likelihood of a B-mismatched season. Some health authorities have preferentially recommended QIVs over TIVs in their influenza prevention programmes.</p></abstract><kwd-group kwd-group-type="author"><title>KEYWORDS</title><kwd>influenza</kwd><kwd>influenza B</kwd><kwd>mismatch</kwd><kwd>quadrivalent influenza vaccine</kwd></kwd-group><counts><fig-count count="2"></fig-count><table-count count="2"></table-count><equation-count count="0"></equation-count><ref-count count="113"></ref-count><page-count count="13"></page-count></counts></article-meta></front><body><sec sec-type="intro" id="s0001"><title>Introduction</title><p>Influenza viruses are enveloped negative-strand RNA viruses that are divided into 3 genera: type A, B and C. The vast majority of human disease is caused by types A and B, which are genetically and structurally similar, but differ in biology, evolutionary and epidemiological framework.<xref rid="cit0001" ref-type="bibr"><sup>1-3</sup></xref> Influenza A viruses are subtyped according to 2 surface glycoproteins: haemagglutinin (H) and neuraminidase (N) whereas influenza B viruses form a homogenous group segregated according to 2 antigenically distinguishable lineages (B/Victoria and B/Yamagata).</p><p>Influenza viruses undergo constant mutation which enables evasion of existing host immunity leading to recurrent infections that manifest as annual outbreaks.<xref rid="cit0004" ref-type="bibr"><sup>4</sup></xref> Periodically, new A subtypes emerge, resulting in a pandemic; the emergent subtype may replace or less frequently co-circulate with the earlier A subtype (<xref ref-type="fig" rid="f0001">Fig. 1</xref>). Currently, 2 influenza A subtypes, A/H1N1 and A/H3N2, and the 2 influenza B lineages circulate globally each year.<xref rid="cit0005" ref-type="bibr"><sup>5,6</sup></xref> In any influenza season, several influenza types, A-subtypes, or B-lineages may co-circulate, such that the annual influenza burden differs unpredictably from year-to-year, potentially fluctuating from age-group to age-group, and from region-to-region.<xref rid="cit0004" ref-type="bibr"><sup>4</sup></xref><fig id="f0001" orientation="portrait" position="float"><label>Figure 1.</label><caption><p>The evaluation of influenza viruses and vaccine development. Information from Hannoun et al.<xref rid="cit0008" ref-type="bibr"><sup>8</sup></xref> and McCullers et al.<xref rid="cit0097" ref-type="bibr"><sup>97</sup></xref> *Asian influenza pandemic caused by the shifted A/H2N2 strain and Hong Kong influenza pandemic caused by the shifted A/H3N2 strain: both examples of A-strain shift through reassortment (sharing) of genetic material. LAIV = live-attenuated trivalent influenza vaccine; TIV = trivalent influenza vaccine; QIV = quadrivalent influenza vaccine; WHO = World Health Organization.</p></caption><graphic content-type="color" xlink:href="khvi-13-07-1313375-g001"></graphic></fig></p><p>Influenza affects all age-groups and while most deaths occur in older adults, influenza deaths also occur in children. In the United States (US), there were 830 reported laboratory-confirmed influenza deaths between 2004–2012 in children < 18 y of age.<xref rid="cit0007" ref-type="bibr"><sup>7</sup></xref> Of these, 25% were children aged < 24 months.</p><p>Since the development of the first monovalent A/H1N1 influenza vaccines more than 75 y ago, influenza vaccines have always required adaptation in response to changes to provide protection against the predominant circulating influenza viruses (<xref ref-type="fig" rid="f0001">Fig. 1</xref>). After influenza B was first isolated in 1940, bivalent (A/H1N1, B) vaccines were developed. The vaccine influenza A subtype was changed in 1958 and in 1969 in response to influenza A shifts that triggered severe pandemics (<xref ref-type="fig" rid="f0001">Fig. 1</xref>). Seasonal trivalent influenza vaccines (TIVs) containing 2 influenza A -subtype viruses and one B virus were first produced in 1978 after the re-appearance and co-circulation of A/H1N1 with A/H3N2 viruses (<xref ref-type="fig" rid="f0001">Fig. 1</xref>).<xref rid="cit0008" ref-type="bibr"><sup>8</sup></xref> Two antigenically distinct lineages of influenza B viruses have circulated globally since 1985 and have co-circulated since 2001.<xref rid="cit0009" ref-type="bibr"><sup>9</sup></xref> The influenza B-lineage vaccine strains induce little or no cross-reactive protection against the alternate B-lineage,<xref rid="cit0010" ref-type="bibr"><sup>10,11</sup></xref> such that for TIVs, protection against the circulating influenza B lineage relies on correctly predicting the B-lineage likely to predominate in the upcoming season. The degree of similarity or difference between the circulating viruses and the strains included in the vaccines is often referred to as “vaccine match” or “vaccine mismatch.” A review of influenza B in 26 countries concluded that the type B lineage selected for inclusion in the annual vaccine differs from the predominant circulating lineage in around 25% of seasons.<xref rid="cit0012" ref-type="bibr"><sup>12</sup></xref> In a mismatched season, influenza vaccine effectiveness may be suboptimal against influenza B epidemics, potentially leading to an increased public health burden during those seasons.<xref rid="cit0013" ref-type="bibr"><sup>13-18</sup></xref> This observation led to international cooperation among the scientific community, leading to the development of quadrivalent seasonal influenza vaccines (QIVs) that included both of the circulating influenza B lineages.<xref rid="cit0010" ref-type="bibr"><sup>10,19</sup></xref> In this work we reviewed the development of currently licensed QIVs and provide an overview of their societal value by focusing on the preventable disease burden associated with vaccination. We identified modeling studies estimating the potential impact of QIVs compared with TIVs in terms of clinical outcomes prevented.</p></sec><sec id="s0002"><title>Clinical evaluation and characteristics of currently licensed of QIVs</title><p>The first QIV was licensed in 2012 and currently 3 manufacturers produce QIV in various forms (inactivated [IIV4] or live-attenuated [LAIV4]), with new vaccines under development.<xref rid="cit0020" ref-type="bibr"><sup>20,21</sup></xref> Seasonal influenza vaccines induce antibody responses against the head of the haemagglutinin glycoprotein. An haemagglutinin inhibition (HI) titer of ≥ 1:40 is generally accepted as indicative of clinical benefit since it has been associated with protection from influenza illness in up to 50% of subjects.<xref rid="cit0022" ref-type="bibr"><sup>22,23</sup></xref></p><p>Cumulative evidence for the immunogenicity and safety of QIVs was obtained through studies designed to demonstrate non-inferiority in terms of the HI geometric mean antibody titres (GMTs) and seroconversion rates (SCRs) to the common 3 strains in the candidate QIVs compared with licensed TIVs, and to demonstrate superiority in terms of the HI GMT and SCR of the added influenza type B lineage compared with licensed TIVs containing either the B/Yamagata or B/Victoria lineages. Safety and reactogenicity of QIVs versus TIVs were also assessed.</p><sec id="s0002-0001"><title>IIV4s manufactured by GSK</title><p>GSK produces IIV4s that are identical in antigen content but manufactured and licensed separately: <italic>FluLaval Quadrivalent</italic> (Q-IIV4) is manufactured in Quebec, Canada, and <italic>Fluarix Quadrivalent</italic> (D-IIV4) is manufactured in Dresden, Germany.<xref rid="cit0024" ref-type="bibr"><sup>24</sup></xref> Both vaccines are approved for use in individuals from 3 y of age. Q-IIV4 is also licensed from 6 months of age in Canada, the US, and Mexico. Individuals from the age of 6 months through to adults > 65 y were enrolled in the clinical development program.<xref rid="cit0024" ref-type="bibr"><sup>24</sup></xref> The results of key studies have been recently reviewed.<xref rid="cit0024" ref-type="bibr"><sup>24-26</sup></xref></p><p><italic>Fluarix Quadrivalent</italic> (<italic>Fluarix Tetra, Influsplit Tetra</italic> and <italic>Alpharix Tetra</italic>): In studies in adults, adolescents and children (≥ 3 y of age), HI GMTs and SCRs following D-IIV4 were non-inferior to licensed D-IIV3s for common strains, and superior in terms of the HI GMT and SCR for the additional type B lineage. Addition of the fourth strain had no impact on the reactogenicity and safety profile of the vaccine.<xref rid="cit0027" ref-type="bibr"><sup>27,28</sup></xref> Efficacy of D-IIV4 is supported by the demonstrated efficacy of trivalent <italic>Fluarix</italic> in healthy adults aged 18–64 y; since both vaccines use the same manufacturing processes. In adults, <italic>Fluarix</italic> demonstrated statistically significant efficacy of 66.9% against culture-confirmed antigenically-matched influenza A and/or B (95% confidence interval [CI] 51.9–77.4).<xref rid="cit0029" ref-type="bibr"><sup>29</sup></xref></p><p><italic>FluLaval Quadrivalent (Flulaval Tetra)</italic>: In studies in adults, adolescents and children (≥ 3 y of age), the immunogenicity of Q-IIV4 was non-inferior to that of licensed IIV3s for common strains, and superior for the additional type B strain from the alternate lineage in terms of HI GMTs and SCRs. Similar to D-IIV4, addition of the fourth strain did not impact the reactogenicity and the safety profile of Q-IIV4 as compared with IIV3s.<xref rid="cit0030" ref-type="bibr"><sup>30,31</sup></xref></p><p>In children 6 to 35 months of age, Q-IIV4 (containing 15 μg of each virus strain) was non-inferior to <italic>Fluzone Quadrivalent</italic> (F-IIV4, Sanofi Pasteur) (containing 7.5 μg of each virus strain) for each vaccine strain, and superior in terms of the immune response to both influenza B strains in 6–17 month old children and unprimed children of any age.<xref rid="cit0032" ref-type="bibr"><sup>32</sup></xref></p><p>Efficacy of Q-IIV4 was demonstrated in children aged 3−8 y (N = 5,220) who were randomized to receive either Q-IIV4 or inactivated hepatitis A vaccine as control.<xref rid="cit0033" ref-type="bibr"><sup>33</sup></xref> Efficacy of Q-IIV4 in preventing influenza of any severity was 55.4% (95% CI 39.1–67.3), and efficacy against moderate-to-severe influenza (defined as a body temperature > 39°C, acute otitis media, lower respiratory tract illness, or serious extra-pulmonary complications) was 73.1% (97.5% CI 47.1–86.3).<xref rid="cit0033" ref-type="bibr"><sup>33</sup></xref> Influenza cases in the Q-IIV4-vaccinated group tended to be of mild clinical severity and were associated with substantially lower numbers of medical visits, hospitalisations, school absences and parental absences from work than episodes of influenza in the control group.<xref rid="cit0033" ref-type="bibr"><sup>33</sup></xref></p></sec><sec id="s0002-0002"><title>IIV4s manufactured by Sanofi Pasteur</title><p>Sanofi Pasteur manufacturers 2 IIV4s administered either intramuscularly (F-IIV4 licensed for use from 6 months of age) or intradermally (<italic>Fluzone Intradermal</italic> Q<italic>uadrivalent</italic> [intradermal F-IIV4] licensed for individuals between 18–64 y of age).</p><p><italic>Fluzone Quadrivalent</italic>: F-IIV4 was evaluated in 3 clinical trials enrolling > 5,500 participants aged 6 months-9 y, ≥ 18 y and ≥ 65 y, respectively.<xref rid="cit0034" ref-type="bibr"><sup>34-36</sup></xref> Non-inferiority was demonstrated between F-IIV4 and IIV3s in terms of HI GMTs and SCRs for common strains in all of these age-groups; except for the SCR for the H1N1 strain in subjects aged ≥ 65 y. The failure to meet this non-inferiority criterion may be related to a high baseline prevalence of seropositivity against this strain.<xref rid="cit0034" ref-type="bibr"><sup>34</sup></xref> Superiority of the immune response to the added influenza type B lineage compared with 2 licensed IIV3 formulations in terms of GMTs and SCRs was also demonstrated in all age-groups, except for the GMT ratio for the B/Victoria lineage strain in adults aged ≥ 65 y. At least 73.2–100% of adults and 66.9%–98.8% of children who received F-IIV4 had HI titres ≥ 40 after vaccination. The safety profile of F-IIV4 was similar to that of the studied IIV3s.<xref rid="cit0034" ref-type="bibr"><sup>34</sup></xref></p><p><italic>Fluzone Intradermal Quadrivalent</italic>: This intradermal vaccine is licensed for use in adults aged 18–64 y and was evaluated in 3360 participants in one study in the US.<xref rid="cit0037" ref-type="bibr"><sup>37</sup></xref> Non-inferiority was demonstrated between the intradermal F-IIV4 and intradermal IIV3 in terms of HI GMTs and SCRs to common strains, and superiority of the immune response to the added influenza type B lineage compared with 2 intradermal IIV3 formulations was also demonstrated. At least 86% of intradermal F-IIV4 recipients had HI titres ≥ 40 after vaccination.<xref rid="cit0037" ref-type="bibr"><sup>37</sup></xref> The safety profile of intradermal F-IIV4 was similar to that of intradermal IIV3s.</p></sec><sec id="s0002-0003"><title>LAIV4s manufactured by AstraZeneca</title><p><italic>Flumist Quadrivalent</italic> (US, Canada) and <italic>Fluenz Tetra</italic> (European Union) are licensed for use in individuals from 2–59 y internationally and 2–49 y in the US. Two clinical trials conducted in the US evaluated immunogenicity and safety in subjects aged 2–49 y.<xref rid="cit0038" ref-type="bibr"><sup>38-41</sup></xref> Non-inferiority of the HI antibody response to LAIV3s was demonstrated for common strains. Post-hoc analyses demonstrated superiority of the HI antibody response for the added B lineage.<xref rid="cit0038" ref-type="bibr"><sup>38</sup></xref> The safety and reactogenicity of LAIV4s were similar to LAIV3s.</p></sec></sec><sec id="s0003"><title>The value of QIVs in reducing the burden of influenza B – review of the literature</title><p>Influenza B causes epidemics approximately every 2–4 years<xref rid="cit0042" ref-type="bibr"><sup>42,43</sup></xref> that impact all age-groups but proportionally more older children.<xref rid="cit0043" ref-type="bibr"><sup>43-47</sup></xref> Influenza B has been reported to be clinically indistinguishable to influenza A,<xref rid="cit0048" ref-type="bibr"><sup>48-50</sup></xref> and has been linked to severe disease, including encephalitis, myositis, pneumonia and fulminant disease in children.<xref rid="cit0051" ref-type="bibr"><sup>51-54</sup></xref> The majority of subjects with lethal influenza B in a US case series died before they could be hospitalised, highlighting the importance of vaccine prophylaxis in mitigating this risk.<xref rid="cit0054" ref-type="bibr"><sup>54</sup></xref></p><p>A systematic review of the literature describing influenza B disease published between 1995 and 2010 concluded that influenza B was more likely to be severe in children than in adults.<xref rid="cit0055" ref-type="bibr"><sup>55</sup></xref> Although influenza B affects all age segments, it is more common among children aged 5–17 y.<xref rid="cit0012" ref-type="bibr"><sup>12,55</sup></xref> Influenza B accounts on average, for approximately 20–30% of influenza isolates from respiratory samples across seasons,<xref rid="cit0012" ref-type="bibr"><sup>12,56</sup></xref> although the reported frequencies vary from year-to-year and from region-to-region, ranging from 0–62.9% in children and 0–48% in adults.<xref rid="cit0055" ref-type="bibr"><sup>55</sup></xref> The Danish 2015/16 influenza season was characterized by a major (88%) B-lineage mismatch and it has been put forward that morbidity during the season may have been lower if QIVs had been used instead of TIVs.<xref rid="cit0018" ref-type="bibr"><sup>18</sup></xref> More recently, a comprehensive review of the influenza B burden in 9 European countries highlighted the scarce attention that the influenza B burden has received over previous decade as compared with influenza A.<xref rid="cit0057" ref-type="bibr"><sup>57</sup></xref> This works also underscores the lack of predictable patterns in strain circulation seen in these countries and thus the continuous risk of mismatch when there is high influenza B circulation.</p><p>For QIVs, modeling studies are sometimes used to assess cost-effectiveness and whether the added value of the vaccine is likely to offset the added cost; models may also contribute information about the societal value of QIVs quantifying the number of preventable influenza outcomes compared with TIVs. The reported added value of QIVs comes from its capacity to provide broader immunity against influenza B, thereby reducing the likelihood of a mismatched season.</p><p>We systematically queried the PubMed database for papers reporting the potential value of QIVs compared with TIVs in terms of illness, hospitalisations and deaths averted using the search string provided in <xref ref-type="fig" rid="f0002">Fig. 2</xref>. Articles were selected by a 3-step selection procedure based on 1) screening of title and abstract, 2) screening of full-text article, and 3) final screening during the data-extraction phase. The titles and abstracts retrieved from the Pubmed database were screened in duplicate by 2 independent researchers. The results were compared and discussed; all selected references from the 2 researchers were included for full text selection.
<fig id="f0002" orientation="portrait" position="float"><label>Figure 2.</label><caption><p>Results of the literature search (30 October 2016). Search string: “(Quadrivalent OR tetravalent) (influenza vaccine OR flu vaccine) (cost OR burden OR epidemiology OR death OR mortality OR illness OR hospitalisation OR hospitalization)” No limits applied.</p></caption><graphic content-type="black-white" xlink:href="khvi-13-07-1313375-g002"></graphic></fig></p><p>In case of discrepancy or disagreements during the selection, a third researcher was consulted and the study was discussed until consensus was reached. If articles reported on the same study, the most relevant or most complete article was included in this review. If articles complemented each other, both articles were included. The reasons for exclusion of full-text papers were recorded.</p><p>We identified 27 eligible studies from 14 countries that used multiple modeling methods and highly variable background assumptions to estimate the potential impact of QIVs over TIVs in various immunisation scenarios (<xref ref-type="table" rid="t0001">Table 1</xref>). All of the estimates were highly dependent upon the choice of baseline data, such as the assumed degree of cross-protection afforded by TIVs and the level of mismatch in a given season. In all cases, the results of more conservative static models (i.e., that could not adjust for potential herd protection or reduction in disease transmission) were lower than dynamic models that included herd-protection or disease transmission effects in the model. A summary of current disease burden information and the potential impact of QIVs on the influenza burden from modeling studies is presented for selected countries below.
<table-wrap id="t0001" orientation="portrait" position="float"><label>Table 1.</label><caption><p>Summary of QIV modeling data in different countries: results from a review of the literature.</p></caption><pmc-comment>OASIS TABLE HERE</pmc-comment><table frame="hsides" rules="groups"><colgroup><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col></colgroup><thead><tr><th align="left"> </th><th align="center">Model</th><th align="center">Vaccinated</th><th align="center"> </th><th align="center">Time</th><th align="center">Influenza vaccine</th><th colspan="3" align="center">Illness averted by QIVs compared with TIVs<hr></hr></th></tr><tr><th align="left"> </th><th align="center">framework</th><th align="center">population</th><th align="center">Population size</th><th align="center">horizon</th><th align="center">coverage (%)</th><th align="center">Total Cases</th><th align="center">Total hospitalisations</th><th align="center">Total Deaths</th></tr></thead><tbody><tr><td align="left"><bold>North America</bold></td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0058"><sup>58</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">270–304 million</td><td align="center">10 y</td><td align="center">18–30<xref rid="t1fn0001" ref-type="fn"><sup>*</sup></xref></td><td align="center">2,741,575 (Range 2200–970,000)</td><td align="center">21,440 (Range 14–8,200)</td><td align="center">1371 (Range 1–485)</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0059"><sup>59</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">311.6 million</td><td align="center">1 y</td><td align="center">21.3–66.6<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">30,251</td><td align="center">3,512</td><td align="center">722</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0060"><sup>60</sup></xref></td><td align="left">Static</td><td align="center">≥ 65 y</td><td align="center">41.5 million</td><td align="center">1 y</td><td align="center">67</td><td align="center">26,701</td><td align="center">1,345</td><td align="center">211</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0061"><sup>61</sup></xref></td><td align="left">Static</td><td align="center">≥ 65 y</td><td align="center">44,704,074</td><td align="center">10 months</td><td align="center">64.7</td><td align="center">39,136</td><td align="center">1,648</td><td align="center">458</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0065"><sup>65</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">US population</td><td align="center">10 y</td><td align="center">∼25–60<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">1,973,849 annually</td><td align="center">—</td><td align="center">1,396 annually</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0064"><sup>64</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">313.9 million</td><td align="center">1 y</td><td align="center">46.2</td><td align="center">1,382,509</td><td align="center">18,354</td><td align="center">2,981</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0062"><sup>62</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">US population without immigration</td><td align="center">13 y</td><td align="center">Weekly age-based from CDC</td><td align="center">6,267,800 (Average 482,000 annually)</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left">US <xref ref-type="bibr" rid="cit0063"><sup>63</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">US population</td><td align="center">20 y</td><td align="center">Weekly age-based from CDC</td><td align="center">16 million</td><td align="center">137,645</td><td align="center">16,199</td></tr><tr><td align="left">Canada <xref ref-type="bibr" rid="cit0068"><sup>68</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">34.8 million</td><td align="center">10 y</td><td align="center">16.1–64.4<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">135,538 annually</td><td align="center">1876 annually</td><td align="center">328 annually</td></tr><tr><td align="left">Ontario, Canada<xref ref-type="bibr" rid="cit0067"><sup>67</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">12.8 million</td><td align="center">2000–2008</td><td align="center">27–81<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">2,516 annually</td><td align="center">27 annually</td><td align="center">5 annually</td></tr><tr><td align="left"><bold>Europe</bold></td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td></tr><tr><td align="left">UK <xref ref-type="bibr" rid="cit0068"><sup>68</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">62.8 million</td><td align="center">10 y</td><td align="center">17.6–71.1<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">88,755 annually</td><td align="center">1050 annually</td><td align="center">230 annually</td></tr><tr><td align="left">UK <xref ref-type="bibr" rid="cit0071"><sup>71</sup></xref></td><td align="left">Static</td><td rowspan="2" align="center">≥ 65 and risk groups</td><td align="center">63.7 million</td><td align="center">100 y</td><td align="center">34.07–100<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">1.4 million</td><td align="center">41,780</td><td align="center">19,906</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center"> </td><td align="center">10 y</td><td align="center"> </td><td align="center">183,844</td><td align="center">4,871</td><td align="center">2,142</td></tr><tr><td align="left">Germany <xref ref-type="bibr" rid="cit0073"><sup>73</sup></xref></td><td rowspan="4" align="left">Dynamic</td><td align="center">0–15 y</td><td align="center">Approx. 80 million</td><td align="center">20 y</td><td align="center">26.8–33.4<xref rid="t1fn0001" ref-type="fn"><sup>*</sup></xref></td><td align="center">79,000 annually</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left"> </td><td align="center">16–60 y</td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center">223,000 annually</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left"> </td><td align="center">≥ 61 y</td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center">93,000 annually</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left"> </td><td align="center">All ages</td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center">395,000 annually</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left">Germany <xref ref-type="bibr" rid="cit0074"><sup>74</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">81.3 million</td><td align="center">20 y</td><td align="center">Not given</td><td align="center">276,505 annually</td><td align="center">5,690 annually</td><td align="center">262 annually</td></tr><tr><td align="left">Finland <xref ref-type="bibr" rid="cit0075"><sup>75</sup></xref></td><td align="left">Dynamic</td><td align="center">All ages</td><td align="center">Finnish population</td><td align="center">20 y</td><td align="center">∼10–75<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">40,500 annually†</td><td align="center">360 annually†</td><td align="center">54 annually†</td></tr><tr><td align="left">Belgium <xref ref-type="bibr" rid="cit0076"><sup>76</sup></xref></td><td align="left">Dynamic</td><td align="center">2–17 y<sup>††</sup></td><td align="center">11.16–11.63 million</td><td align="center">10 y</td><td align="center">50</td><td align="center">2,953,995</td><td align="center">16,968</td><td align="center">1,455</td></tr><tr><td align="left">Spain<xref ref-type="bibr" rid="cit0077"><sup>77</sup></xref></td><td align="left">Static</td><td align="center">≥ 65 y, at risk ≥ 3y</td><td align="center">46,727,891</td><td align="center">100 y</td><td align="center">0–72.47<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">18,565 in the first year</td><td align="center">407 in the first year</td><td align="center">181 in the first year</td></tr><tr><td align="left">Italy<xref ref-type="bibr" rid="cit0078"><sup>78</sup></xref></td><td align="left">Static</td><td align="center">All ages at risk, ≥ 65y</td><td align="center">17,420,318</td><td align="center">2014–2015</td><td align="center">9% QIV, 31.02 total</td><td align="center">2,632</td><td align="center">100</td><td align="center">—</td></tr><tr><td align="left">France<xref ref-type="bibr" rid="cit0079"><sup>79</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">French population</td><td align="center">2003–2012</td><td align="center">Not reported</td><td align="center">6,214 consultations</td><td align="center">614</td><td align="center">372</td></tr><tr><td align="left">5 countries in Europe<xref ref-type="bibr" rid="cit0080"><sup>80</sup></xref></td><td align="left">Static</td><td align="center">6 m-2 y</td><td align="center"> </td><td align="center">2002–2013</td><td align="center">6.1–19.2</td><td align="center">28,877</td><td align="center">140</td><td align="center">0</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">2–17 y</td><td align="center"> </td><td align="center"> </td><td align="center">4.1–14.0</td><td align="center">219,163</td><td align="center">348</td><td align="center">4</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">18–49 y high risk</td><td align="center"> </td><td align="center"> </td><td align="center">30.9–52.0</td><td align="center">83,635</td><td align="center">389</td><td align="center">79</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">18–49 y low risk</td><td align="center"> </td><td align="center"> </td><td align="center">6.5–12.0</td><td align="center">133,656</td><td align="center">110</td><td align="center">0</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">50–64 y high risk</td><td align="center"> </td><td align="center"> </td><td align="center">30.9–52.0</td><td align="center">89,908</td><td align="center">1,801</td><td align="center">325</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">50–64 y low risk</td><td align="center"> </td><td align="center"> </td><td align="center">14.9–25.3</td><td align="center">86,216</td><td align="center">515</td><td align="center">0</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">65+</td><td align="center"> </td><td align="center"> </td><td align="center">48.6–69.2</td><td align="center">393,270</td><td align="center">21,151</td><td align="center">9,391</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">All ages</td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center">1,034,727</td><td align="center">24,453</td><td align="center">9,799</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">All ages</td><td align="center">Extrapolated to 27-EU</td><td align="center"> </td><td align="center"> </td><td align="center">1,624,533</td><td align="center">37,317</td><td align="center">14,866</td></tr><tr><td colspan="3" align="left"><bold>Asia-Pacific and Western Pacific</bold></td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td></tr><tr><td align="left">Hong Kong <xref ref-type="bibr" rid="cit0083"><sup>83</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">7.2 million</td><td align="center">1 y</td><td align="center">11.0–39.1<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">91/100,000</td><td align="center">1.8/100,000</td><td align="center">0.046/100,000</td></tr><tr><td align="left">Hong Kong <xref ref-type="bibr" rid="cit0098 cit0099"><sup>98,99</sup></xref></td><td align="left">Static</td><td align="center">≥ 65 y</td><td align="center">747,000–924,000</td><td align="center">2001–2010</td><td align="center">39.1</td><td align="center">191.3/100,000</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">65–79 y</td><td align="center">601,000–666,000</td><td align="center"> </td><td align="center"> </td><td align="center">104.8/100,000</td><td align="center">0–2.4/100,000</td><td align="center">0–0.14/100,000</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">≥ 80 y</td><td align="center">146,000–258,000</td><td align="center"> </td><td align="center"> </td><td align="center">451.4/100,000</td><td align="center">0–13.1/100,000</td><td align="center">0–0.77/100,000</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">All ages</td><td align="center">Not reported</td><td align="center"> </td><td align="center"> </td><td align="center">25.6/100,000</td><td align="center">—</td><td align="center">—</td></tr><tr><td align="left">Albany, Australia <xref ref-type="bibr" rid="cit0085"><sup>85</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">ABS CCD</td><td align="center">2003–2013</td><td align="center">2–20 (selected range)</td><td align="center">0.1/100,000 (3.8% reduction)</td><td align="center">2.0/100,000 (2.2% reduction)</td><td align="center">0.1/100,000 (2.1% reduction)</td></tr><tr><td align="left">Australia <xref ref-type="bibr" rid="cit0086"><sup>86</sup></xref></td><td align="left">Static</td><td align="center">6–59 months</td><td align="center">173,778</td><td align="center">2002–2012</td><td align="center">41.3</td><td align="center">4,153</td><td align="center">23</td><td align="center">0</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">5–17 y</td><td align="center">509,239</td><td align="center"> </td><td align="center">41.3</td><td align="center">11,824</td><td align="center">11</td><td align="center">0</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">18–49 y</td><td align="center">2,223,249</td><td align="center"> </td><td align="center">36.2</td><td align="center">10,240</td><td align="center">86</td><td align="center">1</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">50–64 y</td><td align="center">1,296,098</td><td align="center"> </td><td align="center">36.2</td><td align="center">5,731</td><td align="center">143</td><td align="center">6</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">65+ y</td><td align="center">3,221,312</td><td align="center"> </td><td align="center">74.6</td><td align="center">36,322</td><td align="center">3,257</td><td align="center">675</td></tr><tr><td align="left"> </td><td align="center"> </td><td align="center">Total</td><td align="center">7,423,676 at risk</td><td align="center"> </td><td align="center">—</td><td align="center">68,271</td><td align="center">3,522</td><td align="center">683</td></tr><tr><td align="left">Thailand <xref ref-type="bibr" rid="cit0100"><sup>100</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">66–68 million</td><td align="center">2007–2012</td><td align="center">3–12<xref rid="t1fn0001" ref-type="fn"><sup>*</sup></xref></td><td align="center">21, 974</td><td align="center">698</td><td align="center">7</td></tr><tr><td align="left">Taiwan <xref ref-type="bibr" rid="cit0101"><sup>101</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">Not reported</td><td align="center">100 y</td><td align="center">0–39.49<xref rid="t1fn0002" ref-type="fn"><sup>**</sup></xref></td><td align="center">529,874</td><td align="center">8,126</td><td align="center">3,590</td></tr><tr><td align="left"><bold>Africa</bold></td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td><td align="center"> </td></tr><tr><td align="left">Agincourt, South Africa <xref ref-type="bibr" rid="cit0085"><sup>85</sup></xref></td><td align="left">Static</td><td align="center">All ages</td><td align="center">40,383</td><td align="center">2003–2013</td><td align="center">2–20 (selected range)</td><td align="center">0.3/100,000 (12.0% reduction)</td><td align="center">4.8/100,000 (18.6% reduction)</td><td align="center">2.0/100,000 (17.6% reduction)</td></tr></tbody></table><table-wrap-foot><fn id="t1fn0001"><label>*</label><p>Coverage across seasons</p></fn><fn id="t1fn0002"><label>**</label><p>coverage across age ranges, <sup>††</sup>this study evaluated immunisation of 2–17 y olds with QIV vs. the baseline scenario of TIV vaccination of at-risk groups, †switching from TIV to Q-LAIV in 2–18 y olds (with QIV in other age groups) was estimated to prevent an additional 76,100 infections, 540 hospitalizations, and 72 deaths compared with TIV</p></fn><fn><p>ABS CCD = Australian Bureau of Statistics Census Collection Districts; CDC = Centers for Disease Control and Prevention in the United States; ONS = Office of National Statistics; QIV = quadrivalent influenza vaccine; TIV = trivalent influenza vaccine; US = United States; UK = United Kingdom; y = years</p></fn></table-wrap-foot></table-wrap></p><sec id="s0003-0001"><title>United States</title><p>A prospective study of medically-attended visits for influenza-like-illness (ILI) in the US from 2009–2013 identified influenza B in 29.0% of influenza-positive respiratory specimens from patients of all ages attending outpatient clinics.<xref rid="cit0056" ref-type="bibr"><sup>56</sup></xref> In each study year the incidence of visits for ILI caused by influenza B was highest in 5–17 year-olds (range 1.0–13.3/1000 population between 2010–2013).<xref rid="cit0056" ref-type="bibr"><sup>56</sup></xref> Retrospective studies reported that around 42% (n = 6,084,951) of annual influenza-attributable office visits in < 65 y olds (2001–2009), and 30% of annual influenza-attributable hospitalisations in all ages (1997–2009), were attributable to influenza B (mortality rate 30/100,000 population).<xref rid="cit0045" ref-type="bibr"><sup>45,47</sup></xref> In 4 of 12 seasons encompassed in one study, 51–95% of all influenza-associated deaths were attributed to influenza B.<xref rid="cit0045" ref-type="bibr"><sup>45</sup></xref></p><p>The impact of using QIVs as compared with TIVs in the US was estimated in 7 studies (<xref ref-type="table" rid="t0001">Table 1</xref>). Reed et al.,<xref rid="cit0058" ref-type="bibr"><sup>58</sup></xref> estimated that over the 10-year period between 1999 and 2009, QIVs could have prevented 2.7 million more influenza cases, 21,440 more hospitalisations and 1,371 more deaths than TIVs. The preventable burden each year ranged from 2,200–970,000 illnesses, 14–8,200 hospitalisations and 1–485 deaths. The all-age estimate obtained by another static model appeared similar, suggesting that QIVs would prevent 30,251 more influenza cases annually than TIVs.<xref rid="cit0059" ref-type="bibr"><sup>59</sup></xref></p><p>Using data from a study that compared the difference between vaccination with QIVs vs. no vaccination and vaccination with TIVs vs. no vaccination, it can be estimated that in one average year, use of QIV rather than TIVs among ≥ 65-year-olds, would prevent 26,701 illnesses, 1,345 hospitalisations and 211 deaths in this age-group.<xref rid="cit0060" ref-type="bibr"><sup>60</sup></xref> A second study that considered adults aged 65 y and older estimated that using QIVs instead of TIVs would prevent 39,136 additional influenza cases, 1,648 additional hospitalisations and 458 additional deaths, annually.<xref rid="cit0061" ref-type="bibr"><sup>61</sup></xref> Differences in the model and in the underlying assumptions likely account for the different estimates.</p><p>Four studies used dynamic models that incorporated effects of disease transmission and herd-protection in the model (<xref ref-type="table" rid="t0001">Table 1</xref>). As a result, the estimates obtained from these models were higher than those from more conservative static models: Crépey et al.,<xref rid="cit0062" ref-type="bibr"><sup>62</sup></xref> estimated that use of QIVs in the US would have averted 15.8% more influenza B cases, or more than 6.2 million influenza cases (average 482,000 per year), than TIVs over the 13-year study period (2000–2013). Using a similar model, de Boer et al., estimated that replacing TIVs with QIVs in the next 20 y (2014–2034) would reduce influenza B cases by 27.2%, or 16 million cases.<xref rid="cit0063" ref-type="bibr"><sup>63</sup></xref> Mullikin et al.,<xref rid="cit0064" ref-type="bibr"><sup>64</sup></xref> calculated influenza illnesses prevented by TIVs, QIVs (or an adjuvanted TIV in elderly with TIV in other ages) compared with no vaccination, and estimated that in an average season with an average vaccine match (obtained using 1999–2014 US data), vaccination with QIVs would prevent 1,382,509 more illnesses than vaccination with TIVs (an estimate which is higher than the upper range of that from Crépey et al.<xref rid="cit0062" ref-type="bibr"><sup>62</sup></xref>), 18,354 hospitalisations and 2,981 deaths. Brogan et al.,<xref rid="cit0065" ref-type="bibr"><sup>65</sup></xref> estimated that over a 10-year period, QIVs instead of TIVs would prevent 1,973,849 additional influenza cases and 1,396 deaths annually. These studies illustrate that although the impact of QIVs may vary in any influenza season, the multi-year cumulative benefit of QIVs over TIVs are predicted to result in substantial societal benefit. This is particularly true for a dynamic model that accounts for herd immunity.</p></sec><sec id="s0003-0002"><title>Canada</title><p>B-lineage mismatches between the vaccine and circulating strain occurred in 7 out of 15 seasons in Canada between 2001–2015.<xref rid="cit0004" ref-type="bibr"><sup>4</sup></xref> During the 2011/12 influenza season the mismatched influenza B lineage contributed substantially to serious outcomes in adults; the hospital-based Serious Outcomes Surveillance Network in Canada identified influenza B in 65% of adults hospitalised with influenza, of which 68% (205/383) were due to a vaccine mismatched lineage.<xref rid="cit0066" ref-type="bibr"><sup>66</sup></xref> Around 12% of influenza B cases required admission to intensive care. The 30-day mortality was 3% for the vaccine-matched lineage and 10% for the mismatched lineage.</p><p>Two studies estimated the potential impact of QIVs over TIVs in Canada: one used a static model and the other a dynamic model. The static model estimated that use of QIV would prevent 2,516 cases, 27 hospitalisations and 5 deaths annually in addition to TIVs.<xref rid="cit0067" ref-type="bibr"><sup>67</sup></xref> The dynamic model estimated that use of QIVs would prevent 135,538 cases, 1,876 hospitalisations and 328 deaths annually in Canada compared in addition to TIVs.<xref rid="cit0068" ref-type="bibr"><sup>68</sup></xref></p></sec><sec id="s0003-0003"><title>United Kingdom (UK)</title><p>Modeling studies conducted over 12–14 seasons (1995/1996/1997–2009) with results extrapolated to the total UK population estimated seasonal rates for general practitioner visits, hospitalisations and deaths attributable to respiratory disease caused by influenza B of 355/100,000, 2/100,000, and 1/100,000 population respectively.<xref rid="cit0043" ref-type="bibr"><sup>43,69</sup></xref> Around one-third of visits to a general practitioner for otitis media were attributed to influenza type B.<xref rid="cit0043" ref-type="bibr"><sup>43</sup></xref> The number and rate of hospitalisations due to influenza B-attributable respiratory disease was highest in 5–17 year-olds and exceeded that due to influenza A in some seasons.<xref rid="cit0069" ref-type="bibr"><sup>69</sup></xref></p><p>Over a 13-year period in Scotland (2000–2012), influenza B detections were close to, or exceeded influenza A detections for 6 out of 13 seasons.<xref rid="cit0070" ref-type="bibr"><sup>70</sup></xref></p><p>Two studies in the UK have compared the impact of TIVs and QIVs in those ≥ 65 y of age and clinical at-risk groups, and its implementation in the whole population.<xref rid="cit0068" ref-type="bibr"><sup>68,71</sup></xref> In a static model that considered vaccination of elderly and at-risk groups, QIVs are expected to prevent a total of 183,844 cases, 4,871 hospitalisations and 2,142 deaths due to influenza B over a cumulative 10-year time horizon.<xref rid="cit0071" ref-type="bibr"><sup>71</sup></xref> A separate study using a dynamic model reported that vaccination of all age-groups (current vaccine coverage rates) was estimated to prevent 88,755 cases, 1,050 hospitalisations and 230 deaths due to influenza B annually.<xref rid="cit0068" ref-type="bibr"><sup>68</sup></xref></p></sec><sec id="s0003-0004"><title>Germany</title><p>In a prospective surveillance study of children ≤16 y of age hospitalised with acute respiratory infection, influenza B was associated with pneumonia in 36% of cases (5/14) and by myositis in 7% (1/14).<xref rid="cit0072" ref-type="bibr"><sup>72</sup></xref> In the same study, influenza A infection was associated with pneumonia in 25% (26/102) of cases, otitis media in 25% (26/102) of cases, anaemia and syncope each in one case.</p><p>Two studies used a simulation model that incorporated cross-immunising events and waning/boosting of immunity over a 20-year time horizon.<xref rid="cit0073" ref-type="bibr"><sup>73,74</sup></xref> One study estimated that compared with TIVs, QIVs would prevent 11.2% more influenza B cases. <xref rid="cit0073" ref-type="bibr"><sup>73</sup></xref> Each year this would reduce the annual number of influenza cases by 3.6% in 0–15 y olds, 4.0% in 16–60 y olds, 6.9% in those aged ≥ 61 y and 4.3% (or 395,000 cases) overall.<xref rid="cit0073" ref-type="bibr"><sup>73</sup></xref></p><p>The second study estimated that QIVs would prevent 4% more influenza cases, 5.7% more hospitalisations and 6.4% more deaths than TIVs.<xref rid="cit0074" ref-type="bibr"><sup>74</sup></xref></p></sec><sec id="s0003-0005"><title>Finland</title><p>A dynamic model using data from the 2000 to 2009 influenza seasons estimated that in the Finnish population, QIVs would prevent 40,500 cases, 360 hospitalisations and 54 deaths each year compared with TIV.<xref rid="cit0075" ref-type="bibr"><sup>75</sup></xref> The number of cases was estimated to be even further reduced if the QIV used in 2–18 y olds was LAIV4.</p></sec><sec id="s0003-0006"><title>Belgium</title><p>Extending the current Belgian influenza immunisation strategy from individuals at-risk (including those aged 50 y or over) to include children 2–17 y of age was assessed in a dynamic model.<xref rid="cit0076" ref-type="bibr"><sup>76</sup></xref> Assuming 50% coverage of QIVs among 2–17 y olds, 2.95 million cases of influenza were calculated to be averted over a 10-year period compared with no vaccination of this age group. Most (63%, or 1,869,582) of these averted cases were due to indirect effects in adults in whom vaccine coverage rates with TIV were assumed to be unchanged. Of a total of 16,968 averted hospitalisations and 1,455 averted deaths, 11,567 and 1,455, respectively, were in adults.</p></sec><sec id="s0003-0007"><title>Spain</title><p>Switching from TIVs to QIVs in at-risk individuals from 3 y of age and in those aged 65 y and over was estimated to prevent an additional 18,565 influenza cases, 407 hospitalisations and 181 deaths in the first year after implementation.<xref rid="cit0077" ref-type="bibr"><sup>77</sup></xref></p></sec><sec id="s0003-0008"><title>Italy</title><p>QIVs were introduced in Italy for the 2015/16 season. Assuming that QIVs were used in 9% of the population targeted by the national immunisation program (all individuals at risk and those aged ≥ 65 y), 1,601 additional cases of uncomplicated influenza and 1,031 additional cases of complicated influenza were estimated to be averted compared with TIVs used alone.<xref rid="cit0078" ref-type="bibr"><sup>78</sup></xref></p></sec><sec id="s0003-0009"><title>France</title><p>By switching from QIVs to TIVs in France during an average epidemic season between 2003 and 2012, it was estimated that 6,214 consultations for influenza, 614 additional hospitalisations and 372 deaths would have been averted.<xref rid="cit0079" ref-type="bibr"><sup>79</sup></xref></p></sec><sec id="s0003-0010"><title>European Union</title><p>A static model using data from France, Germany, Italy, Spain and the UK, estimated that replacement of TIVs with QIVs during 2002–2013 (2009 season excluded) would have prevented 1,034,727 additional influenza cases, 24,453 hospitalisations and 9,799 deaths.<xref rid="cit0080" ref-type="bibr"><sup>80</sup></xref> Extrapolation to the 27-EU suggested that QIVs would have prevented an estimated 1,624,533 influenza cases, 37,317 hospitalisations and 14,866 deaths. The majority of hospitalisations and almost all deaths prevented would have been in high-risk groups or the elderly.</p></sec><sec id="s0003-0011"><title>Hong Kong</title><p>Using hospital records to identify laboratory-confirmed influenza cases between 2000–2010, Chan et al.,<xref rid="cit0081" ref-type="bibr"><sup>81</sup></xref> estimated that the average annual incidence of hospital admission (all ages) due to influenza B was 20.6/100,000 population. The highest annual hospitalisations rates were in children < 5 y and 5–9 y of age (median 238/100,000 and 152/100,000, respectively). Both influenza B lineages co-circulated for 9 out of the 10 study years. In the 6 y where a single influenza B lineage predominated (defined as > 80% of identified strains), a mismatch between the predominant B-strain and the vaccine strain occurred in 4. Modeling using Hong Kong death statistics and sentinel laboratory surveillance between 1998–2009 estimated an annual excess mortality of 2.5/100,000 person-years due to influenza B, increasing to 20.3/100,000 person-years in adults aged ≥ 65.<xref rid="cit0082" ref-type="bibr"><sup>82</sup></xref></p><p>Static models estimated that compared with TIVs, QIVs used at all ages would prevent 91 influenza illnesses per 100,000 population, 1.8/100,000 hospitalisations and 0.046/100,000 deaths over 1 y (<xref ref-type="table" rid="t0001">Table 1</xref>).<xref rid="cit0083" ref-type="bibr"><sup>83</sup></xref> Vaccination of ≥ 65 year-olds with QIV between 2001 and 2009 is estimated to have prevented 191.3 influenza illnesses per 100,000 population in elderly, with the highest reduction in those aged ≥ 80 y (reduction of 451.4 illness per 100,000 population).</p></sec><sec id="s0003-0012"><title>Australia</title><p>The 2015 influenza season in Australia was dominated by influenza B, which accounted for 62% of all cases notified;<xref rid="cit0084" ref-type="bibr"><sup>84</sup></xref> 38% of influenza B isolates were the B/Victoria lineage not included in the 2015 southern hemisphere TIVs. The highest influenza B notification rate was in children 5–9 y of age, followed by 0–4 y and 0–14 y.<xref rid="cit0084" ref-type="bibr"><sup>84</sup></xref></p><p>A static model using 2003–2013 data from a single town in Western Australia estimated that compared with TIVs, QIVs would reduce influenza illness by 3.8%, hospitalisations by 2.2% and deaths by 2.1%.<xref rid="cit0085" ref-type="bibr"><sup>85</sup></xref> The authors noted that there was a good match between the vaccine and circulating lineages during the study period in Australia, under which scenario the benefit of QIVs over TIVs is marginal.<xref rid="cit0085" ref-type="bibr"><sup>85</sup></xref> The same study also investigated the impact of QIVs over TIVs in a rural area of South Africa, and reported a greater impact due to a higher degree of mismatch in the seasons studied (<xref ref-type="table" rid="t0001">Table 1</xref>).</p><p>A second static model estimated that the use of QIVs instead of TIVs in children and adults at-risk for influenza (eligible for free vaccination as defined in the Australian Immunisation handbook) between 2002 and 2012, would have reduced influenza cases, hospitalisations and deaths by 1.02% (68,271), 2.4% (n = 3,522) and 3.7% (n = 683), respectively.<xref rid="cit0086" ref-type="bibr"><sup>86</sup></xref> The highest impact of QIV was in young children and the elderly. In adults aged 65 y and over, QIVs were estimated to prevent an additional 10.1 hospitalisations and 2.1 deaths per 100,000 person-years over TIVs.</p></sec></sec><sec id="s0004"><title>Current recommendations for QIVs</title><p>Since licensure of the first QIV in 2012, an increasing number of countries use QIVs either permissively (TIVs or QIVs), or preferentially (TIVs available but QIVs preferred) (<xref ref-type="table" rid="t0002">Table 2</xref>). However, while several supranational organisations acknowledge that QIVs may improve protection against influenza B strains compared with TIVs, at this time, most health authorities do not preferentially recommend one over the other (<xref ref-type="table" rid="t0002">Table 2</xref>). Health authorities are generally concerned that with a trend toward an increased influenza vaccine uptake overall, preferential recommendations may be counterproductive if a preferred product is not sufficiently manufactured and supplied to cover the entire population to be vaccinated.
<table-wrap id="t0002" orientation="portrait" position="float"><label>Table 2.</label><caption><p>Current recommendations for influenza vaccination using quadrivalent seasonal influenza vaccines (QIVs).</p></caption><pmc-comment>OASIS TABLE HERE</pmc-comment><table frame="hsides" rules="groups"><colgroup><col width="20pt" align="left"></col><col width="20pt" align="left"></col><col width="20pt" align="left"></col></colgroup><thead><tr><th align="left">Countries/authorities with permissive recommendations for QIVs use</th><th align="center">Year recommended</th><th align="center">Age/group indicated for QIVs</th></tr></thead><tbody><tr><td align="left">World Health Organization <xref ref-type="bibr" rid="cit0102"><sup>102</sup></xref></td><td align="center">2012</td><td align="left">Pregnant women, Children <5 y, Health care workers, Elderly >65 y, Chronic conditions</td></tr><tr><td align="left">Germany <xref ref-type="bibr" rid="cit0103"><sup>103</sup></xref></td><td align="center">2013</td><td align="left">Pregnant women, Children <5 y, Health care workers, Elderly >65 y, Chronic conditions</td></tr><tr><td align="left">United States <xref ref-type="bibr" rid="cit0104"><sup>104</sup></xref></td><td align="center">2013</td><td align="left">Children (≥6 months) & Adults</td></tr><tr><td align="left">Hong Kong <xref ref-type="bibr" rid="cit0105"><sup>105</sup></xref></td><td align="center">2013</td><td align="left">Children (≥ 3 y) & Adults</td></tr><tr><td align="left">Canada <xref ref-type="bibr" rid="cit0106"><sup>106</sup></xref></td><td align="center">2014</td><td align="left">From 6 months of age</td></tr><tr><td align="left">Italy <xref ref-type="bibr" rid="cit0107"><sup>107</sup></xref></td><td align="center">2014</td><td align="left">Children (≥ 3 y) & Adults</td></tr><tr><td align="left">France <xref ref-type="bibr" rid="cit0108"><sup>108</sup></xref></td><td align="center">2014</td><td align="left">Children (≥ 3 y) & Adults</td></tr><tr><td align="left">Belgium <xref ref-type="bibr" rid="cit0109"><sup>109</sup></xref></td><td align="center">2015</td><td align="left">From age 2 y</td></tr><tr><td align="left">Brazil <xref ref-type="bibr" rid="cit0110"><sup>110</sup></xref><hr></hr></td><td align="center">2014<hr></hr></td><td align="left">Elderly 60+ y<hr></hr></td></tr><tr><td align="left">Countries preferentially recommending QIVs<hr></hr></td><td align="center"> <hr></hr></td><td align="center"> <hr></hr></td></tr><tr><td align="left">United Kingdom <xref ref-type="bibr" rid="cit0111"><sup>111</sup></xref></td><td align="center">2013</td><td align="left">Children 2–7 y and children at risk 2–18 y.</td></tr><tr><td align="left">Germany <xref ref-type="bibr" rid="cit0112"><sup>112</sup></xref></td><td align="center">2014</td><td align="left">All long-distance travelers</td></tr><tr><td align="left">Brazil <xref ref-type="bibr" rid="cit0110"><sup>110</sup></xref></td><td align="center">2015</td><td align="left">Elderly</td></tr><tr><td align="left">Australia <xref ref-type="bibr" rid="cit0113"><sup>113</sup></xref></td><td align="center">2015</td><td align="left">From 6 months of age</td></tr></tbody></table><table-wrap-foot><fn><p>QIV = quadrivalent seasonal influenza vaccine (LAIV or IIV4)</p></fn></table-wrap-foot></table-wrap></p><p>After successful pilot programmes in 2013 and 2014, influenza vaccination using LAIV4 is now offered to 2–4 y old school children in the UK, as well as to at-risk groups from 6 month to 17 y of age.<xref rid="cit0087" ref-type="bibr"><sup>87</sup></xref> This innovative initiative aims to reduce disease incidence in children and transmission to older age-groups, thereby achieving societal benefit at the overall population level.<xref rid="cit0088" ref-type="bibr"><sup>88</sup></xref></p></sec><sec sec-type="conclusions" id="s0005"><title>Conclusions</title><p>Although varying from year-to-year, on average, influenza B causes up to one-third of influenza infections each season. A large body of evidence from numerous countries demonstrates that influenza B accounts for a significant proportion of the overall burden of influenza that inundates healthcare services annually. Once thought to cause predominantly mild illness, numerous studies now indicate that there is little difference in the clinical symptomatology and outcomes of influenza B vs. A. Hospitalisations and mortality attributable to influenza B may have previously been underestimated, with studies reporting higher mortality following influenza B infection than A in some years.<xref rid="cit0013" ref-type="bibr"><sup>13,89-91</sup></xref> In parallel, the 2 influenza B lineages frequently co-circulate, and due to the complexity involved in accurately forecasting which B viruses will circulate, mismatches between the B strain selected for TIVs and circulating strains have occurred in up to one-half of seasons.<xref rid="cit0004" ref-type="bibr"><sup>4,92</sup></xref> Evidence from clinical trials and observational studies suggest that B-mismatched seasons are accompanied by a higher public health burden than well-matched seasons.<xref rid="cit0015" ref-type="bibr"><sup>15,51</sup></xref> Although the risk of breakthrough influenza A from vaccine strain mismatch remains, the risk of breakthrough influenza B from vaccine lineage mismatch can be eliminated by QIV.</p><p>Brazil is unique with regards to the pattern of influenza and viral circulating in this heterogeneous climate. A recent review paper highlighted that over a 9 y follow-up period, influenza B lineages circulated in 3 seasons, of which, during one season, there was a high degree of mismatch between the vaccine lineage and the predominant circulating lineage (91.4% [2013]).<xref rid="cit0093" ref-type="bibr"><sup>93</sup></xref> Within tropical and sub-tropical regions such as Brazil, influenza B can have protracted circulation patterns and co-circulation of both B-lineages may not be uncommon, thus further highlighting the added value of QIVs in these countries.<xref rid="cit0094" ref-type="bibr"><sup>94</sup></xref></p><p>Modeling the impact of QIVs over TIVs is challenging, not least because of the unpredictable disease burden that differs markedly from year-to-year.<xref rid="cit0095" ref-type="bibr"><sup>95</sup></xref> As might therefore be anticipated, evaluations from different countries all show very large variability in the seasonal impact of QIVs. Analyses that project cumulative effects over multiple seasons based on antecedent virus circulation patterns are therefore most informative. The published dynamic models showed substantially greater improvement in health outcomes based on the use of QIVs as compared with the more conservative static models. However, although dynamic models better reflect the real-world impact of vaccination, dynamic transmission models are inherently more complex and require a greater degree of assumptions in terms of model inputs.</p><p>Influenza vaccines typically show reduced efficacy in the elderly due to immune senescence and novel TIVs developed for use in this age-group include an increased antigen dose or adjuvant to overcome this limitation. Modeling studies suggest that the benefits of enhanced TIV formulations in the elderly (high-dose or adjuvanted TIVs) may be as great, or greater than those provided by QIVs.<xref rid="cit0060" ref-type="bibr"><sup>60,61,64</sup></xref> This underscores the fact that in older adults, improvements in vaccine efficacy can be achieved by improving the immune response and by broadening coverage. However, even with high-dose TIV, efficacy against influenza B due to the lineage included in the vaccine is clearly higher than efficacy against influenza B due to the lineage absent from the vaccine.<xref rid="cit0096" ref-type="bibr"><sup>96</sup></xref> An enhanced QIV in this population appears to be the optimal vaccine choice.</p><p>Influenza vaccines have been in use since 1936 and the move from TIVs to QIVs is the most recent adaption of seasonal influenza vaccines in response to changes in global circulating influenza strains. Based on the available evidence from clinical trials, epidemiological studies and modeling, several countries have progressively issued recommendations preferentially recommending QIVs over TIVs. To address the co-circulation of B-lineage viruses or B-lineage mismatch, QIVs have been developed and are likely to lead to more stable vaccine effectiveness across seasons, providing broader protection than TIVs and contributing to influenza prevention worldwide. Availability of QIV efficacy data in children and estimates of vaccine effectiveness in coming seasons will provide complementary information on the potential added benefits of QIVs on influenza prevention, which may lead more countries to adopt definitive recommendations for QIVs use.</p></sec><sec id="s0006"><title>Trademark statement</title><p><italic>FluLaval, Fluarix, Alpharix</italic> and <italic>Influsplit</italic> are trademarks of the GSK group of companies. <italic>Fluzone Quadrivalent</italic> and <italic>Fluzone Intradermal Quadrivalent</italic> are trademarks of Sanofi Pasteur. <italic>Flumist Quadrivalent</italic> and <italic>Fluenz Tetra</italic> are trademarks of AstraZeneca.</p></sec></body><back><sec><title>Disclosure of potential conflicts of interest</title><p>Riju Ray, Rafik Bekkat-Berkani, Philip O. Buck, Carine Claeys and Gonçalo Matias are employees of the GSK group of companies. Bruce L. Innis reports he was employed by the GSK group of companies at the time of the study and is now an employee of PATH. Riju Ray, Rafik Bekkat-Berkani, Philip O. Buck, Carine Claeys and Bruce L. Innis report ownership of stock options and/or restricted shares in the GSK group of companies. Gaël Dos Santosreports he was employed by Business & Decision Life Sciences (on behalf of GSK) at the time of the study and is now employee of the GSK group of companies.</p></sec><sec><title>Acknowledgments</title><p>The authors thank Philippe Buchy for critically reviewing the manuscript. The authors also thank Joanne Wolter (Independent medical writer, on behalf of GSK) for providing writing services, and Bruno Dumont and Veronique Gochet (Business and Decision Life Sciences, on behalf of GSK) for editorial assistance and manuscript coordination.</p></sec><sec><title>Funding</title><p>GlaxoSmithKline Biologicals SA took in charge all costs associated with the development and publication of the present manuscript.</p></sec><sec><title>Authors' contributions</title><p>All authors participated in assembling and interpreting the data. 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