{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T07:51:45Z","timestamp":1782028305853,"version":"3.54.5"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2021,11,2]],"date-time":"2021-11-02T00:00:00Z","timestamp":1635811200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,1,20]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Despite group B Streptococcus (GBS) being a leading cause of maternal and infant morbidity and mortality, no vaccine is currently available. To inform vaccine developers, countries, and funders, we analyzed the key factors likely to influence the demand for a GBS vaccine and the long-term financial sustainability for a vaccine developer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Using population-based forecasting, we estimated the demand for a GBS vaccine; using a discounted cash flow model we estimated the financial viability for a vaccine developer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Demand for this vaccine can be significant if countries adopt policy recommendations for use, in particular, the largest ones, most of which have a burden that justifies use of the vaccine, and if financing for the vaccine is made available either by countries or by funding mechanisms such as Gavi, the Vaccine Alliance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This analysis suggests the potential for financial and commercial viability for a vaccine developer pursuing the commercialization of a GBS vaccine. Risks exists in relation to the clinical trial design and costs, the level of competition, countries\u2019 ability to pay, the administration schedule, and the availability of policies that encourage use of the vaccine. To reduce those risks and ensure equitable access to a GBS vaccine, the role of donors or financers can prove very important, as can a coordinated operational research agenda that aims at clarifying those areas of uncertainty.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciab782","type":"journal-article","created":{"date-parts":[[2021,9,21]],"date-time":"2021-09-21T11:55:28Z","timestamp":1632225328000},"page":"S70-S79","source":"Crossref","is-referenced-by-count":10,"title":["A Financial and Global Demand Analysis to Inform Decisions for Funding and Clinical Development of Group B<i>Streptococcus<\/i>Vaccines for Pregnant Women"],"prefix":"10.1093","volume":"74","author":[{"given":"Stefano","family":"Malvolti","sequence":"first","affiliation":[{"name":"MMGH Consulting, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clint","family":"Pecenka","sequence":"additional","affiliation":[{"name":"PATH, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten F","family":"Mantel","sequence":"additional","affiliation":[{"name":"MMGH Consulting, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Malhame","sequence":"additional","affiliation":[{"name":"MMGH Consulting, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"Lambach","sequence":"additional","affiliation":[{"name":"Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland"},{"name":"MMGH Consulting, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,11,2]]},"reference":[{"key":"2022012019414638500_CIT0001","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1093\/cid\/cix664","article-title":"Estimates of the burden of group B Streptococcal disease worldwide for pregnant women, stillbirths, and children","volume":"65","author":"Seale","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2022012019414638500_CIT0002","doi-asserted-by":"crossref","first-page":"933","DOI":"10.1097\/INF.0000000000001233","article-title":"Disease burden of group B Streptococcus among infants in sub-Saharan Africa: a systematic literature review and meta-analysis","volume":"35","author":"Sinha","year":"2016","journal-title":"Pediatr Infect Dis J"},{"key":"2022012019414638500_CIT0003","doi-asserted-by":"crossref","first-page":"7307","DOI":"10.1016\/j.vaccine.2016.12.029","article-title":"WHO consultation on group B Streptococcus vaccine development: report from a meeting held on 27-28 April 2016","volume":"37","author":"Kobayashi","year":"2019","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0004","doi-asserted-by":"crossref","first-page":"2865","DOI":"10.1016\/j.vaccine.2016.02.078","article-title":"Report from the World Health Organization\u2019s Product Development for Vaccines Advisory Committee (PDVAC) meeting, Geneva, 7-9th September 2015","volume":"34","author":"Giersing","year":"2016","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0005","doi-asserted-by":"crossref","first-page":"7391","DOI":"10.1016\/j.vaccine.2017.09.087","article-title":"Maternal immunization against group B Streptococcus: World Health Organization research and development technological roadmap and preferred product characteristics","volume":"37","author":"Vekemans","year":"2019","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0006","doi-asserted-by":"crossref","first-page":"76","DOI":"10.7774\/cevr.2018.7.1.76","article-title":"Status of group B streptococcal vaccine development","volume":"7","author":"Lin","year":"2018","journal-title":"Clin Exp Vaccine Res"},{"key":"2022012019414638500_CIT0007","doi-asserted-by":"crossref","first-page":"1263","DOI":"10.2147\/IDR.S203454","article-title":"A vaccine against group B Streptococcus: recent advances","volume":"13","author":"Carreras-Abad","year":"2020","journal-title":"Infect Drug Resist"},{"key":"2022012019414638500_CIT0008","article-title":"Understanding the vaccine ecosystem: structure and challenges.","volume-title":"Powering vaccine R&D: opportunities for transformation","author":"Malvolti","year":"2021"},{"key":"2022012019414638500_CIT0009","author":"United Nations DoEaSA."},{"key":"2022012019414638500_CIT0010","doi-asserted-by":"crossref","first-page":"410","DOI":"10.1016\/j.vaccine.2008.10.069","article-title":"Forecasting demand for Hib-containing vaccine in the world\u2019s poorest countries: a 4-year prospective experience","volume":"27","author":"Zuber","year":"2009","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0011","doi-asserted-by":"crossref","DOI":"10.4161\/hv.6.9.12587","article-title":"Forecasting dengue vaccine demand in disease endemic and non-endemic countries","volume":"6","author":"Amarasinghe","year":"2010","journal-title":"Hum Vaccin"},{"key":"2022012019414638500_CIT0012","doi-asserted-by":"crossref","first-page":"498","DOI":"10.1016\/j.vaccine.2017.12.010","article-title":"Bacillus Calmette-Gu\u00e9rin (BCG) vaccine: a global assessment of demand and supply balance","volume":"36","author":"Cernuschi","year":"2018","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0013","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1007\/978-3-662-45851-8_3","volume-title":"Discounted cash flow methods. Investment appraisal","author":"Gotze","year":"2015"},{"key":"2022012019414638500_CIT0014","author":"World Health Organization."},{"key":"2022012019414638500_CIT0015","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1016\/S0140-6736(15)00837-5","article-title":"Stillbirths: rates, risk factors, and acceleration towards 2030","volume":"387","author":"Lawn","year":"2016","journal-title":"Lancet"},{"key":"2022012019414638500_CIT0016","author":"National Center for Health Statistics."},{"key":"2022012019414638500_CIT0017"},{"key":"2022012019414638500_CIT0018","doi-asserted-by":"crossref","first-page":"e0237718","DOI":"10.1371\/journal.pone.0237718","article-title":"Inferring antenatal care visit timing in low- and middle-income countries: methods to inform potential maternal vaccine coverage","volume":"15","author":"Baral","year":"2020","journal-title":"PLoS One"},{"key":"2022012019414638500_CIT0019","author":"UNICEF."},{"key":"2022012019414638500_CIT0020","volume-title":"Spending targets for health: no magic number","author":"Jowett","year":"2016"},{"key":"2022012019414638500_CIT0021","author":"World Bank."},{"key":"2022012019414638500_CIT0022","author":"World Health Organization.","year":"2020"},{"key":"2022012019414638500_CIT0023","article-title":"Global HPV vaccine market study","author":"Market Information for Access to Vaccines (MI4A).","year":"2019"},{"key":"2022012019414638500_CIT0024","author":"World Health Organization.","year":"2019"},{"key":"2022012019414638500_CIT0025","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/S1473-3099(20)30478-3","article-title":"Safety and immunogenicity of a novel hexavalent group B Streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1\/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial","volume":"21","author":"Absalon","year":"2021","journal-title":"Lancet Infect Dis"},{"key":"2022012019414638500_CIT0026","doi-asserted-by":"crossref","first-page":"e1386","DOI":"10.1016\/S2214-109X(18)30346-2","article-title":"Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study","volume":"6","author":"Gouglas","year":"2018","journal-title":"Lancet Glob Health"},{"key":"2022012019414638500_CIT0027","doi-asserted-by":"crossref","first-page":"3190","DOI":"10.1016\/j.vaccine.2019.04.039","article-title":"The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations","volume":"37","author":"Vekemans","year":"2019","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0028","doi-asserted-by":"crossref","first-page":"6627","DOI":"10.1016\/j.vaccine.2009.07.077","article-title":"Estimated research and development costs of rotavirus vaccines","volume":"27","author":"Light","year":"2009","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0029","doi-asserted-by":"crossref","first-page":"4064","DOI":"10.1016\/j.vaccine.2017.06.003","article-title":"The complexity and cost of vaccine manufacturing","volume":"35","author":"Plotkin","year":"2017","journal-title":"Vaccine"},{"key":"2022012019414638500_CIT0030","author":"Wilson","year":"2010"},{"key":"2022012019414638500_CIT0031","author":"Sanofi.","year":"2020"},{"key":"2022012019414638500_CIT0032","author":"Asen","year":"2019"},{"key":"2022012019414638500_CIT0033","author":"Damodaran"},{"key":"2022012019414638500_CIT0034","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.jhealeco.2016.01.012","article-title":"Innovation in the pharmaceutical industry: new estimates of R&D costs","volume":"47","author":"DiMasi","year":"2016","journal-title":"J Health Econ"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciab782\/40930989\/ciab782.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/74\/Supplement_1\/S70\/42249064\/ciab782.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/74\/Supplement_1\/S70\/42249064\/ciab782.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,9]],"date-time":"2023-11-09T04:15:45Z","timestamp":1699503345000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/74\/Supplement_1\/S70\/6412619"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,2]]},"references-count":34,"journal-issue":{"issue":"Supplement_1","published-online":{"date-parts":[[2021,11,2]]},"published-print":{"date-parts":[[2022,1,20]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciab782","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,1,15]]},"published":{"date-parts":[[2021,11,2]]}}}