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Article: What Drives the Value of a

Hausdorff, William P / Scheele, Suzanne / Giersing, Birgitte K

2022 Volume 10, Issue 2

Abstract: The development and licensure of a safe and highly ... ...

Abstract	The development and licensure of a safe and highly efficacious
Language	English
Publishing date	2022-02-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines10020282
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Article ; Online: Facilitating the development of urgently required combination vaccines.

Hausdorff, William P / Madhi, Shabir A / Kang, Gagandeep / Kaboré, Lassané / Tufet Bayona, Marta / Giersing, Birgitte K

The Lancet. Global health

2024

Abstract: The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as ... ...

Abstract	The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as monopathogen formulations. Nonetheless, the control and elimination of an astonishing number of diseases was realised only after several once-separate vaccines were provided as combinations. Unfortunately, the current superabundance of recommended and pipeline vaccines is now at odds with the number of acceptable vaccine administrations and feasible health-care visits for vaccine recipients and health-care providers. Yet, few new combinations are in development because, in addition to the scientific and manufacturing hurdles intrinsic to coformulation, developers face a gauntlet of regulatory, policy, and commercialisation obstacles in a milieu still largely designed for monopathogen vaccines. We argue here that national policy makers and public health agencies should prospectively identify and advocate for the development of new multipathogen combination vaccines, and suggest ways to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative steps to mitigate current obstacles.
Language	English
Publishing date	2024-04-15
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2723488-5
ISSN	2214-109X ; 2214-109X
ISSN (online)	2214-109X
ISSN	2214-109X
DOI	10.1016/S2214-109X(24)00092-5
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Article ; Online: Vaccine Value Profiles.

Giersing, Birgitte / Karron, Ruth / Tufet-Bayona, Marta / Trotter, Caroline / Lambach, Philipp / Jit, Mark

Vaccine

2023 Volume 41 Suppl 2, Page(s) S1–S2

MeSH term(s)	Vaccines ; Cost-Benefit Analysis
Chemical Substances	Vaccines
Language	English
Publishing date	2023-07-15
Publishing country	Netherlands
Document type	Editorial
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.06.083
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Article ; Online: Key considerations for the development of novel mRNA candidate vaccines in LMICs: A WHO/MPP mRNA Technology Transfer Programme meeting report.

Gsell, Pierre-Stéphane / Giersing, Birgitte / Gottlieb, Sami / Wilder-Smith, Annelies / Wu, Lindsey / Friede, Martin

Vaccine

2023 Volume 41, Issue 49, Page(s) 7307–7312

Abstract: The WHO/MPP mRNA Technology Transfer Programme, initiated in 2021, focuses on establishing mRNA vaccine manufacturing capacity in LMICs. On 17-21 April 2023, Programme partners were convened to review technology transfer progress, discuss sustainability ... ...

Abstract	The WHO/MPP mRNA Technology Transfer Programme, initiated in 2021, focuses on establishing mRNA vaccine manufacturing capacity in LMICs. On 17-21 April 2023, Programme partners were convened to review technology transfer progress, discuss sustainability aspects and promote mRNA product development for diseases relevant to LMICs. To help guide product development, this report introduces key considerations for for understanding the likelihood of technical and regulatory success and of policy development and procurement for mRNA vaccines to be developed and manufactured in LMICs. The report underscores the potential for LMICs to establish sustainable mRNA R&D pipelines.
MeSH term(s)	Developing Countries ; Technology Transfer ; Commerce ; Vaccines ; World Health Organization
Chemical Substances	Vaccines
Language	English
Publishing date	2023-11-08
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.10.027
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Article ; Online: Exploring potential applications of measles and rubella microarray patches (MR-MAPs): use case identification.

Malvolti, Stefano / Ko, Melissa / Menozzi-Arnaud, Marion / Mantel, Carsten / Jarrahian, Courtney / Amorij, Jean-Pierre / Giersing, Birgitte / Hasso-Agopsowicz, Mateusz

Frontiers in public health

2023 Volume 11, Page(s) 1165110

Abstract: Introduction: Innovative vaccine products will be critical in helping to address the existing implementation barriers that have prevented the achievement of the measles and rubella (MR) vaccine coverage targets. Overcoming those barriers will be ... ...

Abstract	Introduction: Innovative vaccine products will be critical in helping to address the existing implementation barriers that have prevented the achievement of the measles and rubella (MR) vaccine coverage targets. Overcoming those barriers will be necessary to achieve the "Immunization Agenda 2030" goals. Microarray patches (MAPs), an innovative needle-free delivery device currently in clinical development, can be a potential game changer in this respect and contribute to the equitable delivery of vaccines in low- and middle-income countries and pandemic preparedness and response. Developing in-depth knowledge of the most desired and impactful uses of MRMAPs can prove critical to identifying the critical attributes of the target product profile, informing policy and adoption decisions, and helping to evaluate the potential public health and economic value of this technology. The first step in this process is the definition of the potential use cases for MR-MAPs, i.e., where and how this product is most likely to be used within the immunization programme. Methods: By applying a design-based user-centric approach, we implemented a three-step process, including a desk review, a survey, and interviews, to define the most relevant use cases for MR MAPS. Results: Six use cases have been identified as relevant across all different countries and immunization programme designs and validated by experts. Discussion: The identified use cases have already informed the demand estimate for MR-MAPs and provided the foundation for developing an initial full vaccine value assessment. We believe that, in the future, they will be highly valuable in ensuring that the roll-out of this promising innovation is designed in a way that maximizes the impact, particularly in populations and countries that are most in need.
MeSH term(s)	Humans ; Rubella/prevention & control ; Measles/prevention & control ; Measles Vaccine ; Rubella Vaccine ; Vaccination
Chemical Substances	Measles Vaccine ; Rubella Vaccine
Language	English
Publishing date	2023-06-12
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2711781-9
ISSN	2296-2565 ; 2296-2565
ISSN (online)	2296-2565
ISSN	2296-2565
DOI	10.3389/fpubh.2023.1165110
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Article ; Online: The Full Value of Vaccine Assessments (FVVA): a framework for assessing and communicating the value of vaccines for investment and introduction decision-making.

Hutubessy, Raymond / Lauer, Jeremy A / Giersing, Birgitte / Sim, So Yoon / Jit, Mark / Kaslow, David / Botwright, Siobhan

BMC medicine

2023 Volume 21, Issue 1, Page(s) 229

Abstract: Background: Several economic obstacles can deter the development and use of vaccines. This can lead to limited product options for some diseases, delays in new product development, and inequitable access to vaccines. Although seemingly distinct, these ... ...

Abstract	Background: Several economic obstacles can deter the development and use of vaccines. This can lead to limited product options for some diseases, delays in new product development, and inequitable access to vaccines. Although seemingly distinct, these obstacles are actually interrelated and therefore need to be addressed through a single over-arching strategy encompassing all stakeholders. Methods: To help overcome these obstacles, we propose a new approach, the Full Value of Vaccines Assessments (FVVA) framework, to guide the assessment and communication of the value of a vaccine. The FVVA framework is designed to facilitate alignment across key stakeholders and to enhance decision-making around investment in vaccine development, policy-making, procurement, and introduction, particularly for vaccines intended for use in low- and middle-income countries. Results: The FVVA framework has three key elements. First, to enhance assessment, existing value-assessment methods and tools are adapted to include broader benefits of vaccines as well as opportunity costs borne by stakeholders. Second, to improve decision-making, a deliberative process is required to recognize the agency of stakeholders and to ensure country ownership of decision-making and priority setting. Third, the FVVA framework provides a consistent and evidence-based approach that facilitates communication about the full value of vaccines, helping to enhance alignment and coordination across diverse stakeholders. Conclusions: The FVVA framework provides guidance for stakeholders organizing global-level efforts to promote investment in vaccines that are priorities for LMICs. By providing a more holistic view of the benefits of vaccines, its application also has the potential to encourage greater take-up by countries, thereby leading to more sustainable and equitable impacts of vaccines and immunization programmes.
MeSH term(s)	Humans ; Vaccines ; Vaccination ; Policy Making ; Developing Countries ; Immunization Programs
Chemical Substances	Vaccines
Language	English
Publishing date	2023-07-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2131669-7
ISSN	1741-7015 ; 1741-7015
ISSN (online)	1741-7015
ISSN	1741-7015
DOI	10.1186/s12916-023-02929-0
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Article ; Online: Meeting Summary: Global Vaccine and Immunization Research Forum, 2021

Ford, Andrew / Hwang, Angela / Mo, Annie X. / Baqar, Shahida / Touchette, Nancy / Deal, Carolyn / King, Deborah / Earle, Kristen / Giersing, Birgitte / Düll, Peter / Hall, B. Fenton

Vaccine. 2023 Mar., v. 41, no. 11 p.1799-1807

2023

Abstract: The 2021 Global Vaccine and Immunization Research Forum highlighted the considerable advances and recent progress in research and development for vaccines and immunization, critically reviewed lessons learned from COVID-19 vaccine programs, and looked ... ...

Abstract	The 2021 Global Vaccine and Immunization Research Forum highlighted the considerable advances and recent progress in research and development for vaccines and immunization, critically reviewed lessons learned from COVID-19 vaccine programs, and looked ahead to opportunities for this decade. For COVID-19, decades of investments in basic and translational research, new technology platforms, and vaccines targeting prototype pathogens enabled a rapid, global response. Unprecedented global coordination and partnership have played an essential role in creating and delivering COVID-19 vaccines. More improvement is needed in product attributes such as deliverability, and in equitable access to vaccines. Developments in other priority areas included: the halting of two human immunodeficiency virus vaccine trials due to lack of efficacy in preventing infection; promising efficacy results in Phase 2 trials of two tuberculosis vaccines; pilot implementation of the most advanced malaria vaccine candidate in three countries; trials of human papillomavirus vaccines given in single-dose regimens; and emergency use listing of a novel, oral poliomyelitis type 2 vaccine. More systematic, proactive approaches are being developed for fostering vaccine uptake and demand, aligning on priorities for investment by the public and private sectors, and accelerating policy making. Participants emphasized that addressing endemic disease is intertwined with emergency preparedness and pandemic response, so that advances in one area create opportunities in the other. In this decade, advances made in response to the COVID-19 pandemic should accelerate availability of vaccines for other diseases, contribute to preparedness for future pandemics, and help to achieve impact and equity under Immunization Agenda 2030.
Keywords	COVID-19 infection ; Human immunodeficiency virus ; disaster preparedness ; endemic diseases ; humans ; immunization ; issues and policy ; malaria vaccines ; pandemic ; prototypes ; technology ; tuberculosis ; BCG ; bnAb ; CEPI ; CHIM ; ECVP ; EUA ; EUL ; GVAP ; GVIRF ; HIV ; HPV ; IA2030 ; MERS ; nOPV-2 ; PPP ; R&D ; SARS ; VIPS
Language	English
Dates of publication	2023-03
Size	p. 1799-1807.
Publishing place	Elsevier Ltd
Document type	Article ; Online
Note	Use and reproduction
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.02.028
Database	NAL-Catalogue (AGRICOLA)

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Article: Considerations for using ETEC and Shigella disease burden estimates to guide vaccine development strategy

Hosangadi, Divya / Smith, Peter G / Giersing, Birgitte K

Vaccine. 2019 Nov. 28, v. 37, no. 50

2019

Abstract: Enterotoxigenic E. coli (ETEC) and Shigella are enteropathogens causing significant global morbidity and mortality, particularly in low-income countries. No licensed vaccine exists for either pathogen, but candidates are in development, with the most ... ...

Abstract	Enterotoxigenic E. coli (ETEC) and Shigella are enteropathogens causing significant global morbidity and mortality, particularly in low-income countries. No licensed vaccine exists for either pathogen, but candidates are in development, with the most advanced candidates potentially approaching pivotal efficacy testing within the next few years.A positive policy recommendation for introduction of any vaccine, following licensure, depends on evidence of vaccine cost-effectiveness and impact on morbidity and mortality. The mortality estimates for these two pathogens have fluctuated over recent years, which has led to uncertainty in the assessment of their relative public health importance for use in low and middle-income countries.This paper summarizes the various ETEC and Shigella disease burden estimates, based on a review of current literature and informal consultations with leading stakeholders in enteric disease modelling. We discuss the factors that underpin the variability, including differences in the modelling methodology; diagnostic tools used to ascertain diarrheal etiology; epidemiological setting; the data that are available to incorporate; and absolute changes in the total number of diarrheal deaths over time. We consider the further work that will strengthen the evidence needed to support future decision making with respect to recommendations on the relative utility of these vaccines.
Keywords	Shigella ; burden of disease ; cost effectiveness ; decision making ; diagnostic techniques ; diarrhea ; enteropathogens ; enterotoxigenic Escherichia coli ; issues and policy ; models ; morbidity ; mortality ; public health ; stakeholders ; uncertainty ; vaccine development ; vaccines
Language	English
Dates of publication	2019-1128
Size	p. 7372-7380.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2017.09.083
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Article ; Online: A review of potential use cases for measles-rubella, measles-mumps-rubella, and typhoid-conjugate vaccines presented on microarray patches.

Soble, Adam / Ko, Melissa / Gilchrist, Shawn / Malvolti, Stefano / Hasso-Agopsowicz, Mateusz / Giersing, Birgitte / Amorij, Jean-Pierre / Jarrahian, Courtney / El Sheikh, Fayad / Menozzi-Arnaud, Marion / Scarna, Tiziana

Vaccine

2024 Volume 42, Issue 6, Page(s) 1230–1246

Abstract: As an innovative vaccine delivery technology, vaccine microarray patches could have a meaningful impact on routine immunization coverage in low- and middle-income countries, and vaccine deployment during epidemics and pandemics. This review of the ... ...

Abstract	As an innovative vaccine delivery technology, vaccine microarray patches could have a meaningful impact on routine immunization coverage in low- and middle-income countries, and vaccine deployment during epidemics and pandemics. This review of the potential use cases for a subset of vaccine microarray patches in various stages of clinical development, including measles-rubella, measles-mumps-rubella, and typhoid conjugate, highlights the breadth of their applicability to support immunization service delivery and their potential scope of utilization within national immunization programs. Definition and assessment of the use cases for this novel vaccine presentation provide important insights for vaccine developers and policymakers into the strengths of the public health and commercial value propositions, and the preparatory requirements for public health systems for the future rollout of vaccine microarray patches. An in-depth understanding of use cases for vaccine microarray patches serves as a foundational input to overcoming the remaining technical, regulatory, and financial challenges. Additional efforts will help to realize the potential of vaccine microarray patches as part of the global effort to improve the coverage and equity of national immunization programs.
MeSH term(s)	Humans ; Infant ; Mumps/prevention & control ; Vaccines, Conjugate ; Typhoid-Paratyphoid Vaccines ; Typhoid Fever/prevention & control ; Rubella/prevention & control ; Measles/prevention & control ; Rubella Vaccine ; Mumps Vaccine ; Vaccination ; Measles-Mumps-Rubella Vaccine
Chemical Substances	Vaccines, Conjugate ; Typhoid-Paratyphoid Vaccines ; Rubella Vaccine ; Mumps Vaccine ; Measles-Mumps-Rubella Vaccine
Language	English
Publishing date	2024-02-06
Publishing country	Netherlands
Document type	Review ; Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.12.047
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Article ; Online: Accelerating access for all through research and innovation in immunization: Recommendations from Strategic Priority 7 of the Immunization Agenda 2030.

Sarley, David / Hwang, Angela / Fenton Hall, B / Ford, Andrew / Giersing, Birgitte / Kaslow, David C / Wahl, Brian / Friede, Martin

Vaccine

2022

Abstract: Research and innovation have been fundamental to many of the successes in immunization thus far, and will play important roles in the future success of Immunization Agenda 2030 (IA2030). Strategic Priority 7 (SP7) of IA2030, which addresses research and ... ...

Abstract	Research and innovation have been fundamental to many of the successes in immunization thus far, and will play important roles in the future success of Immunization Agenda 2030 (IA2030). Strategic Priority 7 (SP7) of IA2030, which addresses research and innovation, is explicitly informed by country needs and priorities, and aims to strengthen the innovation ecosystem through capacity building and collaboration at country, regional, and global levels. SP7 identifies four key focus areas: (1) "needs-based innovation", (2) "new and improved products, services, and practices", (3) "evidence for implementation", and (4) "local capacity". Strategic interventions in these key focus areas apply the lessons of the Global Vaccine Action Plan and the "Decade of Vaccines" to emphasize local innovation, promote the use of research by countries to improve program performance and impact, and encourage capacity building for the development and implementation of innovations. The proposed approach will maintain a focus on the development of new vaccines and the improvement of existing vaccines, and increase attention to innovation in service delivery. Monitoring and evaluation will foster evidence-based priority setting at the country level and help to ground the global research and development (R&D) agenda in the needs of communities. Together, these approaches are intended to harness the power of research and innovation more effectively, to meet the challenges of the future and achieve the ambitious goals of IA2030.
Language	English
Publishing date	2022-12-16
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.11.041
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