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Article ; Online: Strengthening clinical development activities and preparedness for vaccine manufacturers from emerging countries: Results of a survey.

Viviani, Simonetta / Willems, Paul / Pagliusi, Sonia

Vaccine: X

2022 Volume 13, Page(s) 100255

Abstract: Vaccine development, in most cases, is a long, complex process, often lasting years and involving a combination of public and private stakeholders. Particularly, the vaccine clinical development process is highly regulated by several guidelines, ... ...

Abstract	Vaccine development, in most cases, is a long, complex process, often lasting years and involving a combination of public and private stakeholders. Particularly, the vaccine clinical development process is highly regulated by several guidelines, regulatory pathways and science-based recommendations from experts. Designing and executing a successful clinical development plan for any candidate vaccine requires a solid scientific, medical, operational and regulatory knowledge and expertise, to comply with regulations and assure adequate benefit-risk balance for the product to be used in mass vaccination of healthy populations. The purpose of this study was to assess the approaches and practices related to Clinical Development functions, and related activities among vaccine manufacturers based in emerging countries, and to identify industry needs in terms of organizational development and training needs. A structured questionnaire designed specifically for assessing indicators of clinical activities, in the last five years, comprised of four sections aimed to collect information on (1) the organizational structure and the activities conducted by the clinical functions; (2) the clinical trial design ability and the management of clinical trial documents; (3) the clinical trial management and monitoring activities; (4) the quality aspects of clinical activities. The results suggest that the great majority of respondents is engaged in intense clinical development activities, as indicated by the high number of licensed vaccines available and supplied in the national markets or in foreign markets, including vaccines with WHO prequalification status. Areas to further strengthen the clinical activities and medical research preparedness were identified. Greater engagements of stakeholders' and investments will be required to expand the clinical basis in vaccine R&D, and to support achieving a high level of preparedness in emerging countries, for development of new vaccines against future regional epidemics and global pandemics.
Language	English
Publishing date	2022-12-28
Publishing country	England
Document type	Journal Article
ISSN	2590-1362
ISSN (online)	2590-1362
DOI	10.1016/j.jvacx.2022.100255
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Article ; Online: Emerging vaccine manufacturers are innovating for the next decade.

Hayman, Benoit / Pagliusi, Sonia

Vaccine: X

2020 Volume 5, Page(s) 100066

Abstract: The Developing Countries Vaccine Manufacturers Network (DCVMN) is a public health-driven alliance consisting of 43 vaccine manufacturers from 14 countries and territories, operating under the mandate to protect all people against known and emerging ... ...

Abstract	The Developing Countries Vaccine Manufacturers Network (DCVMN) is a public health-driven alliance consisting of 43 vaccine manufacturers from 14 countries and territories, operating under the mandate to protect all people against known and emerging infectious diseases, by improving the availability of high-quality vaccines globally. The Network provides a platform for organizations to come together regularly to share technical information, best practices and future prospects. DCVMN members are playing an increasingly important role in public health supplying over 50% of the doses of vaccines procured by UNICEF globally. To evaluate the progress made by Network's members, a survey consisting of 9 questions covering three important components of the manufacturers in the network was created, focusing on company dedicated human resources, vaccine production, and research and development efforts. Results show that more vaccines from more manufacturers are achieving WHO Pre-qualification, with areas of focus including the contributions to a Polio-free world, ending cholera, and tackling re-emerging diseases, such as measles. An increase by 50% of number of manufacturing companies holding WHO prequalified vaccines was observed from 2013 to 2019, strengthening open competitiveness for global vaccines supply. Notably, Network members have 181 vaccine projects in the research and development pipeline, highlighting novel vaccines against mosquito-borne diseases, such as dengue, chikungunya and Zika, novel human papillomavirus and pneumococcal conjugated vaccines. This report summarizes the progressive efforts of DCVMN members to contribute to reducing the burden of infectious diseases globally and details their commitment to vaccine innovation, particularly in the past five years, in the context of how vaccine innovations of today will shape the fight against infectious diseases tomorrow.
Language	English
Publishing date	2020-04-29
Publishing country	England
Document type	Journal Article
ISSN	2590-1362
ISSN (online)	2590-1362
DOI	10.1016/j.jvacx.2020.100066
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Article ; Online: Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective.

Dellepiane, Nora / Pagliusi, Sonia

Vaccine

2019 Volume 37, Issue 23, Page(s) 2982–2989

Abstract: Vaccines play an essential role in preventing infectious diseases. Their registration in importing countries is often cumbersome and unpredictably lengthy, leading to delays in vaccine access for populations that need them most. This report builds on a ... ...

Abstract	Vaccines play an essential role in preventing infectious diseases. Their registration in importing countries is often cumbersome and unpredictably lengthy, leading to delays in vaccine access for populations that need them most. This report builds on a previous publication identifying challenges for registration of vaccines in emerging countries. As a matter of social responsibility, it was judged necessary to address the challenges and offer a set of solutions for open dialogue. Based on regular exchange of information and experiences, a group of regulatory experts from the vaccine industry developed three sets of proposals for consideration by vaccine stakeholders, with a view to improving the situation, by fostering regulatory convergence, with viable options for streamlining registration procedures through reliance on other experienced regulators or international agencies. Further, it offers options for alignment of structure and contents of Common Technical Document modules and presents a harmonized template application form that could potentially be used by all countries.
MeSH term(s)	Developing Countries/statistics & numerical data ; Drug Industry ; Health Services Accessibility/legislation & jurisprudence ; Humans ; Public Health/methods ; Vaccines/administration & dosage ; Vaccines/economics ; World Health Organization
Chemical Substances	Vaccines
Language	English
Publishing date	2019-04-23
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.03.025
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Article ; Online: Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report.

Pagliusi, Sonia / Hayman, Benoit / Jarrett, Stephen

Vaccine

2021 Volume 39, Issue 18, Page(s) 2479–2488

Abstract: The Developing Countries Vaccine Manufacturers' Network held its 21st Annual General Meeting virtually in November 2020 given the COVID-19 pandemic. Vaccine manufacturing experts, leaders from local and global public health organizations and multilateral ...

Abstract	The Developing Countries Vaccine Manufacturers' Network held its 21st Annual General Meeting virtually in November 2020 given the COVID-19 pandemic. Vaccine manufacturing experts, leaders from local and global public health organizations and multilateral organizations, through diverse presentations, questions and answers, focused on the pandemic and the response of vaccine manufacturers where many are engaged in research and development and production agreements. The pandemic is expanding rapidly which makes the global availability and equitable access to safe and effective COVID-19 vaccines critical. Strategies put in place include the establishment of the Access to COVID-19 Tools Accelerator (ACT-A) within which the COVAX facility aims to distribute 2 billion COVID-19 vaccine doses by the end of 2021, with procurement mechanisms already being established. At the same time, regulatory authorities have emergency use authorizations aimed at the rapid approval of safe and effective vaccines, with a push for harmonization in regulatory approaches being advocated. The Meeting was also apprised of other innovations being developed for vaccines including multi-array patches for easier vaccine application, increased heat stability for mitigating cold chain and storage challenges, the barcoding of primary packaging for enhancing vaccine traceability, and gathering data for decision-making. Over time, these innovations will facilitate the widespread availability and equitable access of vaccines including those addressing epidemics and pandemics. In addition, a number of manufacturers described technologies they have for accelerating vaccine manufacturing and supply globally. Overall, there was agreement that manufacturers from developing countries play a critical role in the global research, development and supply of vaccines for a healthy future, with increasing collaboration and partnering between them a growing strength.
MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Developing Countries ; Global Health ; Humans ; International Cooperation ; Pandemics ; SARS-CoV-2 ; Vaccines
Chemical Substances	COVID-19 Vaccines ; Vaccines
Language	English
Publishing date	2021-04-07
Publishing country	Netherlands
Document type	Clinical Conference ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.03.025
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Article ; Online: Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

Dellepiane, Nora / Pagliusi, Sonia

Vaccine

2018 Volume 36, Issue 24, Page(s) 3389–3396

Abstract: The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This ... ...

Abstract	The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2-5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures.
MeSH term(s)	Developing Countries ; Drug Approval/legislation & jurisprudence ; Drug Approval/methods ; Humans ; International Cooperation/legislation & jurisprudence ; Practice Guidelines as Topic ; Process Assessment (Health Care) ; Technology Transfer ; Vaccines/supply & distribution ; Vaccines/therapeutic use ; World Health Organization
Chemical Substances	Vaccines
Language	English
Publishing date	2018-05-01
Publishing country	Netherlands
Document type	Congress ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2018.03.049
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Article ; Online: Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers' from emerging countries.

Hartmann, Katharina / Pagliusi, Sonia / Precioso, Alexander

Vaccine

2020 Volume 38, Issue 34, Page(s) 5490–5497

Abstract: Developing Countries' Vaccine Manufacturers Network was tasked with the strategic goal of seeking solutions, jointly with manufacturers, for enabling the stable, sustainable supply of quality vaccines to developing countries to increase global ... ...

Abstract	Developing Countries' Vaccine Manufacturers Network was tasked with the strategic goal of seeking solutions, jointly with manufacturers, for enabling the stable, sustainable supply of quality vaccines to developing countries to increase global immunization. As vaccines are given to millions of healthy people, including children, to prevent life-threatening diseases, vaccines must meet high safety standards. Vaccine safety monitoring is of paramount importance to maintain trust in vaccination programs globally. Once a vaccine is licensed and recommended for use, its safety and effectiveness must be monitored during its whole lifecycle, as the safety profile and protective effectiveness may change over time. A well-established safety governance model across the organization with underlying processes for data collection, signal and risk management and communication is essential. A "fit for purpose" pharmacovigilance system may vary as it depends on several factors. However, all vaccine manufacturers strive to achieve a pharmacovigilance system satisfying Good Pharmacovigilance Practices, in compliance with national, international and supranational requirements, as applicable. A landscape analysis, using a questionnaire covering nine pharmacovigilance key areas related to an effective system, was conducted to understand the existing pharmacovigilance structures, practices and expertise of vaccine manufacturers from emerging countries, on an institutional level. 34 of the 43 contacted manufacturers participated voluntarily. The survey results show that all respondents have established vaccine safety capacity, mainly in collecting and handling adverse events following immunization and implementing standardized processes; the survey also shows differences in the maturity of the manufacturers' pharmacovigilance system, Quality Management System, signal and risk management, and safety governance. The analysis provides a tool for manufacturers to gain a "bird's-eye" view of the structure of pharmacovigilance key areas and the operational dimensions covered by each area, to benchmarking against international expectations, serving as a basis to further strengthen pharmacovigilance systems, to support accelerated global vaccine supply.
MeSH term(s)	Child ; Data Collection ; Humans ; Immunization ; Pharmacovigilance ; Vaccination ; Vaccines/adverse effects
Chemical Substances	Vaccines
Keywords	covid19
Language	English
Publishing date	2020-06-24
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.06.016
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Article ; Online: Two decades of vaccine innovations for global public good: Report of the Developing Countries' Vaccine Manufacturers Network 20th meeting, 21-23 october 2019, Rio de Janeiro, Brazil.

Pagliusi, Sonia / Dennehy, Maureen / Homma, Akira

Vaccine

2020 Volume 38, Issue 36, Page(s) 5851–5860

Abstract: The Developing Countries' Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health ... ...

Abstract	The Developing Countries' Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health organizations reviewed efforts to accelerate innovation, improve access to vaccines, overcome inequalities and strengthen technological and public-health management capabilities. Discussion topics included World Health Organization's immunization strategy, Pan American Health Organization's system-strengthening efforts, Gavi's evaluation of vaccine coverage in middle income countries and developments on public-market intelligence. Health market trends, delivery gaps, integration of system-wide needs, costs and benefits, and implications for stakeholder decision-making were areas of focus. Novel thinking was discussed on integration of policy, financing, regulatory pathways and alignment of innovation priorities to improve efficiency in vaccine development pathways. The Vaccine Innovation Prioritization Strategy collaboration presented nine global innovation priorities, and many other partners and members presented updates on their priorities. Novel technologies and platforms, such as RNA-based vaccines, adenoviral vectors, bioconjugation, blow-fill-seal and two-dimensional barcodes, provided opportunities to accelerate vaccine innovations. Challenges in planning and operations at global level included those in health security, polio eradication, re-emergence of diseases, disparities between forecasts and orders and heterogeneous regulatory requirements. Manufacturers were urged to accelerate innovation and prequalification of high-impact vaccines, such as pneumococcal, human papillomavirus and rotavirus vaccines, to strengthen immunization globally.
MeSH term(s)	Brazil ; Developing Countries ; Global Health ; Humans ; Immunization Programs ; Vaccination ; Vaccines
Chemical Substances	Vaccines
Keywords	covid19
Language	English
Publishing date	2020-06-10
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.05.062
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Article ; Online: Roadmap for strengthening the vaccine supply chain in emerging countries: Manufacturers' perspectives.

Jarrett, Stephen / Yang, Lingjiang / Pagliusi, Sonia

Vaccine: X

2020 Volume 5, Page(s) 100068

Abstract: Manufacturers have a significant stake in the vaccine supply chain as their reputations rest on the effectiveness of their vaccines at the point of vaccination. The risks of low performing supply chains are detrimental for the safety and effectiveness of ...

Abstract	Manufacturers have a significant stake in the vaccine supply chain as their reputations rest on the effectiveness of their vaccines at the point of vaccination. The risks of low performing supply chains are detrimental for the safety and effectiveness of vaccines, with potential consequences to future supply in the case of adverse events. For this reason, a study was set up to explore the involvement of developing country manufacturers in the vaccine supply chain over the next decade to determine the areas where innovations could have a positive impact on the supply chain, focusing on the secondary stages of production where formulation, filling and packaging take place. An expert desk review identified eight areas of interest for the vaccine supply chain and informed the development of a survey to assess the relevance of the areas identified. The review also conjectured whether the overall effect of the identified areas is cost-neutral or resulting in net savings to countries. Overall, respondents identified five areas as of highest interest and subsequently an expert working group of representative manufacturers prioritized three of them. Specifically, traceability in the context of global digital health initiatives, stockpiling in the context of addressing vaccine shortages, stock-outs, outbreaks and epidemic prevention, and new packaging technologies are discussed in this report. It is important that vaccine manufacturers be actively engaged in global stakeholders' forums, as equal partners in determining the best ways for improving the vaccine supply chain.
Keywords	covid19
Language	English
Publishing date	2020-06-09
Publishing country	England
Document type	Journal Article
ISSN	2590-1362
ISSN (online)	2590-1362
DOI	10.1016/j.jvacx.2020.100068
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Article: Two decades of vaccine innovations for global public good: Report of the Developing Countries’ Vaccine Manufacturers Network 20th meeting, 21–23 october 2019, Rio de Janeiro, Brazil

Pagliusi, Sonia / Dennehy, Maureen / Homma, Akira

Vaccine. 2020 Aug. 10, v. 38, no. 36

2020

Abstract: The Developing Countries’ Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health ... ...

Abstract	The Developing Countries’ Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health organizations reviewed efforts to accelerate innovation, improve access to vaccines, overcome inequalities and strengthen technological and public-health management capabilities. Discussion topics included World Health Organization’s immunization strategy, Pan American Health Organization’s system-strengthening efforts, Gavi’s evaluation of vaccine coverage in middle income countries and developments on public-market intelligence. Health market trends, delivery gaps, integration of system-wide needs, costs and benefits, and implications for stakeholder decision-making were areas of focus. Novel thinking was discussed on integration of policy, financing, regulatory pathways and alignment of innovation priorities to improve efficiency in vaccine development pathways. The Vaccine Innovation Prioritization Strategy collaboration presented nine global innovation priorities, and many other partners and members presented updates on their priorities. Novel technologies and platforms, such as RNA-based vaccines, adenoviral vectors, bioconjugation, blow-fill-seal and two-dimensional barcodes, provided opportunities to accelerate vaccine innovations. Challenges in planning and operations at global level included those in health security, polio eradication, re-emergence of diseases, disparities between forecasts and orders and heterogeneous regulatory requirements. Manufacturers were urged to accelerate innovation and prequalification of high-impact vaccines, such as pneumococcal, human papillomavirus and rotavirus vaccines, to strengthen immunization globally.
Keywords	Adenoviridae ; Papillomaviridae ; Streptococcus pneumoniae ; World Health Organization ; barcoding ; chemical bonding ; decision making ; humans ; immunization ; income ; industry ; issues and policy ; markets ; prioritization ; public health ; stakeholders ; vaccine development ; vaccines ; Brazil
Language	English
Dates of publication	2020-0810
Size	p. 5851-5860.
Publishing place	Elsevier Ltd
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.05.062
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: The art of partnerships for vaccines.

Pagliusi, Sonia / Che, Yanchun / Dong, Shaozhong

Vaccine

2019 Volume 37, Issue 40, Page(s) 5909–5919

Abstract: The Developing Countries Vaccine Manufacturers Network (DCVMN) convened vaccine manufacturing experts and leaders from local and global public health organizations for its 19th Annual General Meeting. Lectures and panel discussions centered on ... ...

Abstract	The Developing Countries Vaccine Manufacturers Network (DCVMN) convened vaccine manufacturing experts and leaders from local and global public health organizations for its 19th Annual General Meeting. Lectures and panel discussions centered on international cooperation for better access to vaccines, and partnerships in areas ranging from vaccine research and process development, to clinical studies, regulatory, supply chain and emergency preparedness and response. Global vaccine market trends and changes that will impact vaccine financing and procurement methods were discussed as well as capital sources, including funding, for the development of new or improved vaccines. DCVMN members presented their progress in developing novel Hexavalent, Meningitis, Pneumococcal Conjugate Vaccine, Shigella, Mumps, Rotavirus, Yellow Fever, Polio, Hepatitis E and Dengue vaccines, and a novel monoclonal antibody cocktail for post-bite prophylaxis against rabies infections. Access to and availability of vaccines is enhanced through sharing of best practices for vaccine quality control, reducing redundant testing and promoting development of harmonized common standards. Eligible stakeholders were encouraged to join the WHO-National Control Laboratory Network for Biologicals which serves as a platform for collaboration and technical exchange in this area. Increasing regulatory convergence at the regional and global levels through mechanisms such as joint dossier review and the WHO Collaborative Registration Procedure can help to accelerate vaccine access globally. Additionally, four proposals for streamlining procedures and alignment of dossiers were discussed. Successful partnerships between a broad range of stakeholders, including international organizations, manufacturers, academic research institutes and regulators have provided support for, and in some cases accelerated, vaccine innovation, clinical trials and registration, WHO prequalification, vaccine introduction and access. Strong partnerships, based on experience and trust, help leverage opportunities and are critically important to advancing the shared goal of providing quality vaccines for all people.
MeSH term(s)	Animals ; Developing Countries ; Global Health ; Humans ; International Cooperation ; Public Health ; Quality Control ; Vaccines/immunology
Chemical Substances	Vaccines
Keywords	covid19
Language	English
Publishing date	2019-08-22
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2019.07.088
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