Vaccine traceability: Key learnings from the supply chain initiative by manufacturers from emerging countries.

The use of global standards, and the placement of barcodes and data matrix codes on vaccine labels and other levels of packaging are crucial elements for the traceability of finished vaccine products. Vaccine manufacturers are committed to improving health through their products, as vaccine production offers opportunities that can be leveraged to benefit immunization systems. In 2019 the Developing Countries Vaccine Manufacturers Network (DCVMN) created the Supply Chain Initiative aimed at prioritize and explore traceability opportunities; concomitantly procurement agencies announced traceability requirements for vaccine global supply. Vaccine traceability brings benefits including supply chain reliability and safety through enhanced product movement visibility, and a reduction of falsified and expired vaccines circulating in the supply chain. DCVMN has coordinated the development and implementation of global traceability standards, at both primary and secondary vaccine packaging levels, to encourage and enable sharing these experiences. Six pilot studies in four different countries showed successful implementation, and constituted part of larger vaccine traceability work within the respective organizations. The main findings from these pilot studies indicated that stepwise approaches to the adoption of traceability standards allowed vaccine manufacturers to learn by doing, initially with lower risk, and to spread their investments over time. Because the value of traceability is in its scale of adoption and the use of the data, it remains important for all stakeholders to engage in and prioritize the journey of vaccine traceability, but also to suitably manage the financial risks. The DCVMN Supply Chain Initiative has demonstrated that its members are committed to driving supply system changes that benefit immunization, while recognizing that supply chain traceability is part of a larger healthcare ecosystem and should be adopted by countries and immunization programmes as well.

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

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.

How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation.

The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients.

How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation.

Vaccine discovery and vaccination against preventable diseases are one of most important achievements of the human race. While medical, scientific & technological advancements have kept in pace and found their way into treatment options for a vast majority of diseases, vaccines as a prevention tool in the public health realm are found languishing in the gap between such innovations and their easy availability/accessibility to vulnerable populations. This paradox has been best highlighted during the unprecedented crisis of the COVID-19 pandemic. As part of a two series publication on the vaccine industry's view on how to accelerate the availability of vaccines worldwide, this paper offers a deep dive into detailed proposals to enable this objective. These first-of-its-kind technical proposals gleaned from challenges and learnings from the COVID-19 pandemic are applicable to vaccines that are already on the market for routine pathogens as well as for production of new(er) vaccines for emerging pathogens with a public health threat potential. The technical proposals offer feasible and sustainable solutions in pivotal areas such as process validation, comparability, stability, post-approval changes, release testing, packaging, genetically modified organisms and variants, which are linked to manufacturing and quality control of vaccines. Ultimately these proposals aim to ease high regulatory complexity and heterogeneity surrounding the manufacturing & distribution of vaccines, by advocating the use of (1) Science and Risk based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. Capitalizing & collaborating on such new-world advancements into the science of vaccines will eventually benefit the world by turning vaccines into vaccination, ensuring the health of everyone.

The importance of vaccine stockpiling to respond to epidemics and remediate global supply shortages affecting immunization: strategic challenges and risks identified by manufacturers.

While stockpiling vaccines adds another layer of complexity to vaccine manufacturing, it constitutes a crucial component of comprehensive disease preparedness and control strategies in public health management. Stockpiling provides the ability to immediately respond to epidemics, disease outbreaks, vaccine shortages or stock-outs at local, regional or global levels. Some stockpiles are static, not shipped until an emergency occurs; other stockpiles are rotating with vaccines used in on-going routine immunization programmes. Programmatic use indicates which vaccines to stockpile, the nature of the stockpile and the amount of vaccine to be held at any time. For immediate shipment, fully released product must be stockpiled with the challenge of monitoring remaining shelf-life requirements and the potential risk of expiry. Existing stockpiles are managed and financed globally under the purview of international organizations in the global immunization community, except for buffer stocks held by manufacturers for short periods. The added challenges to manufacturers of stockpiling vaccines, including storage, human resources and other related costs including vaccine destruction when no longer useable, needs to be recognized. This is all the more so with the likelihood of vaccine stockpiling becoming more prominent with changing disease patterns due to climate change and population movements, as well as the significant investment in the research and development of new epidemic prevention vaccines. While vaccine stockpiles managed and financed globally provide rapid response to country requests, more attention is needed in the future to ways that vaccine stockpiling can be brought under the direct purview of individual countries or regional groupings.

Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report.

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.

Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities.

Development of novel vaccines and improving existing vaccines is critical to addressing areas of unmet or under-addressed health needs globally and to improving existing vaccination coverage and equity. However, vaccine innovation is costly and highly complex. To understand how vaccine manufacturers from developing countries approach innovation, a survey was conducted among company members of the Developing Countries Vaccine Manufacturers Network, in collaboration with the Clinton Health Access Initiative. The survey confirmed that vaccine manufacturers from developing countries are committed to vaccine innovation: 95% of respondents have interest in pursuing vaccine innovation, with strategies targeted towards supplying to low- and middle-income countries. Key barriers to innovation were also surveyed, with respondents highlighting challenges regarding access to in-licensing or joint venture partnerships, financing, and regulatory barriers. Opportunities for innovation are also discussed.

The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring.

The counterfeiting of vaccines is an increasing problem globally with the safety of persons vaccinated, the trust in vaccines generally and the associated reputation of vaccine manufacturers and regulatory agencies at risk. This risk is especially critical with the on-going development of COVID-19 vaccines. The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced. In this context of traceability, the global immunization community has recently set the barcoding of the primary packaging of vaccines, specifically vaccine vials and pre-filled syringes, as a top priority. Emerging vaccine manufacturers are already engaged in investigating ways to incorporate barcoding in their labelling and packaging using GS1 international standards. A specific pilot taking place in Indonesia by the national vaccine manufacturer, Bio Farma, shows the innovation of barcoding on primary packaging already underway with a relatively modest level of investment and success at this stage. This article highlights the efforts of industry and governments on the value of traceability and introduction to 2D barcodes. Access to financial resources and support from the international immunization community would accelerate such innovations leading to enhanced security of the vaccine supply chain.

Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers.

A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack of predictability of timelines for regulatory review and approval. These shortcomings imply that multiple data packages have to be prepared for submission to different authorities, generating a complex regulatory environment. Moreover, the timelines for approval by individual national regulatory authorities are variable, which results in manufacturers keeping various stocks of vaccines produced in accordance with the various approved specifications and procedures, in the different countries. This can seriously affect timely availability of vaccine in those countries. The World Health Organization (WHO) guidelines on procedures and data requirements for changes to approved vaccines provide a consensual framework for alignment, but are still underused. Reliance on both the review and approval by the regulatory authority in the country of manufacturing, or on the review performed by other national regulatory authorities, recognized by WHO as stringent, or on WHO prequalification dossier, offer alternative ways forward. These and other options to improve the management of post-approval changes during the product lifecycle of vaccines are discussed in this report, and aimed at improving guidelines alignment and regulatory convergence to advance immunization equity and coverage.

Roadmap for strengthening the vaccine supply chain in emerging countries: Manufacturers' perspectives.

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.

Emerging manufacturers engagements in the COVID -19 vaccine research, development and supply.

The World Health Organization declared the COVID-19 disease as a pandemic requiring a rapid response. Through online search, direct communication with network members and an internal survey, engagements of developing countries' vaccine manufacturers' network members in the research and development of COVID-19 vaccines and their capacities in the manufacturing, fill-finish and distribution of vaccines were assessed. Currently, 19 network members engaged in research and development of COVID-19 vaccines, using six principal technology platforms. In addition, an internal survey showed that the number of vaccines supplied collectively by 37 members, in 2018-19, was about 3.5 billion doses annually. Almost a third of network members having vaccines prequalified by the World Health Organization comply with international regulations and mechanisms to distribute vaccines across borders. The use of existing manufacturing, fill-finish and distribution capabilities can support an efficient roll-out of vaccines against COVID-19, while maintaining supply security of existing vaccines for on-going immunization programmes.

Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers' from emerging countries.

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.

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.

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.

Emerging vaccine manufacturers are innovating for the next decade.

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.

Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries

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.

Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries

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.

The art of partnerships for vaccines.

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.

Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective.

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.

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

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.

Vaccines, inspiring innovation in health.

This report covers the topics of pandemics, epidemics and partnerships, including regulatory convergence initiatives, new technologies and novel vaccines, discussed by leading public and private sector stakeholders at the 18th Annual General Meeting (AGM) of the Developing Countries Vaccine Manufacturers' Network (DCVMN). Contributions of Gavi and the vaccine industry from emerging countries to the growing global vaccine market, by improving the supply base from manufacturers in developing countries and contributing to 58% of doses, were highlighted. The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI) and others reported on new strategies to ensure speedy progress in preclinical and clinical development of innovative vaccines for future MERS, Zika or other outbreak response. Priorities for vaccine stockpiling, to assure readiness during emergencies and to prevent outbreaks due to re-emerging diseases such as yellow fever, cholera and poliomyelitis, were outlined. The role of partnerships in improving global vaccine access, procurement and immunization coverage, and shared concerns were reviewed. The World Health Organization (WHO) and other international collaborating partners provided updates on the Product, Price and Procurement database, the prequalification of vaccines, the control of neglected tropical diseases, particularly the new rabies elimination initiative, and regulatory convergence proposals to accelerate vaccine registration in developing countries. Updates on supply chain innovations and novel vaccine platforms were presented. The discussions enabled members and partners to reflect on efficiency of research & development, supply chain tools and trends in packaging technologies improving delivery of existing vaccines, and allowing a deeper understanding of the current public-health objectives, industry financing, and global policies, required to ensure optimal investments, alignment and stability of vaccine supply in developing countries.