Developing Countries Vaccine Manufacturers Network Research Articles

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.

Global equity and timely access: COVID-19 & beyond 23rd DCVMN Annual General Meeting 2022 report

The 23rd Annual General Meeting of the Developing Countries Vaccine Manufacturers’ Network (DCVMN), co-hosted by Serum Institute of India (SII), gathered over 365 delegates and more than 90 high-level speakers for three days of presentations, discussions, and networking, in Pune, India. The meeting provided a platform for vaccine manufacturers from developing countries to voice their experience, challenges and successes, as they play a critical role in the global research, development and supply of vaccines for achieving vaccine equity through increased collaborations and partnerships. The key topics of the 23rd Annual General Meeting revolved around: the key learnings from COVID-19, pandemic preparedness, vaccine sustainability and scalability, strengthening Africa’s local manufacturing, partnerships & collaborations, financing, innovations, and vaccine hesitancy. The overarching theme focused on equity, timely access and sustainability, which was carried through in each session, with each panelist providing their contribution to answering - how can we create a sustainable vaccine ecosystem?

IABS/DCVMN webinar on next generation sequencing.

Next Generation Sequencing (NGS) is a new technology that could overcome some of the limitations of the current viral testing methods for demonstrating the absence of adventitious agents in biologics. This report is for the webinar that was organized by the International Alliance for Biological Standardization (IABS) and the Developing Countries Vaccine Manufacturers Network (DCVMN), held on July 20, 2022, as an introduction to the technical and bioinformatics concepts of NGS and to some of the strengths and limitations of using the technology for those working in vaccine production or development. The current state of scientific knowledge and readiness of NGS to replace or supplement the current viral tests was further discussed in the 3rd Conference on NGS for Adventitious Virus Detection in Biologics for Humans and Animals that was held in Rockville, Maryland, USA, on September 27-28, 2022. The application of NGS to supplement or replace current in vivo and in vitro assays in adventitious virus testing during vaccine production is promising; however, assay performance (sensitivity, specificity, and reproducibility) needs to be demonstrated, which may include laboratory and bioinformatics work. Efforts from regulatory authorities, industry, and researchers are ongoing to facilitate validation and establishment of NGS as a new method for virus detection.

Developing-country vaccine manufacturers’ technical capabilities can make a difference in global immunization

Members of the Developing Countries Vaccine Manufacturers’ Network (DCVMN) have been actively engaged in the development of COVID-19 vaccine candidates. According to the WHO COVID-19 vaccine landscape updated on 29 December 2020, 18 member manufacturers had vaccines in preclinical or clinical trials, including three members with candidates in Phase III trials. Once successful candidates have been identified there will be a need for large scale vaccine manufacturing and supply, in which DCVMN member manufacturers can play a key role. In an internal survey in 2019, DCVMN members reported the capability to supply over 3.5 billion vaccine doses annually, and the provision of over 50 distinct vaccines to 170 countries. To describe the capabilities of DCVMN member manufacturers more precisely, a 121-question survey was circulated to 41 Network members. The survey assessed the manufacturers’ capabilities in utilizing various technology platforms, cell cultures and filling technologies, in addition to their capacities for manufacturing drug products. The survey also evaluated manufacturers’ preparedness to dedicate existing capacities to COVID-19 vaccine production. Results revealed that sampled manufacturers have strong capabilities for manufacturing vaccines based on recombinant technologies, particularly with mammalian cells, and microbial and yeast expression systems. Capabilities in utilizing cell cultures were distributed across multiple cell types, however manufacturing capacities with Vero and CHO cells were prominent. Formulating and filling findings illustrated further large-scale capabilities of Network members. Sampled manufacturers reported that over 50% of their capacity for vaccine manufacturing could be dedicated to COVID-19 vaccine production.

COVID-19 vaccine capacity: Challenges and mitigation – The DCVMN perspective

Vaccine manufacturers from developing countries have a proven track record of developing, producing, and supplying high-quality vaccines globally. However, due to the complexity of vaccine manufacturing, numerous stakeholder organizations support manufacturers across a variety of functions. To optimize the support from stakeholders it is instrumental to first understand which manufacturing processes these manufacturers require support for and what support functions are most beneficial. To this end, the Developing Countries Vaccine Manufacturers Network designed a comprehensive survey to assess the specific needs of the Network’s member organizations.We found that almost all sampled manufacturers are interested in obtaining funding or technology transfers for COVID-19 vaccines. Furthermore, results indicated that manufacturers have a strong appetite for modern technology platforms, particularly RNA technologies. Scale-up, phase III clinical trials, and formulation were also key processes for which manufacturers require support.

Priorities for the COVID-19 pandemic at the start of 2021: statement of the Lancet COVID-19 Commission

Priorities for the COVID-19 pandemic at the start of 2021: statement of the Lancet COVID-19 Commission

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.

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.

Vaccine Safety and Pharmacovigilance in the African Region: Recent updates

Introduction: The number of subjects in clinical trials, is often limited and inadequate for detection of all adverse events which may be associated with vaccines, especially very rare ones. In addition, there is a surge in introduction of new vaccines into national immunization programmes in the WHO African Region, some of which have been used in a limited number of people, highlighting the need for functional national for pharmacovigilance systems for adverse events following immunization (AEFIs). Recognizing this, WHO and partners are supporting countries to develop national plans, providing training and investments in vaccine safety and pharmacovigilance. Despite these efforts, surveillance for vaccine safety in many countries remain weak. This paper reviews cases of AEFI reported by countries countries in the WHO/UNICEF Joint Reporting Form of WHO/AFRO between 2010 and 2015, discusses some of the causes of the low reporting while exploring how countries can rely on new opportunities and systems to improve their reporting and vaccine safety in general. Methodology: The implementation status of multi-stakeholder national plans developed by national immunization programmes, Pharmacovigilance Centres (PVCs) and the National Regulatory Authorities (NRAs) of 28 countries was reviewed. Using data from the WHO/UNICEF Joint Reporting Form and the introduction of new vaccines by countries in the WHO African, the impact of these plans on reporting of AEFIs was assessed for the countries. Results: The analysis of performance revealed that only five countries have fully implemented plans for vaccine safety monitoring and pharmacovigilance in accordance with the Global Vaccine Safety Initiative (GVSI) blueprint. Implementation of the plans in the remaining 23 countries is slow. From 2010 - 2015, just 28 countries reported AEFIs as part of the WHO /UNICEF JRF. Yet 83% of countries introduced at least one new vaccine, with an average of 2 to 3 new vaccines being introduced per country over the period. Many countries have not fulfilled the responsibility of establishing expert committees on AEFI, developed guidelines, trained their staff on vaccine safety and put in place effective vaccine safety communication. Discussion: The low AEFI reporting and weak pharmacovigilance demands special emphasis on capacity building, tailored to country needs to improve the reporting to meet the GVAP goals and UMC ADR guidelines. More sustainable support in ways that strengthen pharmacovigilance in general for all medical products and AEFI surveillance in particular in countries is needed. Opportunities are presented by the GVAP, the GVSI, networks such as the African Vaccine Regulatory Forum (AVAREF), Developing Countries Vaccine Regulatory Network (DCVRN), Developing Countries Vaccine Manufacturers Network (DCVM) and the International Federation of Pharmaceutical Manufacturers (IFPMA) as well the African Medicines Regulatory Harmonization (AMRH). African countries should exploit these opportunities to further strengthen their AEFI monitoring and pharmacovigilance.

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.

Stability testing of vaccines: Developing Countries Vaccine Manufacturers' Network (DCVMN) perspective

Stability testing is an integral part of the vaccine manufacturing process and is crucial for the success of immunization programs. WHO (World Health Organization) has recently published guidelines on the stability testing of vaccines. These guidelines enlist scientific basis and principles for stability testing at various stages like development, pre-clinical, clinical, licensing, lot release and post-licensure monitoring. DCVMN (Developing Countries Vaccine Manufacturers' Network) is an international body of developing countries vaccine manufacturers and has viewpoints on technical and administrative issues in stability testing of vaccines. We here highlight viewpoints, possible roles and global expectations of DCVMN in the area of stability testing of vaccines.

The Developing Countries Vaccine Manufacturers’ Network (DCVMN) is a critical constituency to ensure access to vaccines in developing countries

Six years after its establishment, the Developing Countries Vaccine Manufacturers' Network (DCVMN) has become the main representing body for emerging vaccine manufacturers from the developing world. The Network's main strategic priority (increase access to DPT-based combination vaccines containing vaccines against Hepatitis B (HepB) and Haemophilus influenzae type b (Hib)) has now come close to fulfillment due in part to the transfer of conjugation technology from The Netherlands Vaccine Institute (NVI) to various manufacturers of the Network. It is argued that at the international level more push mechanisms for product development involving DCVM are needed, including those promoting access to technology and transfer of technology, know how and technical skills from Organization for Economic Co-operation and Development (OECD) countries to developing countries. At the national level, governments of countries in which DCVMN manufacturers operate should provide more generous funding for all aspects of vaccines and immunization including incentives to manufacturers to develop and import new technologies. These two approaches will contribute to the long-term viability of domestic or regional vaccine manufacturing, which in itself is critical to ensure global equity of access to vaccines.