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Researchers continue to seek understanding of industrialization as a state managed process. How to create and implement new industries based on advanced knowledge is on the policy agenda of many advanced nations. Measures that promote these developments include national capacity building in science and technology, the formation of technology transfer systems, and the establishment of industrial clusters. What these templates often overlook is an analysis of use. This chapter aims to increase the understanding of the processes that embed new solutions in structures from an industrial network perspective. The chapter describes an empirical study of high-technology industrialization in Taiwan that the researcher conducts to this end. The study shows that the Taiwanese industrial model is oversimplified and omits several important factors in the development of new industries. This study bases its findings on the notions that resource combination occurs in different time and space, the new always builds on existing resource structures, and the users are important as active participants in development processes.

Despite rapid success in bringing SARS-CoV-2 vaccines to distribution by multiple pharmaceutical corporations, supply chain failures in production and distribution can plague pandemic recovery. This review analyzes and addresses gaps in modeling supply chain resilience in general and specifically for vaccines in order to guide researchers and practitioners alike to improve critical function of vaccine supply chains in the face of inevitable disruptions.

Systematic review of the literature on modeling supply chain resilience from 2007 to 2020 is analyzed in tandem with the vaccine supply chain manufacturing literature. These trends are then used to apply a novel matrix analysis to seven Securities and Exchange Commission (SEC) annual filings of pharmaceutical corporations involved in COVID-19 vaccine manufacture and distribution.

Pharmaceutical corporations favor efficiency as they navigate regulatory, economic and other threats to their vaccine supply chains, neglecting resilience – absorption, adaptation and recovery from inevitable and unexpected disruptions. However, explicitly applying resilience analytics to the vaccine supply chain and further leveraging emerging network science tools found in the academic literature, such as artificial intelligence (AI), stress tests and digital twins, will help supply chain managers to better quantify efficiency/resilience tradeoffs across all associated networks/domains and support optimal system performance post disruption.

This is the first review addressing resilience analytics in vaccine supply chains and subsequent extension to operational management through novel matrix analyses of SEC Filings. The authors provide analyses and recommendations that facilitate resilience quantification capabilities for vaccine supply chain managers, regulatory agencies and corporate stakeholders and are especially relevant for pandemic response, including application to the SARS-CoV-2 vaccines.

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies.

A systematic review of literature for the period of 2000‐2010 was conducted by searching academic databases of peer‐reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand‐searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing.

Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution.

Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross‐cultural global delivery system.

This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations.

Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue.

Expert review.

Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA.

Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

This study has aimed to analyse the role of innovation-sharing collaboration in the large-scale manufacturing of Covid-19 vaccination across the globe and its impact on the mortality rate of the countries where the pharmaceutical manufacturers received such innovation.

The authors have relied upon the difference-in-difference (DID) approach by utilizing the data available on public platforms such as World Health Organization (WHO) databank, organization for economic co-operation and development (OECD) data bank, istat, Indian bureau of statistics and European centre for disease prevention and control (ecdc) from 2020 to 2021 to establish the empirical inference of the analysis.

This study’s results present that after the invention and commercialization of the vaccine, the Covid-19 impact was still intact and people were dying continuously. However, it was impossible to fulfil the demand of the 7 billion population in a short time. In the light of these facts, the WHO encouraged sharing vaccine innovation with other countries to enhance production capacity. The authors found that after vaccine innovation sharing, Covid-19’s devastation slowed: the fatality rate was marginally reduced, and economic conditions started their recovery journey.

This study’s findings present that the Covid-19 vaccine played a pivotal role in tackling the Covid-19’s devastating impact on the entire world. It emphasizes the role of innovation-sharing collaborations in curtailing hazardous consequences, including the mortality rate during a crisis, and such collaborations’ impact on the countries where institutions involved in them reside.

The COVID-19 pandemic has devastated economies and public health systems across the globe, increasing the anticipation for the creation of an effective vaccine. With this comes the reinforcement of debates between the right to health and pharmaceutical patent rights. The purpose of this study is to illustrate how the Philippines could attempt to balance the right to health with pharmaceutical patent rights in the introduction of a potential COVID-19 vaccine into the country.

This will be accomplished through an examination of the flexibilities allowed by international agreements and domestic patent laws.

With the economic and health challenges brought about by the COVID-19 pandemic, the Philippine Government will have a strong justification to pursue parallel importation and compulsory licencing under the Agreement on Trade-Related Aspects of Intellectual Property Rights. This is exacerbated by the bold leadership of President Duterte, whose administration has so far shown a propensity to decide in favor of the right to health at the expense of other rights in dealing with the pandemic.

While this paper focuses on the Philippines, it has a potential application in the least developed and developing countries which aim to gain access to a prospective COVID-19 vaccine. Moreover, while this study discusses the harmonization of laws on the right to health and patent laws as a solution to the COVID-19 pandemic and the lack of access to vaccines, it also calls for solutions that go beyond the application of the law.

The article aims to critically examine India's COVID-19 vaccination policy by analyzing the problem, politics and policy developed during the pandemic. The article would help the policy-makers and healthcare administrators to understand the situation in a holistic manner.

The article employs Kingdon's multiple streams framework, which separately analyzes the problem at hand, the politics that are at work and the policy which is being developed when the problem and politics streams are activated. Directed approach to content analysis is adopted in this article.

The article provides a holistic overview of vaccine development and the vaccination policy during the COVID-19 pandemic in India.

The analysis would help policy-makers and healthcare administrators to have a bird's-eye view of the COVID-19 vaccine development and the vaccination drive.

The article is a macro-level analysis of an extremely important situation of COVID-19 vaccine development and the subsequent vaccination drive for the world's largest democracy, which is also one of the largest drugs and vaccine manufacturing countries. The article captures the bird's-eye-view of the problem of vaccine development, the policy of funding as well as procurement, and the politics of vaccine distribution in the country.

Innovation thrives during crises. Covid-19 gives one such opportunity to the pharmaceutical industry. Product innovation gives an opportunity to beat the pandemic. However, process innovation using the concept of co-opetition can help the pharmaceutical industry create a win–win for the market and the industry. This chapter covers co-opetition strategies that pharmaceutical sector can follow to help the customers and marketers win this game. The chapter looks at various co-operation-based strategies including co-operation by division of markets, co-operation by sharing of distribution, co-operation through patent waivers and co-operation with complementary goods manufacturers. After the co-operation, comes competition. The chapter considers duopoly as a means to help divide the market for all to co-exist.

The purpose of this paper is to describe the role of the vaccine manufacturer in the global vaccine enterprise.

Narrative review.

Pharmaceutical companies involved in the vaccine enterprise play critical and often unrecognized roles in the global health management arena. In addition to the obvious role of vaccine production and distribution, companies are often involved in the identification of infectious agents for which vaccines may be of benefit, basic and applied research, process development, pre-clinical and clinical evaluations of vaccine candidates, as well as continuous post-licensure safety monitoring efforts. Vaccine manufacturers interact with health and regulatory agencies, academia and agencies interested in supporting cost-effective means of vaccine distribution to areas most in need of life-saving vaccines.

This review provides the reader with an understanding of the many roles of the manufacturer in the global vaccine enterprise.