Challenges facing the successful introduction of plant-derived vaccines as an alternative or complement to conventional vaccines

Vaccines are considered to be one of the most successful and cost-effective weapons against infectious diseases. Currently, licensed vaccines produced in mammalian cell lines, yeast, and the common enteric bacterium Escherichia coli have their associated technical problems. A decade-old R&D project of developing vaccines in plants has yielded promising results, addressing the technical issues to a great extent with the added benefit of faster and cheaper production. Plant-derived vaccines (PDVs) are therefore poised to play an important role in complementing conventional seasonal and pandemic vaccine supply. This study of the introduction of the concept of PDV and its adoption into the society is a prototypical third-generation plant biotechnology with backgrounds encompassing agricultural practice, public health, and medical biotechnology research. The primary objective of this thesis is to understand the public good and private interests in the introduction and adoption of PDVs. Critical analyses of PDV innovation from biotechnology business case studies within the frameworks of existing socio-economic, organizational theories, and emerging non–socio-economic networked knowledge has been undertaken in this thesis. Among other things, this thesis found that (i) new research-intensive biotechnology small- and medium-sized enterprises (SMEs, with 5–499 employees) can reduce their transaction costs by working in research networks (primarily public–private partnerships); and (ii) by forming strategic partnerships with companies that have established manufacturing and distribution networks, these SMEs increase their chances of accessing capital and other resources. This significantly increases the probability of commercial success by SMEs in the highly competitive environment of global vaccine business. It is anticipated that this understanding will help improve the facilitation of R&D, and the regulation and production of PDVs in Canada and the USA. Research findings address the policy implications for governments, industry, and the non-governmental organization sector. The knowledge generated from this thesis will contribute to the optimization of local and international research, intellectual property protection, licensing, manufacturing, and distribution of PDVs or other vaccine entities/companies. Ultimately, it is hoped that this thesis knowledge will lead to more rapid and widespread adoption of new vaccines such as PDVs in developing countries, where its potential benefits of scale, lower cost, and shorter production time would be best realized