An interdisciplinary analysis of genetically modified vaccines: from clinical trials to market

Abstract

<p class="abstract"><strong><span lang="EN-US">Background: </span></strong><span lang="EN-GB">Immunization is considered the most effective strategy for infectious disease control and maintaining global health. Conventional vaccines have successfully targeted a broad spectrum of pathogens. However, a large number of untargeted diseases still remain. Introduction of novel Genetically Modified (GM) vaccines allow development of new improved vaccines and immunotherapeutics. Moreover, GM vaccines can also target non-communicable diseases outside the range of infectious diseases, including cancer, autoimmune diseases, and allergies. </span><span lang="EN-GB"> </span></p><p class="abstract"><strong><span lang="EN-US">Methods: </span></strong><span lang="EN-GB">We compiled novel and unique datasets encompassing data from literature, patent documents, clinical trials, and vaccine registers in order to provide a thorough overview of the GM market.</span></p><p class="abstract"><strong><span lang="EN-US">Results: </span></strong><span lang="EN-GB">Based on patent data, we found that most patent applications were filed in North America, Asia, and Europe, which coincides with the locations of the largest companies and institutes. Looking at clinical trial data we forecast marketing of two next generation GM vaccines, targeting cancer and malaria. In addition, we calculated phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3).</span></p><p class="abstract"><strong><span lang="EN-US">Conclusions: </span></strong><span lang="EN-GB">These findings indicate viable regions for GM vaccine research and development. Phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3) predict a relatively high chance of marketing approval. Increased registrations of GM vaccines complemented by rising numbers of patent applications suggest global growth of the GM vaccine market, which currently holds a proportion of nearly 20% of the total vaccine market.</span></p>

Probiotics for the Management of Infectious Diseases: Reviewing the State of the Art

“…To identify relevant clinical studies, the EU clinical trials register (CTR.eu), the United States NLM database (CT.gov), and the International Clinical Trials Registry Platform (ICTRP) were queried, as these are regularly updated and contain records of clinical trials from 202 countries, covering a total of 17 different clinical trial databases ( World Health Organization, 2021 ). The selection of these databases is in line with previous research in this field ( Ramezanpour et al, 2015 ; Janse et al, 2020 ; Neevel et al, 2020 ).…”

“…As patent applications are executed to protect the intellectual property of new inventions, they are a measure of output of early-stage, applied research ( Janse et al, 2020 ). Clinical trials are a measure of output of late-stage research, as they are executed near the end of the research and development process before market entry ( Ramezanpour et al, 2015 ; Janse et al, 2020 ). Taken together, they provide an overview of the development of the research field.…”

Reviewing the state of the art of probiotics as clinical modalities for brain–gut–microbiota axis associated disorders

“…Patents can be used to indicate market trends and because they are valid for 20 years, they give insight into long-term research developments (Feddema and Claassen, 2018;Janse et al, 2020). Clinical trials are part of a later stage in the research process and provide insight into short-term trends and developments (Ramezanpour et al, 2015;Janse et al, 2020). Together, patents and clinical trials provide a comprehensive scope of the research landscape, which can be used to estimate and describe the state of the art.…”

Comparison of regulatory framework of clinical trial with genetically modified organism-containing vaccines in the Europe, Australia, and Switzerland

“…Although genetically modified (GM) viruses also taken into consideration as GMO. In between 1990–2000, the clinical trials utilizing gene treatment innovation have fundamentally expanded, the number of registered GE vaccines has increased and continues to increase [ 5 ]. Regarding the clinical trial status of vaccines with GMO, only 5% of human GE vaccines appear to contain GMOs [ 6 ].…”