An interdisciplinary analysis of genetically modified vaccines: from clinical trials to market
DOI:
https://doi.org/10.18203/2349-3259.ijct20151235Keywords:
Clinical trials, Genetic modification, Novel vaccine technology, Patents, Phase transition success rate, Registered vaccinesAbstract
Background: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
References
Greenwood B, Salisbury D, Hill AVS. Vaccines and global health. Philos Trans R Soc Lond B Biol Sci. 2011;366:2733-42.
Ulmer JB, Valley U, Rappuoli R. Vaccine manufacturing: challenges and solutions. Nat Biotechnol. 2006;24:1377-83.
Kew OM, Sutter RW, de Gourville EM, Dowdle WR, Pallansch M. Vaccine-derived polioviruses and the endgame strategy for global polio eradication. Annu Rev Microbiol. 2005;59:587-635.
Ehreth J. The global value of vaccination. Vaccine. 2003;21:596-600.
Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008;86:140-6.
Liu M. REVIEW DNA vaccines : a review. J Intern Med. 2003;253:402-10.
Liu M. DNA vaccines: an historical perspective and view to the future. Immunol Rev. 2011;239:62-84.
Soema PC, Kompier R, Amorij J-P, Kersten GF. Current and next generation influenza vaccines: Formulation and production strategies. Eur J Pharm Biopharm. 2015;94:251-63.
Serruto D, Rappuoli R. Post-genomic vaccine development. FEBS Lett. 2006;580:2985-92.
Fraser CM, Rappuoli R. Application of microbial genomic science to advanced therapeutics. Annu Rev Med. 2005;56:459-74.
FDA. Flumist product information, 2015. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm294307.pdf.
FDA. Flublok product information, 2015. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM336020.pdf.
IMOJEV. Australian product information, 2015: 1-21. Available at: products.sanofi.com.au/vaccines/IMOJEV_AUS_PI.pdf.
FDA. Recombivax HB product information, 2015. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110114.pdf.
Thara E, Dorff TB, Pinski JK, Quinn DI. Vaccine therapy with sipuleucel-T (Provenge) for prostate cancer. Maturitas. 2011;69:296-303.
Offit P. Why are pharmaceutical companies gradually abandoning vaccines? Congress has the power to protect vaccines, a product that is vital to the health of the United States and the rest of the world. Health Aff. 2005;24:622-30.
Plotkin S. Why certain vaccines have been delayed or not developed at all. Health Aff (Millwood). 2005;24:631-4.
Davis MM, Butchart AT, Coleman MS, Singer DC, Wheeler JRC, Pok A, et al. The expanding vaccine development pipeline, 1995-2008. Vaccine. 2010;28:1353-6.
Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet. 2002;359:2188-94.
Ramezanpour B, Pronker ES, Kreijtz JHCM, Osterhaus ADME, Claassen E. Market implementation of the MVA platform for pre-pandemic and pandemic influenza vaccines: a quantitative key opinion leader analysis. Vaccine. 2015;33:4349-58.
Lipscomb CE. Medical subject headings (MeSH). Bull Med Libr Assoc. 2000;88:265-6.
The National Library of Medicine. Fact sheet: Med subject headings, 2015. Available at: http://www.nlm.nih.gov/pubs/factsheets/mesh.html. Accessed 1 January, 2015.
WHO. Health topic: vaccines, 2015. Available at: http://www.who.int/topics/vaccines/en/.
WHO. International clinical trials registry platform (ICTRP), 2015. Available at: http://www.who.int/ictrp/en/. Accessed 1 January 2015.
Davis MM, Butchart AT, Wheeler JRC, Coleman MS, Singer DC, Freed GL. Failure-to-success ratios, transition probabilities and phase lengths for prophylactic vaccines versus other pharmaceuticals in the development pipeline. Vaccine. 2011;29:9414-6.
Pronker ES. Innovation paradox in vaccine target selection. Europe: Erasmus Research Institute of Management (ERIM); 2013.
WHO. Global fund Annual Report, 2002/2003. Geneva: WHO; 2003.
Riedmann EM. Report: state of the world’s vaccines and immunization. Hum Vaccin. 2010;6:157-63.
Widdus R. Bill and Melinda Gates Foundation. Press Release, 2001. Available at: http://www.gatesfoundation.org/Media-Center/Press-Releases/2001/02/PublicPrivate-Partnerships-Developing-Vaccines.
World Health Organization. The world medicines situation. WHO. 2004;1:5-22.
Scott Morton F, Kyle M. Markets for pharmaceutical products. In: Scott Morton F, Kyle M, eds. Handbook of Health Economics. 2nd ed. US: Elsevier B.V; 2011: 763-823.
Barton JH. TRIPS and the global pharmaceutical market. Health Aff (Millwood). 2004;23:146-54.
Fernald KDS, Pennings HPG, Bosch JF Van Den, Commandeur HR. The moderating role of absorptive capacity and the differential effects of acquisitions and alliances on Big Pharma firms’ innovation performance. 2012: 1-27.
Weenen TC, Ramezanpour B, Pronker ES, Commandeur HCE. Food-pharma convergence in medical nutrition - best of both worlds? PLoS One. 2013;8(12):e82609.
Fernald KDS, Weenen TC, Sibley KJ, Claassen E. Limits of Biotechnological Innovation. Technol Invest. 2013;04:168-78.
