Risk in vaccine research and development quantified
Open accessAbstract
To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.
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- Authors
- Pronker, E. S., Weenen, T. C., Commandeur, H., Claassen, E. H. J. H. M., & Osterhaus, A. D. M. E.
- Affiliations
- Erasmus University Rotterdam (NL)
- Erasmus MC (NL)
- Corresponding author
- Pronker, Esther S.
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2013-03-20
- Volume
- 8
- Issue
- 3
- Pages
- e57755
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3603987
- OpenAlex
- W2085284670
- Cited by
- 253
- References
- 28
- Citations by year
- 2026: 15 · 2025: 10 · 2024: 19 · 2023: 22 · 2022: 21 · 2021: 59 · 2020: 54 · 2019: 9 · 2018: 14 · 2017: 7 · 2016: 6 · 2015: 7 · 2014: 7 · 2013: 3
- FWCI
- 17.94
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- VU Research Portal (publishedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Biotechnology and Related Fields
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- vaccine development, risk profile, development timelines, preclinical drug development, clinical trials, pandemic influenza vaccine, chronic infection, prophylactic vaccines, therapeutic vaccines, infectious disease vaccines
- MeSH terms
- Clinical Trials as Topic, Drug Industry, Humans, Risk, Time Factors, Vaccination, Vaccines, Databases, Factual, Biomedical Research, Drug Discovery
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