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Using a bibliometric model for the advance of basic biomedical research, we have found that few targeted therapeutics are successfully developed before research on both the drug target and therapeutic modality pass an analytically described established point, and that timelines of clinical development are significantly shorter when clinical trials commence after this point.
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Research on technological innovation has demonstrated that the maturation level, or readiness, of many different technologies has been a critical determinant in their ability to generate products that satisfy market needs, ,,. As late as 2013, evidence showed that the failure rate for vaccines entering development was as high as 94%, and that the average time from preclinical studies to approval was 10.7 years. Despite successful development of many vaccines, the challenge remained daunting. Rapid success of these initiatives was not guaranteed. Nascent technologies, such as genetically modified viral vectors or mRNA also played an important role, even though these technologies were not previously validated in clinical trials or registered products. Some candidates applied technologies from registered veterinary vaccines against coronaviruses in domesticated species, including (chicken) Infectious Bronchitis Virus (IBV) and bovine Betacoronavirus-1. Others incorporated technologies that had been previously shown to generate immune responses against human coronaviruses including Middle East Respiratory Syndrome virus (MERS-CoV) and SARS-CoV-1. Some candidates incorporated technologies that had already been validated in successful products. Within six months of the first description of the SARS-CoV-2 virus, candidate vaccines employing many diverse methodologies entered development. The urgency of vaccine development necessitated the application of existing vaccine technologies. With infection fatality rates approaching 1%, the prospect of long-term sequelae in those who recover, , and a high level of population immunity required to halt transmission, initiatives have proceeded at “warp speed”. The COVID-19 pandemic has triggered a rapid mobilization of global vaccine development. NIH funding contributed substantially to the advance of technologies available for rapid development of COVID-19 vaccines, suggesting the importance of sustained public sector funding for foundational technologies in the rapid response to emerging public health threats.
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During this period, NIH funding for published vaccine research against specific pandemic threats such as coronavirus, Zika, Ebola, and dengue was not sustained. A robust body of published research on vaccine technologies was supported by 16,358 fiscal years of NIH funding totaling $17.2 billion from 2000–2019. These technologies vary from established platforms, which have been used successfully in approved products, to emerging technologies with no prior clinical validation. This work examines the maturity of ten technologies employed in candidate vaccines (as of July 2020) and NIH funding for published research on these technologies from 2000–2019. Rapid development of vaccines for COVID-19 has relied on the application of existing vaccine technologies.