3.1 Quantitative Result for Comparing R&D Activities
According to the available data, U.S. had more government-funded projects on Ebola (n=187) from 2008 to 2016, which is 7.5 times of those in China (n=25). Meanwhile, U.S. input 180 million dollars for R&D, which is 17.5 times higher than that supported by the Chinese government. Both countries contributed consistent efforts between 2008 to 2015 and the gap was gradually narrowing, regarding the granted project number and research funding. However, the difference suddenly re-increased in 2016 (Fig. 1).
Scientific research outputs
For clinical trials, U.S. supported 21 trials for vaccines in total, including 16 in Phase I, four in Phase II, and one in Phase III. As for China, four vaccine clinical trials were supported with three in Phase I and one in Phase II. pipeline candidates, drugs, diagnostics and vaccines accounted for 51.6%, 32.9%, and 15.5% in China. In comparison, U.S. held 57.4% of candidates in drugs, 23.0% in diagnostics, and 19.5% in vaccines. For patent application, China had no application for Ebola-related medical products before 2009, while U.S. applied for 11 drug-related patents, three vaccine-related patents, and two diagnostic-related patents. The number of Chinese patent applications increased and surpassed the U.S.’s in 2014. For publication, U.S. has been active in Ebola R&D since 2006 (Fig. 2). The total number of publications in the U.S. from 2006 to 2014 is 37.5 times higher than that of China. Drug-related publication accounted the most in two countries. From 2014 to 2015, both countries increased, with a steeper rise in the U.S. After 2015, the number of the U.S. decreased apparently, however, China’s still increased.
As a result, CFDA has licensed six Ebola-related medical products, including five diagnostic reagents and one vaccine products approved for emergency use. U.S. has licensed ten Ebola diagnostic tests for emergency use under FDA’s Emergency Use Authorization (EUA) authority. On December 19, 2019, FDA approved the rVSV-ZEBOV, as the first licensed vaccine for Ebola prevention.
Our study focuses on comparing the R&D timeline of the first two Ebola vaccines successfully developed by China and the U.S.: Ad5-EBOV and the rVSV-ZEBOV (Figure 3). Both China and the U.S. research teams started basic studies prior to the Ebola outbreak. The U.S. got FDA approval for clinical trials on Sept 2014, which is five months earlier than China. However, the initial time of Phase I trials in two countries was only one month apart. For the preparation of oversea clinical trial sites, China spent five months waiting for the approval by Sierra Leone, and another five months for volunteer recruitment and laboratory preparation. Comparatively, the U.S. took only four months, in total, for going through all the process of resource allocation and preparation in Liberia. In the end, the Ad5-EBOV got CFDA approval for emergency use in China, whereas the rVSV-ZEBOV was adopted by the WHO as the only vaccine applied in the re-emerging Ebola outbreak in the Democratic Republic of the Congo.
3.2 Qualitative Result for Exploring the R&D Differences in China
According to interviewees, funding for basic research was sufficiently supported by the NSFC programs. Meanwhile, funding for clinical trials mainly came from the Ministry of Science and Technology (MOST), and the R&D grants were only allocated after candidate products demonstrated promising. This funding process lagged the implementation of consistent scientific research. Many teams had to use funding from other projects for Ebola before the government funding got approved. Our interviews suggested that the successful development of the Ad5-EBOV vaccine highlighted the significance of early research accumulation. China needs to establish R&D pre-planning and resource deployment mechanisms for EID preparedness and response.
Scientific research outputs
Although China’s basic research had achieved satisfying progress, most researchers found it challenging to transform results into applicable products. The underlying gap mainly attributed to the lack of participation and support by private sectors, the stagnant transformation platform, and the inadequate government incentives in China. The lack of economic and monetizing value of EID products disincentivizes biopharmaceutical enterprises to carry on studies and manufacture. Furthermore, academic institutions are incapable of translating basic research into clinical trial phases. Military affiliated research institution seems as the first choice for pushing forward oversea clinical trial; however, many things need to be coordinated under government support. Considering there is no existing department providing such guidance, the inadequate incentive mechanisms impede public and private sectors from transforming outputs into downstream timely and effectively.
Interviewees agreed that the special review process established by CFDA and the technical guidance provided by its subsidiary evaluation center significantly accelerated the product licensing procedure. Still, the government agencies should have enhanced regulatory support for promoting oversea clinical trials. The insufficient experience and lack of well-established coordination mechanisms placed significant workloads on individual research teams. Most interviewees expressed that the time spent on communication at work could have been shortened and more efficient.