Abstract
As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three reasons to test vaccines in wild populations of apes: i) protect apes; ii) reduce Ebola transmission from wild animals to humans; and iii) accelerate vaccine development and licensing for humans. Data obtained from studies of vaccines among wild apes and chimpanzees may even be considered sufficient for licensing new vaccines for humans. This strategy will serve to benefit both wild apes and humans.
Acknowledgements
We express deep thanks to Professor Sir Ali Zumla for his ongoing support at an early conference on research ethics during an epidemic in 2014, through to the launch of PANDORA-ID-NET, funded by EDCTP, an international consortium to respond with OneHealth research to emerging and reemerging infectious diseases in Africa. We also thank delegates of two conferences for any late comments on parts of this article in presentation: those who attended the Grading Evidence of Mechanisms conference on September 4 and 5 at the University of Kent, and the European Philosophy of Science Association conference on September 6–9 at the University of Exeter.
Author Contributions
The article is based on an original combination of ideas by SE, following ethical difficulties with RCTs, recognizing the need to explore the philosophy of causation in science, associating conservation work in apes, OneHealth and Ebola research, and, with CHN, applying evidential pluralism to produce the first draft with reference material. CPN contributed work related specifically to the ethics of animal experimentation, and revised the structure of the article, including in final drafting. PI commented on drafts and made substantive points concerning the need for stratification and strength of evidential claims, while BC emphasized the importance of surrogate outcomes and the possibility of validating them in animal populations between outbreaks, showed how the pharmaceutical industry collects evidence to drive a commercial agenda, and greatly contributed to early versions of the article. ▪