Unprecedented pace and partnerships: the story of and lessons learned from one Ebola vaccine program

ABSTRACT

Introduction: The Ebola epidemic in West Africa from 2014 to 2016 was unique in its size, location, and duration; this article reviews the experiences and lessons learned for one vaccine candidate developed during the outbreak and discusses critical gaps that still exist today which will need to be addressed for successful end to end emerging infectious disease vaccine product development in the future.

Areas Covered: Through the formation of numerous international partnerships, the rVSVΔG-ZEBOV-GP vaccine advanced through Phase I/II/III clinical trials which resulted in favorable Phase III efficacy results. Key lessons learned that could be used to facilitate future vaccine development efforts include sufficient preclinical work in relevant animal models, innovative partnerships created to pool resources and expertise, and ‘hyper’ coordination and communication among partners to build trust and ensure an adequate regulatory package needed to license a vaccine.

Expert Commentary: As evidenced by the 2014–2016 outbreak in West Africa as well as the two other most recent outbreaks in the Democratic Republic of the Congo in 2018, there is an urgent need to develop new models for emerging infection vaccine development where trusted partners come together and where the development of vaccines is a shared responsibility conducted in advance of the next crisis.

KEYWORDS:

• Ebola vaccine
• public private partnerships
• emerging infectious disease
• rapid trial design
• regulatory

Declaration of interest

M Feinberg and S Gupta are former employees of Merck & Co., Inc. and own stock/stock options. B-A Coller is a current employee of Merck & Co., Inc. and own stock/stock options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

The manuscript was funded by Medecins sans Frontieres, Merck & Co., Inc., NewLink Genetics, the Public Health Agency of Canada, the US. Department of Health and Human Services (Biomedical Advanced Research and Development Authority, National Institutes of Health, [HHSO100201500002C, HHSO100201600031C]), the US Department of Defense (Defense Threat Reduction Agency, Joint Vaccine Acquisition Program, [HDTRA1-15-C-0058, HDTRA1-14-C-0045]), the Wellcome Trust, and the World Health Organization. This research is sponsored by Merck and may lead to the development of products.