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Volume 10
Issue 3
10.3390/vaccines10030368
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Review

Vaccine Licensure in the Absence of Human Efficacy Data

by
Courtney L. Finch
1,*,
Christian Martinez
1,
Elizabeth Leffel
2,
Mario H. Skiadopoulos
3,
Adam Hacker
4,
Betty Mwesigwa
5,
Diadié Maïga
6,
Ian Mugisa
7,
Grant Munkwase
7 and
Roxana Rustomjee
1,*
1
Sabin Vaccine Institute, Washington, DC 20037, USA
2
Leffel Consulting Group, LLC, Eagle Rock, VA 24058, USA
3
Microvirion Vaccine Consulting, Rockville, MD 20852, USA
4
Coalition for Epidemic Preparedness Innovations, Bloomsbury, London NW1 2BE, UK
5
Makerere University Walter Reed Project, Kampala 16524, Uganda
6
Regional Office of Africa, World Health Organization, Brazzaville P.O. Box 06, Congo
7
National Drug Authority, Kampala 23096, Uganda
*
Authors to whom correspondence should be addressed.
Vaccines 2022, 10(3), 368; https://doi.org/10.3390/vaccines10030368
Submission received: 14 January 2022 / Revised: 18 February 2022 / Accepted: 19 February 2022 / Published: 26 February 2022
(This article belongs to the Special Issue Vaccine Development Needs for Marburg Virus and Sudan Ebolavirus: Leveraging Lessons Learned from the Zaire Ebolavirus)
Versions Notes

Abstract

Clinical vaccine development and regulatory approval generally occurs in a linear, sequential manner: Phase 1: safety, immunogenicity; Phase 2: immunogenicity, safety, dose ranging, and preliminary efficacy; Phase 3: definitive efficacy, safety, lot consistency; and following regulatory approval, Phase 4: post-marketing safety and effectiveness. For candidate filovirus vaccines, where correlates of protection have not been identified, and phase 2 and 3 efficacy of disease prevention trials untenable, large and/or protracted, each trial may span decades, with full licensure expected only after several decades of development. Given the urgent unmet need for new Marburg virus and Ebola Sudan virus vaccines, the Sabin Vaccine Institute hosted a key stakeholder virtual meeting in May 2021 to explore the possibility of licensure by use of an “animal rule-like” licensure process, based on a risk/benefit assessment specific to regional needs and informed by epidemiology. This may be appropriate for diseases where there are no or limited treatment options, and those prone to sporadic outbreaks with high rates of transmission, morbidity, and mortality. The discussion focused on two contexts: licensure within the Ugandan regulatory environment, a high burden country where Ebola vaccine trials are ongoing, and licensure by the United States FDA—a well-resourced regulatory agency.
Keywords: filovirus; Ebola; Marburg; vaccine; licensure; regulatory; Animal Rule filovirus; Ebola; Marburg; vaccine; licensure; regulatory; Animal Rule

Share and Cite

MDPI and ACS Style

Finch, C.L.; Martinez, C.; Leffel, E.; Skiadopoulos, M.H.; Hacker, A.; Mwesigwa, B.; Maïga, D.; Mugisa, I.; Munkwase, G.; Rustomjee, R. Vaccine Licensure in the Absence of Human Efficacy Data. Vaccines 2022, 10, 368. https://doi.org/10.3390/vaccines10030368

AMA Style

Finch CL, Martinez C, Leffel E, Skiadopoulos MH, Hacker A, Mwesigwa B, Maïga D, Mugisa I, Munkwase G, Rustomjee R. Vaccine Licensure in the Absence of Human Efficacy Data. Vaccines. 2022; 10(3):368. https://doi.org/10.3390/vaccines10030368

Chicago/Turabian Style

Finch, Courtney L., Christian Martinez, Elizabeth Leffel, Mario H. Skiadopoulos, Adam Hacker, Betty Mwesigwa, Diadié Maïga, Ian Mugisa, Grant Munkwase, and Roxana Rustomjee. 2022. "Vaccine Licensure in the Absence of Human Efficacy Data" Vaccines 10, no. 3: 368. https://doi.org/10.3390/vaccines10030368

APA Style

Finch, C. L., Martinez, C., Leffel, E., Skiadopoulos, M. H., Hacker, A., Mwesigwa, B., Maïga, D., Mugisa, I., Munkwase, G., & Rustomjee, R. (2022). Vaccine Licensure in the Absence of Human Efficacy Data. Vaccines, 10(3), 368. https://doi.org/10.3390/vaccines10030368

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