AVAREF Publications
The role of the African Vaccine Regulatory Forum (AVAREF) in the accelerated clinical evaluation of Ebola vaccine candidates during the large West Africa epidemic
J Immunol Sci;2018;S(011):75-79
This article discusses AVAREF’s work on clinical trials, including its models and timelines for review and lessons learned. The authors conclude that, before the next pandemic surfaces, more investment is required to monitor safety during clinical trials, strengthen systems for licensure of new products, and implement robust post-marketing surveillance.
The African Vaccine Regulatory Forum (AVAREF): a platform for collaboration in a public health emergency
WHO Drug Information;2015;29(2): 127-132
This article describes AVAREF’s role in accelerating the review of clinical trial applications for Ebola products. It urges the public health community to strengthen AVAREF’s capacity to address future public health emergencies.
New development of medicines for priority diseases in Africa.
Lancet.2016;388(10049):1053-1054. doi:10.1016/S0140-6736(16)31544-6 (PubMed)
Akanmori BD, Mukanga DO, Mihigo R, Ward M, Ahonkhai V, Moeti MR.
This article explains the emerging roles of AVAREF in responding infectious disease control through expediting product development.
The African Vaccine Regulatory Forum (AVAREF): a platform for collaboration in a public health emergency
Vaccines and Global Health: Ethics and Policy, Center for Vaccine Ethics and Policy, GE2P2 Global Foundation, November 2014
Aiming to make potential Ebola therapies and vaccines available as quickly as possible, the ninth African Vaccine Regulatory Forum (AVAREF), was convened in Pretoria, South Africa, from 3-7 November. The first two days focused on a collaborative mechanism for fast tracking approvals for clinical trials and registration of these (Ebola) products in the affected countries.
Maïga D, Akanmori BD, Chocarro L.
Joint reviews and inspections: strategic forms of collaboration for strengthening the regulatory oversight of vaccine clinical trials in Africa.
Vaccine. 2009;28(2):571-575. doi: 10.1016/j.vaccine.2009.09.117 (PubMed)
Abstract Vaccine developers are required to submit a clinical trial application to the authorities in each country where a clinical trial will be conducted. The application has to be made both to the relevant Ethics Committees and to the National Regulatory Authorities, and only after appropriate clearance by both can a clinical trial commence. This paper describes two specific strategies, joint reviews of vaccine clinical trial applications and joint inspections of clinical trial sites by groups of countries, as part of a WHO initiative to strengthen capacity for the regulatory oversight of clinical trials in Africa.
Maïga D, Akanmori BD, Chocarro L.
Regulatory oversight of clinical trials in Africa: progress over the past 5 years.
Vaccine. 2009 Dec 9;27(52):7249-52. doi: 10.1016/j.vaccine.2009.08.113. Epub 2009 Sep 11.
Abstract Randomized controlled clinical trials represent the best way to establish the therapeutic or preventive value of medicines. This decade has seen a strong shift in the location of clinical trials from industrialized countries to developing countries, including many in Africa. However, without independent strong regulatory and ethical oversight of clinical trials the safety of research subjects, and scientific integrity of clinical data cannot be verified. This article draws up a portrait of clinical trials regulation in Africa in support of development of priority medicines, highlights challenges and presents the progress made by countries under WHO guidance over the past 5 years.
Other Relevant Publications of Interest
Ebola ça Suffit Ring Vaccination Trial Consortium. The ring vaccination trial: a novel cluster randomized controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ. 2015;351:h3740. Published 2015 Jul 27. doi:10.1136/bmj.h3740
doi: https://doi.org/10.1136/bmj.h3740
https://www.bmj.com/content/351/bmj.h3740
Abstract A World Health Organization expert meeting on Ebola vaccines proposed urgent safety and efficacy studies in response to the outbreak in West Africa. One approach to communicable disease control is ring vaccination of individuals at high risk of infection due to their social or geographical connection to a known case. This paper describes the protocol for a novel cluster randomized controlled trial design which uses ring vaccination.
Mooney T, Smout E, Leigh B, et al. EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country. Clin Trials. 2018;15(5):436-443. doi:10.1177/1740774518780678 (PubMed)
https://journals.sagepub.com/doi/full/10.1177/1740774518780678
Abstract During the 2014-2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations.
Higgs ES, Dubey SA, Coller BAG, et al. Accelerating Vaccine Development During the 2013-2016 West African Ebola Virus Disease Outbreak. Curr Top Microbiol Immunol. 2017;411:229-261. doi:10.1007/82_2017_53
https://pubmed.ncbi.nlm.nih.gov/28918539/
Abstract The Ebola virus disease outbreak that began in Western Africa in December 2013 was unprecedented in both scope and spread, and the global response was slower and less coherent than was optimal, given the scale and pace of the epidemic. Past experience with limited localized outbreaks, lack of licensed medical counter measures, reluctance by first responders to direct scarce resources to clinical research, community resistance to outside interventions, and lack of local infrastructure were among the key factors delaying clinical research during the outbreak. Despite these hurdles, the global health community succeeded in accelerating Ebola virus vaccine development in a 5-month interval, initiating phase I trials in humans in September 2014 and initiating phase II/III trails in February 2015.
Completing the Development of Ebola Vaccines: Current Status, Remaining Challenges, and Recommendations. Wellcome Trust and the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. January 2017.
https://www.cidrap.umn.edu/sites/default/files/public/downloads/ebola_team_b_report_3-011717-final_0.pdf
Plotting the Course of Ebola Vaccines- Ebola Vaccine Team B report. Wellcome Trust and the Center for Infectious Disease Research and Policy (CIDRAP). Mar 31, 2016
https://www.cidrap.umn.edu/plotting-course-ebola-vaccines-0
Recommendations for Accelerating the Development of Ebola Vaccines. Ebola vaccine Team B report. Wellcome Trust and the Center for Infectious Disease Research and Policy (CIDRAP). Feb 17, 2015
https://www.cidrap.umn.edu/recommendations-accelerating-development-ebola-vaccines-0
Cunningham KC, Hayney MS. Progress toward vaccines for cholera, dengue, malaria, and Ebola. J Am Pharm Assoc (2003). 2014;54(6):654-657. doi:10.1331/JAPhA.2014.14541
https://pubmed.ncbi.nlm.nih.gov/25379984/
CDC. Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) Q&A.
https://wwwnc.cdc.gov/eid/article/26/3/pdfs/19-1018.pdf
CDC. Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial
https://wwwnc.cdc.gov/eid/article/26/3/19-1018_article
Completing the Development of Ebola Vaccines: Current Status, Remaining Challenges, and Recommendations. Wellcome Trust and the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. January 2017.
https://www.cidrap.umn.edu/sites/default/files/public/downloads/ebola_team_b_report_3-011717-final_0.pdf
CEPI. Summary review on vaccine regulatory pathways important for CEPI. Oct 2016
https://cepi.net/sites/default/files/Summary%20review%2020161109.pdf
Kieny MP, Rägo L. Regulatory policy for research and development of vaccines for public health emergencies. Expert Rev Vaccines. 2016;15(9):1075-1077. doi:10.1080/14760584.2016.1188695
https://www.tandfonline.com/doi/full/10.1080/14760584.2016.1188695
The Rapidly Evolving Regulatory Landscape in Africa
https://docplayer.net/12831133-The-rapidly-evolving-regulatory-landscape-in-africa.html
Principles and considerations for adding a vaccine to a national immunization programme from decision to implementation and monitoring (World Health Organization)
https://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/