Feb 17, 2015 – The ongoing and devastating Ebola epidemic in West Africa has galvanized the will and resources of the international community toward an unprecedented goal: to make and deliver safe, effective vaccines that protect against Ebola virus disease in record time.
To help address this crucial public health undertaking, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and the Wellcome Trust today published "Recommendations for Accelerating the Development of Ebola Vaccines: Report & Analysis" to analyze the issues and challenges involved and offer expert recommendations.
The report represents careful, in-depth synthesis and advice from an international panel of 26 experts in public health, medicine, bioethics, pharmaceutical manufacturing, and humanitarian relief convened by the Wellcome Trust and CIDRAP.
The recommendations will help guide global efforts to expedite the availability of effective and safe Ebola vaccines to help bring an end to the current epidemic in West Africa, in addition to providing a framework to ensure the world is better prepared for inevitable future outbreaks of Ebola and other deadly infectious diseases.
Co-chaired by Wellcome Trust Director Jeremy Farrar, MD, PhD, and CIDRAP Director Michael Osterholm, PhD, MPH, the expert panel proffers 48 specific recommendations (listed in Appendix B of the report). They include advice that Ebola vaccine manufacturing could be accelerated by streamlining production using existing vaccine technologies and that phase 2/3 clinical trials should be continued even if definitive data on vaccine efficacy cannot be guaranteed.
The group also recommends that African stakeholders be at the forefront of ethical decisions that affect the safety and well-being of populations hardest hit by the current outbreak. Further, once this outbreak has been controlled, stockpiling vaccines for future outbreaks must be considered.
The expert panel is called "Team B" in recognition of the principal role played by the World Health Organization (WHO) and national governments in leading the international Ebola response.
"Despite falling infection rates in West Africa, the risk that the current Ebola outbreak may not be brought completely under control remains," said Farrar. "The accelerated development of candidate vaccines, in collaboration between governments, industry, academia and philanthropy, is essential.
"This framework, designed to guide global preparations and focusing on what needs to be done now for this epidemic and put into place in the period between future epidemics, will prove critical in minimizing the chances of the world finding itself in a position again when we do not have treatments and vaccines for these predictable and often devastating diseases."
Osterholm added, "The findings in our analysis and report have far-reaching implications for vaccine development for Ebola vaccines and for other emerging infectious diseases. This is the tool that will provide the ultimate public health lever needed to address Ebola today and in the future."
The report includes sections on manufacturing, safety and efficacy/effectiveness determination, regulatory pathways, ethics, community engagement, vaccination strategies, and funding. Additional key recommendations include:
- Continued assessment of vaccine attributes is needed to inform long-term use and future outbreaks.
- The WHO should continue to coordinate international efforts.
- The clinical trial process needs to be innovative and flexible.
- Post-marketing surveillance should be in place once vaccines are approved.
- The key framework for developing vaccination strategies should be based on initial targeting of those at highest risk of exposure.
- Community engagement efforts should be under way to address any perceived barriers to vaccine acceptance, build trust, promote awareness, and provide education.
- Transparency is essential in financial transactions that affect pricing as well as decisions regarding who receives limited doses.
- Officials should examine creation of an integrated funding strategy that prioritizes public health as the driver over commercial considerations.