New report says urgent action is still needed in Ebola vaccine development

Thursday, March 31, 2016

A panel of international experts today called for critical steps to be taken to complete the development of safe and effective Ebola vaccines, and ensure the world is prepared for future outbreaks.

Although tremendous progress has been made in Ebola vaccine development over the last two years, the latest report by Wellcome Trust and the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) Team B says without renewed commitment from the global public health community, progress towards approved vaccines for Ebola could grind to a halt as memories of the outbreak in West Africa begin to fade. 

To support international efforts, the Wellcome Trust and CIDRAP established the Ebola Vaccine “Team B” in November 2014. The 26 distinguished international leaders in public health, medicine, bioethics, pharmaceutical manufacturing, and humanitarian relief are involved in one or more areas of vaccine work, and provided collective critical analysis in key areas of vaccine development. Team B is co-chaired by Dr. Jeremy Farrar, Director of the Wellcome Trust, and Dr. Michael Osterholm, Regents Professor and Director of CIDRAP.

“While many in the international public health community believe these efforts have solved “the problem of Ebola,” the path forward is not quite so simple, and many unresolved challenges and questions remain,” said Osterholm. “In our report, we identify four key areas in which critical additional work and effort are needed to enhance Ebola preparedness for future outbreaks, particularly in the megacities of equatorial Africa, and to address the ongoing concern that Ebola virus disease may become endemic in West Africa.”

Osterholm and Farrar urge members of the international community not to shift all of their attention to other pressing public health issues but instead strive to complete the work on Ebola vaccines that began so diligently in 2014 as a result of the West Africa Ebola outbreak.

During the 2014-2015 epidemic, a total of 13 Ebola vaccine candidates (including different combinations of vaccines) were evaluated in phase 1 and/or phase 2 clinical trials and three phase 3 efficacy trials were initiated in Africa—one each in Guinea, Liberia, and Sierra Leone.

Trials of one of these vaccines—Merck’s rVSV-ZEBOV—progressed far enough to demonstrate that it was safe and effective, prompting Gavi, the vaccine alliance, to purchase 300,000 doses as a stockpile for use during future Ebola outbreaks. And other vaccines, notably those made by Johnson & Johnson and GlaxoSmithKline, have advanced well into clinical trials.

However, to date, no vaccine has been submitted for regulatory review and many questions regarding Ebola vaccines remain unresolved. Today’s report from the Ebola Vaccine Team B identifies four main areas where work is still needed before we are fully prepared for another Ebola outbreak:

  1. Filling in the gaps in data on the safety and efficacy of Ebola vaccines
  2. Understanding the complex regulatory pathways for Ebola vaccines
  3. Gaining direct input from African public health leaders to clarify how Ebola vaccines will be used or evaluated in respond to future Ebola outbreaks
  4. Creating a business case for ongoing Ebola vaccine development and deployment

“Although a global collaborative effort has moved us from having no drugs or vaccines in the early days of the Ebola epidemic to now having a safe, effective vaccine and other promising candidates, it has taken too long, and the job is still not done,” said Farrar. “As Ebola infection rates come under control it’s a huge concern that complacency sets in, attention moves to more immediate threats, and Ebola vaccine development is left half-finished. Today we’re calling for a renewed commitment from the global health community. After the hard lessons we’ve learned, it would be a tragedy not to put a final stop to the current Ebola epidemic, and be prepared for the next outbreak.”

This report from Team B follows a report published in February 2015, which set out a framework for developing vaccines for Ebola, and increasing preparedness for emerging infectious diseases.

This full report from Team B will be available on the CIDRAP website. A PDF version of the report is available upon request.

The group is called “Team B” in recognition of the principal role played by the World Health Organization and national governments in leading the international Ebola response.