Making history: the world’s first FDA-approved Ebola vaccine

Public-private partners collaborate to prevent the spread of a global health threat

Today, we achieved a historic milestone in global health security with the approval of ERVEBO®, the first vaccine approved by the U.S. Food and Administration (FDA) for the prevention of the Ebola virus disease (EVD). A safe and effective vaccine is a vital tool in combatting the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC), which is the second largest outbreak since the virus was discovered in 1976. Today’s approval by the FDA, which follows last month’s European Union-wide conditional marketing approval by the European Medicines Agency and the World Health Organization’s prequalification of the vaccine, provides healthcare workers and civilians in affected areas with more confidence in the vaccine.

The vaccine is already playing an important role in the fight against Ebola in the DRC.  ERVEBO® has been given voluntarily to over 255,000 people, including first responders, healthcare workers, and burial providers, under an expanded access protocol. Contacts of suspected or confirmed Ebola patients have also been vaccinated to form a “ring of protection” and reduce further spread of the disease. The number of Ebola infections and deaths in the region continues to decline, thanks in part to the investigational vaccines and antivirals, as well as diagnostic tools developed with the support of the U.S. Department of Health and Human Services (HHS).

Support for ERVEBO® began about two decades ago when the Public Health Agency of Canada began developing the vaccine using a live virus vaccine platform based on the vesicular stomatitis virus, a virus that typically infects livestock rather than people.  The Public Health Agency of Canada licensed ERVEBO® to NewLink Genetics Corporation in 2011.  BioProtection Systems, a wholly owned subsidiary of NewLink, continued development of the vaccine with additional funding from the HHS as well as the Department of Defense (DoD).

The 2014 West Africa Ebola outbreak – the largest in history – galvanized public and private partners’ resolve to accelerate the development of the vaccine and other medical countermeasures that would be needed to respond to Ebola outbreaks.  Recognizing the threat to public health and national security, the U.S. Congress allocated supplemental funding to support the development of medical countermeasures and domestic public health preparedness measures.

In late 2014, with the Ebola outbreak at its peak, Merck licensed ERVEBO® from NewLink Genetics, and partners from the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response, and DoD provided BioProtection Systems and Merck with funding and technical support for clinical trials, advanced development, and manufacturing of the vaccine.  When the West African Ebola outbreak finally ended in 2016, BARDA continued to support Merck’s late-stage development and manufacturing of ERVEBO®.

Merck and partners across the federal government remained committed to finishing the important work they started. In response to the current Ebola outbreak in the DRC, BARDA, CDC, and other partners in the U.S. government played an integral role in supporting the investigational use of ERVEBO®.  Throughout this time, the FDA provided critical scientific and technical input to U.S. government partners and Merck to facilitate the development of a safe and effective vaccine for EVD.

I am so proud that BARDA played an instrumental role in providing funding and technical support for this project. I am honored that our office had the opportunity to work with so many amazing people to produce a vaccine that is doing so much good. Our office supported activities from small scale manufacturing and phase 1 clinical development through the late-stage development of ERVEBO® that were required to support the licensure application. ERVEBO® is the 53rd BARDA-supported product to be approved or licensed by the FDA and it is the latest demonstration of the life-saving work that BARDA does each time it forms a new public-private partnership.

ERVEBO® is a critical part of a broader portfolio of medical countermeasures being developed to combat Ebola, including some that are already being used on an investigational basis with promising results.  In addition, BARDA supported the development and eventual marketing authorization of an Ebola diagnostic, and we continue to support the development of therapeutic products as well as another Ebola vaccine.

Although we continue to monitor the current outbreak, and invest in medical countermeasures that are urgently needed, we know that the virus will re-emerge.  When it does, ERVEBO® and the other medical countermeasures in this portfolio will continue to be a critical part of our efforts to save more lives and protect health security.