ERVEBO Now Registered in Four African Countries
Merckhas confirmed that ERVEBO has now been registered by National Health Authorities in the following countries in Africa – DRC, Burundi, Ghana, and Zambia.
ERVEBO was granted a conditional marketing authorization by the European Commission on November 11, 2019 and approved by the U.S. Food and Drug Administration (FDA) on Dec. 20, 2019. In the United States, ERVEBO is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of protection conferred by ERVEBO is unknown. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown.
Approvals by these African countries signify continued, groundbreaking progress in advancing the future of global public health preparedness against Zaire ebolavirus disease, made possible by the unprecedented collaboration between the World Health Organization (WHO), the African Vaccines Regulatory Forum (AVAREF), African governments, the European Medicines Agency (EMA), and Merck. These approvals were the result of the successful implementation of the WHO’s Roadmap for introduction and roll‐out of Merck rVSV-ZEBOV Ebola virus disease vaccine in African countries. The roadmap, designed to coordinate actions and contributions toward the licensing and roll-out of ERVEBO, helped facilitate near-parallel regulatory reviews and led to the approvals of the vaccine in several at-risk countries within 90 days of WHO prequalification.
“We are grateful for WHO’s leadership in establishing a path forward for expediting the prequalification and licensing of this vaccine in countries at greatest risk,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “This important milestone is one more example of the partnership that has formed in response to the outbreaks. While we are far from finished in the Ebola fight, this milestone shows what can be done when we work together to address the most challenging diseases that threaten people and communities.”
As previously announced, Merck is working to initiate manufacturing of licensed doses and expects these doses to start becoming available in approximately the third quarter of 2020. Merck is working closely with the United States government, WHO, UNICEF, and Gavi (the Vaccine Alliance) to plan for how eventual, licensed doses will support future public health preparedness and response efforts against Zaire ebolavirus disease. In the meantime, Merck continues to work urgently with WHO and partners to make investigational Ebola Zaire vaccine (V920) doses available in support of international outbreak response efforts in the DRC and neighboring countries.