On Dec. 20, 2019, Merck announced that the U.S. Food and Drug Administration (FDA) had approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) 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. Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein.

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 U.S. 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.

During this transition period, Merck continues to work urgently with its partners to ensure uninterrupted access to the investigational Ebola Zaire vaccine (V920) in support of ongoing international response efforts in the Democratic Republic of the Congo and neighboring countries. Merck has, to date, shipped more than 275,000 1.0mL doses of V920 based on requests by the WHO.

Merck has also made submissions to African country national regulatory authorities in collaboration with the African Vaccine Regulatory Forum (AVAREF), that will allow the vaccine to be registered in African countries considered to be at-risk for Ebola outbreaks by the WHO.

Among 15,399 subjects vaccinated with ERVEBO, there were two reports of anaphylaxis. Monitor individuals for signs and symptoms of hypersensitivity reactions following vaccination with ERVEBO. Appropriate medical treatment and supervision must be available in case of an anaphylactic event following the administration of ERVEBO.