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On December 19, 2019, the FDA approved ERVEBO (rVSV-ZEBOV), a genetically modified live Ebola virus vaccine for use in persons 18 years of age and older. This vaccine is manufactured by Merck and targets the Zaire ebolavirus strain. ERVEBO is a live, genetically modified Ebola virus vaccine and uses an attenuated vesicular stomatitis virus, a pathogen that infects livestock (cattle, horses, deer, pigs) with one of its genes replaced by an Ebolavirus gene. The virus used in the vaccine is grown in Vero cell cultures and is harvested from the cell culture medium, purified, formulated with stabilizer solution, transferred into vials and stored frozen. When thawed for use, ERVEBO is a colorless to slightly brownish-yellow liquid that has no visible particulates.
Each 1 mL dose of ERVEBO contains 72 million plaque-forming units (pfu) of vaccine virus in a stabilizer solution containing 2.5 mg/mL rice-derived recombinant human serum albumin and 10 mM Tromethamine (Tris). Each dose might also contain residual amounts of host cell DNA (≤10 ng), benzonase (≤15 ng) and trace amounts of rice protein.
ERVEBO vaccine must be stored in the original container to protect the vials from light. Storage temperatures of -80°C and -60°C (-112°F to -76°F) must be maintained and the product must be thawed at room temperature. Once thawed, it can be stored in a refrigerator between 2°C and 8°C (35.6°F to 46.4°F) for up to two weeks and at room temperature (up to 25°C; 77°F) for no more than four hours. Thawed vaccine product cannot be re-frozen. The vaccine must remain protected from light.
The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends this vaccine for adults 18 years and older responding to an outbreak of Ebola virus disease, healthcare workers treating patients at federally-designated Ebola Treatment Center in the U.S., and for laboratory personnel employed at biosafety-level 4 facilities in the United States. It is also recommended for healthcare providers at specialized pathogen treatment centers and for support staff and laboratory workers at Laboratory Response Network facilities.