Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)
The FDA-approved ERVEBO® (Ebola Zaire Vaccine, Live) is an important milestone in the efforts to prepare for and avoid Ebola.
The Ebola vaccine has been used by the World Health Organization and the Congo Democratic Republic for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.
Launch of ERVEBO® Ebola Vaccine
As a research vaccine was declared to help reduce outbreaks of Ebola virus disease (EVD) in a few West African countries between 2014 and 2016.
Merck won European Commission authorization to launch ERVEBO, less than a month after the first-ever vaccine against the virus was approved by a European medicines panel.
Merck works closely with the U.S. government, WHO, UNICEF and Gavi (the Alliance for Vaccines) preparing to start the manufacture of approved doses and hopes that these doses will begin to be available in about the third quarter of 2020.
ERVEBO has been recognized as the first FDA-approved vaccine against the deadly virus that causes hemorrhagic fever and spreads via direct contact with body fluids from person to person.
Ebola Virus Disease (EVD)
Since mid-year, over 2,100 people have been killed in Congo, making it the second-largest outbreak of Ebola in history.
In support of ongoing international response efforts in the Democratic Republic of Congo and neighbouring countries, Merck continues to work closely with its partners to ensure uninterrupted access to the investigational Ebola Zaire vaccine (V920) during the transition period.
To date, Merck has shipped over 275,000 1.0mL V920 doses based on WHO requests.
The Ebola Vaccine’s protection period is uncertain. For immunocompromised individuals, the safety and efficacy of ERVEBO was not tested and the effectiveness of ERVEBO may be decreased.
ERVEBO should not be prescribed to people with a history of an allergic reaction (e.g. anaphylaxis) to any vaccine ingredient, including rice protein.
Two incidents of anaphylaxis were reported among 15,399 subjects vaccinated with ERVEBO. Supervision of individuals for signs and symptoms of hypersensitivity and appropriate medical attention must be available after ERVEBO administration in the case of an anaphylactic incident.
More about Merck & Co., Inc
Merck & Co., Inc is a leading global biopharmaceutical company and one of the top Fortune 500 pharmaceutical companies in the world. Operating in more than 140 countries globally, Merck is at the forefront of research to advance the prevention and treatment of diseases including cancer, cardio-metabolic diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola.
KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE:MRK) – 20 December 2019 Press Release: Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)