After long awaited approval, Merck & Co's (MRK) Ebola virus disease (EVD) vaccine, Ervebo, has finally been authorised by the Food and Drug Administration. Vaccination is essential to help prevent outbreaks and to prevent the Ebola virus from spreading when outbreaks occur, "said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement".
Secretary of Health and Human Services, Alex Azar, referred to as the brand new vaccine "a triumph of American world health management".
EVD is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids.
"Rare cases of relapse - in which a person who has recovered from EVD (Ebola) gets disease symptoms again - have been documented during past outbreaks, but this is the first relapse documented in this outbreak", the report said.
In November, Merck received approval from the European Commission to market Ervebo, less than a month after a European medicines panel backed the first-ever vaccine against the virus. In 2010, NewLink Genetics obtained marketing rights, and then in 2014, it signed a deal with Merck that helped advance the vaccine to clinical trials and scaled up manufacturing.
Severe symptoms may include vomiting, diarrhea, rash, kidney issues, liver issues, and bleeding. The largest individual test was conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older.
Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, said in an FDA press release that the approval is a major advance in helping to protect against Ebola and helps advance USA government preparedness efforts. A particularly troubling strain is the Zaire variant and the Ervebo vaccine has proven to be 100% effective if administered correctly.
In the United States, Ebola infections are rare.
The company said it was working closely with the US government, WHO, UNICEF, and GAVI to prepare against the disease.
The FDA said Ervebo's approval is supported by a study done in Guinea during that outbreak, as well as studies in Liberia, Sierra Leone, Canada, Spain and the United States.
Prior to the FDA and EMA approvals Ervebo had already been approved for use in emergencies by the World Health Organization, based on trials conducted during that epidemic which suggested it had a protective efficacy rate of 93%.