Merck (MSD) has received the US Food and Drug Administration (FDA) approval for its Ervebo vaccine to prevent Ebola virus disease (EVD) caused by Zaire ebolavirus.
Ervebo, the first Ebola vaccine approved in the US, is indicated for patients aged 18 years and above. It is a live, attenuated vaccine genetically engineered to include a Zaire ebolavirus protein, given as a single-dose injection.
Ebola virus spreads through direct contact with blood, body fluids and infected tissues. EVD is characterised by fever, muscle pain, vomiting, diarrhoea and fatigue, among other symptoms.
Confirmed outbreaks of the viral disease have been documented since the 1970s. An outbreak from 2014 to 2016 in Guinea, Liberia and Sierra Leone caused more than 28,000 cases and 11,000 deaths by Zaire ebolavirus.
Currently, the Democratic Republic of the Congo (DRC) is suffering the second-largest outbreak. To address this outbreak, the World Health Organization (WHO) and the DRC started using Ervebo as an investigational vaccine last year.
FDA Policy, Legislation and International Affairs deputy commissioner Anna Abram said: “While the risk of Ebola virus disease in the US remains low, the US government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo.
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“Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the US Department of Health and Human Services, as well as our international partners, such as the World Health Organization.”
FDA approval comes after the review of data from a study performed during the 2014-2016 outbreak in people aged 18 years and older in Guinea.
When 2,108 subjects in the immediate vaccination arm were compared to 1,429 of those in the delayed vaccination arm, Merck’s vaccine was found to be 100% effective in preventing Ebola cases.
Data showed a symptom onset greater than ten days post-vaccination. The company also reported favourable outcomes from additional antibody response studies conducted in Liberia, Sierra Leone, Canada, Spain and the US.
FDA approval follows the European Commission’s marketing authorisation of Merck’s Ebola vaccine in November.