Regulatory authorities in Europe have granted the world's first Ebola vaccine approval ̵
The European Commission announced earlier this week that it has granted groundbreaking marketing approval for Merck's Ebola vaccine Ervebo. The vaccine has been in development since the 2014 West African Ebola outbreak. It is currently being used in the ongoing eruption in the Democratic Republic of the Congo based on a compassionate use protocol.
The current outbreak in the Democratic Republic of the Congo has killed nearly 2,200 people since August 2018, causing nearly 3,300 cases. The outbreak is the second largest to be registered. He was only surpassed by the outbreak in West Africa in 2014, where more than 11,000 people died and 28,000 cases occurred disease. It protected well over 90,000 people at the outbreak.
The vaccine protects against one of four Ebola species known to infect humans – the Zaire Ebola virus. Zaire is responsible for the current eruption in the Democratic Republic of the Congo, as well as for the outbreak in West Africa in 2014 and for almost all other outbreaks that have occurred since the discovery of Ebola in 1976.
"Finding a vaccine against this terrible virus as soon as possible" Today's decision is therefore an important step to save lives in Africa and beyond, "said EU Commissioner Vytenis Andriukaitis on Sunday, November 10. 19659004 The vaccine was originally developed by researchers from the National Microbiology Laboratory (Public Health Agency) in Canada and subsequently licensed to NewLink Genetics Corporation, which was granted the license in 2014 following the outbreak in West Africa.
Monday's approval of the vaccine. "It's a historic milestone and a testament to the power of science, innovation and public-private partnership," said Kenneth Frazier, CEO of Merck, in a statement Urgency of an Ebola Zaire vaccine, many industries have joined forces to eltweiten call to prepare to respond to the outbreak. We at Merck are honored to participate in efforts to fight the outbreak of Ebola, and we remain committed to our partners and the EU. "People we serve."
The US Food and Drug Administration is expected to in March 2020 to take an authorization decision on the vaccine.
In the meantime, the World Health Organization announced on Tuesday, November 12, that it had been "pre-qualified". Ervebo is signaling to member countries that the vaccine meets WHO standards for safety, quality and efficacy. In a statement, the WHO noted that it was the "fastest vaccine prequalification process ever undertaken by the WHO" less than 48 hours after the approval of the vaccine by the European Commission. The organization said it is also working to facilitate approval in countries at risk of Ebola outbreaks.
"[Prequalification] This is a historic step to ensuring that those in greatest need have access to this life-saving vaccine," WHO Director General Dr. Tedros Adhanom Ghebreyesus said in the announcement. "Five years ago, we did not have a vaccine and no therapeutics for Ebola, and with a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable."