Europe's regulatory authorities have issued the world's first Ebola vaccine approval ̵
The European Commission announced earlier this week that it had provided a remarkable marketing authorization for Merck Ervebo's Ebola vaccine. The vaccine has been in operation since the outbreak of West Africa in 2014 in West Africa. It is now being used at the ongoing outbreak in the Democratic Republic of the Congo based on the Compassionate Use Protocol
The present outbreak in the DRC has killed nearly 2200 since August 2018, causing nearly 3,300 cases. The outbreak is the second largest recorded, surpassed only by the West African epidemic in 2014, which has caused more than 11,000 deaths and 28,000 cases.
Preliminary vaccine data from the current DRC epidemic suggest that Hervebo is 97.5% effective in preventing devastating virus disease. He has protected over 90,000 people in the hearth.
The vaccine protects one of the four types of Ebola known to infect humans – the type of ebolavirus in Zaire. Zaire is responsible for the current epidemic in the DRC, as well as the West African epidemic in 2014 and almost all other outbreaks recorded since the first Ebola was detected in 1976.
"Finding a vaccine as soon as possible against this the horrific virus has been a priority for the international community since Ebola struck West Africa five years ago, "said European Commissioner Vitenis Andryukitis in a statement on Sunday, November 10." Therefore, today's decision is an important step forward in saving lives in and outside Africa. "  The vaccine It was originally developed by researchers at Canada's National Microbiology Laboratory, who later licensed it to NewLink Genetics Corporation. Merk received the license in 2014 against the backdrop of the West African epidemic and developed it further.
The company celebrated its approval of the vaccine on Monday.
"This is a historic milestone and a testament to the power of science, innovation and public-private partnerships," Merck CEO Kenneth Fraser said in a statement. "Recognizing the need and urgency of the Ebola Zaire vaccine, many of them have come together in sectors to respond to the global call for readiness for the hearth. We at Merck are honored to be involved in the Ebola outbreak response and remain committed. with our partners and the people we serve. "
The U.S. Food and Drug Administration is expected to decide on the vaccine approval in March 2020.
Meanwhile, the World Health Organization announced on Tuesday, November 12th that "prequalifier of "Ervebo, signaling the Member States that the vaccine meets WHO standards for safety, quality and efficiency. In a statement, the WHO noted that it was "the fastest vaccine re-qualification process ever undertaken by the WHO" and came less than 48 hours after the European Commission approved the vaccine. The organization also said it is working to facilitate licensing in countries at risk of the Ebola epidemic.
"[Prequalification] is a historic step towards ensuring that people who need it most have access to this lifesaving vaccine," WHO Director-General Dr. Tedros Adhanom Hebraeus said in a statement. "Five years ago, we did not have a vaccine and no Ebola therapies. With prior qualification of vaccine and experimental therapists, Ebola is now preventable and treatable."