The Food and Drug Administration (FDA) has approved a vaccine for the Ebola virus in the U.S. for the first time, in a move which the Secretary of Health and Human Services has hailed as a "triumph of american global health leadership."
On Thursday, the FDA approved the Ervebo vaccine made by the pharmaceutical giant Merck for the Zaire strain of virus, which killed more than 11,000 people in the 2014 outbreak in West Africa.
Since an ongoing outbreak was declared in the eastern Democratic Republic of the Congo last summer, over 2,000 people have died. According to the U.S. Centers for Disease Control and Prevention, this tenth outbreak on the border with Uganda is the second largest documented following the West African epidemic which ended in 2016.
The FDA said: "Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months."
Health and Human Services Secretary Alex Azar said in a statement: "The first-ever FDA approval of a vaccine for the prevention of Ebola is a triumph of American global health leadership.
"From research and development to support for manufacturing, the U.S. government played an integral role in advancing the development of Merck's vaccine. The newly approved vaccine, as well as investigational therapeutics and other tools supported by the U.S. government, is playing a huge role in saving lives during the current Ebola outbreak in the Democratic Republic of the Congo."
In September, Azar led the U.S. delegation to Central Africa. He said learning about the situation "underscored that ending the Ebola outbreak is one of the top global health priorities for the Trump administration."
Azar said the government will continue to support the DRC and other governments in the region as well as the World Health Organization "until the Ebola outbreak is brought to an end, and we will continue working with governments around the world to prepare for and prevent such infectious disease outbreaks in the future."
Highly contagious, ebola is passed on through direct contact with blood, body fluids and tissues of infected humans and animals, as well as contaminated surfaces like clothing. It is characterized by fever, fatigue, muscle pain, headache and sore throat, followed by vomiting, diarrhea, and a rash. Ebola can also affect kidney and liver function, and cause internal and external bleeding.
Ervebo, which the European Commission licensed in a landmark moment in November, is given as a live vaccine which contains a protein from the Zaire strain. It was used in a study on adults in Guinea during the 2014 to 2016 outbreak, where it was found to be 100 percent effective in preventing Ebola 10 days after it was administered. Studies involving participants in Liberia, Sierra Leone, Canada, Spain, and the U.S. showed they had similar immune response, and it was found to be safe in further work in Africa, Europe, and North America.
In 2018, the World Health Organization and the DRC started to use the Ervebo vaccine in an attempt to stop the virus, according to the FDA.
The FDA stated the virus is "very rare" in the U.S.. But Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs for the agency, said in a statement the U.S. government is "deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo.
"These efforts, including today's landmark approval, reflect the FDA's unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission," she said.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that the often deadly disease "knows no borders," and described vaccination as essential to preventing outbreaks and stopping it from spreading when outbreaks occur.
"The FDA's approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing U.S. government preparedness efforts. The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency and may help create a model for future studies under similar circumstances," Marks said.
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