周四，食品和药物管理局批准了Ervebo制药巨头默克公司为扎伊尔病毒株制造的疫苗，该病毒株在2014年西非爆发时导致11，000多人死亡。
因为刚果民主共和国东部宣布爆发持续不断的疫情去年夏天超过2000人死亡。根据美国疾病控制和预防中心，这是继2016年西非疫情结束后，与乌干达接壤的第十次疫情。
美国食品和药物管理局说:“因为疫苗对公众健康的重要性EVD，美国食品和药物管理局与该公司密切合作，并完成了对其安全性和有效性的评估Ervebo不到六个月。"
健康和公共服务部部长亚历克斯阿扎在一份声明中说:“美国食品和药物管理局首次批准预防埃博拉的疫苗是美国全球卫生领导的胜利。
“从研发到支持制造业，美国政府在推动默克疫苗的发展方面发挥了不可或缺的作用。新批准的疫苗，以及调查在当前刚果民主共和国爆发埃博拉疫情期间，美国政府支持的疗法和其他工具在拯救生命方面发挥了巨大作用。"
九月，阿扎率领美国代表团前往中部非洲。他表示，了解局势“突显出结束埃博拉疫情是特朗普政府的首要全球卫生优先事项之一。”
阿扎表示政府将继续支持刚果民主共和国以及该地区的其他政府和世界卫生组织，“直到埃博拉疫情结束，我们将继续与世界各国政府合作，为未来爆发这种传染病做准备并加以预防。”
传染性很强，埃博拉病毒通过直接接触血液、体液和受感染的人和动物的组织以及衣物等受污染的表面而传播。其特征是发热、疲劳、肌肉疼痛、头痛和喉咙痛，随后呕吐、腹泻和皮疹。埃博拉还会影响肾脏和肝脏功能，并导致内外出血。
Ervebo该疫苗是欧盟委员会在11月的一个具有里程碑意义的时刻批准的，被作为一种含有扎伊尔毒株蛋白的活疫苗给予。在2014年至2016年疫情爆发期间，在几内亚的一项成人研究中使用了这种药物，并被发现在那里百分之百有效 在注射后10天预防埃博拉病毒。塞拉利昂利比里亚参与者参与的研究利昂加拿大、西班牙和美国表明它们有相似的免疫反应，在非洲、欧洲和北美的进一步研究中发现这是安全的。
2018年，世界卫生组织和刚果民主共和国开始使用Ervebo疫苗试图阻止病毒，根据食品及药物管理局。
美国食品和药物管理局称这种病毒在美国“非常罕见”..但该机构负责政策、立法和国际事务的副专员安娜·亚伯兰(Anna Abram)在一份声明中表示，美国政府“坚定致力于抗击非洲毁灭性的埃博拉疫情，包括刚果民主共和国目前的疫情。
她说:“这些努力，包括今天具有里程碑意义的批准，反映了美国食品和药物管理局坚定不移地致力于利用我们的专业知识，促进开发和提供安全有效的医疗产品，以解决紧迫的公共卫生需求和抗击传染病，这是我们至关重要的公共卫生使命的一部分。”。
彼得·马克斯博士，美国食品和药物管理局中心主任生物制剂“评估与研究”在一份声明中称，这种经常致命的疾病“无国界”，并称疫苗接种是防止疫情爆发和在疫情爆发时阻止其传播的关键。
“美国食品和药物管理局批准Ervebo是在帮助抵御扎伊尔方面的一大进步埃博拉病毒以及推进美国政府的准备工作。马克说:“用于研究这种疫苗有效性和安全性的研究方法在公共卫生紧急情况下是一个先例，可能有助于为类似情况下的未来研究建立一个模型。”。
EBOLA VIRUS VACCINE 'A TRIUMPH OF AMERICAN GLOBAL HEALTH LEADERSHIP' SAYS SECRETARY OF HEALTH ALEX AZAR
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.
