First FDA-approved vaccine for the prevention of Ebola virus disease

The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD. “While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs. “Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization. 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.”

EVD is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Onset of symptoms of EVD can be sudden and can include fever, fatigue, muscle pain, headache and sore throat. This is followed by vomiting, diarrhea, rash, impaired kidney and liver function and in some cases internal and external bleeding. EVD has an incubation period that ranges from 2 to 21 days. Individuals who provide care for people with EVD, including health care workers who do not use correct infection control precautions, are at the highest risk for infection.

Confirmed outbreaks of EVD have been documented since the 1970s, primarily in areas of sub-Saharan Africa, where scientists believe the virus is always present at low levels in certain infected wild animals. On rare occasions, people become sick with EVD after coming into direct contact with infected animals, which can then lead to EVD outbreaks when the virus spreads between people.

An outbreak in three West African countries (Guinea, Liberia and Sierra Leone) from 2014 to 2016 resulted in more than 28,000 cases of EVD and more than 11,000 deaths that were caused by Zaire ebolavirus.

The Democratic Republic of the Congo (DRC) is currently experiencing the world’s second largest EVD outbreak. In 2018, the World Health Organization (WHO) and the DRC began to use Ervebo as an investigational vaccine under an expanded access program to help mitigate this outbreak. With or without vaccination, it is critical to implement appropriate infection control and prevention measures as part of efforts to prevent the spread of EVD.