The first Ebola vaccine approved by the U.S. Food and Drug Administration is a single-dose injection called Ervebo.
The vaccine from Merck & Co. is approved to protect against the Zaire ebolavirus in people ages 18 years and older.
In the United States, Ebola infections are rare. Confirmed cases have involved people in other countries who became infected and then traveled to the United States or health care workers who were infected while treating Ebola patients, according to the FDA.
“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,” Anna Abram, the FDA’s deputy commissioner for policy, legislation, and international affairs, said in a statement.
“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.”
The world’s second-largest Ebola outbreak is ongoing in the Democratic Republic of the Congo. The largest outbreak occurred from 2014 to 2016 in the West African nations of Guinea, Liberia, and Sierra Leone. More than 28,000 people were infected and more than 11,000 died.
The FDA said Ervebo’s approval is supported by a study done in Guinea during that outbreak, as well as studies in Liberia, Sierra Leone, Canada, Spain, and the United States.
Ervebo was shown to be highly effective in preventing infection in people exposed to the virus.
“Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“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.
The FDA is committed to continuing our work across the U.S. government and with our international partners to prevent future Ebola outbreaks and mitigate the current outbreak in the DRC, reflecting our nation’s commitment to preparing for and responding to biological threats, like Ebola.”
The approval of Ervebo is supported by a study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older.
The study was a randomized cluster (ring) vaccination study in which 3,537 contacts and contacts of contacts of individuals with laboratory-confirmed EVD received either “immediate” or 21-day “delayed” vaccination with Ervebo.
This noteworthy design was intended to capture a social network of individuals and locations that might include dwellings or workplaces where a patient spent time while symptomatic, or the households of individuals who had contact with the patient during that person’s illness or death.
In a comparison of cases of EVD among 2,108 individuals in the “immediate” vaccination arm and 1,429 individuals in the “delayed” vaccination arm, Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination.
No cases of EVD with symptom onset greater than 10 days after vaccination were observed in the “immediate” cluster group, compared with 10 cases of EVD in the 21-day “delayed” cluster group.
In additional studies, antibody responses to Ervebo were assessed in 477 individuals in Liberia, approximately 500 individuals in Sierra Leone and approximately 900 individuals in Canada, Spain and the U.S. The antibody responses among those in the study conducted in Canada, Spain and the U.S. were similar to those among individuals in the studies conducted in Liberia and Sierra Leone.
The safety of Ervebo was assessed in approximately 15,000 individuals in Africa, Europe and North America. The most commonly reported side effects were pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle aches and fatigue.
Ervebo is administered as a single-dose injection, and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus.
The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases.
The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. 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.
The approval was granted to Merck & Co., Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.