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.
Although cases of the deadly disease are extremely rare in the U.S., infections have been acquired by those travelling to the country from affected areas, and health care workers who have fallen ill after treating people with Ebola. The Ebola vaccine, which was used by the World Health Organisation and Democratic Republic of the Congo to decrease the extreme outbreak of Ebola disease on patients in West Africa between 2014/16, is the first-ever Ebola vaccine in the entire history, to be approved by the FDA and will only be provided to adults in a single dose.
The Secretary of Health and Human Services, Alex Azar, described the new vaccine as "a triumph of the global American health leadership".
The Zaire strain of the deadly virus has killed upwards of 2,000 people in the current outbreak in the Democratic Republic of the Congo.
EVD is endemic and transmitted through body fluids, direct blood contact and tissues of infected people or wild animals, including blood or fluid contaminated materials or surfaces.
"Rare cases of relapse - in which a person who has recovered from EVD (Ebola) gets disease symptoms again - have been documented during past outbreaks, but this is the first relapse documented in this outbreak", the report said.
The drug, which was developed by Merck & Co., has a record of 100% effectiveness when it is administered a minimum of 10 days before exposure to the virus. Just 10 cases of EVD out of 1,429 individuals in the "delayed" (21-day) test showed positive for EVD.
The Erverbo approval by the FDA is a major step to protect the Zaire ebolavirus.
Ebola cases are very rare in the United States. "Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur", Peter Marks, MD., PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. Following the Guinea study and several investigations in the safety of the vaccine, the FDA granted Breakthrough Therapy designation, which will help facilitate and develop the vaccine.
FDA approval was based on the outcomes of a study conducted during 2014-2016 outbreaks in Guinea in the individuals of 18 years or above. Studies involving participants in Liberia, Sierra Leone, Canada, Spain, and the US showed they had similar immune response, and it was found to be safe in further work in Africa, Europe, and North America.