The U.S. Food and Drug Administration (FDA) has approved an Ebola vaccine for the first time in its history, according tomedia. The news comes just weeks after the vaccine received similar approval from the World Health Organization. The vaccine, called Ervebo, has been “assessed in about 15,000 people in Africa, Europe and North America.”
The vaccine approval process, while rigorous but faster, is due to the joint efforts of the FDA and relevant medical and scientific groups, and the continued outbreak of the disease has created an urgent need for the vaccine.
In the past few years, the Ebola vaccine, called Ervebo, has undergone several major tests. In Guinea, where the outbreak broke out in 2014-16, people over the age of 18 were tested. During this test, Ervebo was given to 3,537 contacts and contacts with laboratory-confirmed EVDs.
In the Guinea test, two different types of vaccine were used, either “immediate” vaccination with Ervebo or 21 days of “delayed” vaccination with Ervebo. The incubation period for EVD is 2 to 21 days.
Of the 2,108 patients tested “immediately,” “Ervbo was 100% effective in Ebola cases with symptoms that occurred more than 10 days after vaccination.” Only 10 of the 1,429 patients in the Delay tested positive for EVD (21 days).
According to the FDA’s release this week, the most commonly reported side effects of the vaccine include “pain, swelling and redness at the injection site, as well as headaches, fever, joint and muscle aches and fatigue.” “
“While the risk of Ebola virus disease remains low in the United States, the U.S. government remains firmly committed to combating the devastating Ebola outbreak in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, the FDA’s deputy commissioner for policy, legislation and international affairs. Dr. Peter Marks, director of the FDA’s Center for Biologics Assessment and Research, said it was important to fight Ebola anywhere in the world, which “knows no borders.”
“The FDA’s approval of Ervebo is a significant step forward in preventing the Ebola virus in Zaire and in advancing the U.S. government’s preparedness efforts,” Marks said. The research methodused to study the effectiveness and safety of the vaccine sets a precedent in public health emergencies and may help model future research in similar situations. “