The Erverbo approval by the FDA is a major step to protect the Zaire ebolavirus.
He added that the approach used to study the safety of the vaccine was "precedent-setting during a public health emergency" and "may help create a model for future studies under similar circumstances".
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.
"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", it said. Ebola can also affect kidney and liver function, and cause internal and external bleeding. It spreads quickly and can be fatal.
While Ebola virus disease (EVD) cases have been very rare in the United States of America, and those cases that have occurred, have been related to global travel and the result of infections acquired when treating an EVD patient. The largest individual test was conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older. The second-largest outbreak ever recorded has been ongoing in the DRC since previous year.
A total of 3,354 people have reported symptoms of hemorrhagic fever in the eastern Congolese provinces of North Kivu, Ituri and South Kivu since August 1 of previous year, and 3,236 of those individuals have tested positive for Ebola virus disease, according to Congolese health officials.
Merck & Co said on Friday it expects to make licensed doses of its recently approved Ebola vaccine available in the third quarter of 2020 and price the single-dose injection at the lowest possible access price for poor and middle-income countries. A study during an outbreak in Guinea " determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination".
Vaccines can be deployed to inoculate health workers, or to build a wall of immunity in the communities facing or near an outbreak. Safety was assessed in approximately 15,000 individuals, with the most commonly reported adverse reactions being pain, swelling, injection site reactions, headache, fever, joint and muscle aches and fatigue. "From research and development to support for manufacturing, the USA government played an integral role in advancing the development of Merck's vaccine".
A recent Ebola outbreak, which started in August 2018, killed more than 2,100 people, including over 160 health workers since the middle of past year.