Researchers from the U.S. government and a British drug manufacturer found that no unfavorable effects resulted from the recent human trials conducted for an experimental vaccine against Ebola in a bid to rush protection efforts for health workers and those at risk in the Ebola-stricken West Africa.
Testifying before the Congress on Tuesday was Anthony Fauci, director for the Institute of Allergy and Infectious Diseases of the U.S. National Institutes of Health (NIH), who said that “no red flags” were observed in 10 out the 20 volunteers initially vaccinated, gathered reports said.
The remaining 10 volunteers will be injected with the vaccine in the succeeding days.
The human trials are part of Phase I of a multistep evaluation. The trials were conducted at a facility of the NIH in Bethesda, MD. The first phase is assumed to be complete by the end of November or early in December. Following that will be expanded trials to verify the safety of the vaccine further.
“Safety is paramount; it’s absolutely paramount,” Fauci was quoted saying previously to gathered reporters. “The data [on the vaccine] in nonhuman primates is really quite impressive. But in science, you never know, and that’s why we do the trials.”
GlaxoSmithKline developed the vaccine, in collaboration with NIH. The basis of the vaccine is a “chimpanzee cold virus, chimp adenovirus type 3” that is said to be a “carrier of pieces of genetic material of two Ebola strains: Sudan and Zaire.” Zaire is the cause of the outbreak in West Africa.
The genetic material of Ebola doesn’t replicate or pose any harm to people receiving it, reports said.
Earlier reports said similar Ebola vaccine human trials are being planned in Mali, Gambia and the U.K. and may start as soon as researchers get the regulatory and ethical approvals.
In the U.K, the first human trial is all set in Oxford for Sept. 17, with about 60 healthy individuals to be provided with the Ebola vaccine in different doses at the University of Oxford, reports said. Side effects and immune response to the vaccine will be monitored.
Fauci previously said human trials in places where Ebola cases are present, however, is impossible for now because their infrastructure won’t permit the type of studies applied in Phase I.
The researchers and regulators of the medicine are said to be speeding up the clinical testing, which normally would take about 18 months at least, hoping they could begin with the widespread use of the Ebola vaccine early in 2015 in West Africa.
About 10,000 doses of the Ebola vaccine are expected to be available by then.
So far the epidemic has killed an estimated 2,400 people in West Africa, and thousands more are thought to be infected. It has caused deaths in Guinea, Liberia and Sierra Leone, and has spread into Nigeria as well as the Democratic Republic of the Congo, Gabon, South Sudan, Ivory Coast, Uganda, and Republic of the Congo. In response to the growing problem, the United States will send troops, materials to build field hospitals, additional health care workers, community care kits and badly needed medical supplies.
Efforts are hampered by a lack of protective clothing for health workers, the need for strict infection control procedures and a lack of medical personnel, since many were infected in treating patients in the first wave of the outbreak and have themselves succumbed to the infection.
The Ebola hemorrhagic fever is caused by the Ebola virus and is spread by physical contact with bodily fluids. According to the World Health Organization, "there is no specific treatment or vaccine," and the fatality rate can be up to 90%. Patients are given supportive care, which includes providing fluids, electrolytes and food.
