A DONATION of as many as 1,000 doses of an Ebola vaccine never tested in humans is raising questions among authorities about whether to give it to healthy people as officials try to control a raging outbreak in Western Africa.
The World Health Organization has said experimental treatments could be made available to people infected with the disease. The WHO hasn’t decided what to do with the donation by the Canadian government of a preventive vaccine. The ethical calculation is being made as the fast-moving outbreak has killed more than 1,000 people and shows no signs of abating.
The first to test the experimental vaccine may be health workers on the front lines, as they may be in a better position to understand the risks of an unproven drug and reap any benefits, said G. Kevin Donovan, director of the Pellegrino Centre for Clinical Bioethics at Georgetown University. “It does change the calculus,” he said in a telephone interview.
Exposure to vaccine
“Those who would be predictably and regularly exposed should get the vaccine. It’s ethically a more tolerable situation in that health-care workers are presumably more medically sophisticated and understand the risks and benefits.”
The vaccine, called VSV-EBOV and developed by National Microbiology Laboratory in Winnipeg, has never been tested on humans and its safety and effectiveness is unknown. The Canadian government said it would offer 800 to 1,000 doses of the vaccine to the Geneva-based WHO, while keeping a small supply in case it’s needed in Canada. The WHO is deciding what to do with the donation, said Tarik Jasarevic, a spokesman. Unproven drugs have already been used in the course of the outbreak first reported in March. An antibody cocktail from Mapp Biopharmaceutical Inc. was given to two American health workers infected while working in an Ebola centre in Liberia.
Clinical trials: A vaccine, given to the healthy rather than those already infected, is a different matter, though. “We need to be finding out if it is safe and effective before offering it to people beyond health workers,” Donovan said. Plans are being made to start trials of the Canadian vaccine and another by the end of September, Marie-Paule Kieny, the WHO’s assistant director-general for health systems and innovation, said to reporters in Geneva. “We are fortunate that a number of these new products – vaccines and medicines also – have shown enough potential for efficacy” in animal studies, Kieny said. “It really gives hope that they would be efficacious in humans. Even though we don’t have anything proven, we are in a much better position than we were a few years ago.”
Nigeria deaths: There is no cure for Ebola and 54 percent of the people reported with the virus have died in the current outbreak. The disease is normally treated by keeping patients hydrated, replacing lost blood and using antibiotics to fight off opportunistic infections. The hope is that a patient’s immune system will eventually fight off the virus’s aggressive attack. Ebola has killed 1,069 of 1,975 people afflicted in four West African nations, making it the worst outbreak since the virus was first identified in 1976, according to the WHO.
An official with the Economic Community of West African States died with Ebola in Lagos, Nigeria, becoming the third victim in Africa’s biggest city, according to a statement on the bloc’s website.
Jatto Asihu Abdulqudir, a 36-year-old protocol assistant at ECOWAS, had been in quarantine after helping Liberian Patrick Sawyer get to a regional meeting, according to the statement. Sawyer died of Ebola on July 25, five days after showing symptoms of the virus at the Lagos airport in the country’s first reported case of the disease. A nurse who came into contact with Sawyer has also died. The disease is spread by direct contact with bodily fluids.
Antibody therapy: Finding doses of potential treatments poses an immediate challenge after Mapp, a closely held San Diego-based company, said this week that it has already exhausted the supply of its experimental therapy ZMapp. While the Canadian vaccine VSV-EBOV hasn’t been tested on humans, it protected 100 percent of monkeys in a study, according to NewLink Genetics Corp., the Ames, Iowa-based company that is working on the vaccine. NewLink said last week it received $1 million from the U.S. Defence Threat Reduction Agency to test the therapy.
The U.S. National Institute of Health is also developing a vaccine, which may begin enrollment in a early-stage human testing by this fall. The Confederation of African Football has asked Sierra Leone, Liberia and Guinea to play soccer matches scheduled until mid-September on neutral ground. That follows advice from the WHO against large gatherings of people that might help spread the disease.
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