Researchers and health professionals should be accelerated extraordinary efforts to give people unproven treatments and vaccines in communities hard hit by the Ebola virus, more than 0 experts attending a World health Organization forum (WHO) recommended today.
"We must change the sense that there is no hope in this situation in a realistic hope," said Deputy Director General Marie -Paule Kieny, who spoke at a press conference with two other participants of the consultation. More people became ill and died of Ebola in the last months in the 4 decades since the virus was discovered, she noted.
No treatment or vaccines exist that have been proven against Ebola, and when the epidemic in West Africa has begun to receive the attention ago 2 months, many rejected the idea that biomedical interventions might help. The epidemic grew up in what some call an epidemic despite containment efforts that have proven effective in the past, the idea of deploying experimental treatments and vaccines moved to the scene.
The two days WHO consultation , which mixture researchers with ethicists, legal and regulatory authorities, and health officials from affected countries reached a consensus that the blood of people who had survived an Ebola infection, as a "priority", could be used to treat infected people. "There was a consensus that this has a good chance to work and also it's something that can now be produced in the affected countries now," said Kieny. "There are many people now who are convalescing, who survived and is doing well."
The hope is that the whole blood or plasma purified contain Ebola antibodies and possibly other immune warriors who can fight the virus. Kieny stressed that the international community must urgently assist the countries affected blood collection, purification and reinfusion safely. Some places have already started using the convalescent serum, she said. The treatment has never been formally tested, but whole blood was used in eight in the Democratic Republic of Congo during the outbreak in Kikwit 1995; one died.
As early as November, researchers can have enough human small studies of data from two Ebola vaccines to justify providing workers with health care and other health care providers first line for patients Ebola, Kieny said. "This will enable their use in countries infected immediately," said Kieny. "This is real. This is in the field. It does not remain in the laboratory."
Traditionally, regulators closely regulate vaccine trials as they move from small phase I studies evaluating the safety and immune responses in phase II studies that essentially the same question in a greater number of people. Phase III studies on the effectiveness of testing whether the products work, usually with a placebo control group.
In this current emergency scenario, however, vaccines can skip Phase I vaguely organized phase II / III studies, with little that has no regulatory oversight placebo control, but try to collect data that allows comparison of vaccinated and unvaccinated recipients who have similar health risks.
"It is quite unprecedented, there is no doubt," Kieny said. "Everybody has to move as quickly as possible and this includes regulators." She said that while regulators and ethics committees attempt "to preserve as much as possible, security," the objective is to allow the development to move very quickly.
only about 10,000 doses of vaccine will be available at the end of the year, so there is no possibility of their wide distribution. Kieny explained that this is something of a mixed blessing, as vaccines in the past have been proven safe and effective in small studies, but caused harm when used extensively. "We must be careful about this and deployment should be done as quickly as possible, but step by step."
involved in the press conference Oyewale Tomori, a virologist at the University Redeemer Redemption City, Nigeria, insisted that the attention to the consultation not affect what we know how to stop Ebola transmission. "If we had control of the appropriate infection in other countries where it has taken place, we would not be the same problem that we have now," said Tomori, whose own country has struggled to contain the spread, in part because infected people dodge the health care system.
Samba Sow general director of the center for vaccine development in Bamako, noted at the conference release that experimental vaccines could indirectly help control the epidemic by calming the fears of workers in the health field. "health workers are now afraid to come to the health center and take care of patients," Sow said, the center will soon begin phase I trials of a vaccine against the Ebola virus. he talked about his own risk of taking blood from 18 patients with suspected infections, including four years, had the autopsy. (Mali, which shares a border with Guinea severely affected, has not yet had any positive test person.) "If there is a potential vaccine coming I have to be the first to get this," he said. "Moreover, it will show the transparency, it will show confidence, it will show respect to the rest of the community."
* Ebola files: given the epidemic Ebola ongoing, unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine have a collection of research and articles on the viral disease available for researchers and the general public.
* update, September 6th, 11:48 :. This article has been updated and includes links to clarify the practical test
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