世衛：伊波拉疫苗2015年初推出 2014年08月12日 02:25 潘勛 西非洲爆發的伊拉波病情迅猛，全歐洲各醫院如臨大敵，唯恐該病毒傳到歐洲，而「世界衛生組織」(WHO)表示，2015年初可能快速推出伊波拉疫苗。德國柏林市伊波拉隔離醫院「慈善」醫院表示已準備就緒，原因是兩名德國人可能帶有該致命病毒；其中一人係由獅子山回國，在當地伊波拉已造成12人喪生，而另一名醫學系學生刻在盧安達，據說也出現伊拉波病情。感染上伊波拉病毒者，目前9成會死亡；西方各國在非洲疑感染者，都被隔離空運回國，然後接受還在實驗中的藥物「Zmapp」救治；Zmapp或能改善病人的存活機率。只是Zmapp劑量不多。WHO副理事長瑪莉－保羅‧基耶尼(Marie-Paule Kieny)受訪表示，她估計伊波拉疫苗到2015年可以上市，是很務實的事。WHO疫苗首席貝萊(Jean-Marie Okwo Bele)指出，英國藥廠葛蘭素史克9月起即將對其研發的伊波拉疫苗進行臨床實驗。
Ebola vaccine: how could GSK have it ready by next year? By Denise Roland1:49PM BST 12 Aug 2014 An experimental vaccine for the Ebola virus has become the latest hope for health authorities battling the deadly outbreak in West Africa. The World Health Organisation has said the vaccine - which has only ever been tested on animals - could be ready as early as next year. Meeting this goal will place an unprecedented timeframe on GlaxoSmithKline, the drug maker which runs the research programme in collaboration with the National Institutes of Health. The WHO has acknowledged that there is not enough time for the vaccine to undergo the standard, years-long clinical trials process, but has concluded that in this case it would be ethical to make it widely available with much less testing. It is likely that the vaccine would be widely available following only a small trial in humans to determine its safety, scheduled to take place later this year. GSK's Dr Ripley Ballou has spoken to the Telegraph about how the drug giant is approaching this unique situation, one which he says he has "not experienced or even seen done" in his 30-year career. He stresses that GSK will endeavour to put the vaccine through all the safety procedures it would have gone through under normal circumstances. "The pathway and process are probably going to be a little different, but the basic principles are the same," he says. "What we trying to develop this vaccine so we are aware of the emergency and urgent need for intervention but also the need to protect safety of our volunteers," he said. GSK is planning to test the vaccine on a small group - probably tens - of people at the National Institutes for Health Vaccine Research Centre in Maryland in the US later this year. This process - recruiting volunteers, injecting them with vaccine, following up and analysing their blood samples - normally takes six months from start to finish. GSK is hoping to trim the timeframe down to five months so it can report the results by the end of the year. Under normal circumstances, the drug maker would then run a series of so-called randomised control trials in areas affected by the disease. This kind of trial involves some volunteers being injected with vaccine and others being given a placebo. It would determine the effectiveness of the vaccine by finding out whether the group given the vaccine was less likely to contract the disease than the placebo group. But in the midst of an Ebola outbreak it would not be ethical to give some people a placebo version of a vaccine which had even a small chance of protecting them against the disease. So far the WHO has only asked GSK to accelerate its first-in-human trials to get safety data as soon as possible. After that, it is unclear how drug maker will be asked to proceed. But Dr Ballou says GSK is in constant discussion with the WHO about the longer term plan. "We cannot give a very accurate roadmap, but we're trying to get meaningful answers as quickly as possible."
As Ebola's Toll Rises, Drug Makers Race to Test Medicines By ANDREW POLLACKAUG. 13, 2014 Because outbreaks are sporadic and mainly confined to Africa, the Ebola virus has not been a priority for profit-seeking pharmaceutical companies. But with the largest ever Ebola outbreak now having killed more than 1,000 people in West Africa, drug companies and doctors are scrambling to see whether any existing medicines or drugs under development can help stem the epidemic. Options include experimental treatments that have never before been tested on people and some of the world's most widely used drugs — statins like Lipitor, which are approved to lower cholesterol but might, some advocates say, also help with Ebola. The search is especially intense among smaller companies whose research has been funded by the government. Investors, too, are watching the drug makers. Stock in one of the hopefuls, Tekmira, which is based in Canada, has nearly doubled in the last month. Shares of BioCryst Pharmaceuticals, which announced on Wednesday that it was receiving more federal money to test its Ebola drug candidate in monkeys and people, have also been rising. Experts caution that most of these drugs are so early in development and in such limited quantities that they may not make a difference. "I wish I had a better story for you, but that's it," one official at the Health and Human Services Department said after discussing the relative handful of drugs and vaccines in the pipeline, most of which have yet to be tested even in small clinical trials. Despite the long odds, two Ebola vaccines could begin initial safety testing in people as early as next month, according to the official, who spoke on the condition of anonymity because his agency did not have formal contracts with some of the companies involved. While testing will be in healthy volunteers, some of those volunteers might be health care workers who intend to go to Africa. One of the vaccines was developed by a government laboratory in Canada. The Canadian government on Tuesday said it would donate 800 to 1,000 doses to the World Health Organization, presumably for use in Africa. That vaccine is licensed to NewLink Genetics, a company in Ames, Iowa. Charles Link, the chief executive, said NewLink could manufacture tens of thousands of doses over the next couple of months. The other vaccine is being developed by the National Institutes of Health and GlaxoSmithKline. There are 400 doses available now, enough for a clinical trial in healthy adults, the federal official said. As far as treatments for people already stricken with Ebola, most attention has focused on ZMapp, developed by Mapp Biopharmaceutical of San Diego. The drug, which consists of antibodies that bind to and neutralize the virus, appears to have helped two American aid workers stricken in Liberia. Although the company says it has exhausted its supply — apparently enough to treat only six people — the federal official said he hoped 10 to 50 more treatment courses could be made by the end of the year, enough to begin a small safety study. Tekmira's drug uses a technique called RNA interference to silence genes in the Ebola virus. Its early-stage clinical trial in healthy volunteers was halted by the Food and Drug Administration last month because of side effects. But the F.D.A. last week said that the drug was safe enough to test in people actually infected with Ebola. Mark J. Murray, Tekmira's chief executive, told analysts Wednesday that the company was exploring possible use of the drug in Africa Sarepta Therapeutics has said it has enough experimental drug left over to treat about two dozen people. The company stopped developing the drug, which also uses RNA interference, after the Defense Department halted its funding. A flu drug being developed by Fujifilm Holdings of Japan has shown some effectiveness against Ebola in mice, and BioCryst also has an antiviral drug that has been tested in mice. The next step is for those drugs to work in monkeys. "I have shelves full of things that protect rodents that don't work in monkeys," said Dr. Thomas W. Geisbert, a professor and Ebola expert at the University of Texas Medical Branch at Galveston. "If it doesn't protect a monkey, it's hard to imagine how you would push it forward for use in humans." The World Health Organization said on Tuesday that it would be permissible to try to treat Ebola patients with untested medicines, providing certain ethical standards were observed. Even so, Dr. Marie-Paule Kieny, the organization's assistant director general, was cautious. "It is very important to not give false hope to anybody that Ebola can be treated now," she said at a news conference in Geneva. Since drugs directed specifically at Ebola are still in early development, some doctors are suggesting trying drugs already approved for other uses that are readily available and proved to be relatively safe — like statins. The champion of this idea is Dr. David Fedson, a retired professor and vaccine company executive living in France. He said that although statins did not attack the virus, they might help calm the runaway immune system reaction that could follow infection, which is what inflicts much of the damage on the body. "The concept of treating the host response is sitting there in front of our noses," said Dr. Fedson, who has been trying to rally support for his proposal. So far, however, the W.H.O. had turned up its nose at the idea, he said. Some Ebola experts are also skeptical. "When you start talking about modulating the immune response, you can have unintended consequences," said Dr. Geisbert of the University of Texas.
Posts
No comments:
Post a Comment