Research

REUTERS                                                                                                                    Dec. 9, 2014

CHICAGO -- The U.S. Department of Health and Human Services on Tuesday offered liability protections to drugmakers rushing to develop Ebola vaccines and urged other countries to follow suit.

Health and Human Services (HHS) Secretary Sylvia Burwell made the announcement as part of the Public Readiness and Emergency Preparedness (PREP) Act in a move aimed at encouraging the development and availability of experimental Ebola vaccines.

The declaration provides immunity under U.S. law against legal claims related to the manufacturing, testing, development, distribution, and administration of three vaccines for the Ebola virus. However, it does not provide immunity for a claim brought in a court outside the United States...

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http://www.reuters.com/article/2014/12/09/us-health-ebola-vaccine-idUSKBN0JN1S920141209

Clinical Trials Are Being Launched in Africa but Face Challenges in Designing Ethical Studies, Compensating Donors

WALL STREET JOURNAL                                                                                                    Dec. 5, 2014
by Betsy McKay in Atlanta, David Gauthier-Villars in Conakry, Guinea, and Patrick McGroarty in Monrovia, Liberia

...Nearly a year after Ebola began spreading in West Africa, and with a proven drug or vaccine still far off, researchers are launching clinical trials on a product at hand: the blood of survivors.

 They want to determine whether so-called convalescent plasma or serum, chock full of antibodies, can help fight off the disease. But they face a number of complexities in carrying out the trials, including persuading survivors to participate....

THE NEW ENGLAND JOURNAL OF MEDICINE                                                                                 Dec. 3, 2014
By Edward Cox, M.D., M.P.H., Luciana Borio, M.D., and Robert Temple, M.D.

...Studying investigational therapies for EVD presents scientific, practical, and ethical challenges. Not surprisingly, there has been substantial debate about the best and most appropriate study approaches.2,3 It is generally agreed that a trial with a concurrent control group, in which patients are randomly assigned to receive the test drug plus the best available supportive care (BASC) or to BASC alone, would be the most efficient and reliable way to evaluate the safety and effectiveness of candidate products.

 Some people in the health care community, however, have argued against such trials, urging instead use of a historical control — that is, making investigational drugs as widely available as their supply allows and then comparing mortality rates among treated patients with rates that would have been expected absent the drugs, on the basis of past experience with EVD.

ASSOCIATED PRESS                                                                                                        Dec. 2, 2014 

BETHESDA, Maryland  — Declaring the "fight is nowhere close to being over," President Barack Obama on Tuesday heralded strides in the effort to confront Ebola in West Africa and in protecting the U.S. against the spread of the deadly virus. He said squelching the disease remains an urgent priority even if the American public's attention has shifted elsewhere.

"We cannot let down our guard, even for minute," Obama said. "We can't just fight this epidemic, we have to extinguish it."

Obama spoke after touring the National Institutes of Health in Washington's Maryland suburbs where he witnessed advances in Ebola-fighting research. He highlighted the NIH's progress in developing an Ebola vaccine, calling the initial results "exciting" while cautioning that there are "no guarantees" about the vaccine's ultimate success.

NIH researchers last week reported that the first safety study of a vaccine candidate found no serious side effects, and that it triggered signs of immune protection in 20 volunteers. U.S. health officials are planning much larger studies in West Africa to try to determine if the shots really work...