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US regulators recall 10-minute Ebola test

AFP                                                                                April  23, 2015
Miami  - US regulators have issued an international recall for a 10-minute Ebola blood test made by a California-based company, saying it has not been proven to work and could put lives at risk.

"A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale," said the Food and Drug Administration in a statement emailed to reporters on Thursday.

"The results obtained from these test kits have not demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection."

Contacted by AFP, a company representative in San Diego said early trials have shown the test to be 86 percent accurate. The problem with the FDA came down to a labeling error, he said. The equipment had not been properly labeled "for research purposes only."

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http://news.yahoo.com/us-regulators-recall-10-minute-ebola-test-193530081.html;_ylt=AwrC1CmnSjlVNDsAZTDQtDMD;_ylu=X3oDMTByaWg0YW05BGNvbG8DYmYxBHBvcwM4BHZ0aWQDBHNlYwNzcg--

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UN envoy: Expect Ebola vaccine in coming months

INQUIRER.NET  by Kristine Angeli Sabillo                  APRIL 8, 2015

MANILA --As the Ebola outbreak in West Africa winds down, the United Nations is optimistic that a vaccine against the deadly virus will be made available in the next several months.

“Clinical trials have have now been undertaken of candidate vaccines, two of them. They are now at an advanced stage,” Dr. David Nabarro, UN secretary general special envoy on Ebola, told reporters in Manila on Wednesday.

“I believe that we will have a vaccine against Ebola that is available and can be used particularly for doctors and nurses who provide treatment for people with the disease in the coming months,” he added.

According to the World Health Organization, the two vaccine candidates undergoing efficacy trials are ChAd3-ZEBOV, developed by GlaxoSmithKline (GSK), and rVSV-ZEBOV, developed by NewLink Genetics and Merck Vaccines USA. The first is being developed in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID) and the second with the Public Health Agency of Canada.

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http://globalnation.inquirer.net/120463/un-envoy-expect-ebola-vaccine-in-coming-months/

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Ebola Vaccine 2015: Guinea Seen As Best Hope For Preventative Drug Trials, But Time Is Running Out

INTERNATIONAL BUSINESS TIMES by Philip Roth       April 7, 2015

(Two stories. Scroll down)
Health officials’ best bet for discovering a vaccine for Ebola lies with the West African country of Guinea, where the outbreak that has killed an estimated 10,500 over the past year began, and the place that researchers largely ignored when it came time for drug trials. As researchers race to find a vaccine before the window of opportunity closes – essentially, before the epidemic is brought to an end -- scientists with the World Health Organization are beginning to test a vaccine in Guinea manufactured by researchers in the U.S. and Canada.

 

The race to find a vaccine for Ebola is in its final lap. Pictured, research assistant Georgina Bowyer works on a vaccine for Ebola at the Jenner Institute in Oxford, southern England, Jan. 16, 2015. Reuters

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Ebola pioneer, stem cell researcher honoured with Canada Gairdner Awards

CANADIAN PRESS                                                                                March 25, 2015
One of the co-discoverers of the Ebola virus and a leading Canadian stem cell researcher are among this year's winners of the prestigious Canada Gairdner Awards.

Dr. Peter Piot is the recipient of the Canada Gairdner Global Health Award, recognizing his work on the discovery of the Ebola virus in 1976 and his leadership in the global response to the HIV-AIDS epidemic.

Dr. Janet Rossant, chief of research at Toronto's Hospital for Sick Children, is the recipient of the 2015 Canada Gairdner Wightman Award, which honours a Canadian who has demonstrated outstanding leadership in medicine and medical science.

Five international scientists are also being honoured with Canada Gairdner Awards, two each from the United States and Japan and one from Switzerland....

Dr. Peter Piot won the 2015 Canada Gairdner Global Health Award in recognition of his work on the discovery of the Ebola virus in 1976 and his leadership in the global response to the HIV-AIDS epidemic. (David Azia/Associated Press)

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FDA panel to discuss Ebola vaccine development in May

REUTERS                                                    March 18, 2015

WASHINGTON ==The U.S. Food and Drug Administration said an advisory panel will discuss the development of Ebola vaccines, days after an American health worker was flown back after being tested positive for Ebola in Sierra Leone.

The federal health regulator would discuss the development of vaccines on May 12, it announced on its website on Wednesday.

The resurgence of the virus last year prompted drugmakers from across the world to develop new treatments that are in different stages of studies....

The World Health Organization said it will decide on mass vaccination against the virus in August.

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http://www.reuters.com/article/2015/03/18/us-health-ebola-fda-idUSKBN0ME1D520150318
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See Federal Register notice of meeting.

https://www.federalregister.gov/articles/2015/03/17/2015-06116/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting

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New Ebola drug trial starts in Sierra Leone

SCIENCE By Kai Kupferschmidt                                                                       March 11, 2015

Researchers in Sierra Leone today started a new phase II trial of an experimental drug in Ebola patients. The first participant received an injection of the therapeutic, called TKM-Ebola, this morning at an Ebola treatment unit in Kerry Town. The trial may expand to other sites; the study team hopes to have an answer fast so that it can either move on to another drug or start a phase III study of TKM-Ebola.

Produced by Tekmira Pharmaceuticals in Burnaby, Canada, TKM-Ebola is made of synthetic, small interfering RNAs packaged into lipid nanoparticles. The RNAs target three of Ebola’s seven genes, blocking the virus’s replication. TKM-Ebola has been shown to work well in monkeys; the efficacy trial in humans is only starting now because there was not enough of the drug available earlier. Also, the RNAs have been adapted to the strain circulating at the moment.

The study does not have a placebo arm; all patients at the trial site are eligible for the drug, and researchers hope to determine whether it works by comparing them with patients treated elsewhere.

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Ebola doctors, nurses no longer recruited for West Africa: Canada

CBCNEWS.CA                                                      March 5, 2015

A national recruitment drive for health-care workers to help with the Ebola outbreak in West Africa has been halted for now as the number of new cases of the disease is dropping.

The Canadian Red Cross says the focus is shifting from an emergency response to recovery.

Almost 900 Canadians responded to a recruitment drive last fall by the federal government and the Red Cross....

Dr. Gregory Taylor, Canada's chief public health officer, said a second mobile lab is on its way back to Canada and should arrive by spring. But he said Canada is not walking away from West Africa.

Instead, he said, the federal government is about to send a team of five new experts into the field for four to eight weeks.  "What we're sending is epidemiologists, border health specialists and some emergency management skills, and in particular we've been asked to send French-speaking experts in those areas," Taylor told CBC News.

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https://ca.news.yahoo.com/ebola-doctors-nurses-no-longer-100000922.html

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WHO names Ebola response chief

AFP                                                                      Feb. 3, 2015
GENEVA: The World Health Organization said Tuesday it had appointed its assistant director-general Bruce Aylward to head its overall response to the deadly Ebola outbreak.

It also said an independent commission was being created to assess WHO's widely criticised response to the epidemic, after the UN agency admitted last month it had been caught napping on Ebola and pledged reforms to avoid similar mistakes in the future.

WHO spokeswoman Fadela Chaib told reporters that Alward, a Canadian, will be responsible for coordinating all the different aspects of the agency's response to the devastating outbreak, which has killed nearly 9,000 people, almost all of them in Guinea, Sierra Leone and Liberia.

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Canada sends more help to fight Ebola in West Africa

TORONTO SUN      by Hal Roberts                              Jan. 13, 2015

OTTAWA — A third mobile lab and two more scientists from the Public Health Agency of Canada are on their way to help fight Ebola in West Africa.

 

Sean Freeman points out on a map of Africa where he was working at the Red Cross offices in downtown Calgary, Alta. where he has returned from working at the Red Cross Ebola Treatment Centre in Kenema, Sierra Leone. on Monday January 5, 2015. Stuart Dryden/QMI Agency

The doctors will spend a week in Amsterdam and Belgium to train with Doctors without Borders before heading to Sierra Leone on Jan. 18.

"It is our hope that the work of this third mobile laboratory — providing physicians with ongoing information about the health of their patients — will allow health-care workers to provide medical treatments tailored to their patients' needs and ultimately, save more lives," Health Minister Rona Ambrose said in a statement Tuesday.

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http://www.torontosun.com/2015/01/13/canada-sends-more-help-to-fight-ebola-in-west-africa

 

 


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Merck-NewLink Ebola vaccine trial resumes at lower dose: Geneva hospital

(Two stories. Scroll down.)

REUTERS                                                       Jan. 5, 2015

GENEVA --The clinical trial of an Ebola vaccine developed by Merck and NewLink resumed on Monday at a lower dose after a pause to assess complaints of joint pains in some volunteers, the University of Geneva hospital said.

The Geneva hospital announced on Dec. 11 that its vaccine trial had been suspended as a precautionary measure after four patients complained of joint pains. On Monday, the hospital said 10 of 59 volunteers who received the vaccine had felt pains in their joints "similar to rheumatism" after some two weeks, but these symptoms had disappeared rapidly without any treatment.

Swissmedic, the Swiss regulatory agency, and ethics and safety committees have approved the resumption of the trial at a lower dose, the hospital said in a statement.

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http://www.reuters.com/article/2015/01/05/us-health-ebola-vaccine-idUSKBN0KE0XP20150105
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Read related announcement.

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