Drug Manufacturers Race To Cure Ebola.

Leading the News

Drug Manufacturers Race To Cure Ebola.

The Wall Street Journal (10/18, Loftus, Mckay, Subscription Publication) explored in depth the status of experimental drugs to treat Ebola and participation from the Bill and Melinda Gates Foundation and the WHO in getting these experimental drugs tested and distributed.

        Bloomberg News (10/18, Langreth) also reported on the Bill and Melinda Gates Foundation’s participation in finding a viable treatment for Ebola, giving Mapp Biopharmaceutical Inc. of San Diego, California a $150,000 grant to pursue the drug ZMapp. Amgen notes it would also work with the Foundation. Bloomberg also mentions an email from the Biomedical Advanced Research and Development Authority (BARDA), under the Department of Health and Human Services, which states that the US government previously asked three centers to develop drugs using tobacco plants, to which Texas A&M replied with a proposal.

        Reuters (10/17, Begley) also reports BARDA’s request submit plans for expediting production of the Ebola treatment ZMapp using tobacco plants. Amgen Inc. also announced on Friday that it would begin work on producing the treatment using mammalian cells.

        McClatchy (10/18, Zarocostas, Subscription Publication) also covers the delay in GlaxoSmithKline’s Ebola vaccine that “likely won’t be ready before the current epidemic has passed.” GSK Ebola research director Dr. Ripley Ballou “told the BBC that full data on a vaccine’s safety and efficacy won’t be ready until late 2015, and full-scale production for general use won’t happen until well into 2016.” On the otherhand, Reuters (10/18) reports GlaxoSmithKline said its development of an experimental Ebola vaccine was progressing rapidly. In a statement on its website, GSK says, “Development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the USA, UK and Mali, and further trials due to start in the coming weeks.”

        The AP (10/17) reported that Chimerix of North Carolina got permission from the FDA on Thursday to take its antiviral Ebola treatment drug to the trial stage.

        The Baltimore Sun (10/18, Dance) reported that the Center for Vaccine Development will begin testing an Ebola vaccine on humans by next month, though it has already started testing in Mali. Testing was able to begin in Mali within days of the WHO’s decision to allow for clinical trials in the field. Results from the Mali testing are expected within months.

        Canada To Ship Experimental Vaccine To WHO Monday. The AP (10/18) reported that a Canadian news release sent Saturday, the Public Health Agency of Canada announced it would send 800 vials of an experimental vaccine to the WHO. Reuters (10/18, Hodgson) also covers the announcement, adding that Canada is unsure how many people the experimental vaccine will immunize and that the manufacturer, NewLink Genetics Corp “would be able to produce tens of thousands of vaccine doses within a month or two.” The Hill (10/18, Barron-Lopez) reports on the vaccine and also includes that food will be delivered to quarantined people in Sierra Leone from the UN’s World Food Program. TIME (10/20) quotes Dr. Gregory Taylor, Chief Public Health Officer of Canada, as saying, “This vaccine, the product of many years of scientific research and innovation, could be an important tool in curbing the outbreak,” about the vaccine.

        The Wall Street Journal (10/18, Menon, Subscription Publication) reported that in addition to the vaccines, Canada has pledged $30 million (Canadian) to Ebola. Canada had earlier given $35 million (Canadian) to the Red Cross and other NGO’s.

        NIH Researcher’s Work May Play Key Role In Ebola Vaccine Development. In a front-page story, the Wall Street Journal (10/19, A1, Burton, Subscription Publication) examines the history of Dr. Nancy J. Sullivan, a senior investigator at the National Institutes of Health’s Vaccine Research Center, and her research on an Ebola vaccine, which is now being tested on healthy people by NIH. Dr. Anthony Fauci of the NIAID says the testing has not revealed any “red flags” yet, but he supports following up with full randomized trials, rather than testing it in the field.

        Hiltzik: Alternative Drug Testing May Speed Up Ebola Vaccine. Michael Hiltzik wrote in his Los Angeles Times (10/17, Hiltzik) column that GlaxoSmithKline’s vaccine will likely not begin phase III testing until early next year, and “even if immunogenic response is good, it doesn’t mean vaccine takers are necessarily protected.” Randomized control trials will be used to test the vaccine, though Hiltzik considers other options such as giving alternative antivirals rather than a placebo to participants or the “stepped-wedge” approach, which gives all participants the vaccine but at different times.

        Dallas Hospital’s Ebola Screening Device Went Unused Because Of FDA Guidelines. The Washington Times (10/18, Ernst) reports Texas Health Presbyterian Hospital “had a version of the Ebola-screening device used by the U.S. military in West Africa sitting on a shelf, but FDA guidelines prohibited staff from using it on the patient.” When Duncan came to the hospital with a fever, a “$39,000 machine called FilmArray was available” to the hospital. The machine “has a high success rate for detecting Ebola in less than one hour, but sat idly because current federal guidelines prevented the hospital from obtaining a specific ‘kit’ needed for screening, the military website Defense One reported Thursday.”