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Yes. But notice that the original poster said to give this thing to health care workers first. I think that's a fairly reasonable position to take given that th
by icegreentea 12y ago
Yes. But notice that the original poster said to give this thing to health care workers first. I think that's a fairly reasonable position to take given that the confidence in the safety of the vaccine is high, and that even if the health care workers were given the vaccine, they should be following the same decontamination/personal protection protocols anyways (for person health reasons - no vaccine is 100% perfect and for public health reasons - it minimizes cross infection).
In addition, it is possible to do accelerated Phase 2/3 in Africa. This is also a compromise position. In this scheme, they would likely dispense a few thousand vaccines in a relatively highly developed, but still high risk area to aid in their ability to track efficacy. From the NIH FAQ on Ebola vaccines (http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxResultsQA.aspx http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxResultsQA.asp...)
Given the encouraging results of the bivalent version of the NIAID/GSK experimental Ebola vaccine at the NIH Clinical Center, are there plans for Phase 2/3 clinical trials in West Africa?
NIAID is in active discussions with Liberian officials and other partners about next-stage vaccine testing in West Africa. The goal of these studies would be to test efficacy and safety of the NIAID/GSK vaccine compared to other Ebola vaccine candidates prior to wider vaccine distribution. Phase 2/3 clinical trials are designed to inform efficacy—whether or not the vaccine works—and provide additional critical safety data. Plans for such studies are dependent on additional safety and immunogenicity data derived from the currently ongoing clinical trials. Announcements about larger-scale testing will not be made until early 2015.
Keep in mind that is basically is impossible to do Phase 2 and 3 testing in North America given the fact that there basically isn't any Ebola there at all.
- hga 12y agoIndeed. And after testing it on volunteers in the U.K. and maybe US (it is being tested in Bethesda by the NIH, I don't know the timing), this particular vaccine is being tested on volunteer healthcare workers in Mali, see e.g. http://www.citypress.co.za/news/africas-first-ebola-vaccine-trial-starts-mali/ http://www.citypress.co.za/news/africas-first-ebola-vaccine-... (I think they've tested it on more people since that article, you no doubt want to go a bit slowly since many of the worst reactions are fairly quick). And I think there are some other African locations scheduled. Vaccines and epidemics are a pretty well understood concepts after all (ignore the "public health" types who are obsessed with lifestyle etc. issues to the detriment of infectious diseases, like the current head of the CDC), there's no surprise people are attempting to Do The Right Thing with these candidate vaccines. E.g. as I note elsewhere in this discussion, this one is in the process of being produced at an intermediate scale of 10,000 doses, which is a necessary step before true mass production.
- tim333 12y agoUpdate - they do seem to be trying to crack on: "Ebola Vaccine May Be Ready as Early as January 2015" "If further clinical trials result in an effective vaccine, health care workers who treat those with Ebola will likely be the first to receive it." http://newsone.com/3074615/ebola-vaccine-may-be-ready-as-early-as-january-2015/ http://newsone.com/3074615/ebola-vaccine-may-be-ready-as-ear...