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posted by Fnord666 on Tuesday December 27 2016, @03:34PM   Printer-friendly
from the now-let's-work-on-the-cold dept.

An experimental vaccine for Ebola has been developed by the World Health Organization and has displayed a 100% success rate on its trials in Guinea.

"It's the first vaccine for which efficacy has been shown," said Dr Marie-Paule Kieny, a WHO assistant director-general and the study's lead author.

The vaccine was distributed to 5,837 people last year in Guinea, according to the Lancet medical journal. Within 10 days, all participants were free of the virus; they were followed up on for 84 days. It has proven to be nearly free of major side-effects (minor side-effects included headaches, fatigue, and muscle pain, but what doesn't), except for 80 people who had severe problems, only 2 of which could accurately be linked to the vaccine. All recovered without complications.

Other treatments are still under study, and other strains of Ebola such as Sudan still need a vaccine.

Sources: The Lancet Al Jazeera NY Times


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  • (Score: 1, Interesting) by Anonymous Coward on Tuesday December 27 2016, @08:20PM

    by Anonymous Coward on Tuesday December 27 2016, @08:20PM (#446438)

    They also say:

    To assess safety, vaccinees were observed for 30 min post-vaccination and at home visits on days 3, 14, 21, 42, 63, and 84. The possible causal relationship of any adverse event to vaccination was judged by the study physicians and reported to the DSMB. Vaccinees were provided with acetaminophen or ibuprofen for the management or prevention of post-vaccination fever.
    [...]
    The primary outcome was a laboratory confirmed case of Ebola virus disease, defi ned as any probable or suspected case from whom a blood sample was taken and laboratory confi rmed as positive for Ebola virus; or any deceased individual with probable Ebola virus disease, from whom a post-mortem sample taken within 48 h after death was laboratory confirmed as positive for Ebola virus disease
    [...]
    vaccinated cases of Ebola virus disease with an onset of more than 31 days after random assignment were censored

    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32621-6/fulltext [thelancet.com]

    So they monitored them for 84 days but only reported results up to 31 days, and of those didn't count the first 10 days. So overall they seem to be reporting on 21/84 = 25% of the data. If your incubation period of 3 weeks is correct that would be even more insane, I have no idea where they got that number from though.

    Also it is interesting that an unspecified number also received acetaminophen/ibuprofin after being vaccinated. I presume this would affect the rate of diagnosis. From their ref 23, we see that "onset of fever" is a huge determinant of whether to suspect a case:
    http://www.who.int/csr/resources/publications/ebola/ebola-case-definition-contact-en.pdf [who.int]

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  • (Score: 1, Informative) by Anonymous Coward on Tuesday December 27 2016, @08:39PM

    by Anonymous Coward on Tuesday December 27 2016, @08:39PM (#446445)

    Besides just masking symptoms, supposedly ibuprofin binds to and destabilizes the virus coating:

    In what is being hailed as a significant breakthrough in the battle against the deadly Ebola virus, researchers have found an unlikely treatment source - an everyday ibuprofen painkiller.

    http://www.wired.co.uk/article/ibuprofen-ebola-treatment-cure [wired.co.uk]
    http://www.nature.com/nature/journal/v535/n7610/full/nature18615.html [nature.com]

  • (Score: 3, Interesting) by Joe on Tuesday December 27 2016, @08:43PM

    by Joe (2583) on Tuesday December 27 2016, @08:43PM (#446446)

    vaccinated cases of Ebola virus disease with an onset of more than 31 days after random assignment were censored to account for vaccination in the delayed clusters on day 21

    They did not include disease within the first ten days post-vaccination in their efficacy calculations because that is too early for the vaccine to establish immunity. The first ten days in the immediate vaccination group were days 0-10 and the first ten days for the delayed vaccination group were days 21-31.

    Vaccinees were provided with acetaminophen or ibuprofen for the management or prevention of post-vaccination fever.

    I highly doubt that acetaminophen or ibuprofen would be able to prevent ebolavirus disease, especially in the long-term. I'm sure that much stronger anti-inflammatories were used in the palliative care of patients with disease.

    - Joe

    • (Score: 0) by Anonymous Coward on Tuesday December 27 2016, @08:52PM

      by Anonymous Coward on Tuesday December 27 2016, @08:52PM (#446452)

      Yes I understand the reasoning behind the 10 days rule, but nevertheless that data is rendered unusable, and I want to know how many people got Ebola more than 31 days after vaccination. There is no reason to truncate that.

      Also, see my additional posts about Ibuprofen. This is way worse than I first thought. Apparently that confound is well known and easily searchable (took me a few minutes to speculate and search around). Usually I don't recommend it, but this paper should be retracted.

      • (Score: 2) by Joe on Tuesday December 27 2016, @09:30PM

        by Joe (2583) on Tuesday December 27 2016, @09:30PM (#446468)

        how many people got Ebola more than 31 days after vaccination

        Zero, in the immediate vaccination group. The follow-up period was 84 days and public health surveillance continued throughout the epidemic.

        The ibuprofen paper you linked to was a molecular modelling paper with no actual wet experiments. There is another paper that does some in vitro binding assay that shows a 6mM (at least three orders of magnitudes off typical small molecule antivirals) binding constant for ibuprofen and their high dose of ibuprofen in their ebolavirus surface protein pseudotyped HIV particles only show a small effect in their in vitro fusion assay.

        - Joe

        https://www.ncbi.nlm.nih.gov/pubmed/27362232 [nih.gov]

        • (Score: 0) by Anonymous Coward on Tuesday December 27 2016, @09:52PM

          by Anonymous Coward on Tuesday December 27 2016, @09:52PM (#446482)

          How do you interpret this line from the paper:

          vaccinated cases of Ebola virus disease with an onset of more than 31 days after random assignment were censored

          Also,

          The ibuprofen paper you linked to was a molecular modelling paper with no actual wet experiments. There is another paper that does some in vitro binding assay that shows a 6mM (at least three orders of magnitudes off typical small molecule antivirals) binding constant for ibuprofen and their high dose of ibuprofen in their ebolavirus surface protein pseudotyped HIV particles only show a small effect in their in vitro fusion assay.

          Sure, we don't need to bother with mentioning it when interpreting the results. It must be the vaccine because that is our favorite explanation. How about that ibuprofen suppresses the primary ebola symptom, is purposefully used to this end to avoid detection, and warned against by public health organizations?

          • (Score: 3, Informative) by Joe on Wednesday December 28 2016, @12:32AM

            by Joe (2583) on Wednesday December 28 2016, @12:32AM (#446515)

            In the context of the paragraph, they excluded ebolavirus disease in their efficacy calculations that occurred up to 10 days after vaccination due to the lag time of immunity. In the context of the paper, the authors report ebolavirus disease "through the 84 days follow-up period and from the indefinite surveillance system throughout the epidemic period".

            we don't need to bother with mentioning it when interpreting the results

            The patients reported 14 cases of fever out of 5837 patients and 11 of those were within the first 3 days after vaccination (within the 10-day period excluding ebolavirus disease). You can look at the graph and see that patients are still getting ebolavirus disease during this time in both treatment groups. There is no evidence for ibuprofen curing ebolavirus disease and there is incredibly weak data of it as an direct ebolavirus antiviral.

            Scientific papers are not gospel, so feel free to disagree with their conclusions or my interpretation of their findings. If you take the position of assuming bad faith (hiding data, deliberately giving patients a cure for ebolavirus to alter their results, deceptive in their presentation of their conclusions), then there is no amount of evidence in the paper that could convince you of anything. What I don't understand is that you seem to require very little scientific evidence to support your idea of ibuprofen acting as a curative ebolavirus antiviral or as a long-lasting curative preventative treatment.

            - Joe

            • (Score: 0) by Anonymous Coward on Wednesday December 28 2016, @04:50AM

              by Anonymous Coward on Wednesday December 28 2016, @04:50AM (#446556)

              Thanks, are you sure that does not refer to some subgroup? I am not willing to put the effort towards parsing phrases like this right now:

              Moreover, when comparing all contacts and contacts of contacts in clusters immediately vaccinated versus all contacts and contacts of contacts in delayed clusters plus all contacts and contacts of contacts never vaccinated in immediate or non-randomised clusters...

              And no, you have misinterpreted my concerns. I expect attempts to avoid obvious confounds, and discussion of alternative explanations in the paper with justification for why some (including not obvious) could not be dealt with. Sampling bias, which is all they discuss, is one tiny part.

              • (Score: 0) by Anonymous Coward on Wednesday December 28 2016, @12:43PM

                by Anonymous Coward on Wednesday December 28 2016, @12:43PM (#446642)

                Yes.

                As for the quote:
                The ring strategy used contact tracing from an index case, so anyone who had direct contact with someone with Ebola (contacts) or indirect contact through another person (contacts of contacts).
                Patients were randomly assigned to the immediate or delayed vaccination group prior to vaccination, but not all patients consented or showed up to be vaccinated (never vaccinated group).

                The numbers for these groups and the percent compliance for each day of interaction is in the supplement.

  • (Score: 0) by Anonymous Coward on Tuesday December 27 2016, @08:43PM

    by Anonymous Coward on Tuesday December 27 2016, @08:43PM (#446447)

    More on the ibuprofin approach:

    Detailed analysis of these drugs revealed the non-steroidal anti-inflammatory drug ibuprofen as an inexpensive, widely accessible and minimally toxic candidate for prevention and treatment of EVD. Furthermore, the molecular mechanism underlying this possible protective effect of ibuprofen against EVD is suggested in this article.

    https://www.ncbi.nlm.nih.gov/pubmed/26167272 [nih.gov]

    And it is common knowledge that ibuprofin is used to mask symptoms:

    People who contract Ebola in West Africa can get through airport screenings and onto a plane with a lie and a lot of ibuprofen, according to healthcare experts who believe more must be done to identify infected travelers.

    http://www.reuters.com/article/us-health-ebola-screening-idUSKCN0HS09J20141003 [reuters.com]

    Yea, the current paper is inadmissible as evidence that this vaccine works.

  • (Score: 0) by Anonymous Coward on Tuesday December 27 2016, @08:48PM

    by Anonymous Coward on Tuesday December 27 2016, @08:48PM (#446449)

    Wow, it is even in Washington State health guidelines that ibuprofen and acetaminophen should be avoiding when monitoring for diagnosis:

    Recommend the person not use antipyretic analgesics (e.g., aspirin, ibuprofen, acetaminophen) while under monitoring to avoid suppressing a diagnostic fever.

    http://www.doh.wa.gov/portals/1/documents/5100/420-126-guideline-ebola.pdf [wa.gov]