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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
(Score: 2) by Runaway1956 on Tuesday December 27 2016, @06:05PM
"Not one of the 6,000 people in Guinea who were given the test vaccine last year contracted the disease within 10 days, WHO said on Friday announcing the final results, without elaborating on what happens after 10 days as Ebola has an incubation period of up to three weeks."
TFS gives us a number of 5837. TFA says 6000. We have a LOT of room for error here. What happened to those other 163 patients? They all died, so the numbers were discarded? Probably not, but when there is such a huge discrepancy, we want to ask questions.
Then, the incubation period for the disease is three weeks - so we put the survival date at ten days? That's almost like chicken's eggs take 28 days to hatch (I think) so you look at them on day ten, see that none hatched, and you trash them all. DERP!!
"If we compare zero to 23, this strongly suggests that the vaccine is very effective, that it could be up to 100 percent effective," Marie-Paule Kieny, WHO's assistant director-general and lead author of the study, told AFP news agency.
I'm having problems here. I don't see it spelled out that both populations had equal exposure to the ebola virus.
FURTHER DOWN in the article, I find "Of the more than 6,000 people injected with the Ebola vaccine only two showed serious adverse effects, the study reported. Both recovered fully." So, now it's MORE THAN 6000 people? My bullshit meter is starting to go crazy here . . . .
Let's read between the lines a little:
initially developed in Canada . . . fast-track approval process . . . China and Russia have also developed vaccines . . . "We may have a vaccine which is registered in 2018," Kieny said at a press conference on Thursday, noting that the standard approval process for a new drug takes a decade, if not more.
What it sounds like to me is, western megacorporations have bribed health officials to approve of an experimental drug, so that they can beat Russian and Chinese competitors to market? Does anyone else get that message?
Abortion is the number one killed of children in the United States.
(Score: 3, Informative) by Joe on Tuesday December 27 2016, @08:00PM
Stick to the Lancet article since it is the primary research article and there may be things lost in popular press translation.
The prespecified primary outcome was a laboratory confirmed case of Ebola virus disease with onset 10 days or more from [vaccination] [...] The evidence from randomised and non-randomised clusters and the fact no cases of Ebola virus disease occurred 10 or more days after vaccination (through the 84 days follow-up period and from the indefinite surveillance system throughout the epidemic period)
The primary outcome was disease after 10+ days of vaccination, since the appearance of disease earlier than that would mean that the vaccine didn't have enough time to induce immunity. In the immediate vaccination arm, there was no cases of ebolavirus disease. The group checked individual cases of those vaccinated to 84 days, but the continued public health surveillance (that was independently looking for any ebolavirus disease) did not identify any additional cases of disease in the vaccinated groups.
The total numbers were "5837 individuals in total received the vaccine (5643 adults and 194 children)". The exposure level was the same initially, since it was randomized (one group of 2119 and another of 2041), but after efficacy had been established the vaccination was made immediately available to the rest.
The vaccine seems to have been in development since at least 2002 (and the pseudotyping strategy much before that), but the ebolavirus outbreak seemed to put a lot of pressure on governments to allow fast-tracking of treatments (such as this and ZMapp).
- Joe
http://jid.oxfordjournals.org/content/196/Supplement_2/S404 [oxfordjournals.org]
(Score: 1) by khallow on Tuesday December 27 2016, @11:19PM
The vaccine seems to have been in development since at least 2002 (and the pseudotyping strategy much before that), but the ebolavirus outbreak seemed to put a lot of pressure on governments to allow fast-tracking of treatments (such as this and ZMapp).
Maybe this implies, on top of everything else, that fast-tracking medical research should be the norm rather than the exception?
(Score: 2) by nethead on Tuesday December 27 2016, @11:52PM
Maybe this implies, on top of everything else, that fast-tracking life saving medical research should be the norm rather than the exception?
FIFY.
We don't need to fast track yet another baldness cure.
How did my SN UID end up over 3 times my /. UID?
(Score: 0) by Anonymous Coward on Tuesday December 27 2016, @11:56PM
I don't remember what happened with ZMapp, but remember when the original paper came out it was BS too. IIRC, unblinded technicians euthanized monkeys according to subjective and poorly described criteria. The primary outcome was survival of the monkeys! Then there is this study: They gave the subjects a substance that suppresses ebola symptoms (and has also been proposed to "cure" ebola) after the vaccination, then only looked at data for the next 1.5 weeks.
If the medical field is still struggling with basic concepts like blinding and making sure you are measuring the correct thing, I don't think more money should be thrown at it.
(Score: 0) by Anonymous Coward on Tuesday December 27 2016, @11:59PM
No idea where 1.5 weeks came from, that should be 4 weeks.
(Score: 2) by Joe on Wednesday December 28 2016, @12:54AM
It is the norm (at least in the US) for disease with very low survival rates. It is hard to give a patient something that is worse than Ebola or stage 4 cancer, so many clinical trials start in patients with little hope of survival. Drug companies are sometimes hesitant to do this (or compassionate use) for fear of investors getting cold feet when they see patients dying (they would've died anyway but the drug still didn't work).
"Do no harm" is an easy standard to meet when the patient is dying.
- Joe
(Score: 1) by khallow on Wednesday December 28 2016, @09:56AM
"Do no harm" is an easy standard to meet when the patient is dying.
The patient is always dying. Not of male pattern baldness as the other poster noted, but everyone dies of something.
(Score: 1, Interesting) by Anonymous Coward on Tuesday December 27 2016, @08:20PM
They also say:
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]
(Score: 1, Informative) by Anonymous Coward on Tuesday December 27 2016, @08:39PM
Besides just masking symptoms, supposedly ibuprofin binds to and destabilizes the virus coating:
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
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
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
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
How do you interpret this line from the paper:
Also,
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
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
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:
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
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
More on the ibuprofin approach:
https://www.ncbi.nlm.nih.gov/pubmed/26167272 [nih.gov]
And it is common knowledge that ibuprofin is used to mask symptoms:
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
Wow, it is even in Washington State health guidelines that ibuprofen and acetaminophen should be avoiding when monitoring for diagnosis:
http://www.doh.wa.gov/portals/1/documents/5100/420-126-guideline-ebola.pdf [wa.gov]