The Russian vaccine for Covid-19(thelancet.com)
thelancet.com
The Russian vaccine for Covid-19
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30402-1/fulltext
184 comments
As far as I understood, from the bureaucratic point of view this was some kind of temporary approval needed to include risk groups in phase 3 trial, which could be a good thing given the general urgency of the situation. And then, yes, Putin made a political gesture out of this implementation detail.
Let’s hope under the covers things are progressing in the typical prudent manner. Even so, I worry about the extra pressure on phase 3 trials for a vaccine that’s already been announced publicly.
There are two vaccines on the final stages of development in Russia. One from Gamaleya center (Moscow), another from «VECTOR» facility (Novosibirsk).
From my (layman's) point of view, Gamalaeya's vaccine is somewhat hurried in development. Also, Gamaleya is known for its lobbying power. In the past, it approved and popularized a number of controversial drugs like Kagocel and a few of «-feron» drugs.
VECTOR's vaccine, on other hand, looks more trustworthy.
Vector is an established facility with a long history.
I'd wait until Vector's stuff is ready if I were living in Russia.
I'd wait until Vector's stuff is ready if I were living in Russia.
Yes, as someone who lives in ex-USSR, I agree.
Yep, Vector has a long history: https://www.youtube.com/watch?v=_w7SAeNcXA8
> Post-registration clinical trials involving more than 40,000 people in Russia will be launched in a week starting from August, 24. ... The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to start in September 2020.
It feels like it's "under emergency" marketing and it is still ongoing phase 3 trials. I hope they have enough sense to not mass vaccinate everyone in a month or two.
It feels like it's "under emergency" marketing and it is still ongoing phase 3 trials. I hope they have enough sense to not mass vaccinate everyone in a month or two.
It's actually here at the bottom:
> On the other hand, it is entirely possible that Russia will hold off vaccinating its general population until it has received favourable results from the phase 3 trial. In which case, the announcement of the approval of Sputnik V might amount to a political gesture, rather than a serious attempt to circumvent the standard process of vaccine development. The FDA has stipulated that a vaccine against COVID-19 should be at least 50% effective. Sputnik V might well meet this criterion. But until the phase 3 trial is completed and the results are made available, it will not be possible to make any judgement. “It is certainly not advisable for any vaccine to be used in an uncontrolled way before it has been through proper testing to determine whether the immune response it produces is actually protective, and there are no unexpected adverse events”, stressed Openshaw.
> On the other hand, it is entirely possible that Russia will hold off vaccinating its general population until it has received favourable results from the phase 3 trial. In which case, the announcement of the approval of Sputnik V might amount to a political gesture, rather than a serious attempt to circumvent the standard process of vaccine development. The FDA has stipulated that a vaccine against COVID-19 should be at least 50% effective. Sputnik V might well meet this criterion. But until the phase 3 trial is completed and the results are made available, it will not be possible to make any judgement. “It is certainly not advisable for any vaccine to be used in an uncontrolled way before it has been through proper testing to determine whether the immune response it produces is actually protective, and there are no unexpected adverse events”, stressed Openshaw.
No one has production capacity to vaccinate everyone in a month or two. So yes of course, they said only healthcare workers and teachers are going to get it this month, and not all of them. Will it be actually voluntary, as promised, or some new absurd process? You never can tell with Russian government.
Yeah, it could easily be mandatory. You must get the vaccination to work in health care. You must get the vaccination to be a teacher. You get the gist. We have this here with hepatitis B vaccine. Why not with this vaccine? They definitely could do this.
m0zg(1)
Good for Russia: taking steps towards allowing free & consenting adults the ability to use an experimental vaccine at their own risk, should they consent to do so, and with the potential to generate massive positive externalities for the rest of the world in the process.
How cringe is it that Russia (of all places) has beat the U.S. in allowing their population the right to access new technology?
Literally hundreds of thousands of people have died during this pandemic, and our regulatory agencies have -- in the name of "protecting us" -- literally blocked off people from being able to experiment (on their own property) with ways to prevent the spread of more mass death. Unbelievable.
Not to mention the tail risk of bottlenecking a life-saving vaccine until a government agency deems it "safe", and then suddenly releasing it all at once to massive portions of the population. If instead you let early risk-takers experiment on their own watch, you get orders of magnitude more data to work with gradually as opposed to suddenly unleashing a single vaccine (deemed "safe" by the FDA) to tends of millions of people at once.
How cringe is it that Russia (of all places) has beat the U.S. in allowing their population the right to access new technology?
Literally hundreds of thousands of people have died during this pandemic, and our regulatory agencies have -- in the name of "protecting us" -- literally blocked off people from being able to experiment (on their own property) with ways to prevent the spread of more mass death. Unbelievable.
Not to mention the tail risk of bottlenecking a life-saving vaccine until a government agency deems it "safe", and then suddenly releasing it all at once to massive portions of the population. If instead you let early risk-takers experiment on their own watch, you get orders of magnitude more data to work with gradually as opposed to suddenly unleashing a single vaccine (deemed "safe" by the FDA) to tends of millions of people at once.
Hasn’t one of the major vaccine candidates failed out of the trails already?
Perhaps you're thinking of the pause in the AstraZeneca Phase 3 trial. That's common and it has resumed. So, in that case, no.
Yes, AstraZeneca's trial was put on hold after a case of transverse myelitis. Obviously, in a large trial there's a chance the illness was unrelated to the vaccine, but this is one of those reasons why trials exist.
And now it has resumed
Eh, if this turns out to be the next Theranos, then we'll be glad that the government stopped our innocent civilians from being duped by this trickery. It's kind of a double-edged sword.
What happens if I no longer trust our government to protect me from predatory business practices? I ask that, because I no longer trust the CDC after their series of recent scandals.
Ironically, it's largely due to successful Russian efforts that I no longer know who to trust for advice on vaccines.
From what we're hearing so far [1], it seems that POTUS will promise a vaccine is on its way just before the election, but then never deliver it. What I'm worried about, though, is that a vaccine will simply show up and start being rolled out by a compromised CDC, or FEMA, or Army, or whoever the administration can force to do it.
[1] https://www.axios.com/trump-cdc-redfield-vaccine-d266121c-88...
Ironically, it's largely due to successful Russian efforts that I no longer know who to trust for advice on vaccines.
From what we're hearing so far [1], it seems that POTUS will promise a vaccine is on its way just before the election, but then never deliver it. What I'm worried about, though, is that a vaccine will simply show up and start being rolled out by a compromised CDC, or FEMA, or Army, or whoever the administration can force to do it.
[1] https://www.axios.com/trump-cdc-redfield-vaccine-d266121c-88...
Maybe this is the October surprise? The rushed Russian vaccine that Trump’s friendly relationship with Putin helped to secure?
I wouldn’t put it past them to try.
I wouldn’t put it past them to try.
> I no longer trust the CDC after their series of recent scandals
Care to link? Feel I must have missed some news, as I'm not aware of any scandals around the CDC?
Care to link? Feel I must have missed some news, as I'm not aware of any scandals around the CDC?
Sure, most of it comes down to the administration putting unqualified people with poor financial incentives in positions of high power.
There was this particularly transparent example by the Director of the CDC a couple of years ago, about buying tobacco stocks when put in charge of programs for reducing tobacco usage: https://www.politico.com/story/2018/01/30/cdc-director-tobac...
Also this story about how FDA appeared to bend to political pressure to greenlight an experimental treatment due to political pressure, bypassing the normal guidelines for demonstrating efficacy: https://www.nbcnews.com/health/health-news/why-did-fda-autho...
There's also been a general failure to respond appropriately to the pandemic. We're so many months in and PPE is still an issue: https://www.msn.com/en-us/news/world/8-months-into-pandemic-...
And that's not even counting what the White House is doing, which is not good. Especially with the recently leaked audio tapes from Woodward from the same time POTUS was publicly downplaying it: https://youtu.be/-cfd_pJVYiM?t=179
Plus the hydroxychloroquine thing...
There's a lot of buzz lately about how the administration is trying to influence the CDC, but most of it is journalism/politics blue twitter insider type chatter:
* https://www.motherjones.com/kevin-drum/2020/09/politico-trum...
* https://www.msn.com/en-us/health/medical/trump-e2-80-99s-att...
* https://www.motherjones.com/kevin-drum/2020/09/politico-trum...
* https://www.msn.com/en-us/news/politics/trump-appointees-sou...
But there is a lot of it, and that's pretty unusual for an organization like the CDC. Maybe it's all disinformation, but keep in mind it's the President's job to appoint the Director of the CDC: https://www.motherjones.com/politics/2020/03/trumps-cdc-dire...
I'm not saying every smear against the man is true. But after the last director had to resign over the tobacco thing, and the current director is now clearly affiliated with the President, so I'm skeptical if he has the public interest at heart.
I've never had less faith in American institutions, and I think it's for good reason. There's a lot of corruption at the top, and it's clearly infiltrating the institutions.
If they say a vaccine is safe to get, I don't think I can trust it. I'm going to need to dive deeper into opinions of professionals when it becomes available before I get it.
There was this particularly transparent example by the Director of the CDC a couple of years ago, about buying tobacco stocks when put in charge of programs for reducing tobacco usage: https://www.politico.com/story/2018/01/30/cdc-director-tobac...
Also this story about how FDA appeared to bend to political pressure to greenlight an experimental treatment due to political pressure, bypassing the normal guidelines for demonstrating efficacy: https://www.nbcnews.com/health/health-news/why-did-fda-autho...
There's also been a general failure to respond appropriately to the pandemic. We're so many months in and PPE is still an issue: https://www.msn.com/en-us/news/world/8-months-into-pandemic-...
And that's not even counting what the White House is doing, which is not good. Especially with the recently leaked audio tapes from Woodward from the same time POTUS was publicly downplaying it: https://youtu.be/-cfd_pJVYiM?t=179
Plus the hydroxychloroquine thing...
There's a lot of buzz lately about how the administration is trying to influence the CDC, but most of it is journalism/politics blue twitter insider type chatter:
* https://www.motherjones.com/kevin-drum/2020/09/politico-trum...
* https://www.msn.com/en-us/health/medical/trump-e2-80-99s-att...
* https://www.motherjones.com/kevin-drum/2020/09/politico-trum...
* https://www.msn.com/en-us/news/politics/trump-appointees-sou...
But there is a lot of it, and that's pretty unusual for an organization like the CDC. Maybe it's all disinformation, but keep in mind it's the President's job to appoint the Director of the CDC: https://www.motherjones.com/politics/2020/03/trumps-cdc-dire...
I'm not saying every smear against the man is true. But after the last director had to resign over the tobacco thing, and the current director is now clearly affiliated with the President, so I'm skeptical if he has the public interest at heart.
I've never had less faith in American institutions, and I think it's for good reason. There's a lot of corruption at the top, and it's clearly infiltrating the institutions.
If they say a vaccine is safe to get, I don't think I can trust it. I'm going to need to dive deeper into opinions of professionals when it becomes available before I get it.
Hum, okay I see what you mean. I think maybe it's premiditated to conclude that it's untrusworthy yet, but I wouldn't blame anyone from being a bit skeptical and double checking with say the Canadian and European health institutions to see if the advice is similar, and if not that might need to trigger some investigation into why they'd differ so much? And I don't know, throw in China and South Korea and Russia in there as well, in theory, all country should advise pretty similar things, medical science is mostly universal so any major discrepancy would be disconcerting a bit I admit.
That said, I also don't want to fall into some fallacy of nirvana, I don't believe any governement ever existed in a perfect state with zero bias and total absence of corruption, sometime all we have is good enough to go by.
And I also wouldn't want to fall in the fallacy of inflation of conflict, where because there are scientific disagreement in the medical community, especially given a very new very unknown problem such as Covid, that no conclusion can be reached or that the legitimacy of that field of knowledge is questionable.
That said, I also don't want to fall into some fallacy of nirvana, I don't believe any governement ever existed in a perfect state with zero bias and total absence of corruption, sometime all we have is good enough to go by.
And I also wouldn't want to fall in the fallacy of inflation of conflict, where because there are scientific disagreement in the medical community, especially given a very new very unknown problem such as Covid, that no conclusion can be reached or that the legitimacy of that field of knowledge is questionable.
I agree with you entirely, and I think that will be my plan. It could be a problem though if US society is back to "normal" with a "vaccine" that ends up rushed through some how, and I'm one of a few crazy holdouts that don't trust it.
Would any of our Russian comrades reading along care to weigh in on how they're feeling about getting the vaccine on release day?
Would any of our Russian comrades reading along care to weigh in on how they're feeling about getting the vaccine on release day?
eugene3306 summarized it best: https://news.ycombinator.com/item?id=24512974. As someone fairly familiar with Gamaleya I agree completely, they are known to be responsible for some "bullshit-micyn" drugs as we call it here, so I'd hesitate to be an early adopter for their vaccine.
(also you'd get funny looks if you called someone comrade in Russia, just saying)
https://www.marketwatch.com/story/the-cdc-says-americans-don...
https://www.foxnews.com/media/surgeon-general-explains-masks...
https://www.foxnews.com/media/surgeon-general-explains-masks...
I mean, if not making wild guesses is considered a big scandal, well so be it, but I find it quite exaggerated to call this a "scandal". There was no lie, no one was mislead, they weren't even wrong in a sense. At first there was no evidence that masks could prevent the spread, and then there was a shortage of masks for medical workers who needed them, and only later did the data show that asymptomatic and pre-symptomatic transmission was possible, so there was now evidence to advice wearing a mask, even a non-surgical one.
You could say they are to be blamed from making the default position the status quo. But the opposite is a harder default, how far do you go when nothing has been shown to be necessary or prevent anything yet? Like do you tell people to just go full on quarantine? To wash all their delivered packages and produce with soap? Like how far? And then if you tell them to do all that, and it later shows they arn't necessary and don't help prevent the spread? So in some way, the status quo does seem like a good default.
Basically, the CDC just said: Go on with your daily life, don't panic, don't buy all medical equipment that the medical professionals need, and as the data arrives and shows evidence of what measures actually help to prevent the spread we will update our guidelines.
You could say they are to be blamed from making the default position the status quo. But the opposite is a harder default, how far do you go when nothing has been shown to be necessary or prevent anything yet? Like do you tell people to just go full on quarantine? To wash all their delivered packages and produce with soap? Like how far? And then if you tell them to do all that, and it later shows they arn't necessary and don't help prevent the spread? So in some way, the status quo does seem like a good default.
Basically, the CDC just said: Go on with your daily life, don't panic, don't buy all medical equipment that the medical professionals need, and as the data arrives and shows evidence of what measures actually help to prevent the spread we will update our guidelines.
Posting stuff that was not approved by CDC scientists, as coming from the CDC is a pretty massive scandal however you want to slice it.
Thalidomide or maybe the Cutter Labs Polio vaccine might be a better comparison than Theranos.
The biggest risk to my mind here is that if something bad (long term effects) happen to people taking this vaccine it might become an argument that anti-vaccine folks will market all over the globe. We can get actual vaccination slow down.
Here's how someone in the field recently explained it to me...
Let's say you have a vaccine that appears effective (great, right?) You give it to 1000 willing test subjects, and most become immune (fantastic, right?). Then, three to six months later 50 of the subjects go into terminal liver failure due to their body's immune response to the vaccine (as determined by their genetics.)
It's not just whether a vaccine 'works' for you, it's whether it's effective AND safe over the huge genetic pool that is humanity (as measured over a sufficient period of time). This kind of stuff comes up all the time with drug trials, and it's why there's a process, and things can't be rushed.
Let's say you have a vaccine that appears effective (great, right?) You give it to 1000 willing test subjects, and most become immune (fantastic, right?). Then, three to six months later 50 of the subjects go into terminal liver failure due to their body's immune response to the vaccine (as determined by their genetics.)
It's not just whether a vaccine 'works' for you, it's whether it's effective AND safe over the huge genetic pool that is humanity (as measured over a sufficient period of time). This kind of stuff comes up all the time with drug trials, and it's why there's a process, and things can't be rushed.
Yeah and just imagine how the anti-vax conspiracy crowd would respond in that situation. Things would get really crazy really fast. Even in a pandemic we can't rush this.
Well, in this pandemic we don't need to rush this as mortality is relatively low. If it were a variant Ebola, but with the same transmission rate as Covid19 then we'd sure was hell be rushing it.
Your reply bugs me. Not yours personally, but especially in the US this attitude seems to be a very binary thing. You either die, or most people survive it and your chances of survival seem to be good.
What this leaves out is all those nasty consequences observed, where Covid victims survive, but encounter all sorts of health issues. From kidney - to heart damage, up to funky things it may do to your brain.
This leaves out the long timers[1], who survive it, but have massive health issues for month with no end in sight.
I, for one, are really hell bent not to catch it and as a society there seems to be number of quite simple measures to avoid spread.
Unfortunately even those, like masks, in my opinion a no brainer, get politicized.
[1] https://www.theatlantic.com/health/archive/2020/06/covid-19-...
What this leaves out is all those nasty consequences observed, where Covid victims survive, but encounter all sorts of health issues. From kidney - to heart damage, up to funky things it may do to your brain.
This leaves out the long timers[1], who survive it, but have massive health issues for month with no end in sight.
I, for one, are really hell bent not to catch it and as a society there seems to be number of quite simple measures to avoid spread.
Unfortunately even those, like masks, in my opinion a no brainer, get politicized.
[1] https://www.theatlantic.com/health/archive/2020/06/covid-19-...
Funny that you've shifted your argument from death rates to "long-term effects" when it no longer fits your agenda.
> Sweden is slithering into a full blown catastrophy […] the numbers are bound to explode in the next few days.
> The grim reality, however, looks very different and Sweden is on the best way to one of the greatest corona catastrophies in Europe.
Didn't happen and the curve continued to sharply decline after you made your comment. Sweden currently has one of the lowest infection rates in Europe and exactly what I said would happen is happening in other countries.
> Sweden is slithering into a full blown catastrophy […] the numbers are bound to explode in the next few days.
> The grim reality, however, looks very different and Sweden is on the best way to one of the greatest corona catastrophies in Europe.
Didn't happen and the curve continued to sharply decline after you made your comment. Sweden currently has one of the lowest infection rates in Europe and exactly what I said would happen is happening in other countries.
Thank you, just to expand, as I fear there's a disconnect.
"we don't need to rush this" and put out a vaccine super-quick that might itself inadvertently kill/harm a large proportion of the population.
I'm not at all diminishing the severity of Covid19 (deaths _&_ life-changing health effects, as you remind us), but thankfully it's not killing 40% (IIRC) of the infected like Ebola. Under that pressure a vaccine would probably be advisable even if it 'only' killed 20% (!) - if you could get anyone to have such a vaccine?
All vaccination programmes cause some harm, mass inoculation in a rush has the potential to cause more harm than no vaccination.
There's some very interesting work on apparent immunity to Covid19 going on (The Lancet article recently), which I'm hoping will suggest that an endemic "common cold" coronavirus has effectively inoculated people. That would seem to give an inoculation known to already be relatively safe. But it's way out of my areas of expertise.
"we don't need to rush this" and put out a vaccine super-quick that might itself inadvertently kill/harm a large proportion of the population.
I'm not at all diminishing the severity of Covid19 (deaths _&_ life-changing health effects, as you remind us), but thankfully it's not killing 40% (IIRC) of the infected like Ebola. Under that pressure a vaccine would probably be advisable even if it 'only' killed 20% (!) - if you could get anyone to have such a vaccine?
All vaccination programmes cause some harm, mass inoculation in a rush has the potential to cause more harm than no vaccination.
There's some very interesting work on apparent immunity to Covid19 going on (The Lancet article recently), which I'm hoping will suggest that an endemic "common cold" coronavirus has effectively inoculated people. That would seem to give an inoculation known to already be relatively safe. But it's way out of my areas of expertise.
However you put it there is a limit to how long you can wait. It’s never going to be risk free.
Of course incidents where 5% of the subjects of a drug test die do not happen ‘all the time’, if they happen it’s on the news. And it’s not on the news ‘all the time’.
Balancing risks does not mean attempting to avoid all the risks.
Of course incidents where 5% of the subjects of a drug test die do not happen ‘all the time’, if they happen it’s on the news. And it’s not on the news ‘all the time’.
Balancing risks does not mean attempting to avoid all the risks.
Given the enormous amount of advertizing bought by the pharmaceutical companies, I would not think that the "news" can be considered objective.
I did not research this, but in my undirected layman reading have encountered at least the following three cases in which vaccine was more harmful than the disease:
Live polio vaccine which wasn’t properly attenuated and caused polio;
A vaccine in the us that caused Gillan-Barre syndrome way more often than disease symptoms (1960s or early 1970s, don’t remember disease name)
A vaccine given to children in Sweden that dramatically increased chances for narcolepsy.
It is important to recognize that not all vaccines ever produced are safe for everyone, and there are a few which were a total net negative for society (even though most are net positive despite some bad outcomes)
Vaccines, especially if mandatory, need to be held to an extremely higH standard of Safety. It is my impression that the COVID-19 panic is leading us to approved though net negative vaccines. We will only know much later , unfortunately.
Live polio vaccine which wasn’t properly attenuated and caused polio;
A vaccine in the us that caused Gillan-Barre syndrome way more often than disease symptoms (1960s or early 1970s, don’t remember disease name)
A vaccine given to children in Sweden that dramatically increased chances for narcolepsy.
It is important to recognize that not all vaccines ever produced are safe for everyone, and there are a few which were a total net negative for society (even though most are net positive despite some bad outcomes)
Vaccines, especially if mandatory, need to be held to an extremely higH standard of Safety. It is my impression that the COVID-19 panic is leading us to approved though net negative vaccines. We will only know much later , unfortunately.
I’m sure you agree that 3 incidents in a century hardly mean it ‘happens all the time,’ that’s just a gross exaggeration.
As I mentioned, I didn’t research this - it is things I came across accidentally in my reading. I assume these three are not the whole story.
I agree even 10 over 60 years is likely worth it to society as a whole. But ignoring this reality and saying “all vaccines are always safe and no vaccine ever caused anything bad” which many supposedly science people do is not good either.
I agree even 10 over 60 years is likely worth it to society as a whole. But ignoring this reality and saying “all vaccines are always safe and no vaccine ever caused anything bad” which many supposedly science people do is not good either.
I'm generally of that opinion, but I have read that it seems to be more complex then that.
First off, there's a trust factor. If people start to hear about all these vaccines with side effects and misbehaving, it can cause people to fear and not trust the vaccines themselves, even when some that do work and are safe come out.
Second, and this I am not sure of the validity, but I've seen claims that a bad vaccine could actually make it more difficult to later make a good vaccine. For example, it seems certain type of vaccine can only be used once, so if you've got a bad vaccine, the good vaccine wouldn't work on you anymore, etc.
First off, there's a trust factor. If people start to hear about all these vaccines with side effects and misbehaving, it can cause people to fear and not trust the vaccines themselves, even when some that do work and are safe come out.
Second, and this I am not sure of the validity, but I've seen claims that a bad vaccine could actually make it more difficult to later make a good vaccine. For example, it seems certain type of vaccine can only be used once, so if you've got a bad vaccine, the good vaccine wouldn't work on you anymore, etc.
The choice of name is interesting. Is this a throwback to the space race as in, “we got there first”?
I found it funny because Sputnik 2 took the first mammal into space, only to let it die in space.
And you find it funny why exactly?
Because Sputik has connotations to experimentation on animals, along with death?
It isn't the death that is funny, it is that the name and its relationship with killing.
It isn't the death that is funny, it is that the name and its relationship with killing.
This always reminds me of Trentemoller's music video honoring that flight (and the aforesaid mammal): https://www.youtube.com/watch?v=zDZPxvO1ftY
Yes.
For those who didn't read the article yet, the vaccine is called 'Sputnik V'.
Sputnik means travel companion. In the context of COVID-19, its probably a bit more surreal than it ought to be, name-wise ..
It's a two-component vaccine using two different adenovirus vectors. Hence "traveling companion" and "v(irus/ector)". Plus, of course, the name is a reminder of Soviet space achievements.
On August 11th, 2020 the Russian government announced the world's first release of a vaccine against COVID-19, referring to the vaccine as "Sputnik 5" (Gam-COVID-Vac) to reflect Russia's previous victories in the Space Race. ([1])
[1] https://en.wikipedia.org/wiki/Korabl-Sputnik_5
[1] https://en.wikipedia.org/wiki/Korabl-Sputnik_5
What's weird to me is this emphasis on being first. Most of the media trumpeting that there will be some huge advantage to being first seems wrong and misplaced. Even if you manage to create a vaccine, you still have to manufacture and convince everyone it is effective. Rollout is likely to be pretty slow and uneven. This will take months.
In the meantime, other vaccines will be created that work just as well. The vaccine might be manufactured faster and be distributed more widely.
Create a vaccine isn't planting a flag or even reaching a specific destination. Creating a vaccine is travelling a known distance in similar types of cars. There's only so fast you can go.
In the meantime, other vaccines will be created that work just as well. The vaccine might be manufactured faster and be distributed more widely.
Create a vaccine isn't planting a flag or even reaching a specific destination. Creating a vaccine is travelling a known distance in similar types of cars. There's only so fast you can go.
My take on this emphasis on being first: it's a reflection of how we view society as a competition, in business, warfare, and interpersonal relationships. To be "first to market", to have "first-mover advantage", is to demonstrate competence and superiority. Planting a flag on the moon was, partly, such a move.
There's some truth to it, I believe, but the mentality is seemingly applied too broadly, to areas where there aren't any advantages - other than maybe reputation (which could be considered a real advantage).
I agree with you that the apparent focus on "me first" is misplaced, when the effort to create a reliable vaccine is a global concern. The emphasis should be on its efficacy, in solving the immediate problem together.
There's some truth to it, I believe, but the mentality is seemingly applied too broadly, to areas where there aren't any advantages - other than maybe reputation (which could be considered a real advantage).
I agree with you that the apparent focus on "me first" is misplaced, when the effort to create a reliable vaccine is a global concern. The emphasis should be on its efficacy, in solving the immediate problem together.
Well, their previous 'Sputnik', the Google alternative (sputnik.ru) failed miserably, so they're trying another one. And besides Chinese vaccine was first.
Seems like you can gain some hunting skills after using this vaccine: https://www.youtube.com/watch?v=vN2eQ_CKZT8
One interesting coronavirus metric I’ve been tracking is mobility indexes. I know it sounds tin-foil-hat-y but I don’t trust western media coverage on Russia or China and so to gauge the situation in those countries I’ve tried looking at data rather than opinion.
The Citymapper app has a “CityMapper Mobility Index” which shows what percentage of a given city is moving compared to a pre-March peg. It’s been interesting to see Moscow and St.Petersburg back to almost 100% capacity.
The Citymapper app has a “CityMapper Mobility Index” which shows what percentage of a given city is moving compared to a pre-March peg. It’s been interesting to see Moscow and St.Petersburg back to almost 100% capacity.
But is ‘city mobility’ a lead indicator of ‘rising new COVID cases’, or a lag indicator of ‘declining active COVID cases’? I could make the hypothesis for either (or both), so are you using it to track improvements in a city or prepare for worsening conditions?
I had never occurred to me that something could be a leading indicator for changes in one direction but lagging in another.
Thanks for upgrading my thinking!
Thanks for upgrading my thinking!
Thanks for the comment! I’ve been doing a bit of research into various economic indicators aiming to help my (business owner) clients, and it pretty rapidly becomes a complicated mess of cause and effect.
Take Unemployment - a lag indicator of economic conditions (things were better/worse last month and so people found/lost work); but also in a small way a lead indicator of economic conditions (more people in/out of work and the wider confidence arising from the news has an impact on future spending).
Take Unemployment - a lag indicator of economic conditions (things were better/worse last month and so people found/lost work); but also in a small way a lead indicator of economic conditions (more people in/out of work and the wider confidence arising from the news has an impact on future spending).
Probably both-- it's probably why these cycles occur.
Modeling positivity with mobility would be interesting.
Modeling positivity with mobility would be interesting.
sjg007(1)
Well, assuming that metric is a reliable indicator, that presumably just indicates the perception of the vaccine amongst the population is positive; it says little about the actual success of it.
And what happens if the vaccine turns out to be a dud? How will that mobility then be positive, given the spread? And what about the damage to trust both in Russia and internationally for vaccine announcements after a failure there?
I've obviously no idea about whether or not the vaccine works.
The problem is - by international norms - neither do those deploying it, and yet they are.
And what happens if the vaccine turns out to be a dud? How will that mobility then be positive, given the spread? And what about the damage to trust both in Russia and internationally for vaccine announcements after a failure there?
I've obviously no idea about whether or not the vaccine works.
The problem is - by international norms - neither do those deploying it, and yet they are.
there have been no reports of people getting vaccinated on a large scale in russia (the article also implies this).
Do you mean this one? https://citymapper.com/cmi
Because it shows Moscow and St P at 79 and 88%. Around the same as Brussels but lower than Paris and Lyon.
Because it shows Moscow and St P at 79 and 88%. Around the same as Brussels but lower than Paris and Lyon.
I think it must be. It's kind of interesting the data. You can see London shutting down around when I left and now can see Paris and Lyon as the most back to normal which maybe explains why there are a lot of new cases there now.
I’m skeptical of this metric because the data seems to come from app usage and excludes auto traffic as a transit focused app. In SF I would peg the movement well above 8%. Maybe this app is mostly used by Euros and tourism is the gap...
I doubt Citymapper is a good source. No one really uses their app there; except for tourists and new expats, I guess.
[deleted]
If you look at yesterdays' stats, Lyon (#1) and Paris (#2) are respectively at 97% and 90% of usual mobility. Yet the number of confirmed cases in France, over the last 15 days, went from 293 024 to 404 888.
This index won't tell you wether it's safe to move around or not, just what people are doing and what authorities are allowing.
This index won't tell you wether it's safe to move around or not, just what people are doing and what authorities are allowing.
I may be wrong but it seems that the number of confirmed cases isn't a great indicator either because we've been testing a lot more so it's expected that we're getting more positives. What matters is the number of people who die or get seriously ill, isn't it?
It's the same virus no matter where you are in the world. Weekly new cases (per capita) is the best metric for how likely you are to get it when you step outside.
Completely false. Weekly new cases per capita is merely a function of number of tests performed by authorities, and furthermore the false positive rate of those tests too. Percent positivity of those tests is a somewhat more accurate indication, but those figures rarely see headlines because they are less sensationalist. For example, UK test positivity rates are less than 1/10th what they were at the peak.
Weekly new hospital admissions is better.
Case numbers are massively skewed by testing capacity.
Case numbers are massively skewed by testing capacity.
Even that isn't good - it doesn't account for people who don't go in and drop dead. It is suspected this is happening in India.
Well, as of early May there were 198 variants identified: https://www.bbc.com/news/health-52557955
We don't know that there's any difference, currently, between what variants are dominant in different parts of the world. But, we sure don't know they're the same, either.
Mm, how to account for the percent of tests given that are positive? That seems like important information.
BTW, this is a very well done indicator dashboard for the Netherlands. https://coronadashboard.government.nl/landelijk
BTW, this is a very well done indicator dashboard for the Netherlands. https://coronadashboard.government.nl/landelijk
> I may be wrong but it seems that the number of confirmed cases isn't a great indicator either
Personal anecdote, but I generally avoid doctors at pretty well all costs.
I have one, and I go for my yearly physical when they call me to schedule it. Other than that, I've found the doctor to be a great way to waste a lot of money and get an ambiguous result. Usually, "Take pain killers for a week and see if it gets better"
Since I am relatively well off, I have to imagine there is an enormous portion of the population who feels similarly to me about going to the doctor, and who also don't actually have the money to pay those bills.
It seems likely to me that coronavirus cases are probably just going undetected among the less well off in (American) society, especially for the portion where the illness is mild (which is literally every case I have heard about in my area for people under 40).
Personal anecdote, but I generally avoid doctors at pretty well all costs.
I have one, and I go for my yearly physical when they call me to schedule it. Other than that, I've found the doctor to be a great way to waste a lot of money and get an ambiguous result. Usually, "Take pain killers for a week and see if it gets better"
Since I am relatively well off, I have to imagine there is an enormous portion of the population who feels similarly to me about going to the doctor, and who also don't actually have the money to pay those bills.
It seems likely to me that coronavirus cases are probably just going undetected among the less well off in (American) society, especially for the portion where the illness is mild (which is literally every case I have heard about in my area for people under 40).
What about long term effects. If "mild" covid cases come back in 2 years as death (this does happen in the case of some diseases), or you are never seriously ill but have other problems. There has been speculation that Chronic Fatigue is caused by a seemly mild cold.
We don't know what the long term effects might be. There are some reports that they are pretty bad, but nothing is confirmed.
We don't know what the long term effects might be. There are some reports that they are pretty bad, but nothing is confirmed.
In the case of COVID, I don't think we need two years. My wife had COVID a few months ago and got beat up pretty badly.
She would be the last person you would think would get seriously ill - she eats only healthy food, is(was) a Crossfit rat, vitamins, meditation. She checks all the boxes for a healthy lifestyle and some).
We would go on 30 miles bike rides often and now she can't go up a hill mounted on the bike anymore. She was still going to a Crossfit gym that was (illegally) open during the pandemic but just for sanity. She couldn't do much of the workouts.
That was up to three weeks ago. One day she woke up with a swollen leg and has gone to three doctors already and is going to another to try to find why her leg is that way.
My suspicion is that COVID affected her circulatory system and is caused the problem that she is having on her leg. I hope that it's not the case, but this worry is enough to lose some sleep.
She would be the last person you would think would get seriously ill - she eats only healthy food, is(was) a Crossfit rat, vitamins, meditation. She checks all the boxes for a healthy lifestyle and some).
We would go on 30 miles bike rides often and now she can't go up a hill mounted on the bike anymore. She was still going to a Crossfit gym that was (illegally) open during the pandemic but just for sanity. She couldn't do much of the workouts.
That was up to three weeks ago. One day she woke up with a swollen leg and has gone to three doctors already and is going to another to try to find why her leg is that way.
My suspicion is that COVID affected her circulatory system and is caused the problem that she is having on her leg. I hope that it's not the case, but this worry is enough to lose some sleep.
Not sure why you're being downvoted, yes it's an anecdotal, but it's also something that can't be explained other than "we don't know what long term effects are". If you said "my 20 year old nephew got covid and died and he was healthy", then sure, that's an annecdote of a rare event.
The general view now seems to be "it only affects over 55s", and that's mostly true -- there's lots of data to show that kids particularly are far more at risk of dying from other every day activities.
We have a rough idea of the IFR of 40 year old fit men, or 20 year old obese women, or of 7 year olds and 70 year olds. There's little long term studies for a disease that was identified less than a year ago - at least that I'm aware of.
The general view now seems to be "it only affects over 55s", and that's mostly true -- there's lots of data to show that kids particularly are far more at risk of dying from other every day activities.
We have a rough idea of the IFR of 40 year old fit men, or 20 year old obese women, or of 7 year olds and 70 year olds. There's little long term studies for a disease that was identified less than a year ago - at least that I'm aware of.
Please have her ask her doctor to get an ultra sound for blood clots!! First of all, that’s really common in very active people who stop being active suddenly and it seems to be even more common for Covid patients.
Also, I am not a physician - I just have some personal experience with blood clots. Hope she recovers!
Thank you! She will see another doctor and do some more exams today.
> this does happen in the case of some diseases
Which disease is being cured by your body entirely and then comes back 2 years later with long term effects?
> We don't know what the long term effects might be
Isn't this true for everything though? How do you know if there are any long term effects for a new developed vaccine? Does it mean out of fear that theoretically anything in life can suddenly unexpectedly cause long term effects that you are not going to do anything which hasn't been done by other humans for at least 10-20 years? People don't know about long term effects of cellular data, yet we are using it every day.
Given that nobody has any long term effects from COVID which are different from other post viral issues seen with the flu and normal colds I think it's more pragmatic to assume that COVID will also behave very similar to other coronaviruses like the common cold.
Which disease is being cured by your body entirely and then comes back 2 years later with long term effects?
> We don't know what the long term effects might be
Isn't this true for everything though? How do you know if there are any long term effects for a new developed vaccine? Does it mean out of fear that theoretically anything in life can suddenly unexpectedly cause long term effects that you are not going to do anything which hasn't been done by other humans for at least 10-20 years? People don't know about long term effects of cellular data, yet we are using it every day.
Given that nobody has any long term effects from COVID which are different from other post viral issues seen with the flu and normal colds I think it's more pragmatic to assume that COVID will also behave very similar to other coronaviruses like the common cold.
Chicken pox which comes back as shingles year latter.
Shingles can vary quite a lot as well, sometimes just being a nasty rash all the way to blindness.
I'd like to read more for that, if you can remember the source? I have chronic fatigue and am constantly stuffy, have I just had a cold for 20 years?
Here is a recent review with open access:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6787585/pdf/dia...
It's been a while since I left virology so I can't comment on the veracity of the article. It does look pretty comprehensive though, and a bunch of the articles I remember to have read a decade ago are referenced.
It's been a while since I left virology so I can't comment on the veracity of the article. It does look pretty comprehensive though, and a bunch of the articles I remember to have read a decade ago are referenced.
I feel dumb here, but isn't "high mobility" being correlated with "high cases" kind of what you'd expect in a regime where the number of cases had previously been low, and then began to spread again?
Google (https://www.gstatic.com/covid19/mobility/2020-09-11_RU_Mobil...) shows that workplaces are still down by 29% but parks are up by 89%. That could be explained by increased unemployment or people still working from home
Sitting in Germany this makes me really wonder how things are going to change in winter. The parks have been exploding with people because with most of the indoor spaces closed, or only accessible with masks, this became one of the only ways to spend free time. Restaurants are now available as well, and people are back at work in a more limited way, but parks are still the dominant form of recreation in Berlin as far as I can tell.
How is this going to change when it's not so pleasant to sit or walk outside anymore? I have the feeling that either case counts are going to rise, or mental health is going to become a bigger issue (even more so than it usually is at this latitude in the winter time).
How is this going to change when it's not so pleasant to sit or walk outside anymore? I have the feeling that either case counts are going to rise, or mental health is going to become a bigger issue (even more so than it usually is at this latitude in the winter time).
Parks and playgrounds both. That's been a real difference-maker for Berlin families with young children up to this point in the pandemic. I have my fingers crossed for a mild winter, but there's no way things won't get more difficult.
The drop in humidity will increase transmissibility and the drop in temperature will force more people indoors. Winter probably will show an increase in infection.
I plan on building fires, getting heavy coats, and staying outside anyway. :)
Buy a snowboard. Get some exercise while you're at it :)
Snow? In Berlin?! It'll melt before you get out to the park with your snowboard...
Berlin used to have lots of snow. People used to worry about icicles falling on them. Even five years ago when I moved here we had a few big snowfalls. Not so much any more.
I even bought a nice down jacket to brave the winters here but it turned out not to be a good investment.
Of course finding so much as a small hill anywhere near here is a whole other problem...
I even bought a nice down jacket to brave the winters here but it turned out not to be a good investment.
Of course finding so much as a small hill anywhere near here is a whole other problem...
I think you have misread the index. The first (100%ish) result is from March.
The latest (70%ish) is at the bottom. There has been hardly any change since the vaccine was introduced in the middle of August.
To be fair, it is not a well-designed UX (unusual for the superb CityMapper).
https://citymapper.com/cmi/moscow
The latest (70%ish) is at the bottom. There has been hardly any change since the vaccine was introduced in the middle of August.
To be fair, it is not a well-designed UX (unusual for the superb CityMapper).
https://citymapper.com/cmi/moscow
I think you’ve misread my comment.
So I’ve said it’s interesting to see that both those cities are “back to almost 100% capacity” - almost being an operative word - from end of august to now Moscow has been @ 70-90% consistently, and St Petersburg has actually had 80-100+% in that time.
I also see people jumping to conclusions around taking this to mean it’s now safe there, I never said, nor implied, that.
So I’ve said it’s interesting to see that both those cities are “back to almost 100% capacity” - almost being an operative word - from end of august to now Moscow has been @ 70-90% consistently, and St Petersburg has actually had 80-100+% in that time.
I also see people jumping to conclusions around taking this to mean it’s now safe there, I never said, nor implied, that.
I think it's quite a stretch to call any of the August or September numbers "almost 100%".
Fair enough, there has been a bit of change day to day but not overall from the vaccine release date compared to yesterday; they are pretty much the same (Moscow). St Petersburg seems more upbeat.
I accept and know you were not saying it was safe; just commenting on the mobility (which is an interesting metric, thanks for the pointer) - but I don't agree with your interpretation of it wrt Moscow.
I accept and know you were not saying it was safe; just commenting on the mobility (which is an interesting metric, thanks for the pointer) - but I don't agree with your interpretation of it wrt Moscow.
The Russian case numbers seem a bit unusual to me. How they have been between 5 and 10k cases for so long without either driving it down further or having it get out of control.
They're unusual because they're false.
By falsifying data. Source: I'm from Russia.
Russian fatality rate is probably somewhat lower in US / Europe, but it's only because our elder citizens (the most vulnerable group) have patriotically died long before reaching the age at which they become vulnerable to the virus.
Russian fatality rate is probably somewhat lower in US / Europe, but it's only because our elder citizens (the most vulnerable group) have patriotically died long before reaching the age at which they become vulnerable to the virus.
[deleted]
> I know it sounds tin-foil-hat-y, I don’t trust western media coverage on Russia or China
That's not tin-foil-hat-y at all. Of course Western media isn't going to paint a too rosy picture of traditional "adversaries" compared to their own countries.
Look at how the situation in Belarus has all but eclipsed the protests against police brutality in the US. Even in Wikipedia's front page list of ongoing events! Apparently everything must be fine back home now.
That's not tin-foil-hat-y at all. Of course Western media isn't going to paint a too rosy picture of traditional "adversaries" compared to their own countries.
Look at how the situation in Belarus has all but eclipsed the protests against police brutality in the US. Even in Wikipedia's front page list of ongoing events! Apparently everything must be fine back home now.
Snatching people from the streets, turtur and arrests without trial or seeing a court. Sending the opposition to forced exile.
That's just objectively worse than the shit going on in the US. But I do feel the US is getting there. This new war on crime the is planning, his sending federal agents to democratic states and basically calling parts of the population enemies is very worrying.
That's just objectively worse than the shit going on in the US. But I do feel the US is getting there. This new war on crime the is planning, his sending federal agents to democratic states and basically calling parts of the population enemies is very worrying.
There was an interesting study about Germany, that r0 went below 1 even before the nation wide shutdown because people started reducing their own mobility quite heavily. I can't find the source though.
I know it sounds tin-foil-hat-y but I don’t trust western media coverage on Russia or China
But mobility index by itself doesn't tell you anything about the number of infected people. Without reliable statistics on coronavirus cases in the area you can't tell if the mobility is high because the infection is contained, or because nobody cares/knows. And there are reasons to doubt official stats on corona cases in Russian cities.
jojo2000(2)
I was just in a call with somebody who is working in the medical industry on COVID vaccine and he explained to me that GDPR puts many of their efforts in jeopardy because if any patient issues a deletion request they have to delete the data which is very ward for them. It is interesting to see how legislation can slow down progress.
What do you mean by puts in jeopardy? So they realistically expect that a large portion of the tested people will request to delete their data? Is there any basis for that? As I understand it's a very uncommon occurrence even in companies people really should be requesting it from.
It is enough that one requests it if the data system is not prepared for that.
Did this anecdotal conversation actually happen? I'm highly skeptical for several reasons. The first being that GDPR's "right to be forgotten"[1] absolutely, unequivocally, without a shadow of doubt would not apply to a patient in a medical trial. Even if the patient withdrew consent for data processing and objected to the continued processing of their data under GDPR they still would not have the right to have the data deleted for several reasons:
1. The data isn't being processed on the data subject's consent alone. It's also being processed because it's necessary to perform a public task which is a legal basis for processing data under GDPR. It's also probably being processed under the "legitimate interests" of a third party (the pharmaceutical company) whose interests in the data, in this case, override the individual's interests in having the data deleted which is another legal basis for processing. So the medical trial has two (of only six) lawful bases for data processing should the patient withdraw consent. Only one lawful basis is necessary.
2. Article 17(3) specifically exempts compliance with the right to be forgotten when data processing is necessary "for reasons of public interest in the area of public health" (paragraph c) OR for record-keeping purposes "in the public interest, scientific or historical research purposes or statistical purposes" (paragraph d).
3. Article 17(1)c and Article 21(1) would allow continued processing of the data due to "compelling legitimate grounds for the processing which override the interests".
4. Article 21(6) would allow continued processing of the data for reasons of public interest.
Surely someone in the EU conducting medical research would be well aware that GDPR is not at all a barrier to medical trial data processing.
[1]https://gdpr.eu/article-17-right-to-be-forgotten/
1. The data isn't being processed on the data subject's consent alone. It's also being processed because it's necessary to perform a public task which is a legal basis for processing data under GDPR. It's also probably being processed under the "legitimate interests" of a third party (the pharmaceutical company) whose interests in the data, in this case, override the individual's interests in having the data deleted which is another legal basis for processing. So the medical trial has two (of only six) lawful bases for data processing should the patient withdraw consent. Only one lawful basis is necessary.
2. Article 17(3) specifically exempts compliance with the right to be forgotten when data processing is necessary "for reasons of public interest in the area of public health" (paragraph c) OR for record-keeping purposes "in the public interest, scientific or historical research purposes or statistical purposes" (paragraph d).
3. Article 17(1)c and Article 21(1) would allow continued processing of the data due to "compelling legitimate grounds for the processing which override the interests".
4. Article 21(6) would allow continued processing of the data for reasons of public interest.
Surely someone in the EU conducting medical research would be well aware that GDPR is not at all a barrier to medical trial data processing.
[1]https://gdpr.eu/article-17-right-to-be-forgotten/
End of 2020 and people still don't know what is GDPR and how it works.... For fuck's sake we have all the knowledge of the world one click away, and these people working in the "medical industry" don't take 5 minutes of their day to learn about laws regulating them ? Don't they have a legal department ? Didn't they get any GDPR training ? They probably spent more time complaining to you than actually researching the issue ....
Of course someone in a vaccine trial can't ask for all their records to be deleted. Does anyone really expect the EU law makers to be that dense ?
What's next ? You call the police and ask them to delete your criminal records ?
``` However, an organization’s right to process someone’s data might override their right to be forgotten. Here are the reasons cited in the GDPR that trump the right to erasure:
- The data is being used to perform a task that is being carried out in the public interest or when exercising an organization’s official authority.
- The data being processed is necessary for public health purposes and serves in the public interest.
- The data being processed is necessary to perform preventative or occupational medicine. This only applies when the data is being processed by a health professional who is subject to a legal obligation of professional secrecy.
- The data represents important information that serves the public interest, scientific research, historical research, or statistical purposes and where erasure of the data would likely to impair or halt progress towards the achievement that was the goal of the processing. ```
https://gdpr.eu/right-to-be-forgotten/
Of course someone in a vaccine trial can't ask for all their records to be deleted. Does anyone really expect the EU law makers to be that dense ?
What's next ? You call the police and ask them to delete your criminal records ?
``` However, an organization’s right to process someone’s data might override their right to be forgotten. Here are the reasons cited in the GDPR that trump the right to erasure:
- The data is being used to perform a task that is being carried out in the public interest or when exercising an organization’s official authority.
- The data being processed is necessary for public health purposes and serves in the public interest.
- The data being processed is necessary to perform preventative or occupational medicine. This only applies when the data is being processed by a health professional who is subject to a legal obligation of professional secrecy.
- The data represents important information that serves the public interest, scientific research, historical research, or statistical purposes and where erasure of the data would likely to impair or halt progress towards the achievement that was the goal of the processing. ```
https://gdpr.eu/right-to-be-forgotten/
What the law says does not really matter. What matters in the perception of what it says. In the case of medicine, all clinical trials need to go through "Ethics committee". And ethics committees overwhelmingly consider that GDPR and co also applies to medical studies. So your study protocol absolutely has to take it into account. It's not like you can really argue with them - or get ready for months/years of delays. At the end of the day, their job is to protect the institution, so it's less dangerous for them to refuse a valid study than to accept an invalid one.
The European union included various narrow and strangely worded "exemptions" from the law, but the damage is done: "Better safe than sorry, just apply GDPR to all data collections".
The European union included various narrow and strangely worded "exemptions" from the law, but the damage is done: "Better safe than sorry, just apply GDPR to all data collections".
But... that's valid for every single law then...
Every company have an official GDPR contact person, who is trained for their industry, for this very purpose, it's not rocket science. I debunked this in literally 15 seconds on the official gdpr website.
How is GDPR different than the other hundred thousands laws regulating medical companies ? GDPR isn't the first law they have to worry about, it's probably not even remotely close to the most complex regulations applied to medical research. They're used to deal with very convoluted texts of law, I'm sure they can figure a list of 5 bullet points...
> but the damage is done: "Better safe than sorry, just apply GDPR to all data collections".
I don't even understand your logic to be honest, do you think any high level person working in a medical research company in Europe would have this line of thought ? If it's the case I hope everyone in charge of that specific organisation gets replaced real quick. You're telling me your "Ethics committee" is OK with injecting experimental drugs to people who can potentially ask them to delete all contact information (thus endangering them in case side effects are discovered) but they would not be OK with getting familiar with the law ? I have a hard time seeing how that works
How is GDPR different than the other hundred thousands laws regulating medical companies ? GDPR isn't the first law they have to worry about, it's probably not even remotely close to the most complex regulations applied to medical research. They're used to deal with very convoluted texts of law, I'm sure they can figure a list of 5 bullet points...
> but the damage is done: "Better safe than sorry, just apply GDPR to all data collections".
I don't even understand your logic to be honest, do you think any high level person working in a medical research company in Europe would have this line of thought ? If it's the case I hope everyone in charge of that specific organisation gets replaced real quick. You're telling me your "Ethics committee" is OK with injecting experimental drugs to people who can potentially ask them to delete all contact information (thus endangering them in case side effects are discovered) but they would not be OK with getting familiar with the law ? I have a hard time seeing how that works
My comment is not related to medical studies performed by pharmaceutical companies - which are indeed probably very well covered by legal experts - but by students/professionals working in university hospitals. Think PhD students.
The ethics committees of these hospitals have far less access to trained legal professionals. Especially if you factor in the amount of studies that re submitted. The combination of "little time" + "lots of studies submitted" + "no real expertise", leads to very shallow analysis of each individual study protocol. They basically run some kind of checklist that all studies have to pass before being validated. And because there is no time to review each study in depth, the tendency is to say "regardless of what the law says, we'll just cover the hospital potential liability by refusing any study that does not include strong privacy protection". No one has the time or expertise to say "I believe it's ont of those case where the law does not apply, and I am willing to undersign that study protocol".
In the hospital where my wife works, getting your study refused by the ethics committee leads to at least 3 month of delay in the study, since the commitee gathers once per quarter. PhD grants are given on a year-by-year basis, so getting 3 month of delay on your first target can sometimes be a death sentence.
The ethics committees of these hospitals have far less access to trained legal professionals. Especially if you factor in the amount of studies that re submitted. The combination of "little time" + "lots of studies submitted" + "no real expertise", leads to very shallow analysis of each individual study protocol. They basically run some kind of checklist that all studies have to pass before being validated. And because there is no time to review each study in depth, the tendency is to say "regardless of what the law says, we'll just cover the hospital potential liability by refusing any study that does not include strong privacy protection". No one has the time or expertise to say "I believe it's ont of those case where the law does not apply, and I am willing to undersign that study protocol".
In the hospital where my wife works, getting your study refused by the ethics committee leads to at least 3 month of delay in the study, since the commitee gathers once per quarter. PhD grants are given on a year-by-year basis, so getting 3 month of delay on your first target can sometimes be a death sentence.
> but by students/professionals working in university hospitals.
Yeah but then it doesn't matter because these student wouldn't come up with a covid vaccine in the first place. The GP comment is about the fact that covid vaccines are (supposedly ?) delayed by gdpr, which is non sense
Yeah but then it doesn't matter because these student wouldn't come up with a covid vaccine in the first place. The GP comment is about the fact that covid vaccines are (supposedly ?) delayed by gdpr, which is non sense
it’s not really an issue until it happens often.
also, gdpr is about privacy - I don’t think it can be used to remove the data if it’s anonymised. That is - I can ask google to remove the history of what I clicked on their site, but they can still retain info that someone clicked this or that.
also, gdpr is about privacy - I don’t think it can be used to remove the data if it’s anonymised. That is - I can ask google to remove the history of what I clicked on their site, but they can still retain info that someone clicked this or that.
Not only that research data can become anonymous, but there can be a valid legal basis to continued handling of personal data, such as fulfilling a contract.
There is so much misunderstanding around GDPR, it's frightening.
There is so much misunderstanding around GDPR, it's frightening.
> There is so much misunderstanding around GDPR, it's frightening.
That’s because the law is intentionally vague and has uneven enforcement baked into its design.
To be clear: I am a privacy advocate and agree that GDPR is not a barrier to medical trials, but it is basically a mess of a regulation. It’s almost as if the legal industry was consulted and wrote it to ensure continuing billions in legal fees from every company in the world.
That’s because the law is intentionally vague and has uneven enforcement baked into its design.
To be clear: I am a privacy advocate and agree that GDPR is not a barrier to medical trials, but it is basically a mess of a regulation. It’s almost as if the legal industry was consulted and wrote it to ensure continuing billions in legal fees from every company in the world.
What part of it makes you suspect intentional vagueness?
There are still technical scenarios for which the law has not been tried, and no consensus exists among experts.
Much confusion, in my opinion however, comes from overinterpreting the regulation.
The EU certainly has technocratic tendencies, but I firmly believe the spirit of GDPR is at the right place.
There are still technical scenarios for which the law has not been tried, and no consensus exists among experts.
Much confusion, in my opinion however, comes from overinterpreting the regulation.
The EU certainly has technocratic tendencies, but I firmly believe the spirit of GDPR is at the right place.
There were questions [0] to phase 1/2 results published data, which AFAIK has not been answered yet.
0. https://cattiviscienziati.com/2020/09/07/note-of-concern/
0. https://cattiviscienziati.com/2020/09/07/note-of-concern/
[deleted]
From the article:
"...the middle of a Pandemic is not the time to be cutting corners"
In reality an emergency is of course exactly the time to take more risks.
I'm no anti-vaxxer, but I cannot tell what's worse: a little known virus that hit us like an unexpectedly motile wall of bricks, or a rushed vaccine. I'd rather be exposed to neither, so I'll keep on keeping away from people until this thing blows over.
There are some risks wroth taking and some that are not. The problem with risks in an emergency is they can make things worse. Emergency officers are often killed when they choose to risk going faster than the speed limit - even though they have sirens on to warn everyone they are taking extra risk for an emergency.
Part of the definition of risk is that it can make things worse!
My point is that in emergencies, stakes are higher, so the potential benefit from taking a risk is higher.
My point is that in emergencies, stakes are higher, so the potential benefit from taking a risk is higher.
I thought airline pilots and marines trained specifically to avoid taking unnecessary risks in an emergency. They rely on playbooks, checklists, training.
There are also other tools left in the Arsenal before throwing Hail Mary passes — like, everyone could wear masks.
There are also other tools left in the Arsenal before throwing Hail Mary passes — like, everyone could wear masks.
In this instance, cutting corners is equivalent to not gathering data, and acting on the premise that what you want to be true is true.
Which is another way of saying: when there are massive consequences, is not the time to proceed on wishful thinking.
Because, as TFA pointed out: if you give people an ineffective vaccine, they will act as though they have an effective vaccine, and likely increase spread.
If you give someone a vaccine that has more antibody-mediated enhancement than protective effect (or at least, just a significant proportion of), you may do more harm than good as well.
And once you've deployed the vaccine to the general population, you've significantly impaired your ability to resolve questions about the above.
When stakes matter, and consequences are large and long-lasting, isn't the time to make blind leaps of faith.
Which is another way of saying: when there are massive consequences, is not the time to proceed on wishful thinking.
Because, as TFA pointed out: if you give people an ineffective vaccine, they will act as though they have an effective vaccine, and likely increase spread.
If you give someone a vaccine that has more antibody-mediated enhancement than protective effect (or at least, just a significant proportion of), you may do more harm than good as well.
And once you've deployed the vaccine to the general population, you've significantly impaired your ability to resolve questions about the above.
When stakes matter, and consequences are large and long-lasting, isn't the time to make blind leaps of faith.
Overstating it? Folks are not all behaving responsibly as it is, so nothing new there. Deploying in larger numbers, then measuring the result is gathering data too. There are massive consequences to the plague as it is.
This same person says "the difference between doing things correctly and not doing things correctly is a matter of a few months".
First, this is not a matter of "correct", it's a matter of "allowing people to voluntarily take additional risk on a vaccine similar to a phase III trial which we let people do already".
Second, A "few months" is huge. Like a vaccine working a few months earlier would be the biggest global event of 2020. He must be in quite the nice position if the pandemic going an extra "few months" is no big deal.
First, this is not a matter of "correct", it's a matter of "allowing people to voluntarily take additional risk on a vaccine similar to a phase III trial which we let people do already".
Second, A "few months" is huge. Like a vaccine working a few months earlier would be the biggest global event of 2020. He must be in quite the nice position if the pandemic going an extra "few months" is no big deal.
Let’s say a vaccine is safe — you still have to know if it’s actually effective. That’s one of the things measured in these trials. We can’t just say, whoops, and mail a new dose to everyone. So, the risk isn’t just the safety. It’s about not squandering the precious resources that have been pulled together to manufacture distribute untold numbers of doses of a vaccine.
That stood out to me as well. There's a real opportunity cost to not moving more deliberately: those few extra months represent several hundred thousand lives lost. Could a vaccine be worse than that? Of course if the answer is yes, then that would be horrific -- you wouldn't want to vaccinate hundreds of millions of people and then discover that you've unintentionally shipped Thalidomide 2.0. But at the same time, the probability of such risks should be balanced against the certainties of what will happen without a vaccine.
Anybody who says that this is a simple or easy calculation frankly has no idea what they're talking about.
Anybody who says that this is a simple or easy calculation frankly has no idea what they're talking about.
If it's a vaccine that does anything other than exactly what it's supposed to is going to erode public trust in any future vaccines that might actually work.
Unfortunately these kind of calculations clash with ethics. You can’t take actions that cause people to die, even if they prevent more other people from dying.
COVID has leapt from the realm of science and reason into fear and hysteria.
If we 'saved' 1 million elderly people from dying of COVID, and they instead died over a period of time from vaccine side effects, those effects would be impossible to quantify via a binary PCR test and so would be ignored.
Additionally if people were vaccinated, but still died, we could at least say 'oh well, we tried'.
Rushing out a vaccine and giving it to people near the end of their natural lives is a completely legitimate decision to end this hysteria and get back to normal life.
If we 'saved' 1 million elderly people from dying of COVID, and they instead died over a period of time from vaccine side effects, those effects would be impossible to quantify via a binary PCR test and so would be ignored.
Additionally if people were vaccinated, but still died, we could at least say 'oh well, we tried'.
Rushing out a vaccine and giving it to people near the end of their natural lives is a completely legitimate decision to end this hysteria and get back to normal life.
Elderly does not imply "near the end of their natural lives." Consider folks who are about to retire. They're certainly at risk but they still have a whole phase of their lives ahead of them.
Agreed. Here it means, older than 50. Which is still running marathons, still having children, still working, still riding century rides for some.
I’m not an expert on this, but my guess would be: it’s logistically very difficult to produce the required number of doses. They’ve been gearing up all over the world to get ready. So, I would think that you really don’t want to spend those resources on a vaccine that’s either 1) not safe, or 2) not as effective as you thought it was.
When the risks of cutting these corners are significantly outweighed by the risks of getting to a vaccine slower.
With due respect to the many losses from Covid-19 - the numbers are not huge. 0.012% of the world's population has died from Covid over a period of about half a year. The annual death rate of all other causes in the world is 0.77%, or (normalizing to half a year) about 33 times as high.
So, Covid is a serious pandemic but not terrible enough to risk significant corner-cutting in vaxine development - as I see it.
With due respect to the many losses from Covid-19 - the numbers are not huge. 0.012% of the world's population has died from Covid over a period of about half a year. The annual death rate of all other causes in the world is 0.77%, or (normalizing to half a year) about 33 times as high.
So, Covid is a serious pandemic but not terrible enough to risk significant corner-cutting in vaxine development - as I see it.
> I wonder when is the time
Wartime would be such time - scarcity of resources in combination with lack of alternative measures.
As long as simple measures like wearing masks, keeping your distance and minimising risky activities are sufficient, there is no rush.
It's also not as if COVID-19 is a zombie apocalypse or some primarily airborne and highly infectious variant of Ebola that threatens to wipe out huge parts of the population within weeks or months.
Wartime would be such time - scarcity of resources in combination with lack of alternative measures.
As long as simple measures like wearing masks, keeping your distance and minimising risky activities are sufficient, there is no rush.
It's also not as if COVID-19 is a zombie apocalypse or some primarily airborne and highly infectious variant of Ebola that threatens to wipe out huge parts of the population within weeks or months.
So, I could totally believe that this is mostly a political gesture, and Russia is doing this mostly for propaganda purposes. But, honestly, even given that, I found the tone of the article to be biased and speculative, in an anti-Russia way. FUD should not be the main component of an article in a medical journal. Give us some facts about the situation, or if you don't have any facts to give, write a shorter article.
The second paragraph contains a link to the phase 1/2 results that the vaccine creators published in the same journal. Because of unexpected patterns in the data in those results, there are doubts about their veracity, which is consistent with the idea that the institute is cutting corners in the trial. If it turns out that they did make up the results and the vaccine is more dangerous and/or less effective than expected, the journal will be known as complicit in the backlash that ensues not just against this vaccine, but against all others as well. So the journal wanted to temper their implicit endorsement made by publishing the original article, and this is the result.
Pointing out facts is biased?
That's just it. We don't have many facts about this vaccine other than it was rushed. Many folks are probably going to hear 'a vaccine has been created' and think it's a panacea. This article seeks to correct that by pointing out what we don't know about the trial (which appears to be a lot).
There is a Polish joke video about Russian vaccine
https://youtu.be/vN2eQ_CKZT8
You can get 'vaccines' on the dark markets (ie Agartha). Hard to say if they are real. They say they are from animal and human trails. $500
No Russian vaccine yet I can see.
But if it is being produced in India, which this is, along with permission for the Indians to produce it for internal use, then I'd guess it'll be available on the clearnet.
Do you let your 80 year+ male family and friends risk death from Covid or buy it online... Plus of course to do it for fun.
No Russian vaccine yet I can see.
But if it is being produced in India, which this is, along with permission for the Indians to produce it for internal use, then I'd guess it'll be available on the clearnet.
Do you let your 80 year+ male family and friends risk death from Covid or buy it online... Plus of course to do it for fun.
Do you mean this agartha, reviews seem to indicate it is a scam? https://www.darknetstats.com/agartha-market/
Good point. You definitely seem correct.
Most of the big ones were being DOSed when I was checking.
I found this which suggested Agartha, but they do actually mention it's not ‘approved’ by Darknetlive.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3581387
I wouldn't expect the Russian vaccine yet, and I'd google around before buying it. I'm already on a trial vaccine so I'm not supposed to get any other vaccines. But I might buy a non-animal vaccine for family when it comes out.
Most of the big ones were being DOSed when I was checking.
I found this which suggested Agartha, but they do actually mention it's not ‘approved’ by Darknetlive.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3581387
I wouldn't expect the Russian vaccine yet, and I'd google around before buying it. I'm already on a trial vaccine so I'm not supposed to get any other vaccines. But I might buy a non-animal vaccine for family when it comes out.
> Hard to say if they are real.
I think it's rather easy to say.
I think it's rather easy to say.
StriverGuy(2)
I would take it if it was available to me. The risk of a side effect seems much lower than the risk of catching or spreading the disease to others.
You have absolutely no basis on which to make that statement. There is no data about the vaccine (and about the virus) to reasonably assert that the risk of the vaccine is lower than the (low) risk of infection if you take mitigation measures such as wearing masks and limiting interaction.
Yes, it really was mostly a political gesture. General inoculation isn't planned for until Jan 1st, 2021.