Brazil Rejects Sputnik V Vaccine, Says It's Tainted With Replicating Cold Virus (arstechnica.com) 110
Artem S. Tashkinov shares a report from Ars Technica: Health regulators in Brazil say that doses of Russia's Sputnik V COVID-19 vaccine contain a cold-causing virus capable of replicating in human cells. The unintended presence of the virus in the vaccine can "lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems," Brazil's Health Regulatory Agency, Anvisa, said Wednesday in a translated statement. Russia has unequivocally denied the claim, lobbed legal threats at Anvisa, and accused the respected regulators of being politically motivated to reject the vaccine. Still, Brazil's findings raise serious questions about the quality and safety of the vaccine, which is now being used in many countries. The findings also support concerns of Slovak regulators, who said earlier this month that batches of Sputnik V they received did not "have the same characteristics and properties" as the Sputnik V vaccine that was described in a peer-reviewed publication and found to be 91.6 percent effective.
Moreover, quality-control issues weren't the end of Anvisa's concerns. In an overall evaluation of the Russian vaccine, Brazil's regulators found its safety and efficacy were based on insufficient, limited, and sometimes faulty data and analyses. "Flaws... were identified in all stages of clinical studies," Anvisa said. The agency also reported that its inspectors who traveled to Russia to assess the vaccine's production were barred from vaccine facilities at Gamaleya Institute, which developed Sputnik V. Russia touts that "the safety and efficacy of Sputnik V has been confirmed by 61 regulators in countries where the vaccine has been authorized." However, Brazil's regulators said that of the 51 countries it contacted, only 14 were using the vaccine, and most of those countries did not have a tradition of vigilant drug-safety monitoring.
Moreover, quality-control issues weren't the end of Anvisa's concerns. In an overall evaluation of the Russian vaccine, Brazil's regulators found its safety and efficacy were based on insufficient, limited, and sometimes faulty data and analyses. "Flaws... were identified in all stages of clinical studies," Anvisa said. The agency also reported that its inspectors who traveled to Russia to assess the vaccine's production were barred from vaccine facilities at Gamaleya Institute, which developed Sputnik V. Russia touts that "the safety and efficacy of Sputnik V has been confirmed by 61 regulators in countries where the vaccine has been authorized." However, Brazil's regulators said that of the 51 countries it contacted, only 14 were using the vaccine, and most of those countries did not have a tradition of vigilant drug-safety monitoring.
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Cuban Soberana cannot handle -180C storage because glass vials shatter, or something..
-180C?
OK, listen I don't mind saving Frozone, Iceman, Jack Frost, and the Snow Queen. Annoying, but I might even consider Elsa and Akira.
But Mr. Freeze can go fuck himself. No vaccine for that asshole.
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Poor quality control (Score:5, Insightful)
The Brazilian incident [arstechnica.com] is not the only instance of delivered vaccines being of lower quality than one should expect..
Slovak testing indicated serious quality control issues [arstechnica.com] three weeks ago.
Re: Poor quality control (Score:5, Interesting)
Re: Poor quality control (Score:5, Insightful)
It can happen. We had to throw out 15M doses of the J&J vaccine in the US due to mixing the base ingredient from a different vaccine by accident. https://www.google.com/amp/s/w... [google.com]
The key difference here is that this incident was found by quality control before shipping the vaccines, while Sputnik seems to have been delivered to the vaccination authorities without any quality control (ref links in my original post).
Re: Poor quality control (Score:4, Interesting)
Sounds like standard practice for dodgy suppliers, the first batch you get, and submit for certification, easily meets IEC 60950 / EN 60 950 / UL 60950. and you wonder how they can make them for the price you're paying them (if you're in on it, you can even specifically request a version of the product for certification rather than one for sale). Then once it's certified and you happen to pull apart what they're shipping you now, you realise why they can make it for that price.
Sounds like the Russian vaccine is being made under the same principles...
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> the first batch you get, and submit for certification, easily meet
The problem with ALL of these rushed vaccines is that all the research and papers were done by the top scientists in small batches in the best labs.
Then they need to scale that up by six orders of magnitude and it's different people, different equipment, different facilities, and - most importantly - different incentives.
QA is meant to compensate for these differences but when it's rushed the processes are just too big to do a good job.
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Sputnik has always been two human adenoviruses. But they are supposed to be castrated, unable to reproduce. Brazil is claiming that the vectors in the vaccine batch they have received are able to replicate.
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Nope, because this is how you'd make the virus jump species. Theirs is unable to replicate as well, with the downside that they use the same vector for both shots making the recipient partially immune to the second shot.
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brazil just didnt understand what they were buying, or maybe to fill in the shortage russia is re-branding the chinese vaccine?
Brazil has a lot of socio-economic problems, but it is not a STEM-lightweight, specially in the pharma, nuclear energy and aerospace fields. Sorry, but no. I am going to have a very hard time believing that scientists and regulators at Anvisa didn't know what they were buying.
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The difference is whose lobbyists have the best access. As desire for the vaccine wains so they are fighting over fewer doses and much reduced profits which can to a degree still be achieved as long as competing products are pushed off the market. They are attacking each others products because of a shrinking market, those willing to take the vaccine. It looks awful from the outside because the lobbyists are willing to say anything to win for the pharmaceutical paying them, a lobbyists war.
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The critical difference here being that the faulty vaccine was thrown out at the point of manufacture. They didn't say, "Hell, ship it!"
Re:Poor quality control (Score:5, Informative)
The discovered that Sputnik used replicating viruses by "analyzing the documents"
whatever that means https://cbn.globoradio.globo.c... [globo.com]
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Scaling up is hard (Score:4, Insightful)
I suspect that the scaling up aspect of vaccine effectiveness is a bit underestimated. It's mentioned for Sputnik vaccine but I'm thinking in general.
The test batch may have certain testresults but then telling people to scale it up to hundreds of millions of doses, distributing them , innoculating people correctly, that is a huge challenge. There were leaked mails about the Pfizer vaccine that in the early stage(before approval, i don't know about afterwards) the concentration was half of what it was in the testbatch.
It's possible that there are quality problems with the final product, as well as with later batches where early batches were fine.
I know cases where the very last step of administering the vaccine was fucked up. They aimed too high and the vaccine likely ended up in the shoulder joint.
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I know cases where the very last step of administering the vaccine was fucked up. They aimed too high and the vaccine likely ended up in the shoulder joint.
There are something like 100 entries in VAERS of mostly hospital staff complaining about receiving intravenous covid injections rather than intramuscular. From some of the comments its hard to believe hospitals can so royally fuck up something so simple.
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That is a serious communication failure. If we can assume for every complaint from hospital staff there are many cases which are never reported then there will be (guesstimate) tens of thousands of people who think they've been vaccinated and haven't been. Just for one type of mistake.
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That is a good point, maybe it will just work.
I assumed however that once you tune it for one approach you can't count on it working for the other approach. Maybe you need a much larger dose, or a different composition.
Krusty pregnancy test (Score:3)
May cause birth defects.
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Yeah, Krusty or not, don't eat those pregnancy tests.
Re:With all these reports of hazards in the vaccin (Score:4, Insightful)
It seems like they have rushed them out too fast without doing proper testing.
Then don't take the Sputnik V, there are several other options out there. The Russian vaccine was the first one available to the wider public, but it's because they made it available before the phase 3 trials were over. Then again, just because Sputnik V was rushed doesn't mean that others were too.
I have had personal experience with a few people close to me getting infected, but somehow I have not yet got infected even after being in direct contact with [them]
Good for you. It's hard to tell if it's because you just happen to be immune or you just got lucky. As any casino manager will tell you, there is no such thing as luck. You might have dodged a bullet couple of times, but it doesn't mean you are more likely to dodge the next one.
In any case, it's not a good idea to make health decisions based only on articles on the internet. You are much more likely to see extensive coverage on how a plane crashed than how millions of planes safely landed. These kinds of risk calculations are not that hard. It's "chance to get infected" times "for infected person chance to get severe illness/die" compared to "chance to get severe complications/die from vaccine". In theory you should care about the chance that the vaccine doesn't prevent severe illness/death, but that number is ridiculously small.
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Even if you were infected, it's still a good idea to get the vaccine unless you had a severe case (eg. hospitalized).
Immunity is really complicated, with an enormous number of complex variables that are impossible to measure if you're not in a hospital-like setting. A minor infection may not have set those variables in such a way to provide long-lasting immunity.
The vaccine gives your body a lot of known values for those variables, which makes it much more predictable that you are actually immune.
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Re:With all these reports of hazards in the vaccin (Score:5, Informative)
The new vaccines were not rushed out. The basic technology has been funded by the U.S. government for the last 10 years. The drug companies couldn't have simply whacked together the mRNA technology in a few months. Time is an important perspective to have.
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You completely missed the point. They have been working on them for decades. There were a lot of problems that had to be solved - that did not happen 'in a few months'. Now that those problems have been solved, new mRNA vaccines can be made 'in a matter of months' because 'all' they need to do is make the mRNA.
Re:With all these reports of hazards in the vaccin (Score:4, Insightful)
Not really. It's more like they spent 10 years developing a multi-tool, then only needed to create a specific attachment for the job at hand at the end. The vast majority of the work had already been done.
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The work on mRNA vaccines started 30 years ago, not a few months ago.
https://en.wikipedia.org/wiki/... [wikipedia.org]
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No. They changed the mRNA payload, which took about 2 weeks. The rest of the vaccine is technology developed and tested for SARS and MERS, and that took many years.
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Sputnik V was the first vaccine to become available if I recall correctly (due in no small part to truncated testing), and it is not an mRNA vaccine.
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Right, just like we have cured cancer, heart disease, lung diseases, etc. Oh, we didn't? I guess it is only because those also only affect gays, drug users, and third world countries, right?
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Money is an important perspective to have. You can get an awful lot done with tens of billions of dollars at stake and massive political pressure being applied - just to put that figure into perspective, using GDP as a measure you can buy entire nations with that sort of money. We'd have cured AIDs long ago if it didn't mostly affect the gay community (1980s) and intravenous drug users and third-world countries (today).
One thing which helps immensely with vaccine testing is a widely spread, very contagious disease - you get far more data from the control groups much faster than normal, which helps you evaluate efficiency. Also, no shortage of volunteers...
Wasnt that the design? (Score:2)
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I was under the impression that Sputnik V was a vector-virus vaccine similar to the Oxford and Chinese vaccines. But unlike Oxford, who used a chimpanzee adenovirus, the Chinese and Russian vaccines used a human adenovirus (cold virus).
China's Sinovac is not a fancy newfangled viral vector. It is just old school "dead" bits of actual virus.
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Sputnik V is two human adenoviruses, but there are two genes that are supposed to be removed from the viruses. Removing those genes prevents replication.
In samples that Brazil (and Slovakia) tested, those genes were not removed. One, the other, or both genes were still active depending on the sample, which points to a quality control problem.
It's not a bug, but a feature! (Score:2)
My experience (Score:1)
I was vaccinated with the Sputnik V vaccine, in Russia, so here is my experience. I'm almost 40. The OP here.
I didn't feel anything after the first shot, but the place where I got the injection hurt for up to 36 hours, and I couldn't sleep on that side because it hurt too much. I didn't have a fever or anything like that, just pain in my left arm.
After the second shot in my right arm, I felt like I was either dying or was poisoned. My mind was extremely foggy (I'd never felt this way even after alcohol)
ANVISA: one of the most respectable agencies here (Score:2)
ANVISA is suffering a lot of pressure from politicians and, in some cases, companies that are expecting to make big money. But they're clearly inspecting all incoming vaccines with scientific approach. For all current allowed vaccines here, they spent a reasonable time deeply investigating, verifying scientific papers with studies and visting the manufacturer site.
So far, ANVISA approved Pfizer, Oxford and Sinovac.
The pro-Bolsonaro group is pressuring ANVISA to give the green for the India one, Covaxin, but
Technical Account from Drug Researcher Derek Lowe (Score:2)
"Anvisa, the Brazilian drug agency, said that every single lot of the Ad5 Gamaleya shot that they have data on appears to still have replication-competent adenovirus in it." – Derek Lowe, https://blogs.sciencemag.org/p... [sciencemag.org]. The article gives an extended account of why this is Bad.
Also, this from Lowe on the conduct of Russia in response to this rejection, "I mentioned the Twitter response to the Brazilian rejection of the Gamaleya vaccine. I believe that the official blue-check-marked “Sputnik V
Re:Yeah I read about that (Score:5, Insightful)
This is the shoot the messenger thing. This is not coming from "you", the USA, this is coming from the Brazilian "Agência Nacional de Vigilância Sanitária". Sure, I guess the CIA and other anti-Russians may have an input here trying to say Russia is garbage. On the other hand, Russia has considerable form recently with misinformation, likes and lack of the rule of low. In this cawe however you have to show specific stupidity in what will be a large group of scientists with a reasonable reputation [wikipedia.org]. The fact that there's some mud about doesn't mean that everyone is wallowing in it.
The original Russian vaccine has been quite well respected. It's an interesting and good design coming from scientists in institutes with good history in a country with a long history of very interesting medical research (look up Russian history in bacteriophages). The Oxford vaccine group started tests with combining the original Sputnik with the AstraZenica (Oxford) vaccine. This is the proper way to behave. Try to read widely from different reputable sources that you have the right level of education or experience to understand and then don't shoot messengers until you have a clear history of them having lied, not just what your friends spread on Facebook. Like RT, and like the CIA. Unlike the ANVC.
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misinformation, lies and lack of the rule of law - though likes and lack of the rule of low somehow fits too
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Actually for months on end we read that the Russian vaccine was probably crap. Then Europe decided it really needed it and strong proof made it hard to deny that it worked, but Europe is still acting 'very concerned' as this article shows https://www.reuters.com/articl... [reuters.com]
.
You don't know to what extent Russia is sowing disinformation when most of the hard disinformation work is coming from our side. Everyone is indeed wallowing in it.
Re:Yeah I read about that (Score:5, Informative)
And while politics may be in play in the Brazilian side, it's certainly in play on the Russian side. Russia is way behind on vaccinating its own population - even behind India per capita. Yet it's doing everything it can to send vaccines to countries that it wants to win political support with. They also launched a disinformation campaign against other vaccines to try to scare people away from them.
The whole thing I find so unfortunate because Russia has a lot of very capable scientists, and IMHO the design of the Russian vaccine looks better than that of AstraZeneca's (even if not up to the standards of mRNA vaccines), by use of two separate adenovirus vectors, one for each dose, to help avoid triggering an immune reaction against the vector during the second shot. But they've been undercut by their government sowed doubt by putting out a whole bunch of dubious statements, from the "first approved vaccine in the world" statement, to fake production numbers, to trying to one-up every other vaccine in efficacy claims. And it's been pretty clear that mass production has not gone as planned.
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I don't take the part about 'undercut by their government' seriously. As I've said many times on here (and been modded as troll many times more for it) our anti-russian propaganda dwarfs any other propaganda on the market in terms of effectiveness and quantity. The others are negligeable in comparison.
I don't know yet if their mass production is having problems but it wouldn't surprise me. I also think Brazil , given the crisis they're facing shouldn't be picky. But I recall early on that the predicted prod
Re:Yeah I read about that (Score:5, Insightful)
the worst part about this, is that there is no room for any country or company to be shitting on any effective vaccine. Despite how well the USA has been about hoarding vaccines for our citizens, outbreaks in India and Brazil only increase the chance that one of these fuckers are going to get on a plane and be sick, and the virus mutates into something the vaccine is less effective against. This is a zero sum game people. Its like an oil shortage in Venezuela affecting gas prices here even though we dont buy oil from there. Its all one big pot of supply subject to global demands.
And let me be critical of our new president, because he is fucking up in the same way our old president did.... stop letting these infected countries travel here! If you fly into China from brazil or india (probably other countries), you MUST stay in their quarantined hotels for two weeks. So yesterday the US State department advised Americans in India to fly home. Asked them to take a convid test 3-5 days after arriving here, and to quarantine at home for one week. Seriously?!? WTF?!? Ask? How about "you just flew in from a covid shit storm, here is your two week hotel. Meals will be delivered to your door, and medical staff are on standby taking daily temperature reads, ask medical questions, and covid tests every 3 days".
If you leave it up to the people fleeing, at least a couple are going to deliberately endanger the entire passenger group. Its happened multiple times already. One incident involved Californians who were in Orlando florida and got on a plane, lied on the questionaire, and then collapsed on the plane, and died right there. His wife was heard telling the EMT trying to save his life that he had covid. All the measures in place rely on people being forthcoming and certainly not intentionally putting others at risk. And yet, here we are, acting in self interest only. So lets just transport a strain from one side of the USA to the opposite side of the USA, because you wanted to be home when you were sick. Fuck the rest of the country. Now instead of Orlando, its now Brazil (where two new mutations are being found weekly) or India with a mutation that kicked in with a blind vengeance. And our policy is self policing? Either stay there and die, or come here and be inconvenienced for two weeks in order to prevent another 500,000 deaths.
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How about "you just flew in from a covid shit storm, here is your two week hotel. Meals will be delivered to your door, and medical staff are on standby taking daily temperature reads, ask medical questions, and covid tests every 3 days".
Whoa there! Don't get any of your dirty, stinky socialism in our medical system!!
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That really would be surprising when China's conducting its own vaccine diplomacy.
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I asked the google and it replied:
https://www.globaltimes.cn/pag... [globaltimes.cn]
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I stand corrected (and surprised).
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Russia is way behind on vaccinating its own population
In the remote areas, yes.
In the major population centres, you can get an appointment for a vaccination for the next day, in any hospital. Whoever wants to be vaccinated definitely had ample opportunity by now.
Source: My wife did just that, six weeks ago.
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Russia is way behind on vaccinating its own population
In the major population centres, you can get an appointment for a vaccination for the next day, in any hospital.
Both can be true at the same time. Even though vaccines are available to anyone in Russia and have been available for longer than any other nation, the vaccination numbers are significantly lower compared to US or Europe. Correct me if I'm wrong, but the Russian population doesn't seem to trust the Sputnik V that much.
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Yes, from what I've heard (again, my wife was there) quite a few Russians don't want to get the vaccination. That trend was shifting more towards yes some weeks ago, we haven't followed it since.
And I don't know what the situation outside Moscow or St. Petersburg, etc. is. Russia is a vast country, and there may be considerable logistical challenges getting it into the more remote areas. Though at least in the very north you don't have to freeze it, just open the door and you're good. :-)
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There's a lot of people there who don't trust vaccination , who don't trust the Russian vaccine, who don't htink it is good enough. Given that i expect there also to be a lot of people who intend to get vaccinated but kind of keep postponing it until it feels really urgent. Vaccine hesitancy includes everything which causes you to postpone it.
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Russia is way behind on vaccinating its own population
In the remote areas, yes.
In the major population centres, you can get an appointment for a vaccination for the next day, in any hospital. Whoever wants to be vaccinated definitely had ample opportunity by now.
Source: My wife did just that, six weeks ago.
Most Russians live in major population centers (75% of the population is urban). And the large majority of them are not vaccinated (only 13 doses per 100 pop).
So if what you are saying is true, it's only because of wide-scale vaccine hesitancy in Russia. Most people just don't want it (yet).
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As of today, 8,43% of the Russian population has gotten at least one dose. By comparison:
India: 9,09%
Brazil: 13,71%
Germany: 26,73%
US: 43,32%
UK: 50,4%
Israel: 62,44%
I'll repeat: Russia is way behind on vaccinating its own population. Regardless of how inequal vaccine distribution may also be on top of that.
Re:Yeah I read about that (Score:4, Insightful)
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Apologies for the anonymity, but I already modded one of your posts above.
I mean to buy a human adenovirus vector vaccine (like the chinese vaccine) and then complain it has a replicating cold virus seems like a bazar claim to make. Thats like buying a tesla and then complaining it had Li-ION batteries in it.
No, the viral vectors used in these vaccines are not supposed to replicate. They have been engineered to lack certain key protein (iirc) coding genes, so while they do invade our cells, do produce additional copies of the spike protein, and do provoke the various strands of our immune system they cannot create additional copies of themselves, 'break out' and spread to additional cells or other people.
At least that's the idea.
Problems
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another issue with the production of these viral vector vaccines is possible contamination with other viruses that can infect and replicate, which i believe may be the case with the vaccine brazil got.
Re:Yeah I read about that (Score:4, Interesting)
The adenoviruses in the vaccines are supposed to have two genes removed, which prevents replication.
In the samples in Brazil, those genes are still active. Either one or both, depending on the sample. Which points to a quality control problem, not a fundamental problem with the vaccine.
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but isnt the russian adenovirus vectors both human adenovirus?
It's supposed to be a disabled adenovirus. Russia is notorious for great scientists and bad (non military) manufacturing. Even their military manufacturing is, in part, good because it makes a virtue of imprecision and brutality. Sometimes a gun that works is more important than one that came out of the factory with perfect accuracy. Sometimes a plane that can take off on a junk covered runway is more important than one that's hyper efficient.
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It is even worse than that. Russian citizens are reluctant to vaccinate with Sputnik V [bbc.com], probably because of decades of mistrust in government, and history of the latter lying to the people. Add to that rumors ea
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The problem is that Russia did not follow the proper process and trial data has been questionable - https://www.dw.com/en/is-sputn... [dw.com]
This combined with Russia's dictatorship government permanently tainted international perception. China's Sinovac has a similar issues with regime, trial data, and a history of bribing regulators.
Authoritative regimes have public relations reasons they want to claim to be first, these run contrary to ensuring pharmaceuticals are safe & effective.
Stephen Colbert says hi (Score:2)
Sure, I guess the CIA and other anti-Russians may have an input here trying to say Russia is garbage.
This reminds me of Stephen Colbert's quip back in the day: "I cannot prove it, but I can say it."
Either you have proof of this or get the fuck out.
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I can prove that they may have input. They exist. Nobody fully controls their activities. QED. I never claimed that they do have an input so that proof is sufficient.
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>In this cawe however you have to show specific stupidity in what will be a large group of scientists with a reasonable reputation
Where do scientists come in? If the vaccine didn't work, that would be on the scientists who developed it. But this is a claim that the vaccine production was contaminated - and I doubt there are many scientists involved in large-scale production. Scientists do research, mass production safety is handled by technicians, managers, and inspectors.
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Re: Yeah I read about that (Score:1)
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Putin actually doesn't even speak Russian well,
[citation required]
None of my russian-native-speaker friends ever mentioned anything like that, despite Putin coming up as a topic now and then. So I'm really curious where you got that.
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The only reason for the real political bent is that Bolsonaro must suspect Russian agents to be the source of the leaks regarding corruption in the Brazilian government and this is payback. Well, it wont last that long and Bolsonaro will lose the next election, so.
Re:Yeah I read about that (Score:4, Interesting)
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He is said to speak German well and has given a speech in it fairly recently.
Much is likely an image issue.
He spoke in the German parliament once. I think there's videos of it online. He starts out by saying in clear German "I will of course speak in Russian", and then continues to do just that.
He would definitely have been able to read a prepared speech in German - he intentionally decided not to do that, but force the entire parliament to listen to translators, in their own parliament hall.
Re:Yeah I read about that (Score:5, Informative)
Perhaps you were talking about a second appearance maybe. However, in 2001 [youtube.com], he made a much longer address in German to an appreciative audience. There are three parts, I didn't watch them so I'm not vouching for content.
It's surprising how 'good' Putin's disinformation campaign really works on things he wants to project.
Re: Yeah I read about that (Score:2)
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Does he? Last I checked he was good in German, and struggled with English. Has to do with where he was stationed and trained for.
Re:Yeah I read about that (Score:4, Informative)
U.S. officials pushed Brazil to reject Russia’s coronavirus vaccine, according to HHS report
The West accuses Russia and China of "vaccine diplomacy". Here is the vaccine diplomacy. The West's style.
Russia's vaccine diplomacy - give countries vaccine
The US vaccine diplomacy - stop countries from getting vaccine
Re:Yeah I read about that (Score:5, Interesting)
And China is to give vaccine to countries on friendly terms with China.
China has given more vaccines away than they have inoculated their own citizens. Of course, they are all to friendly countries - anyone who's shown even the slightest interest in democracy, or Taiwan, or human rights, have been denied China's generous donations.
And we're talking millions of doses given away for free, and heavily subsidized doses after that. All trying to push China's "Harmony" goal which is about "making people happy". Minus any talks about human rights, free speech, democracy, criticizing the government, etc.
Re: Yeah I read about that (Score:2)
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anyone who's shown even the slightest interest in democracy, or Taiwan, or human rights, have been denied China's generous donations
That is untrue. For example CoronaVac is being used in the Philippines, Chile, Brazil, Albania, Ukraine, Pakistan and Mexico, and they are all democracies.
https://en.wikipedia.org/wiki/... [wikipedia.org]
And that's just one of the three they have developed.
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