Nice career ya got there, be too bad if something happened to it…
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But the studies were “too small” and the study was not a randomised double blind design.
The Russian trials, held at two hospitals in Russia, were open-label and not randomised, meaning participants knew they were receiving the vaccine and were not assigned by chance to different treatment groups.
Volunteers were healthy adults aged between 18 and 60 who self-isolated as soon as they were registered for the trial and remained in hospital for the first 28 days after vaccination.
Dr Ohid Yaqub, senior lecturer at the University of Sussex’s Science Policy Research Unit, said: “Normally, such a study would be the basis for debating whether to proceed into larger trials and the costs that entails. In that context, the study results are encouraging in terms of safety and possible efficacy.
“However, in the context of regulatory approval, the design and size of a phase 1/2 study is not anywhere near sufficient for widely recognised standards of approval. The study was not randomised, and it was not large enough to detect rarer safety issues.”
Throughout the article, “appears to be” is doing a lot of heavy lifting.
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Remind me…Weren’t there similar upbeat reports in the very early days with very small groups about hydroxy-whatsis until there weren’t, and it’s now been more or less contraindicated???
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With Trump swirling the drain in the turd bowl over his military smear drama now would be the perfect time for him to announce an Executive Office mandated EUA on a vaccine, effective 10/31. Just watch.
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They used to be, but I wouldn’t count on that now.
Is there even a valid medical professional in charge there anymore?
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They did try a cyber attack on Oxford where the best vaccine candidate is being worked on and Oxford also had a head start.
I trust Putin would only steal from the best and then do a second cyber attack that is caught and thwarted.
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Kushner is in negotiations with the Mossad right now to buy the pilfered vaccine research from them. Israel hacked it from Putin.
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Those statements came from the CDC, not the FDA.
On the whole, if Fauci’s saying November is possible, but still extremely unlikely, then that makes the ‘please be ready by Nov 1’ a little more likely to be the ‘look, we just want everyone ready before the vaccine is, so we don’t have to go scrambling to figure THAT out once we have it’ that the CDC says it was.
Still ain’t trusting it w/out foreign (or NYS, since Cuomo’s taking the stand he has) corroboration.
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In related news, Russia seems to be releasing some data:
Here is the published article regarding the Sputnik vaccine:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31866-3/fulltext
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Tries, fails.
Not true. To help the President Skanky and the Republican party win re-election, the FDA granted emergency approval of hydroxychloroquine and convalescent plasma. Just last week under pressure from conservatives, the FDA walked back concerns regarding plasma. You cannot trust the FDA. Fauci is making sh*t up to stay relevant in the administration and to the public.
Also, remember Fauci’s and his NIAID has zero track record of a successful vaccine. They have not developed a vaccine against HIV, malaria, SARS etc. despite enormous resources and plenty of time. The Gates Foundation has a far better and very impressive track record and experience with vaccines and public health than the NIAID and CDC.
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Asked Thursday if he worried the process had become too political, Fauci said there might be a perception of outside influence, “but I don’t see that as being something that’s going to be practically playing out,” he said.
Regulators at the Food and Drug Administration and experts at the independent Data and Safety Monitoring Board are “very, very committed to making sure that science prevails and not politics,” he said.
bookmarking
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During an NPR interview yesterday the lead scientist/researcher/doctor for Operation Warp Speed said whenever the vaccine is “ready” production limitations will limit administration strictly to at-risk populations, those 70 or older, and those in the health care industries. He said initially there would be about 15 million doses released, and that production would be at similar scale each month thereafter. So after a year that’s roughly only half the populace vaccinated. That does not account for other nations we may have agreements with to share our vaccine production. He was less than excited about the near term outlook so far as release of a vaccine being a panacea, a route out of our current plight. There was definitely a “long slog” tone to the interview.
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The Russian two-stage vaccine has two adenoviruses vectors so that the subjects who don’t respond to the first adenovirus-5 vaccine respond to the adenovirus-2 shot. The scientists are technically correct but some of the American companies in the virus race that got billions of dollars of taxpayer money are also using the same adenovirus system. Remember there were plenty of public health scientists who were certain that masks did not slow the virus. Everybody likes their 15 minutes.
Most of the vaccines technologies in the Trumpvirus vaccine race are untested and unproven. Only one or two companies are working with proven vaccine technologies. Time will tell, let us wait for the data to speak and let us try to be hopeful during this colossal failure of national leadership.
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Sorry Dr. Fauci; the days of enjoying the benefit of the doubt expired when it became clear that the CDC and similar agencies were willing to play politics with sound scientific policy to please the dictator.
At this point it doesn’t matter who broke it, even though we all know that republicans wreck what they cannot control.
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I wonder if one of the reasons to rush this, aside from the obvious political/election angle, is to create the predicate for massive class action lawsuits against the FDA that Biden’s DoJ will be saddled with and Treasury will have to pay for, putting a dent into the budget. Because when Repubs know they’re going to lose, they switch to planting poison pills for Dems.
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To date the FDA and CDC have distorted science and out right lied to the public. Sorry Dr. don’t put yourself in the same boat.
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Sorry, Dr. I’ll still wait 4 or 5 years, the damage has been done and it will take 50 years to undo, if ever.
ETTD
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