The reason the phase III trial placebo groups were all given the vaccine after three months without any blinding was that maintaining blinding while also giving the placebo group the chance to get vaccinated was considered “onerous” by the companies.
J&J had a median of TWO MONTHS follow up when it amended its protocol to implement unblinding of the two phase III trials.
The FDA guidance was that at least six months if not twelve months of placebo-controlled followup.
The FDA itself said that continuing the blinded placebo control after emergency use authorization would be critical to collect the safety data needed for approval.
Meissner of Tufts/FDA said that licensure is important because they won’t get made mandatory without it, and they are currently considered “experimental.”
No one knows what happens to the vaccine components once they enter your body, and rushing passed that usually asked question is not considered a problem.
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@krosenque@ZKForTre@Jbpoiuytrewq A quick search turns up this Finnish study saying that 1.95 children under 15 get myocarditis every 100,000 person-years. That suggests that ~900,000 children under 15 have been vaccinated in Connecticut. Let me check.
@krosenque@ZKForTre@Jbpoiuytrewq I can’t find the number vaccinated in the 12-15 year old range. For example this page breaks it down by age but only goes down to 16 years old.
After 80 million people took it, in September 2004, five years later, it became clear it was causing heart attacks and strokes.
In 2009, ten years after FDA approval, Scott Reuben admitted that data from 21 efficacy studies was fabricated.
Between 2006 and 2011, hundreds of millions of dollars were paid out in civil suits, including wrongful death suits.
In 2015, the FDA reiterated its own conclusion that there is no specific risk of Vioxx but rather all NSAIDs have the same increased risk of heart attacks and stroke with high doses and long duration, and it should come back to market.
I think this is correct. CDC has stopped reporting breakthrough cases because if they don’t tell people how many there are, more people will get the vaccine. CDC says once you do no need for a mask because... more people will get the vaccine. It’s all behavioral psychology.
If the vaccine isn’t fully effective, can’t people without a mask still spread it?
If vaccination rates go from 40 to 60% because of the no mask rule and the unvaxxed 40% all take their masks off, won’t transmission net INCREASE?
And if the CDC stopped reporting the rate of breakthrough cases, isn’t the most reasonable interpretation that they don’t like the way the data looks and vaccination is less effective in the general population than suggested by the trials?
I found the CDC definition of breakthrough case, and it does require the ct value be reported if defined using PCR, but the definition of a case does not require PCR or any specific ct value.
However, I stand by my criticism that not counting the breakthrough cases unless they are hospitalized or die prevents us from knowing the hospitalization rate and case fatality ratio for vaccinated individuals.
This 28 ct value guidance is specifically for ensuring high levels of RNA in samples that will be sequenced for variants after breakthrough cases have been identified:
The quotes from these southern elementary school history textbooks are, besides terribly pro-slavery, also laughably promoting their home state like a hotel brochure. Each state teaches that the surrounding states treated their slaves terribly but the home state masters were nice
I didn’t grow up with anything like this, although I never had much respect for history as taught in elementary or high school anyway.
My BA is in history. My favorite teacher had taught us left-wing and right-wing interpretations of every era, made our exams essays where we had to pick a side and defend it, and I never had a damn clue what his own views were.
The Fed and US govt may be allowing bitcoin to freely run right now because it absorbs a trillion dollars preventing real estate and other assets from skyrocketing, smoothing stimulus fallout.
He suggests they see this as helping to calm political instability and civil unrest that would otherwise occur from skyrocketing prices in things that are not merely speculative instruments.
He also suggests that at some point in the future if we have stagflation they could ban BTC as a tool of monetary policy to release the trillion (or I would imagine by then $10 trillion).
However, that strikes me as them playing with fire. At some point BTC is “too big to ban.”