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Pfizer Had Interim Vaccine Results in October; Changed Study Design to Wait until November 4th to Analyze Samples
Statnews ^ | 11/9/2020 | Matthew Herper

Posted on 11/09/2020 6:59:33 AM PST by brookwood

https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/

The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported. Scientists can now design genetic material called mRNA to help us build immunity to certain viruses, including SARS-CoV-2, the coronavirus that causes Covid-19. Find out how mRNA vaccines work in this video. Hyacinth Empinado/STAT

That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.

In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.

Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.

This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.


TOPICS: Government
KEYWORDS: covid; pfizer
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"IN LATE OCTOBER THEY DECIDED TO STOP TESTING SAMPLES."

"TESTING BEGAN THIS PAST WEDNESDAY"

YES THE DAY AFTER THE ELECTION!!!!

1 posted on 11/09/2020 6:59:33 AM PST by brookwood
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To: brookwood

And the Durham report?


2 posted on 11/09/2020 7:01:00 AM PST by DIRTYSECRET (urope. Why do they put up with this.)
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To: brookwood

I’m sure just like the harvest ballots magically appearing, Pfizer just happen to realize this breakthrough today, not a few days ago BEFORE the election.

Amazing the widespread corruption.


3 posted on 11/09/2020 7:02:13 AM PST by 1Old Pro
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To: DIRTYSECRET

There will be no Durham report. Deep State has deep-sixed it.


4 posted on 11/09/2020 7:03:30 AM PST by salmon76 (Trump won the 2020 vote in a landslide. He did not win the ballot count--at least not yet.)
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To: DIRTYSECRET
And the Durham report?

The checks to Durham, Barr, Wray, Horowitz and Haspel will clear, as usual, on the 15th of the month. Be patient. Mr. Soros is good for it.

5 posted on 11/09/2020 7:03:46 AM PST by montag813
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To: 1Old Pro

The knew in October it was effective. They waited to release the results so it wouldn’t help Trump. Life is like that.


6 posted on 11/09/2020 7:04:10 AM PST by brookwood (Obama said you could keep your plan - Sanders says higher taxes will improve the weather)
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To: brookwood

So basically, Pfizer stopped counting also?


7 posted on 11/09/2020 7:04:43 AM PST by Toespi
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To: brookwood
I thought the timing was suspicious.
Turns out I was right. Along with most Freepers.
8 posted on 11/09/2020 7:05:28 AM PST by SmokingJoe
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To: Toespi
So basically, Pfizer stopped counting also?

Toilets overflowed there like in Atlanta.

9 posted on 11/09/2020 7:06:09 AM PST by 1Old Pro
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To: brookwood

Its almost impossible not to attach conspiracy to anything any more. Thanks to the Marxists for that gift.


10 posted on 11/09/2020 7:07:56 AM PST by Don Corleone (The truth the whole truth and nothing but the truth)
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To: brookwood

Biden will claim the credit. The media will give it to him. All hail Biden.


11 posted on 11/09/2020 7:09:50 AM PST by BlueStateRightist (Government is best which governs least.)
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To: Toespi

They stopped analyzing the samples. 10,000 people are dying every day and they “Stopped analyzing the samples”. They intentionally delayed the progress of the vaccine until after the election to hurt Trump. In the 10 days from when they knew it worked until the decided it was time to look at the data, 50,000 people died from the disease for which they developed the magic bullet. All to hurt Trump. I don’t give a rat’s ass about the voter fraud, but this intentional scientific fraud makes me angry.


12 posted on 11/09/2020 7:10:14 AM PST by brookwood (Obama said you could keep your plan - Sanders says higher taxes will improve the weather)
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To: brookwood

Because it’s THE FLU.

The death rate in my state is officially under 2% and FALLING.

They KNEW it was no more deadly than the regular flu.


13 posted on 11/09/2020 7:12:22 AM PST by Skywise
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To: brookwood

bttt


14 posted on 11/09/2020 7:14:10 AM PST by Pajamajan ( PRAY FOR OUR NATION. I will never be a peaceful slave to a Socialist new America.)
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To: Don Corleone

Right now the chatter is that Pfizer never took any money or was involved in operation warp speed because they didn’t want to be political. Anyone here that can dispute that?


15 posted on 11/09/2020 7:19:00 AM PST by lilypad
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To: brookwood

Good news, Pfizer vaccine uses mRNA which has no association with fetal stem cells.


16 posted on 11/09/2020 7:20:02 AM PST by G Larry (There is no merit in compromising with the Devil.)
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To: brookwood

And Trump was touting Pfizer, among others, at his campaign speeches.


17 posted on 11/09/2020 7:20:52 AM PST by libh8er
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To: G Larry

mRNA vaccines are the most effective.


18 posted on 11/09/2020 7:21:54 AM PST by libh8er
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To: Skywise

Correct


19 posted on 11/09/2020 7:24:12 AM PST by StoneWall Brigade (Live Free or Die)
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To: brookwood
This is why I've been saying for many months that all of the following organizations are totally 100% anti-Trump (and 100% pro-Biden): This list of Democrat Party surrogate organizations is not comprehensive but it gives you at least some idea as to the massive, unprecedented, nationwide scope of the desperate Democrat Party's highly-planned, strategized, coordinated, and implemented 2020 Election-Year Orchestrated-Chaos Master Plan. Even far worse, the desperate Democrat Party deviously perpetrated its anti-America scheme against the American people during the Communist China Party (CCP) Wuhan virus (Wu-Flu) Global Pandemic invasion of the United States. Absolutely reprehensible and despicable.
20 posted on 11/09/2020 7:37:14 AM PST by gw-ington
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