2019 Novel Coronavirus

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jean15paul_PE

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For reporting of side effects, is there any threshold for statistical significance?
That's a good question. I don't know. (But I know someone I could ask.)

From what I understand, anything that happens to any trial participants during the trial has to be reported. So even if there's no stated statistical cutoff, there would be a de-facto cutoff just because trials only have so many people in them. If the trial was thousands or 10's of thousand of people, but not millions, everything could have been done correctly and this could have still been missed.

It's also interesting to me that all of the people who experience blood clots are women.

Historically sex as a biological variable (SABV) has been ignored in research studies. Interestingly, most of the drug recalls in the last couple of decades have been because of women-specific side effects that weren't discovered during trials. Human trials are pretty even between men and women today, but animal trials (which is the first step for almost all research) typically uses male animals, simply because boy mice are cheaper to purchase than girl mice. Also most of the cell lines that scientist use for research are male cells. Awareness has been growing over this as a major oversight in science.

In the past few years the US National Institute of Health, the European Commission, and the Canadian Institute of Health Research have all instituted SABV policies. Some scientific journals have stopped publishing research where SABV isn't considered. So things are improving, but I'm curious if this is related to this specific J&J blood clotting issue.

Anyway, I went off on a tangent, but if you want to learn more.



 
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JayKay PE

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How is it any more complicated than that? Pretty good chance that, out of 7 million people, there are going to be a few that end up getting cancer. Are we now supposed to jump to the conclusion that the vaccine also causes cancer?
I mean, we jumped to the conclusion that McDonalds french fries cause cancer, so why not?
 

DuranDuran

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I got my first dose last week. I literallly felt like I had the flu the next day. It was worse than when I had Covid. The second day, I felt fine.

I uploaded a gif and it produced a still image because I forgot to save it on my desktop first and THEN upload it. Can I conclude the vaccine causes forgetfulness? Or was I already forgetful? I don't remember.
 

kevo_55

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Oh, that felt better. I've been away for too long.
 

Dleg

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I think the issue with the J&J blood clot statistics is not the rate (6 out of over 6 million) but the timing. Yes, the rate is less than the statistical background, but the fact that they occurred so soon after the vaccination is reason to be concerned and why CDC and FDA are taking the steps now to pause and investigate.
 

Dleg

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That is interesting, but I have two thoughts:

1. Africa shouldn't be congratulating themselves yet. This isn't over (look at India - they were slow to take off but now their numbers are crazy).

2. The age structure / demographics in Africa may explain most of the difference in death toll. Regardless of political correctness, Africa still remains a place where people just don't live that long. See the population pyramid:

View attachment 18865

Compare this to the US:



There are simply more old people in the US than there are in Africa. From that alone, we should expect a higher death rate in the US compared to Africa. The so-far lower death rates in India may also be attributed to this, to a great extent:

Wow, India is really losing control: 273,802 new cases yesterday:

1618873971762.png
 
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