We all knew this would happen. It's called regulatory capture.
Fine sounding words about "thoroughly tested" and "safe and effective" are bs, of course. They haven't been tracking the effects of the experimental drug and we all know it. The only source we have is VAERS, and they trashtalk that as unworthy. OK, then why isn't there some sort of honest tracking and accounting? Why did the FDA refuse to hold a public hearing? How do you run an experiment with millions of people, refuse to track results, admit that it doesn't work as advertised, and then approve it?
Now that we have social media we know that many people are having horrible side effects and that many people are dying. I talked to one woman whose healthy 50 y.o. brother died after the jab, while their mother held his hand and cried for him to hold on. She told me that she begged the doctor, in tears, to report it to VAERS, but he refused. Apparently, it is an involved process of many pages and on every page, they warn the health care providers of harsh repercussions if they submit a "false" report. And who determines what is "false"? Maybe the same people who have banned the Nobel Prize-winning drug that has been given to billions of people as "unsafe"?
No wonder doctors refuse to submit the side effects and deaths.
The FDA's press release gives more details on their "thoroughly tested" methods. Speaking of the trials that started just last year...
"Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. ("Based on results from the clinical trial", they say. That is because we already know from "real life" that the vaccine is much less effective.)
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months."
So I read that as they had 44,000 people in the trial, and they evaluated 20,000 for "effectiveness" (now shown to be fake news, but, you know, that's not part of the "trial", so it can be ignored). Maybe if they evaluated all 44,000 they could have figured it out. They only monitored the 44,000 for "safety". And now they are only evaluating 12,000? Out of 44,000? For six months? WTF?
And WTF is this? They admit that it causes heart damage, so they will follow that in post-marketing, but that is ALL that they are required to follow?
"These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy"
They recommend it for pregnant women, but they haven't studied it and don't require it???? Why are Americans putting up with this?