Posted on 08/23/2021 9:16:12 AM PDT by fireman15
The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.
This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.
The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.
"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," acting FDA Commissioner Janet Woodcock said in a statement.
A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.
(Excerpt) Read more at npr.org ...
Yeah. At this point death isn’t much of threat. I have had a good run, but I’m definitely on the downhill slope.
If it was compulsory at work I’d have to take it.
Not.
It appears to be just a reissuing of the EUA.
You are entirely correct, it doesn’t seem to be cleared yet.
Of course, anyone who relies on social media or the lamestream media for news will be very confused to learn that the vaccine had not always had full FDA approval, since any mention of the fact that the vaccine had not yet been approved was censored.
I found THIS from ABCnewsgo.com:
The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.
That’s shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding whether to fully license the vaccine for people 16 and older, those studied the longest. Pfizer’s shot is still being dispensed to 12- to 15-year-olds on an emergency basis.
(emphasis mine)
So, I just don't know.
That is actually speculative. The study from Israel demonstrating this was based on a population with 90% vaccination compliance. The remaining 10% did not get vaccinated mostly because they had serious health issues and their doctors felt the vaccines might kill them. I think it is fairly obvious that people with serious health issues are more likely to be hospitalized than those who are healthy.
More than anything else this “pandemic” has been characterized by misleading statistics.
I read it as the FDA Did NOT fully approve the Pfizer shot as being reported! It only extended the Emergency use authorization!
https://www.fda.gov/media/150386/download
Yeah, like that wasn’t going to happen. LOL.
Absolutely political ....
++++++++++++++++++++++++++++++++++++++++++++++++
With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety
Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues. Without a control group there is nothing to compare the vaccinated group against. According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose ....
Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials. As noted in the example above, the control group was intentionally lost under the auspices of “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.
There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed. This is nuts. That NPR article is one to bookmark when people start claiming the vaccination is effective.
How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?
More at the link.
They also did away with a hearing they were supposed to have - I believe Sen. Ron Johnson addressed this in a letter he wrote (which was ignored).
All you need to hear is the Surgeon General Murthy .... more will be mandating the vax because of approval.
“Then you could actually have a conversation.”
Is that what you call what you do?
Pfascism is mandatory for the sheeple.
I’m making the point, he believes this crap is just fine to put into our bodies, and encouraged us to do so! Again, why shouldn’t he be thrilled that this “vaccine” was approved?
It is illegal for a vaccine to be forced, if there is an effective therapeutic. Ivermectin appears to be quite effective.
More than half of gas_dr posts talk about other people or posters. He rarely discusses an argument. I guess he is not capable.
......Vaccines don’t allow you to get a disease you are vaccinated from.
Vaccines don’t allow you to transmit a disease you are vaccinated from.
Vaccines don’t require booster shots every six months.......
Well, flu vaccines DO require a new shot every year!!!!
And they are not 100% effective, so some vaccinated people DO get the flu!! Presumably they can transmit it, too!!!!
I’ve been getting a flu shot every year for decades, and have never gotten the flu ever since I’ve started being vaccinated!!!! (I started being vaccinated way back in the 1980s, after a very bad case of the flu!!!!)
Sad! Must be an experimental gene therapy side effect.
Yep next up attempted forced vaccinations. Key word is attempted.
It is illegal for a vaccine to be forced, if there is an effective therapeutic. Ivermectin appears to be quite effective.
https://www.youtube.com/watch?v=tUE5EBPt-lU
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