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 ...
It’s not a vaccine. What a complete scam as millions of people will die and lose their livelihoods. The great reset is among us.
Just a reminder:
https://prescriptiondrugs.procon.org/fda-approved-prescription-drugs-later-pulled-from-the-market/
Did you forget the /sarc tag?
He/she forgot his/her/it’s brain.
Imagine grafting all the decades of credibility of the word “vaccine” onto this experimental gene therapy. A great day for Farma shills.
I wouldn’t even take it for work.
2banana wrote: “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.”
A simply incorrect strawman argument typical of the anti-vaxxer movement. No vaccine ever made provided total 100% protection from infection or transmission. Many also required booster shots.
Trump was pushing these crap vaccines at his rally! Why wouldn’t this make him very happy?
If a vaccine needs a booster shot every few months, it’s not effective.
But since the Pfizer Jab is not a vaccine....
If it was designed to force people to get a new expensive treatment on a regular basis, then I have to congratulate Pfizer for a great business decision. And with immunity from lawsuits by labeling their gene therapy as a vaccine, this is a literal liability free goldmine.
Are you invested in these pharmaceutical companies?
Do you believe Trump would have handled it different?
Early on he supported banning flights and then alternative treatments.
I doubt he would have been in favor of kids getting the shot.
It’s the difference between the way Trump would have handled Afghanistan and biden mishandled Afghanistan.
You obviously did not watch the rally! President Trump said specifically at the rally that people should be forced to take the vaccines. This step which will force people to take the vaccines does not make him happy. You are a moron and would be better off not continuing to embarrass yourself.
I just read every word of the FDA approval letter to Pfizer. Be very aware of the exact syntax of the words chosen in that letter. Words mean things, every word.
The letter approves of:
1. The MANUFACTURING.
2. Timetables for long term effects data gathering. Most have the time table of 2024 for completion.
3. Nowhere does the letter state the product is approved for patient USE or medical authority USE.
The devil is in the details.
This was a purely political decision, you understand. Nothing to do with the “syenz” involved, of which there is no connection at all with rigorously reviewed and authentic science.
And by the way, why isn’t there an effective vaccine for HIV/AIDS developed yet? They certainly had enough time to be working on it.
The Kool-Aid doesn’t work unless everyone drinks it.
President trump gets bejng an American. There is no challenge we cannot meet with American ingenuity. We used to talk of our manifest destiny. Americans see those who put a man on the moon when we were behind in the space race. We are the ones who have built marvelous achievements. Built the greatest economy. We did it because we used to revere great men. And we weren’t scared.
I agree with you about Trump should be thrilled. There will always be those who don’t celebrate our American birthright. We are the best in the world
42 percent effective against infection. Reduces risk of hospitalization for 8 months. I fear that if you don’t take the booster, you will end up MORE vulnerable to variants
Imagine if you actually knew what gene therapy was. Or had a rudimentary understanding of basic biology. Then you could actually have a conversation.
Go to:
https://www.fda.gov/media/150386/download
“On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.”
Is this FDA legal terminology for extension of emergency use authorization? This letter does not seem to be more than an extension, not full “clearance”. Am I reading this correctly?
(By the way NPR does not know what they are talking about. The FDA “clears” medical devices, drugs, IVD’s etc. for marketing. It does not “approve” them.)
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.