covid-19 /

FDA approves Pfizer COVID-19 Vaccination

The company announced its vaccine received full FDA approval Monday morning


Pfizer-BioNTech became the first company to have its COVID-19 vaccination fully approved by the Food and Drug Administration as of Monday morning.

Eight months ago, the same vaccination was first to be granted emergency approval in the United States. In July, the federal government bought an additional 200 million doses of the company’s COVID-19 vaccine. They should be delivered from October 2021 through April 2022.

So far, the US has exercised its option “to buy 500 million of the 600 million doses of Pfizer’s vaccine that were secured through an agreement announced last year by the Trump administration,” per The New York Post.

Pfizer CEO Albert Bourla said in a statement at the time, “Vaccines have been and will remain critical to protecting lives against this devastating disease. These additional doses will help the U.S. government ensure broad vaccine access into next year.”

The license application includes more than 340,000 pages of material. The earlier emergency use authorization submission was 110,000 pages.

“The approval of Pfizer-BioNTech’s vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said,” says The Washington Post. “The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said. The company plans to follow the enrollees for 24 months. To [qualify] for FDA emergency use authorization last December, the company followed trial participants for a median of two months after getting their second shot.”

The FDA decision also clears the way for the companies to market their vaccine, which is not permitted without full licensure. And it may launch a race for booster shots, allowing doctors to prescribe extra Pfizer-BioNTech shots ‘off label’ to anyone they think should get one,” reports USA Today.

Institutions across the country, including businesses and colleges, previously said they would require the vaccination as soon as the FDA officially signed off. 

*For corrections please email corrections@timcast.com*

17 responses to “FDA approves Pfizer COVID-19 Vaccination”

  1. WeaponizedMemes says:

    Remember when the FDA also approved Vioxx in 1999? And then nearly 50,000 died from it? What about all the pesticides and chemicals they approved that were later found to be toxic?

    Not saying the vax will kill people… just saying that FDA approval is pretty much meaningless.

  2. UppityG says:

    Part of the problem is our electeds have, little by little over time, built all kinds of protections for themselves such that when they mess up, we cannot hold them accountable. We can’t sue them. Which would be the only peaceful way to hold them accountable.

    So guess what’s left.

  3. Judah@hellands.com says:

    For myself and for about 20% of the 1.3 million service members in the country this is the start of the end of our careers. i will not be getting this stupid vaccine and with full approval they will now be forcing us all to get it. idk how many others have the moral fiber to simply say no but… I for one will be getting kicked out over it pretty soon.

    • Fool_Moony says:

      Good for you for standing up for yourself

    • Turk_Longwell says:

      Judah is it really that big of a deal? Have you gotten the Anthrax shots? if they still do that.
      Shoot, we got a bunch of shots and just did it, because it allowed us to go overseas for our country.
      It’s a very safe shot, from what I’ve read. I’m not trying to be a douche about it. I know that the “Leaders” of this country and the Media f-ed it up real bad on how they went about promoting it. It’s just that we need people like you serving in the Military. If you’re here on this site, chances are that you’re a critical thinker and an American for the Constitution. You’re not some Woke collective cultist. That’s why we need you serving in the Military.
      Just something to think about. Bless you and your fellow Servicemen. Be safe.

  4. Orion1632 says:

    How can this be full release? the documents I have seen still say Emergency Use, and the trials are still not completed and will be completed in 2023-2024

  5. Wolv256 says:

    I don’t care what the FDA says. I don’t respect them or acknowledge their authority.

  6. PapaShrek says:

    I think it was only extending the Extended Use Authorization, not fully FDA approved.

    https://www.fda.gov/media/150386/download

  7. CrispyBacon says:

    I’m assuming the US has a time machine somewhere? That was awfully fast for the standard length of the long term safety studies. By golly they completed 1-5yrs worth of studies in 8 months. The FDA should really share how they managed to speed up time.

    • A.J. says:

      More like 5-10 years. Hard to believe they’ve proven it safe going from concept to mass production in under a year while still doing the safety checks of a 5-10 year study every other new medication has to go through. But hey, it’s safe right. So I guess that means those pharma companies won’t be needing those protections that keep them from getting sued if it seriously injures or kills someone right? No? So safe…

      That and one might question its effectiveness when you look at a place like Israel, who has a majority of the population fully vaxed and a majority of all new Covid cases are fully vaxed people. Also, what happened to the Flu? Remember the Flu? That strange sickness similar to Covid transmitted in much the same way. Where did that ever go?

  8. ButtonPuncher says:

    Sooo, does this mean that we can now get Ivermectin approved?

  9. Swiftmind says:

    Here come the across-the-board mandates! Vax papers for all!

  10. JohnNelson says:

    No liability is such a dangerous thing. I don’t understand why they went extreme on it. Why not just give them less liability. So if something is blatantly wrong they are liable but if someone gets a minor side affect they aren’t. I don’t like absolutes.

    • Judah@hellands.com says:

      For myself and for about 20% of the 1.3 million service members in the country this is the start of the end of our careers. i will not be getting this stupid vaccine and with full approval they will now be forcing us all to get it. idk how many others have the moral fiber to simply say no but… I for one will be getting kicked out over it pretty soon.

  11. Another Beer says:

    Ok, so now are they liable for all the side effects, like the tobacco companies?