Welcome • User Guide
ToS • Privacy • Canary
Donate • Bugs • License

©2026 Poal.co

1.1K

Full approval in record time. Can we now find cures for other things in record time? Looks like it is easy in 2021, lets go! Seriously, lawsuits need to flood everything. Mandates have to be illegal, right?

Full approval in record time. Can we now find cures for other things in record time? Looks like it is easy in 2021, lets go! Seriously, lawsuits need to flood everything. Mandates have to be illegal, right?

(post is archived)

[–] • 3 pts (edited )

The FDA is supposed to approve drugs that have been proven to be safe & efficacious. None of those 3 terms apply here.

1 PROVEN .. no clinical trials except the brief animal trials that were stopped because all the animals died. 2 SAFETY .. even discounting the indirect evidence of causing blood clots in 2/3 of the people that receive it; the vaccine reporting system of the CDC reports 10 times the occurrence (% of those received) of vaccine-related deaths and permanent disabilities in comparison to any other vaccine released. 3 EFFICACY .. in countries where the government is not hiding the stats (US), infection rates among the vaccinated is >95%. Even at Obummer's BD party it was reported that nearly all of the cases were vaccinated.

These facts did not change overnight because of bribery to get a specific brand to wear the badge as the "only FDA-approved Covid vaccine"

[–] • 1 pt

Patriot, what part do they not understand ? The Hell or the No ?

[–] • 1 pt

My employer is now talking about mandating it. I'm going to have to find a new job.

[–] • 0 pt

I already posted this as a post. One commenter said it's for the 3rd booster. And said the Pfizer was fully approved. My reply was it would be helpful if they could provide a document stating that it was fully FDA approved, and not just under emergency use approval. So we will see if they can provide that documentation. This is the document I have. Don't see anywhere where it says it's for the 3rd booster. It just approves again for emergency use https://www.fda.gov/media/150386/download

[–] • 0 pt

It is approved. read it

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

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.

[–] • 0 pt

It is approved for EMERGENCY USE ONLY That doesn't give it the license approval they are claiming. Sorry read the 13 pages again. Better yet show a document that gives it the full license approval.

[–] • 0 pt

It has an EUA for certain uses that are not included in the approved BLA. The BLA approves COMIRNATY for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

[–] [deleted] • 0 pt
[–] • 0 pt

Read it again it is not as of yet fully approved. An application has been approved. That does not equate to a fully approved vaccine.

[–] • 0 pt

They Are Lying!!!!!

The FDA Did Not Approve The Covid-19 Vaccine!!!

They Only "REISSUED" The "Emergency Use Authorization" (EUA)

Read Their Own Statement On From Their Site Titled

"Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021"

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

[–] • 0 pt

It's a mandate. Not a law. Irregardless of any approval of anything outside of the law.

[–] • 0 pt (edited )

I think the re-issue of distribution is only approved for continued emergency use. At least they also admit it can cause heart damage.

https://linksharing.samsungcloud.com/nxqLGJlhZSas

[–] • 1 pt

It is fully approved. read it

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

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.

[–] • 0 pt

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

PAGE 12 "This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19)"

[–] • 0 pt

Let me fix it for you: "This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19), for children 12-15 years of age." For individuals 16 years of age and older, it is fully approved.

[–] [deleted] • 0 pt

LICENSING U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

https://www.fda.gov/media/151710/download