What full FDA approval? It is still only allowed under emergency act | |
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OGEBY User ID: 78971166 United States 08/24/2021 04:14 AM Report Abusive Post Report Copyright Violation | COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. • It is also authorized under EUA to be administered to: o prevent COVID-19 in individuals 12 through 15 years, and o provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to: • prevent COVID-19 in individuals 12 years of age and older, and • provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. Seems like they approved COMIRNATY, but Pfizer-BioNtech is still under EUA? [link to www.fda.gov (secure)] |
Subway Prophets Just A Watcher on the Wall User ID: 80447217 United States 08/24/2021 04:27 AM Report Abusive Post Report Copyright Violation | n/m Last Edited by Subway Prophets on 08/24/2021 04:32 AM "Sir, are you classified as human?" "Negative. I am a meat-popsicle." ~Corbin Dallas |
TheExPatrioticGirl User ID: 27314376 United States 08/24/2021 04:48 AM Report Abusive Post Report Copyright Violation | I'm not sure if anyone read the FDA docs from today: Quoting: Sheepster [link to www.fda.gov (secure)] page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation. ------ 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 use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. ------- The rest of the documents are here: [link to www.fda.gov (secure)] No, I don't think it's about re-naming. Something else is going on here. The letter to Pfizer from the FDA basically says that there are two vaccines, one is the Pfizer-BioNTech, the one in current use today. For THIS vaccine, they are hereby RENEWING THE EMERGENCY APPROVAL to basically continue on. That's all. The second vaccine is called COMIRNATY, also made by Pfizer, and THIS IS THE VACCINE THAT WAS SUBMITTED FOR APPROVAL AND IS NOW BEING APPROVED. HOWEVER, the letter goes on to say that while the COMIRNATY vaccine is interchangeable with the BioNTech, the problem is that THERE ARE NOT ENOUGH DOSES AVAILABLE TO EVEN BEGIN TO GIVE IT TO THE PUBLIC. Before they begin to make and distribute COMIRNATY, all the (KILLER) doses of the EXPERIMENTAL BioNTech must be used up. These people are sick!! This is another HOAX. There IS a vaccine approved but it's not the one they are handing out and since they made SO MANY, they have to use up the deadly one first. It's a very sneaky letter. It's all fun & games until the Dogman stands up Life's journey is not to arrive at the grave safely in a well-preserved body but rather to skid in sideways, totally worn out, shouting "Holy Shit! What a ride!" In times of trouble, I ask myself, "What would Sarah Conner do?" |
aningeniousname User ID: 78711976 Belgium 08/24/2021 05:20 AM Report Abusive Post Report Copyright Violation | [link to www.fda.gov (secure)] Just reading the insert for the Comirnaty (link above) and as well as admitting the heart problems associated with it's use especially in young men it also says: "COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility" So they basically are saying in the product insert we don't think it causes female infertility or miscarriages, we aren't sure whether it is safe for breast feeding, young healthy men can definitely die from from heart attacks, we didn't even bother to check for cancer causing, gene damaging, or male fertility problems. I wonder why they didn't bother to check for those problems? Now reading the leaflet that comes in the box do you still want to take it? If that was on the side of any other product would you take it? |
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RickHarley User ID: 80785023 Ukraine 08/24/2021 07:35 AM Report Abusive Post Report Copyright Violation | Developing software requires several different steps like in this blog [link to mlsdev.com (secure)] , each of which is executed by a software development team. First, the developers create the project's "blueprint," detailing everything from start to finish. This blueprint gives developers a look at what the project will entail, including objectives, estimated time frames, estimated costs, specifications, and critical functionality requirements. A software development company may work with smaller teams or as a large outsourcing group. Last Edited by RickHarley on 08/25/2021 09:38 AM Handle |
Levski User ID: 77069575 Sri Lanka 08/24/2021 07:44 AM Report Abusive Post Report Copyright Violation | What about this part here: 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. A friend says that the EUA was extended for under 16. For everyone else it is approved. True or false? Or did they simply "approve" that BLA license. And we should read the next paragraph instead: 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. ------------------ I think I found it on page 12, like the other thread said. Last Edited by Levski on 08/24/2021 07:51 AM Noah was a conspiracy theorist too, until it started raining. |
Copious_Sedition User ID: 79556370 Switzerland 08/24/2021 07:45 AM Report Abusive Post Report Copyright Violation | They say in the insert that they did a double blind placebo study. Then later admit they were "unblinded" and given the Vax. WTF? Also they don't actually list out what serious adverse events happened, their count, or percentage. Even if there was one death it should be called out. They only list out pain at the injection site, headache, etc... If you report more serious events in the placebo group than the Vax group, say you gave them saline but really did saline then gave them the Vax anyways? You just split the serious events in half so you can say they were statistically significant. They did recognize the increase in heart risk with no math on how many cases there were. |
Larphillips User ID: 78895011 United States 08/24/2021 07:49 AM Report Abusive Post Report Copyright Violation | This is the same level of total and complete confusion that has been evident for the entirety of the pandemic. This is on purpose. Clear answers, clear direction, and clear information is NOT what they want. They want us confused, afraid, and (most importantly) bitterly fighting with one another. They are succeeding. “A person is smart, people are stupid.” “Nobody knows until everybody knows” |
Anonymous Coward User ID: 11850570 United States 08/24/2021 07:51 AM Report Abusive Post Report Copyright Violation | They say in the insert that they did a double blind placebo study. Quoting: Copious_Sedition Then later admit they were "unblinded" and given the Vax. WTF? Also they don't actually list out what serious adverse events happened, their count, or percentage. Even if there was one death it should be called out. They only list out pain at the injection site, headache, etc... If you report more serious events in the placebo group than the Vax group, say you gave them saline but really did saline then gave them the Vax anyways? You just split the serious events in half so you can say they were statistically significant. They did recognize the increase in heart risk with no math on how many cases there were. Dr.Jane Ruby on the FDA Approval yesterday, says something that caught her attention was , "According to the new insert which is now going into the box with the medicine , 50% of those who were given the med (up until march of 2021) got a placebo!"... This fact is NOW included on the insert paper of the box by Phizer! IT should be front page news! This fact means millions did not actually get their medicine they got a saline water shot... and no one except Phizer knows who got what. Doesn't this fact completely invalidate the so called V passport??... Stupid has gotten the upper hand. |
Vidura108 User ID: 80785468 Singapore 08/24/2021 08:05 AM Report Abusive Post Report Copyright Violation | I'm not sure if anyone read the FDA docs from today: Quoting: Sheepster [link to www.fda.gov (secure)] page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation. ------ 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 use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. ------- The rest of the documents are here: [link to www.fda.gov (secure)] That says its been approved for 16 yrs and up but still EUA for 12 to 15 yr. olds. Vidura108 |
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Justme C'est Moi User ID: 80193276 United States 08/24/2021 08:11 AM Report Abusive Post Report Copyright Violation | Brilliant! It is just a reauthorization of the emergency Use authorization of Dec 2020. The Government didn't realize that some citizens can actually read. :) Last Edited by JustmeTX on 08/24/2021 08:16 AM Justme |
Deplorable TailDragger User ID: 80457626 United States 08/24/2021 08:28 AM Report Abusive Post Report Copyright Violation | [link to www.fda.gov (secure)] :stab: Brilliant! It is just a reauthorization of the emergency Use authorization of Dec 2020. Quoting: Justme C'est Moi The Government didn't realize that some citizens can actually read. :) Last Edited by Deplorable TailDragger on 08/24/2021 08:28 AM I feel suffocated by the Oxygen Channel. Found John Galt. (finally saw part 3) Philly Sux! Fucking Pot Holes from last winter are just bigger. |
N0vajay05 User ID: 79039270 United States 08/24/2021 08:31 AM Report Abusive Post Report Copyright Violation | The approval is in the first paragraph of Page 2. They are keeping the emergency auth in total to cover all deployments before approval, and emergency auth for ages 12-16. full approval is granted for anyone 16 an over using pfizer. Some of you need to learn to read. |
Mason Firefly User ID: 79925043 United States 08/24/2021 08:31 AM Report Abusive Post Report Copyright Violation | Looks like they approved it after all. Check this out below from the FDA. How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE? The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. [link to www.fda.gov (secure)] Last Edited by Mason Firefly on 08/24/2021 08:32 AM |
Anonymous Coward User ID: 80697090 United Kingdom 08/24/2021 08:34 AM Report Abusive Post Report Copyright Violation | I'm not sure if anyone read the FDA docs from today: Quoting: Sheepster [link to www.fda.gov (secure)] page 12 or just search for word emergency and you will realize this is still only approved under emergency act, and drug was renamed. That's it. It is main stream media manipulation and misinformation. ------ 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 use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. ------- The rest of the documents are here: [link to www.fda.gov (secure)] ... |
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Jay.Crew User ID: 40230781 United States 08/24/2021 09:02 AM Report Abusive Post Report Copyright Violation | Looks like they approved it after all. Check this out below from the FDA. Quoting: Mason Firefly How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE? The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. [link to www.fda.gov (secure)] The fact that they are calling it conformity is actually pretty funny If you omit the widespread murder element. Check out this thread for important statistics which have showed (since early summer 2021) that Covid “Vaccine” is more likely to KILL YOU than save you: Thread: COVID JAB statistically more likely to KILL YOU per official CDC DATA. You’re 3.87x more likely to die from the Pfizer vax than save your life!! |
SamAdams User ID: 80367713 United States 08/24/2021 09:02 AM Report Abusive Post Report Copyright Violation | NOT FDA AUTHORIZED, EXCEPT UNDER EUA!!!! Page 2 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. |
SamAdams User ID: 80367713 United States 08/24/2021 09:13 AM Report Abusive Post Report Copyright Violation | Or, is the BLA the official FDA approval? 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. The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. |
SamAdams User ID: 80367713 United States 08/24/2021 09:17 AM Report Abusive Post Report Copyright Violation | Yes, the BLA is the actual FDA approval. By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved. In conclusion, it is FDA approved for ages 16+. |
lil_g User ID: 78275883 United States 08/24/2021 09:24 AM Report Abusive Post Report Copyright Violation | Yes, the BLA is the actual FDA approval. Quoting: SamAdams By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. FDA evaluates the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and whether the manufacturing and facility information assure product quality and consistency. After its evaluation, FDA decides whether to approve (also known as to license) the vaccine for use in the United States. If FDA approves the vaccine, the company is permitted to market it in the United States for use in the population for which it is approved. In conclusion, it is FDA approved for ages 16+. to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. What'uses' are and are not included in the approved BLA? dream |
Happy in Nature User ID: 80639409 Nicaragua 08/24/2021 09:36 AM Report Abusive Post Report Copyright Violation | I shared this on a thread yesterday: How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE? The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. [link to www.fda.gov (secure)] Quoting: STRONGMAN SHELFORD I interpret this as Pfizer will list the ingredients in Comirnaty (I hate that name!) without graphene dioxide and whatever other poisons they have put in their original experimental jab, but still has permission to use the original generically named jab with the poisons as a legal substitute, thereby continuing their crimes against humanity without the legal liability. Last Edited by Happy in Nature on 08/24/2021 09:36 AM |