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| 08:50 AM | ||
| Users Online Now: 2,037 (Who's On?) | Visitors Today: 512,498 | |
| Pageviews Today: 816,359 | Threads Today: 331 | Posts Today: 5,093 |
| 08:50 AM | ||
Clot shot not authorized as a vaccine. | |
| Feistylorax
Offer Upgrade  User ID: 79731348  United States08/23/2021 02:05 PM  Report Abusive Post Report Copyright Violation | |
| Feistylorax
(OP) User ID: 79731348 United States08/23/2021 02:11 PM Report Abusive Post Report Copyright Violation | |
| AlphaWolf
User ID: 80247695  Canada08/23/2021 02:15 PM Report Abusive Post Report Copyright Violation | They Authorized it as a BLA Quoting: Feistylorax Per their own website that means it is not a vaccine. [link to www.fda.gov (secure)] Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors) Other non-vaccine therapeutic immunotherapies It was authorized today. Its the same shot they used under EAU and now it has a new name comirnaty. Its physically the same shot but now approved and not under the EAU anymore. They are also allowed to use the vials that were manufactured under the EAU because it is the same shot. |
| Blenderizer
User ID: 80562797 United States08/23/2021 02:15 PM Report Abusive Post Report Copyright Violation | If they approved it as a Therapeutic Biologics Applications (BLA) then wouldn't the patient have to be diagnosed with some condition warranting the shot? They can't just force everyone to get a BLA with no diagnosis of need. Modeling reality |
| Anonymous Coward User ID: 79863586 United States08/23/2021 02:19 PM Report Abusive Post Report Copyright Violation | Where is your link showing them approving it under this use and not as a vaccine? Quoting: Blenderizer If they approved it as a Therapeutic Biologics Applications (BLA) then wouldn't the patient have to be diagnosed with some condition warranting the shot? They can't just force everyone to get a BLA with no diagnosis of need. If it was not licensed as a vaccine then hypothetically the manufacturer can be sued, like any other drug. Only vaccines are exempt. |
| Feistylorax
(OP) User ID: 79731348 United States08/23/2021 02:19 PM Report Abusive Post Report Copyright Violation | They Authorized it as a BLA Quoting: Feistylorax Per their own website that means it is not a vaccine. [link to www.fda.gov (secure)] Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors) Other non-vaccine therapeutic immunotherapies It was authorized today. Its the same shot they used under EAU and now it has a new name comirnaty. Its physically the same shot but now approved and not under the EAU anymore. They are also allowed to use the vials that were manufactured under the EAU because it is the same shot. It's approved as a BLA for over 16. It is still under the EUA for 12-16. It's on page 2 of the updates here. [link to www.fda.gov (secure)] “Unless someone like you cares a whole awful lot, Nothing is going to get better. It's not.” Dr. Seuss, The Lorax ENTP SAHM raising chickens and kids preparing for whatever happens |
| Feistylorax
(OP) User ID: 79731348 United States08/23/2021 02:20 PM Report Abusive Post Report Copyright Violation | Where is your link showing them approving it under this use and not as a vaccine? Quoting: Blenderizer If they approved it as a Therapeutic Biologics Applications (BLA) then wouldn't the patient have to be diagnosed with some condition warranting the shot? They can't just force everyone to get a BLA with no diagnosis of need. If it was not licensed as a vaccine then hypothetically the manufacturer can be sued, like any other drug. Only vaccines are exempt. It's how they licensed it. Here from their own source again. [link to www.fda.gov (secure)] “Unless someone like you cares a whole awful lot, Nothing is going to get better. It's not.” Dr. Seuss, The Lorax ENTP SAHM raising chickens and kids preparing for whatever happens |
| Anonymous Coward User ID: 79863586 United States08/23/2021 02:21 PM Report Abusive Post Report Copyright Violation | Where is your link showing them approving it under this use and not as a vaccine? Quoting: Blenderizer If they approved it as a Therapeutic Biologics Applications (BLA) then wouldn't the patient have to be diagnosed with some condition warranting the shot? They can't just force everyone to get a BLA with no diagnosis of need. If it was not licensed as a vaccine then hypothetically the manufacturer can be sued, like any other drug. Only vaccines are exempt. Further, if a physician gives you the drug for an off label use, such as utilizes as a viral inhibitor instead of a BLA, you can sue said physician. Can of worms. |
| MountainTux NLI
User ID: 79879094 Canada08/23/2021 02:22 PM  Report Abusive Post Report Copyright Violation | They Authorized it as a BLA Quoting: Feistylorax Per their own website that means it is not a vaccine. [link to www.fda.gov (secure)] Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors) Other non-vaccine therapeutic immunotherapies It was authorized today. Its the same shot they used under EAU and now it has a new name comirnaty. Its physically the same shot but now approved and not under the EAU anymore. They are also allowed to use the vials that were manufactured under the EAU because it is the same shot. Nope. States clearly that Comirnasty has two different components, but doesn't state what they are, and that they are legally different though interchangeable.  ad ignorantiam - The assumption of a conclusion or fact based primarily on lack of evidence to the contrary. Usually best described by, “absence of evidence is not evidence of absence.” |
| Feistylorax
(OP) User ID: 79731348 United States08/23/2021 02:24 PM Report Abusive Post Report Copyright Violation | |
| Feistylorax
(OP) User ID: 79731348 United States08/23/2021 02:25 PM Report Abusive Post Report Copyright Violation | |
| Milo_Jeeder
User ID: 67312550 United States08/23/2021 02:26 PM Report Abusive Post Report Copyright Violation | |
| Blenderizer
User ID: 80562797 United States08/23/2021 02:27 PM Report Abusive Post Report Copyright Violation | This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Modeling reality |
