Vaccine not approved, simple EUA is extended | |
Friends Matter User ID: 75523416 Canada 08/23/2021 06:17 PM Report Abusive Post Report Copyright Violation | Not FDA approval... the media is evil... spin spin spin spin spin rinse rinse rinse and repeat repeat. and never retract ever... Friendship isn't about whom you have known the longest...Its about who walked into your life and said...I am here for you. |
oniongrass User ID: 80365283 United States 08/23/2021 06:19 PM Report Abusive Post Report Copyright Violation | I love it. They get to say on all the morning programs that they are approving it, and then quietly... they don't Quoting: Eilonwy Wife's work, right after the "news", announced more coercive policies. If the news is withdrawn, will the policies be reversed? How often does that happen? . DON'T VAX, PROPHYLAX! ____________ There is no anger in Me: If one offers Me thorns and thistles, I will march to battle against him, And set all of them on fire. But if he holds fast to My refuge, He makes Me his friend; He makes Me his friend. (Isaiah 27:4-5) |
Phoenix Light User ID: 79367328 United States 08/23/2021 06:19 PM Report Abusive Post Report Copyright Violation | :MV80ODg3NTg4XzZEMDM1OTU=] Quoting: Foodstampwhat is going on, they said it would be approved? are we being lied to ? 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA). 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) 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. more here: [link to www.fda.gov (secure)] specifically check page 2 and page 12 However, they will still use it as such and push the narrative. They plan to keep the unvaccinated from the grocery stores. Phoenix Light |
Zither User ID: 75850278 United States 08/23/2021 06:20 PM Report Abusive Post Report Copyright Violation | |
oniongrass User ID: 80365283 United States 08/23/2021 06:20 PM Report Abusive Post Report Copyright Violation | They got approval for 12 years old...and up...now. Quoting: Friends Matter Not FDA approval... the media is evil... spin spin spin spin spin rinse rinse rinse and repeat repeat. and never retract ever... How else can we find out whether puberty completes normally if we don't start vaxing some male and female 12 year olds? . DON'T VAX, PROPHYLAX! ____________ There is no anger in Me: If one offers Me thorns and thistles, I will march to battle against him, And set all of them on fire. But if he holds fast to My refuge, He makes Me his friend; He makes Me his friend. (Isaiah 27:4-5) |
Mason Firefly User ID: 79925043 United States 08/23/2021 06:29 PM Report Abusive Post Report Copyright Violation | |
Phillip J. Fry User ID: 73177101 United States 08/23/2021 06:36 PM Report Abusive Post Report Copyright Violation | |
Scorched User ID: 80365094 United States 08/23/2021 06:37 PM Report Abusive Post Report Copyright Violation | |
Mason Firefly User ID: 79925043 United States 08/23/2021 06:38 PM Report Abusive Post Report Copyright Violation | The EUA was extended for 12-15 year olds and for third doses. It was granted full approval for 16+. Here is the actual approval: [link to www.fda.gov (secure)] |
Scorched User ID: 80365094 United States 08/23/2021 06:38 PM Report Abusive Post Report Copyright Violation | |
Limpan User ID: 76068685 Sweden 08/23/2021 06:40 PM Report Abusive Post Report Copyright Violation | |
Bog Babe User ID: 74113044 United States 08/23/2021 06:40 PM Report Abusive Post Report Copyright Violation | |
oniongrass User ID: 80365283 United States 08/23/2021 06:44 PM Report Abusive Post Report Copyright Violation | The EUA was extended for 12-15 year olds and for third doses. Quoting: Mason Firefly It was granted full approval for 16+. Here is the actual approval: [link to www.fda.gov (secure)] We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion. (<50%) That's like saying there was no evidence of fraud in the 2020 presidential election. Worse actually. Truth is totally absent. Will some decent judge tell FDA to go stuff it and to follow their own rules for extremely controversial applications? . DON'T VAX, PROPHYLAX! ____________ There is no anger in Me: If one offers Me thorns and thistles, I will march to battle against him, And set all of them on fire. But if he holds fast to My refuge, He makes Me his friend; He makes Me his friend. (Isaiah 27:4-5) |
oniongrass User ID: 80365283 United States 08/23/2021 06:46 PM Report Abusive Post Report Copyright Violation | Sadly, it is approved. Remember those doctors saying no way in hell it would be approved? Well those doctors were bypassed, the whole advisory process was bypassed, because the advice was deemed unnecessary. . DON'T VAX, PROPHYLAX! ____________ There is no anger in Me: If one offers Me thorns and thistles, I will march to battle against him, And set all of them on fire. But if he holds fast to My refuge, He makes Me his friend; He makes Me his friend. (Isaiah 27:4-5) |
oniongrass User ID: 80365283 United States 08/23/2021 06:51 PM Report Abusive Post Report Copyright Violation | Look who signed it at the end of the letter: Sincerely, Mary A. Malarkey Director Office of Compliance Office of Vaccines and Biologics Quality Research and Review (<50%) Her name is Malarkey! That's the word Biden uses to indicate nonsense. Are we sure this isn't from The Onion? Last Edited by oniongrass on 08/23/2021 06:51 PM . DON'T VAX, PROPHYLAX! ____________ There is no anger in Me: If one offers Me thorns and thistles, I will march to battle against him, And set all of them on fire. But if he holds fast to My refuge, He makes Me his friend; He makes Me his friend. (Isaiah 27:4-5) |
Riverat User ID: 79814486 United States 08/23/2021 06:51 PM Report Abusive Post Report Copyright Violation | Page 2 – Pfizer Inc. 10, 2021, 5 June 25, 2021,6 and August 12, 2021.7 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.8 5 In |
Anonymous Coward User ID: 79386144 United States 08/23/2021 06:58 PM Report Abusive Post Report Copyright Violation | Vaccines are included in biologic therapeutic definition. Quoting: Space DJ [link to www.fda.gov (secure)] "Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.” I see, they closed all the doors by changing the definition of vaccine and the altering the definition of therapy. Pure nosense. Vaccines have been considered biologic 119 years. [link to en.wikipedia.org (secure)] "The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. It was enacted in response to two incidents involving the deaths of 22 children who had contracted tetanus from contaminated vaccines.This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. Biologics control is now under the supervision of the U.S. Food and Drug Administration (FDA)." How many children have died shortly after "Pfizer biotech COVID19"? How many children have gotten covid and died after getting "Pfizer Biotech COVID19"? Why have the infection rates gone up in ages 12-15 since vaccinations in that age group began? I'm asking these questions to be answered by the FDA, CDC and any other government or healthcare entity promoting the safety of this "therapy." Why aren't the reporters asking these questions? This data should be on the nightly news along with the covid infection and death rates. Daily statistics for cases/deaths in vaccinated and un-vaccinated. All must be told. Now that comirnaty has been approved we have the right to be given full disclosure about what we are being asked to consent to. We do not have to consent to something we do not have all the information needed to make the right choice for our own bodies. The truth will be revealed to everyone. |
lil_g User ID: 78275883 United States 08/23/2021 07:00 PM Report Abusive Post Report Copyright Violation | On August 23, 2021, FDA approved the biologics license application (BLA) submitted by Quoting: REaliZe 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. Today's FDA letter explains that they are only revising the original scope of authorization to add the Comirnaty shot. No where does it say any shot has been granted approval now... This is as of today. What's going on here? dream |
DaveNKansas User ID: 80646086 United States 08/23/2021 07:39 PM Report Abusive Post Report Copyright Violation | On August 23, 2021, FDA approved the biologics license application (BLA) submitted by Quoting: REaliZe 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. Today's FDA letter explains that they are only revising the original scope of authorization to add the Comirnaty shot. No where does it say any shot has been granted approval now... This is as of today. What's going on here? The top paragraph says it’s approved 16 and older. What am I missing? |
DaveNKansas User ID: 80646086 United States 08/23/2021 07:41 PM Report Abusive Post Report Copyright Violation | |
JamesBob User ID: 80759513 08/23/2021 08:20 PM Report Abusive Post Report Copyright Violation | 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. --- This is actually half-way GOOD NEWS. Why? Because NUREMBERG CODE is still in effect effers ! We are coming for you medical doctors that are violating the NUREMBERG CODE against Forced Experimental Medical Treatment! DEATH PENALTY STILL IN PLAY ! WE ARE COMING FOR YOU DOCTORS ! JamesBob |
Judethz User ID: 79555498 United Kingdom 08/23/2021 09:02 PM Report Abusive Post Report Copyright Violation | |
#1FanNirvana User ID: 79298980 United States 08/23/2021 10:19 PM Report Abusive Post Report Copyright Violation | covid doesn't even meet the criteria for an eua. Death are less than 1 percent. This whole event is a product of the micky mouse jack off club of communist. Let me know when 3 out of 5 are dying from covid and you have tent cities set up by the national guard and red cross as hospitals. Last Edited by messagehalted on 08/23/2021 10:21 PM All my post are theatrical artistic writing . |
www.SIZZLER.com User ID: 77679734 United States 08/23/2021 10:38 PM Report Abusive Post Report Copyright Violation | Butthurt? Click 'Add to Ignore List' under my username Si vis pacem, para bellum VACCINES ARE THE LEADING CAUSE OF COINCIDENCES 'Your user name here makes me want to punch you in the fucking face, you sick fucking diseased cunt' Quoting: Anonymous Coward 8100888 |
Mr. Cheese User ID: 49358062 United States 08/23/2021 11:33 PM Report Abusive Post Report Copyright Violation | What that document did confirm is that there exists a control group which got saline. Quoting: TREKWEBMASTER And another group got the actual vaccine. But what I want to know is: "How do you know who got the saline and who got the vaccine?" I saw a bitchute video talking about this. They said it was in the serial number. Example a: 897918978 Example b: 897928978 Example c: 897938978 Notice the 1,2,3 above. If it's a 1 2 or 3 it tells if it's a placebo or the death vaxx. The video said it was something like this. A number in the middle of the vial's serial number. (I don't remember the exact spot of the 1,2,3 digit that apparently tells if it's real or fake. You'd have to hunt for that video. It's on glp somewhere i saw it like 3 days ago) Last Edited by Mr. Cheese on 08/23/2021 11:36 PM |
cdn-joe User ID: 73779328 United States 08/23/2021 11:35 PM Report Abusive Post Report Copyright Violation | |
Big Durk User ID: 80700406 United States 08/23/2021 11:39 PM Report Abusive Post Report Copyright Violation | Look who signed it at the end of the letter: Quoting: oniongrass Sincerely, Mary A. Malarkey Director Office of Compliance Office of Vaccines and Biologics Quality Research and Review (<50%) Her name is Malarkey! That's the word Biden uses to indicate nonsense. Are we sure this isn't from The Onion? https://imgur.com/Lrhm2vl https://imgur.com/5Hg1ptO https://imgur.com/soXB0Tn "It is the privilege of the gods to want nothing, and of godlike men to want little." |
Creationist1 User ID: 80757758 Canada 08/24/2021 12:04 AM Report Abusive Post Report Copyright Violation | |
taternuts User ID: 80543426 United States 08/24/2021 12:24 AM Report Abusive Post Report Copyright Violation | Yes the FDA Fully Approved It, but what they don't tell ya', is for continued EUA Testing, along with a curve ball new name for the drug, which isn't a new name at all...smoke and mirrors, what color rabbit will be pulled from their hat next time? Why, With So Many Good People Trying To Help Me This Past Year, Why I feel, I'm in a Dr. Who show lately, with all the daleks trying to stick and hurt me. |
OU8122 User ID: 79553795 United States 08/24/2021 12:27 AM Report Abusive Post Report Copyright Violation | |