BCSnob
Middletown, MD
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Joined: 02/23/2002
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PDQXYZ wrote:BCSnob wrote:Quote:That is the problem. I can find Pfizer shots all over. Can't find the "legally distinct" Comirnaty. When I call places that advertise Pfizer, they tell me it is not labeled as Comirnaty, it's labeled as Pfizer/Biontech which is released under the EUA. Same way it shows here. https://www.vaccines.gov/search/
Can anyone else find Comirnaty?
What/where is your requirement that it must have the label “comirnaty”?
The only thing that has changed with full fda approval about this vaccine since the beginning of the clinical trials is the label on the vial. Nothing is allowed by the fda to change about what is in the vial, how it got in the vial, how it is tested, and perhaps not even the vial. The fda approved not only the vaccine but the entire manufacturing process of the vaccine based upon the data collected during the clinical trials (if Pfizer changes something about the process then the fda may view the clinical trial data as no longer be applicable to their vaccine after the change).
The product that was approved is Comirnaty. Until the other day, Comirnaty was the only FDA approved product. The FDA clearly states on it's website that it is a legally distinct product. Can anyone tell me where I can find that product?
Good luck finding vials labeled with the new drug name. Be sure your vaccine card is filled out with the vaccine name and not just the manufacturer’s name; otherwise your efforts will have been in vain. Better tell the CDC to update their VAMS records to use the vaccine name and lot number as opposed to the manufacturer name and lot number.
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MEXICOWANDERER
las peñas, michoacan, mexico
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Joined: 06/01/2007
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I believe the FDA delineates between subsidized and rebranded products. Serums that are for sale differ in liability and manufacturer's tax status. It was true in the 1950's with the Salk vaccine.
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BCSnob
Middletown, MD
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Joined: 02/23/2002
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Novavax filed for EAU for their vaccine.
From the novavax press release
Quote: NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax
Refrigerator storage not frozen at dry ice temperatures.
Recombinant protein not viral vector or mRNA
* This post was
edited 02/01/22 11:18am by BCSnob *
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BCSnob
Middletown, MD
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Joined: 02/23/2002
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My last effort to address your concerns. This is from the fda
Quote:How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably 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. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Link
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PDQXYZ
NY
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Joined: 01/18/2022
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BCSnob wrote:My last effort to address your concerns. This is from the fda
Quote:How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably 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. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Link
Thank you for that link. Same page, next paragraph.
Is Comirnaty interchangeable with other COVID-19 vaccines?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
Legally distinct. Different product in a very real and legal sense. Can anyone help me find the FDA approved product?
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BCSnob
Middletown, MD
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Joined: 02/23/2002
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Still no answer to why you require Comirnaty; it’s starting to feel like an excuse for not fulfilling the vaccination mandate at work (tried but unable to locate Comirnaty).
Good luck on your search, no one here will be better able to check vaccine stocks in your area than you personally calling since the FDA allows for both to be use interchangeably (acknowledging the existing supply of Pfizer-BioNTech COVID-19).
* This post was
edited 02/01/22 12:33pm by BCSnob *
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Boon Docker
Mountain Foothills of Southern Alberta
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Joined: 10/30/2015
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Here is a quote from the Pfizer website.
The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date.
No need to find "Comirnaty" specifically as the vaccine manufactured by Pfizer is now FDA approved.
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Geo*Boy
Unknown
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Joined: 04/27/2020
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Boon Docker wrote:Here is a quote from the Pfizer website.
The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date.
No need to find "Comirnaty" specifically as the vaccine manufactured by Pfizer is now FDA approved.
Thank you, Boon Docker.
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Boon Docker
Mountain Foothills of Southern Alberta
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Joined: 10/30/2015
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You're welcome.
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Moderator
Tennessee
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Joined: 01/19/2004
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PDQXYZ. You have been provided sufficient info re FDA approved vaccines. Time to move on. Thank you.
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