The Comirnaty saga......
01-14-2022, 09:54 AM
#1
Gets Weekends Off
Thread Starter
Joined APC: Jan 2015
Posts: 217
The Comirnaty saga......
From the FDA:
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."
Can I get the legally distinct, non EUA, shot anywhere in the USA? Can I ask my shot giver to read the label of the shot and be able to actually find Comirnaty labelled shots?
Apparrently the other thread was memory holed. I think it's still important...legally speaking ....to get to the bottom of this apparent bait and switch.
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."
Can I get the legally distinct, non EUA, shot anywhere in the USA? Can I ask my shot giver to read the label of the shot and be able to actually find Comirnaty labelled shots?
Apparrently the other thread was memory holed. I think it's still important...legally speaking ....to get to the bottom of this apparent bait and switch.
01-18-2022, 03:37 PM
#3
Gets Weekends Off
Joined APC: Dec 2021
Posts: 413
Originally Posted by MiLtoMajor123
From the FDA:
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."
Can I get the legally distinct, non EUA, shot anywhere in the USA? Can I ask my shot giver to read the label of the shot and be able to actually find Comirnaty labelled shots?
Apparrently the other thread was memory holed. I think it's still important...legally speaking ....to get to the bottom of this apparent bait and switch.
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."
Can I get the legally distinct, non EUA, shot anywhere in the USA? Can I ask my shot giver to read the label of the shot and be able to actually find Comirnaty labelled shots?
Apparrently the other thread was memory holed. I think it's still important...legally speaking ....to get to the bottom of this apparent bait and switch.
01-18-2022, 05:32 PM
#4
Gets Weekends Off
Joined APC: Mar 2018
Posts: 2,352
Originally Posted by Nordhavn
You cannot get Comirnaty in the US. Pfizer has said this themselves. They will not distribute Comirnaty until all EUA have been used. It also shields them from damages which is really nice for them, don't you think?
The PREP act shields them from damages. That applies to both vaccine versions.
03-27-2022, 08:09 AM
#5
Disinterested Third Party
Joined APC: Jun 2012
Posts: 6,008
Originally Posted by Nordhavn
You cannot get Comirnaty in the US. Pfizer has said this themselves. They will not distribute Comirnaty until all EUA have been used. It also shields them from damages which is really nice for them, don't you think?
Comirnaty is an identical formulation to what was issued under the emergency use authorization; no changes. Pfizer did state that insufficient stock of vaccine labeled under the new marketing name existed to vaccinate the entire population, and that labels designated Comirnaty would not initially be given in boosters and in the 12-15 age group.
You may be parroting ron johnson and the russian prophet tucker carlson, with your misinformation, or pehaps you've been led about by the nose with conspiracy website pandering, but the fact is that Comirnaty was approved on August 23, last year, and was available at the time, and has been, since. The Pfizer vaccine was the approval: Comirnaty is the marketing name. Getting labeled vials out bearing the name, vs. a label without the name, on the same formulation, doesn't change the approval, the vaccine, or mean it's unavailable; it's been available and administered from the same day it was approved, and continues to be administered, under the Comirnaty marketing name, today.
The labeling doesn't shield Pfizer from anything. The product had an emergency use authorization prior to FDA full use approval, and the same product now has FDA full use approval; the only change with the product itself is marketing: a name. Prior to full use approval, the company produced the product under authorization, and does so after approval. Same product.
There's no bait and switch. Comirnaty-labled Pfizer vaccine is available, and administered in the US.
Few will argue that the marketing name was a badly conceived choice: it comprises several words Covid-19 immunity, mRNA, community, to make "Comirnaty," and the marketing folks at Brand Institute should rightfully be embarrassed. It would have been better marketed under its generic name, Tozinameran. That's a marketing choice, however, and neither affects the product nor it's approval.
Swiss and European regulators approved the use of the name Comirnaty prior to the FDA, and the same product was accepted by the WHO as Tozinameran. Other names considered for the Pfizer product were RnaxCovi, Covimerna, RNXtract, and Covuity, all of which were filed with the US patent office at various times in the development and certification process. Moderna currently has the vaccine in Europe under Spykevax, and has looked at that, or. Spikevax, as well as Mnravax, Covidvax, Covidmvax, and Mvax, all patent filings in the same preparatory process for FDA approval. Moderna fortunately abandoned four different permutations of Wuhan in the drug name, such as Wuhan Vax and Wuhan Corona Mvax.
Johnson and Johnson has marketed their vaccine as the Janssen vaccine, after their Belgian subsidiary, Janssen Pharmaceuticals. Under consideration are Jcovax, Ovcinden, Aqcovsen, Fampelsen, Ecoyan, Abfiden, and Jcovden.
Is the Pfizer product Comirnaty available and administered in the US? Yes, it is. Is it the same product administered prior to full FDA approval under the marketing name, Comirnaty? Yes, it is. Is it legally distinct, because of a marketing name? Yes, it is. Would you get the same product if you received it three days prior to full FDA approval, three days after, or five months later? Yes, you would.
03-28-2022, 01:30 AM
#6
Gets Weekends Off
Joined APC: Dec 2021
Posts: 413
Originally Posted by JohnBurke
You're not telling the truth
Comirnaty is an identical formulation to what was issued under the emergency use authorization; no changes. Pfizer did state that insufficient stock of vaccine labeled under the new marketing name existed to vaccinate the entire population, and that labels designated Comirnaty would not initially be given in boosters and in the 12-15 age group.
You may be parroting ron johnson and the russian prophet tucker carlson, with your misinformation, or pehaps you've been led about by the nose with conspiracy website pandering, but the fact is that Comirnaty was approved on August 23, last year, and was available at the time, and has been, since. The Pfizer vaccine was the approval: Comirnaty is the marketing name. Getting labeled vials out bearing the name, vs. a label without the name, on the same formulation, doesn't change the approval, the vaccine, or mean it's unavailable; it's been available and administered from the same day it was approved, and continues to be administered, under the Comirnaty marketing name, today.
The labeling doesn't shield Pfizer from anything. The product had an emergency use authorization prior to FDA full use approval, and the same product now has FDA full use approval; the only change with the product itself is marketing: a name. Prior to full use approval, the company produced the product under authorization, and does so after approval. Same product.
There's no bait and switch. Comirnaty-labled Pfizer vaccine is available, and administered in the US.
Few will argue that the marketing name was a badly conceived choice: it comprises several words Covid-19 immunity, mRNA, community, to make "Comirnaty," and the marketing folks at Brand Institute should rightfully be embarrassed. It would have been better marketed under its generic name, Tozinameran. That's a marketing choice, however, and neither affects the product nor it's approval.
Swiss and European regulators approved the use of the name Comirnaty prior to the FDA, and the same product was accepted by the WHO as Tozinameran. Other names considered for the Pfizer product were RnaxCovi, Covimerna, RNXtract, and Covuity, all of which were filed with the US patent office at various times in the development and certification process. Moderna currently has the vaccine in Europe under Spykevax, and has looked at that, or. Spikevax, as well as Mnravax, Covidvax, Covidmvax, and Mvax, all patent filings in the same preparatory process for FDA approval. Moderna fortunately abandoned four different permutations of Wuhan in the drug name, such as Wuhan Vax and Wuhan Corona Mvax.
Johnson and Johnson has marketed their vaccine as the Janssen vaccine, after their Belgian subsidiary, Janssen Pharmaceuticals. Under consideration are Jcovax, Ovcinden, Aqcovsen, Fampelsen, Ecoyan, Abfiden, and Jcovden.
Is the Pfizer product Comirnaty available and administered in the US? Yes, it is. Is it the same product administered prior to full FDA approval under the marketing name, Comirnaty? Yes, it is. Is it legally distinct, because of a marketing name? Yes, it is. Would you get the same product if you received it three days prior to full FDA approval, three days after, or five months later? Yes, you would.
Comirnaty is an identical formulation to what was issued under the emergency use authorization; no changes. Pfizer did state that insufficient stock of vaccine labeled under the new marketing name existed to vaccinate the entire population, and that labels designated Comirnaty would not initially be given in boosters and in the 12-15 age group.
You may be parroting ron johnson and the russian prophet tucker carlson, with your misinformation, or pehaps you've been led about by the nose with conspiracy website pandering, but the fact is that Comirnaty was approved on August 23, last year, and was available at the time, and has been, since. The Pfizer vaccine was the approval: Comirnaty is the marketing name. Getting labeled vials out bearing the name, vs. a label without the name, on the same formulation, doesn't change the approval, the vaccine, or mean it's unavailable; it's been available and administered from the same day it was approved, and continues to be administered, under the Comirnaty marketing name, today.
The labeling doesn't shield Pfizer from anything. The product had an emergency use authorization prior to FDA full use approval, and the same product now has FDA full use approval; the only change with the product itself is marketing: a name. Prior to full use approval, the company produced the product under authorization, and does so after approval. Same product.
There's no bait and switch. Comirnaty-labled Pfizer vaccine is available, and administered in the US.
Few will argue that the marketing name was a badly conceived choice: it comprises several words Covid-19 immunity, mRNA, community, to make "Comirnaty," and the marketing folks at Brand Institute should rightfully be embarrassed. It would have been better marketed under its generic name, Tozinameran. That's a marketing choice, however, and neither affects the product nor it's approval.
Swiss and European regulators approved the use of the name Comirnaty prior to the FDA, and the same product was accepted by the WHO as Tozinameran. Other names considered for the Pfizer product were RnaxCovi, Covimerna, RNXtract, and Covuity, all of which were filed with the US patent office at various times in the development and certification process. Moderna currently has the vaccine in Europe under Spykevax, and has looked at that, or. Spikevax, as well as Mnravax, Covidvax, Covidmvax, and Mvax, all patent filings in the same preparatory process for FDA approval. Moderna fortunately abandoned four different permutations of Wuhan in the drug name, such as Wuhan Vax and Wuhan Corona Mvax.
Johnson and Johnson has marketed their vaccine as the Janssen vaccine, after their Belgian subsidiary, Janssen Pharmaceuticals. Under consideration are Jcovax, Ovcinden, Aqcovsen, Fampelsen, Ecoyan, Abfiden, and Jcovden.
Is the Pfizer product Comirnaty available and administered in the US? Yes, it is. Is it the same product administered prior to full FDA approval under the marketing name, Comirnaty? Yes, it is. Is it legally distinct, because of a marketing name? Yes, it is. Would you get the same product if you received it three days prior to full FDA approval, three days after, or five months later? Yes, you would.
03-28-2022, 08:42 AM
#8
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Joined APC: Oct 2008
Position: JAFO- First Observer
Posts: 997
A federal judge has already ruled back in December 2021 that Comirnaty is NOT the same and IS NOT interchangeable with the EUA C19 “vaccines”:
https://www.technocracy.news/federal...terchangeable/
https://www.technocracy.news/federal...terchangeable/
03-28-2022, 09:08 AM
#9
Disinterested Third Party
Joined APC: Jun 2012
Posts: 6,008
https://www.precisionvaccinations.co...vid-19-vaccine
'Legal and distinct' means just that: the label on the Pfizer BioNtec Covid 19 Vaccine and on the Cominarty vial is the difference; one has full FDA approval, the former, which was sent out until expiration date, had emergency use authorization. Same product, different labels, and the legal difference and what made them distinct was receipt of the full FDA approval. The language in the initial press release, "certain other differences" is common to most vaccinations and products upon receiving full approval, and has the same effect as saying "on or about" when describing a date. It's a catch-all phrase that doesn't mean there were were changes to the product, beyond the labeling.
Presently, the Cominarty vaccine is available throughout the world, and is available in the US.
Obtaining full FDA approval did not increase legal "liability." The duty of Pfizer remained the same before and after FDA full approval. Pfizer doesn't magically become more culpable for a faulty product with the name change, nor is it more insulated. If a law suit were to be pressed, it's against the manufacturer, not against the label. Pfizer eliminated any distinction from a duty ("liability") perspective by stating quite clearly that the formulation is the same.
The issue of "legal liability" with regard to the Pfizer vaccine prior to full FDA approval, or after, is largely a non-starter and irrelevant, however, because of the PREP act (public readiness and emergency preparedness act; 12/30/2005); the Covid pandemic was declared a public health emergency and the PREP act invoked by the Secretary of Health and Human Services under the trump administration on 2/4/2020.
https://www.congress.gov/109/plaws/p...8.pdf#page=140
https://www.govinfo.gov/content/pkg/...2020-05484.pdf
Under the PREP act, the vaccine manufacturers cannot be sued under state or federal law, except in the case of wilfull misconduct.
https://crsreports.congress.gov/prod...f/LSB/LSB10443
The companies previously announced that they expect to produce four billion doses of the Comirnaty / Pfizer-BioNTech COVID-19 Vaccine in 2022. This capacity is not expected to change if an adapted vaccine is required. As of March 2022, the Comirnaty COVID-19 Vaccine is available in about 152 countries including Germany, the USA,Brazil, Canada, Europe, Iceland, Israel, Italy, Qatar, Finland, Pakistan, and the U.K.
Presently, the Cominarty vaccine is available throughout the world, and is available in the US.
Obtaining full FDA approval did not increase legal "liability." The duty of Pfizer remained the same before and after FDA full approval. Pfizer doesn't magically become more culpable for a faulty product with the name change, nor is it more insulated. If a law suit were to be pressed, it's against the manufacturer, not against the label. Pfizer eliminated any distinction from a duty ("liability") perspective by stating quite clearly that the formulation is the same.
The issue of "legal liability" with regard to the Pfizer vaccine prior to full FDA approval, or after, is largely a non-starter and irrelevant, however, because of the PREP act (public readiness and emergency preparedness act; 12/30/2005); the Covid pandemic was declared a public health emergency and the PREP act invoked by the Secretary of Health and Human Services under the trump administration on 2/4/2020.
https://www.congress.gov/109/plaws/p...8.pdf#page=140
https://www.govinfo.gov/content/pkg/...2020-05484.pdf
Under the PREP act, the vaccine manufacturers cannot be sued under state or federal law, except in the case of wilfull misconduct.
https://crsreports.congress.gov/prod...f/LSB/LSB10443
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