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Pfizer wants booster approval based on studies covering about 300 people

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posted on Sep, 18 2021 @ 05:47 PM
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Rather interesting. According to this person and post it seems that Pfizer wants booster approval based on studies covering about 300 people with no Control Arms.

The third booster shot will be known as "Comirnaty"
Pfizer wants booster approval based on studies covering about 300 people

According to the source attached.



2 doses 3 weeks apart

3rd dose for individuals ≥12 years and who have undergone solid organ transplantation, or diagnosed with conditions considered to have an equivalent level of immunocompromise





Some observational studies have suggested declining efficacy of COMIRNATY over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions. Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.



posted on Sep, 18 2021 @ 05:51 PM
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a reply to: HawkEyi




The third booster shot will be known as "Comirnaty"

No.
Comirnaty is the brand name for the Pfizer mRNA vaccine. Until it was licensed it had no brand name. Now it does. It is no different from the vaccine which was used under the original EUA.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

www.fda.gov...

edit on 9/18/2021 by Phage because: (no reason given)



posted on Sep, 18 2021 @ 06:00 PM
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a reply to: Phage




It is no different from the vaccine which was used under the original EUA.


Its spelled different. So wrong again



posted on Sep, 18 2021 @ 06:00 PM
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a reply to: Phage

Comirnaty is the same as Pfizer. No difference. Same side effects nothing changes.
edit on 18-9-2021 by HawkEyi because: (no reason given)



posted on Sep, 18 2021 @ 06:06 PM
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a reply to: HawkEyi

Correct.



posted on Sep, 18 2021 @ 06:07 PM
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Don’t they usually test drugs on thousands of people? At least in the last stage anyway.

Seems pretty suspect to me. Pretty sure my mouthwash had more rigorous testing than this stuff.



posted on Sep, 18 2021 @ 06:08 PM
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a reply to: Ohanka




Don’t they usually test drugs on thousands of people? At least in the last stage anyway.

Yes. Stage III trials involved thousands of people.



posted on Sep, 18 2021 @ 06:13 PM
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Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
www.fda.gov...


So the answer as to whether it is exactly the same is, "yes and no".


edit on 18-9-2021 by queenofswords because: (no reason given)



posted on Sep, 18 2021 @ 06:13 PM
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a reply to: HawkEyi

Great! My immune system was obviously advance enough to be improved by the vaccine, look forward to the booster. You weak anti vaccination experts are just worried that you are being left behind.



posted on Sep, 18 2021 @ 06:14 PM
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last l heard Japan is in a wait and  see trial period
edit on 0900000008152021-09-18T18:15:08-05:00150809pm6 by musicismagic because: (no reason given)

edit on 0900000051152021-09-18T18:15:51-05:00155109pm6 by musicismagic because: (no reason given)



posted on Sep, 18 2021 @ 06:16 PM
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a reply to: queenofswords

So the answer as to whether it is exactly the same is, "yes and no".
The answer is "yes."



Comirnaty has the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine


Legally, one is now licensed and one was not. Legally, one can now have a brand name and one could not.

edit on 9/18/2021 by Phage because: (no reason given)



posted on Sep, 18 2021 @ 06:22 PM
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a reply to: Phage

Yes, and now with Comirnaty the Prescribing Information includes a warning about the risks of myocarditis and pericarditis especially in males 12 through 17 years of age.



posted on Sep, 18 2021 @ 06:27 PM
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a reply to: queenofswords

Is it different from this, in June? Well before approval?
myocarditis

edit on 9/18/2021 by Phage because: (no reason given)



posted on Sep, 18 2021 @ 06:33 PM
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originally posted by: Ohanka
Don’t they usually test drugs on thousands of people? At least in the last stage anyway.

Seems pretty suspect to me. Pretty sure my mouthwash had more rigorous testing than this stuff.


The Pfizer injection is still in trial phase until 2023




Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Sponsor:
BioNTech SE
Collaborator:
Pfizer
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023

clinicaltrials.gov...



posted on Sep, 18 2021 @ 06:38 PM
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Not sure why any intelligent person would trust a Pfizer product anyways....
They just had to recall another popular product that people have been using for MANY years....

Pfize r is recalling ALL stocks of its popular anti-smoking drug Chantix after it was found to contain high levels of chemical that can cause cancer

TrUsT the pharmaceutical industry with your life.



posted on Sep, 18 2021 @ 06:41 PM
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a reply to: Phage

Full FDA approval was given on August 23rd.

According to the FDA, they did a rigorous evaluation of the surveillance data pertaining to myocarditis and pericarditis following the Pfizer-BioNTech COVID-19 injection and determined that the data did indeed demonstrate increased risks.

Your article is dated June, so by that time they were becoming well aware of this problem and therefore, two months later when the FDA issued their full approval, the risk was substantial enough that they included it the Prescribing Information.



posted on Sep, 18 2021 @ 06:46 PM
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a reply to: queenofswords

Yes. Just making sure that you were aware that the increased risk was made public and considered before full approval.

Prescribing information usually includes that sort of thing, for any drug or vaccination. "Watch out for this, it can happen once in a while."

Do you happen to have any information about myocarditis rates with COVID infections, btw?



posted on Sep, 18 2021 @ 06:46 PM
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originally posted by: Phage
a reply to: HawkEyi

Correct.


I always imagined you were at a very remote radio observatory telescope site and maybe haven't left in awhile.

Now I still think that but also think that you are The Fact Checker.

In your opinion is 300 subjects observed over less than four weeks time a reliable medical study?



posted on Sep, 18 2021 @ 06:50 PM
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a reply to: MDDoxs

Have you got a microscope?



posted on Sep, 18 2021 @ 06:59 PM
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a reply to: Phage




Do you happen to have any information about myocarditis rates with COVID infections, btw?


I don't. I have read articles that Covid 19 can cause heart problems, but I haven't found anything pertaining to teenage males getting heart problems from just Covid 19. They seem to acquire the problems after getting the "vaccine".

I would assume that since Covid 19 affects the elderly more detrimentally, they probably had some heart disease to begin with, and the virus exacerbated already present heart issues.



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