Covid vaccines still not licensed nor approved by the FDA

So....from another thread I posted on. This is the full list of FDA licensed vaccines. Of note is the absence of any covid vaccines.

FDA Licensed Vaccine List

Now Pfizer applied for it May 7. It has still not gotten any approval or licensing for the manufacturer. This is why they are not allowed to advertise for it and why we haven't seen any vaccine manufacturer made commercials.

Here is the Pfizer announcement from May 7.

Pfizer presser

The important part:

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Bold is mine.

So.....not on the list and still not approved nor licensed....seems there is some need for concern in my mind.

I believe Moderna finally applied as well, but also has not been approved or licensed.

originally posted by: Vasa Croe
So....from another thread I posted on. This is the full list of FDA licensed vaccines. Of note is the absence of any covid vaccines.

FDA Licensed Vaccine List

Now Pfizer applied for it May 7. It has still not gotten any approval or licensing for the manufacturer. This is why they are not allowed to advertise for it and why we haven't seen any vaccine manufacturer made commercials.

Here is the Pfizer announcement from May 7.

Pfizer presser

The important part:

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Bold is mine.

So.....not on the list and still not approved nor licensed....seems there is some need for concern in my mind.

I believe Moderna finally applied as well, but also has not been approved or licensed.

I suspect this is why there is another concentrated push for people to get vaccinated. They cant operate under emergency approval forever. Sooner or later the FDA will say that's enough of this crap, we are no longer under a national emergency

First the china virus shot pushers are protected until 2024, soo the need to get the china shot approved is because they want to make it mandatory with a yearly mandatory booster, if the china shot gets approved then the protection will be easier to extend, it will harder for anybody to try to inquire on the dangers of this shot like is been done now.

In 2024 is election also, soo the china shot pushers need to get this done now.

Does anyone know if any of the COVID vaccines currently in use are a second or third version of the original?

I don’t know if Pfizer or Moderna would broadcast or announce it if they were administering version 2.0 of the vaccine that was initially approved. There would be a lot of expense associated with version 1.0 vaccines being wasted because everyone would want the newer version.

I am asking because the requirements for clinical testing of a revised version of an emergency-use authorized COVID vaccine are much lower than the requirement were for the COVID vaccine when it was initially approved.

Here is a link to the eu clinical testing requirements for a “modified” COVID vaccine. www.ema.europa.eu... ant_en.pdf

a reply to: Vasa Croe

a reply to: Vasa Croe

None of them will be until 2022 at the earliest. The process usually takes years after application, and in this case the FDA has made them a 'priority review' which will take ~6 months. So why would a few months be 'concerning'?

[clown talk]
Hurry up and give it to your kids before they find out if it's safe or not

[/clown talk]

a reply to: Vasa Croe

Good thread.

Furthermore, ALL of the 4 drug companies of the experimental drugs being pushed as vaccines themselves state that their drugs do NOT prevent the getting or giving of covid-19. They state that they only MAY lessen the severity of symptoms.

I don’t know how fooled and deluded people have to be, to still want to take these shots, when the makers of the shots tell you that they don’t prevent covid-19. And it’s clearly true, since many reports have gotten out of many people having been “fully vaccinated” yet still dying with covid-19 or testing positive for covid-19.

That puts the defenders of these shots in a dicey position, which is why I suspect none of them respond to or comment on that factual information. Either: the shots don’t work (and of course they don’t, as the makers of the shots tell you); or, the covid-19 tests are crap. And if the covid-19 tests are crap, then they may have to admit that there was no need for the non-working “vaccines.”

originally posted by: OccamsRazor04
a reply to: Vasa Croe

None of them will be until 2022 at the earliest. The process usually takes years after application, and in this case the FDA has made them a 'priority review' which will take ~6 months. So why would a few months be 'concerning'?

Phase 4 doesn't usually take years. It is usually around 6 weeks. I'd have to look them all up, but I believe this is the longest phase 4 wait for any vaccine.

The woke celebrities who are pushing the vaccine in their commercials should be held liable.

a reply to: KansasGirl

The tests have been known to be crap....all kinds of false positives and having the levels too high to be accurate.

Even the inventor of the pcr test said you can find almost anything in anyone with them....anything.

originally posted by: putnam6

originally posted by: Vasa Croe
So....from another thread I posted on. This is the full list of FDA licensed vaccines. Of note is the absence of any covid vaccines.

FDA Licensed Vaccine List

Now Pfizer applied for it May 7. It has still not gotten any approval or licensing for the manufacturer. This is why they are not allowed to advertise for it and why we haven't seen any vaccine manufacturer made commercials.

Here is the Pfizer announcement from May 7.

Pfizer presser

The important part:

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Bold is mine.

So.....not on the list and still not approved nor licensed....seems there is some need for concern in my mind.

I believe Moderna finally applied as well, but also has not been approved or licensed.

I suspect this is why there is another concentrated push for people to get vaccinated. They cant operate under emergency approval forever. Sooner or later the FDA will say that's enough of this crap, we are no longer under a national emergency

Prion disease of the brain would put us under national emergency. Let the vaccine do its job, and give it a few years.

VACCINE

noun A preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a portion of the pathogen's structure that upon administration to an individual stimulates antibody production or cellular immunity against the pathogen but is incapable of causing severe infection.

...that upon administration to an individual stimulates antibody production or cellular immunity against the pathogen

... but is incapable of causing severe infection.

These are NOT vaccines!

a reply to: Tempter

The odd part about this is that all of the companies named theirs with the word "Vaccine" in the name.....specifically capitalized "V". So....here is another excerpt from the Pfizer presser to show what I mean:

TextThe Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. 

Notice they only capitalize the "V" when used with "The Pfizer-BioNTech COVID-19 Vaccine", while the rest of the time they refer to it as the Covid-19 vaccine, with a lowercase "v".

I have been wondering if there is some legal reasoning behind this.

a reply to: Vasa Croe

Yes, not approved or licensed, and I can tell you it does not take much for the FDA to approve and license a drug. They approved an alzheimers drug which literally does nothing for alheimers disease last week, amirite?

a reply to: Vasa Croe

What I still don't understand, is there are alternative treatments for covid, and a vaccine only gets EUA approval if there are no other treatment methods available, hence the term EMERGENCY USE AUTHORIZATION.

There are treatments available for covid, these vaccines shouldn't have EUA authorization they have.

I don't know if it is criminal, but it damn well should be.

Again, THERE ARE TREATMENTS FOR COVID, THEREFORE THE EUA OF THE VACCINE IS ILLEGAL.

The whole #ing world is doing it too...

not a very bright outlook on society.

a reply to: OccamsRazor04

Apt user name 👆

If 'they' can keep changing the meaning/definition of things then it's about time we started calling this an UNLICENSED MEDICINE, period. That's exactly what it is.
If it was called that, how many more people would refuse to take it?

Rainbows
Jane

a reply to: Vasa Croe

Wrong and wrong.

It's been granted emergency approval. The rest is a formality.

There us no difference in the safety aspects of a fast track and a standard approval.

Sjw and never Trumpers need step down and to stop deliberately trying to create FUD over the shots.

a reply to: AaarghZombies
Seriously?
From the paper below....

"AstraZeneca COVID-19 Vaccine and COVISHIELD (the version of the AstraZeneca COVID-19 Vaccine manufactured by the Serum Institute of India) are now contraindicated in individuals who have previously experienced episodes of CLS."

This is NOW a contraindication? How many more are there that they 'don't know' about .....yet?
These are the symptoms and consequences

"Healthcare professionals should be alert to the signs and symptoms of CLS. CLS is a very rare disorder, which is frequently life threatening, characterised by a dysfunctional inflammatory response, endothelial dysfunction, extravasation of fluid from the vascular space to the interstitial space leading to shock, hemoconcentration, hypoalbuminemia and consequent organ failure. Patients may present with a rapid swelling of the arms and legs, sudden weight gain and have symptoms associated with low blood pressure/shock."

This is something they should have known about BEFORE rolling out the UNLICENSED MEDICINE.
Link

Rainbows
Jane