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FDA approval document Page 12 States Something That MSM/Biden ignores

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posted on Aug, 23 2021 @ 06:18 PM
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There is a little oops with the new Mainstream New Media Announcement looks like they did misssinform a number of their audinces according to the horse's mouth from FDA's own site and page under page 12.


Read Under Section Page 12 of the FDA declaration




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...

This product has not been approved or licensed by FDA



posted on Aug, 23 2021 @ 06:22 PM
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originally posted by: HawkEyi
There is a little oops with the new Mainstream New Media Announcement looks like they did misssinform a number of their audinces according to the horse's mouth from FDA's own site and page under page 12.


Read Under Section Page 12 of the FDA declaration




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...

This product has not been approved or licensed by FDA


It is a sneaky way for them to get everyone to get the original jab that was not labeled with the new name. Unless it says Comirnaty on it, it hasn't been approved or licensed. There are still hundreds of millions of this one out there.....



posted on Aug, 23 2021 @ 06:24 PM
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a reply to: HawkEyi

Unfortunately, you're omitting some key facts. Yes, you did understand that correctly.

I'll add some emphasis.


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...


However! Page two states this, again with added emphasis.


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.


Essentially this means the jab is approved for anyone 16 and up, but still considered experimental in ages 12-15.



posted on Aug, 23 2021 @ 06:26 PM
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a reply to: cmdrkeenkid

See the manipulation on page II?



for active immunization to prevent COVID

The Pfizer is to prevent COVID but in Israel the effectiveness rate has already dropped.



posted on Aug, 23 2021 @ 06:27 PM
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a reply to: HawkEyi

I'm confused. The Pfizer-BioNtech is still emergency authorized but they have approved Comirnaty for ages 12 and up. Is Comirnaty somehow different than the Pfizer vaccine and if so, how? And why would it only be fully approved under a different name but not the name Pfizer-BioNtech, which is still only emergency authorized? Is this just a totally new shot or what?
edit on 23-8-2021 by Chalcedony because: (no reason given)



posted on Aug, 23 2021 @ 06:27 PM
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I think this is the original document relating to the EU's and has been amended.

The amendment will supercede any predated parts of the agreement.

I think.



a reply to: HawkEyi



posted on Aug, 23 2021 @ 06:28 PM
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a reply to: HawkEyi

Re: www.fda.gov...

Holy smokes. It looks like all the FDA did is re-issue/renew the Emergency Use Authorization for the Pfizer vaccine, and added injection #3 as an authorized booster.



posted on Aug, 23 2021 @ 06:31 PM
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a reply to: carewemust

Then what is Comirnaty that they have approved for ages 12 and up after stating that the current Pfizer is still emergency authorized but now Comirnaty is fully approved and licensed?



posted on Aug, 23 2021 @ 06:35 PM
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originally posted by: cmdrkeenkid
a reply to: HawkEyi

Unfortunately, you're omitting some key facts. Yes, you did understand that correctly.

I'll add some emphasis.


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...


However! Page two states this, again with added emphasis.


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.


Essentially this means the jab is approved for anyone 16 and up, but still considered experimental in ages 12-15.


The important part of what you posted is this: for active
immunization to prevent COVID-19 caused by SARS-CoV-2

It does not state it stops SARS-CoV-2, it says it prevents the disease covid -19 forming from the virus....remember the virus and the disease are not the same, Covid-19 is more like Sepsis forming from Pneumonia.



posted on Aug, 23 2021 @ 06:37 PM
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a reply to: Chalcedony




Is this just a totally new shot or what?

Probably booster shots for the coming seasons fall/winter.



posted on Aug, 23 2021 @ 06:38 PM
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a reply to: rickymouse

Rather strange for the FDA to call it to prevent Covid as a disease and not virus.



posted on Aug, 23 2021 @ 06:42 PM
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a reply to: cmdrkeenkid

It says they approved a license application.
That really doesn't sound like approval to me.



posted on Aug, 23 2021 @ 06:42 PM
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a reply to: rickymouse

The wording in this is clear. It's approved for ages 16 and up, and still authorized for experimental use in ages 12 through 15. I'm not arguing the effectiveness or lack thereof or any other aspect of the jab. This is simply about the thread author's simple misunderstanding of the legalese.



posted on Aug, 23 2021 @ 06:43 PM
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a reply to: HawkEyi

Soooooo, how does it stack against all the variants?????



posted on Aug, 23 2021 @ 06:48 PM
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a reply to: HawkEyi

No, I'm sorry, but I don't see any manipulation. I do see a simple misunderstanding of the legalese. I missed your response before, my apologies. I addressed this here in this post.

I'm very pro-choice in this matter, and have no intentions of getting jabbed myself, but you're really not doing anything to help with this.

a reply to: underpass61

That's exactly what it is. Here are a couple links with more information.

Biologics License Applications (BLA) Process (CBER)
The Biologics License Application (BLA) Process Explained



posted on Aug, 23 2021 @ 06:55 PM
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a reply to: HawkEyi

I would like to add this to your thread.

Pfizer Packet Insert August 23, 2021

www.fda.gov...

Just read through and picked up a few things. Enjoy.

"5.1 Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in
the event an acute anaphylactic reaction occurs following administration of COMIRNATY. "

"5.3 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, including
COMIRNATY. Procedures should be in place to avoid injury from fainting."

"5.5 Limitation of Effectiveness
COMIRNATY may not protect all vaccine recipients."

"Throughout the placebo-controlled safety follow-up period, Bell’s palsy (facial paralysis) was reported by
4 participants in the COMIRNATY group and 2 participants in the placebo group. Onset of facial paralysis was
Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. In the placebo
group the onset of facial paralysis was Day 32 and Day 102. Currently available information is insufficient to determine a causal relationship with the vaccine. "

"6.2 Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of COMIRNATY, including
under Emergency Use Authorization. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Cardiac Disorders: myocarditis, pericarditis Gastrointestinal Disorders: diarrhea, vomiting Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions
(e.g., rash, pruritus, urticaria, angioedema) Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm) "

"8.1 Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to COMIRNATY
during pregnancy. Women who are vaccinated with COMIRNATY during pregnancy are encouraged to enroll
in the registry by visiting mothertobaby.org..."

"Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the
estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to
4% and 15% to 20%, respectively. Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of COMIRNATY on 4 occasions; twice prior to mating and twice during gestation. These studies revealed no evidence of harm to the fetus due to the vaccine (see Animal Data).

Animal Data
In a developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of
nucleoside-modified messenger ribonucleic acid (mRNA) (30 mcg) and other ingredients included in a single
human dose of COMIRNATY was administered to female rats by the intramuscular route on 4 occasions: 21
and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female
fertility, fetal development, or postnatal development were reported in the study. "

"8.2 Lactation

Risk Summary It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any
potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition.
For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. "

"8.4 Pediatric Use
Safety and effectiveness of COMIRNATY in individuals 16 through 17 years of age is based on safety and effectiveness data in this age group and in adults [see Adverse Reactions (6) and Clinical Studies (14.1)]. The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established. "

"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. In a developmental toxicity study in rats with COMIRNATY there were no vaccine-related
effects on female fertility [see Use in Specific Populations (8.1)]."

In conclusion. Who the hell would take this willingly? This was no real trial.
edit on 23-8-2021 by Zitterbewegung because: Added conclusion.



posted on Aug, 23 2021 @ 07:09 PM
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How does this compare to other medications in the US?

Do they not all have a huge list of disclaimers given the tendancy to sue companies in the US?



a reply to: Zitterbewegung



posted on Aug, 23 2021 @ 07:11 PM
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a reply to: nonspecific

We can't sue these companies. The US Government gave them immunity.



posted on Aug, 23 2021 @ 07:12 PM
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a reply to: nonspecific

The CDC has been telling pregnant women to get the vaccine. How can they do that knowing there was barely any testing done on fertility. None in men and none on breastfeeding and birth defects.

Except for a few rats.....


edit on 23-8-2021 by Zitterbewegung because: adding fix



posted on Aug, 23 2021 @ 07:24 PM
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originally posted by: Zitterbewegung
a reply to: nonspecific

The CDC has been telling pregnant women to get the vaccine. How can they do that knowing there was barely any testing done on fertility. None in men and none on breastfeeding and birth defects.

Except for a few rats.....



Because the people are the tests....kind of like most democratic bills, you have to take the vaccine to see what it does.




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