FDA fully approves clotshot Pfizer.

Thread: SO FDA APPROVED "COMIRNATY" but the OLD PFIZER vaxxed NOT APPROVEd. KEEPS IN EU and safe from lawsuits?

i guess thats why no news outlet is talking about it over here.
im pretty sure it would be big news here too, if true.

On February 4, 2020, pursuant to section 564 of the FD&C Act, I determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad {LIVING ABROUD} and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).


Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a, chemical, biological, radiological, or nuclear (“CBRN”) agent or agents; (2) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act [1] sufficient to affect national security or the health and security of _united_states___citizens living abroad; (3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or (4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents.[2]

In there or derived from.

They worship Moloch. Moloch was historically worshiped to bring an end to suffering through sacrifice (appeasement of the demonic). Primitive cultures did the same; human sacrifice for a good harvest or to end an famine.

They are trying to force you to worship Moloch now too, sharing in this sacrifice. Hoping that it makes the virus go away (notice they keep this lie up even though it's now widely known to be false).

It's a perversion of the Holy sacrifice in many ways. It brings death and damnation. These people are never long for the world.

It is clear that God is not here. Angels are not here. Nothing is here but OURSELVES to take a stand against these free range demonic reptiles that are roaming this planet.
And since we are left to fend for ourselves until God or angel shows up then its ANYTHING GOES.
We have been peaceful.
We have obeyed laws for the common good.
Paid our taxes.
Worked our fingers to the bone.
We have shared our fruits with the entire WORLD and asked nothing in return except to be left the fuck alone behind our own doors.
But that is not enough for these decrepit robbers of innocents.
They want it ALL.
They literally want our blood.

Then let's get the show on the road.
You will not inject me with anything except I give my willing consent.

reading from this FDA official document:

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.

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA

What it really means is 2 simple things:
1. FDA reauthorizes Pfizer covid-19 vax - BUT still under
EUA ( emergency authorization change ) - thus NO CHANGE HERE !!! just an extension with revisions

2. in addition to that FDA authorizes COMIRNARY vax,
that's some different vax that Pfizer applied for ...
but again it's under EUA !!!

that's is all it means
both vaxes are under EUA rules !

moreover both licenses are under BLA -->
list of all possible applications here:
[link to www.fda.gov (secure)]

definition of BLA here -->
[link to www.fda.gov (secure)]

in particular it states on this page:
Other non-vaccine therapeutic immunotherapies

originals:


[link to www.fda.gov (secure)]

[link to www.fda.gov (secure)]

on page 12 regarding the printing matter it clearly states:

All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:

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
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

looks like COMIRNATY is the new vax name
looks like it's still under EUA
looks like it under BLA license

Thread: "The Fight Has Just Begun" -Robert Barnes VivaFreiBarnes: Update even Athiesm is a Religious Exemption (Page 2)

Doesn't do away with many of the legal lawsuit issues, and the FDA is going to be sued as well, in addition a stay order is being requested.

Some main updates on the legal challenge thread.

People love to say "they can't all be in on it together". Well yes they can and this is proof. You have a major regulatory body in America completely ignoring all the standard protocols and safety requirements, allowing the use of experimental products on a nationwide scale and now fully approving one of those products without any of the applicable regulations ever having been followed. As if the countless governments around the world all doing and saying the same things at the same time for over a year while all the state/provicincal and local governments follow suit in lockstep isn't enough proof we now have this have as the ultimate proof. Yes, they can all be in on it together and yes everyone or at least the vast majority will follow the orders they're given on command and without question regardless of what those orders are. What's worse, as many have pointed out this is far from the first time this has happened in North America and it won't be the last.

Not fully approved !!! Only extension of EUA!!

Seen that mistake many times today, is wrong, what got extended was the EUA for under 16 years old because the Biologic license application (BLA) covers from 16 years old up.

BLA Approval [link to fda.gov (secure)]

EUA Extension [link to fda.gov (secure)]

I'm very confused.

It looks like, according to the FDA links provided earlier in the thread, the BLA approval is about marketing a drug under a new name. It looks like they approved them to market the vax as Comirnaty (sp?).

It's not very clear cut or simple is it? My guess it's that's on purpose.

Here's from the FDA site regarding BLa

Biologic License Application (BLA)

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Last Edited by Bright Side on 08/23/2021 10:36 PM

The trade brand has always been Comirnaty for the Pfizer vaccine, that's not new at all. It's just that the vials distributed in the USA were not using it, but in Europe all of them were using that brand.

[link to www.bitchute.com (secure)]

direct link, was too small to read/ part 6

Last Edited by savcash on 08/24/2021 07:13 PM

Quite alright with that.

Nope. Pfizer did not get approved.

Its still EU authorization only.

Comirnarty which is not yet manufactured, their "new" product, has been rushed probably incorrectly, lawyers be on that, to be approved for 16 and up.

In the meantime, Pfizer, the current product is still EU and in a strange manner covers the same group, ie everyone, the 16 on group, that the full approval supposedly covers, not a normal thing to do.

And, one top lawyer wondered why? Curious things usually have reasons.

Perhaps that immunity does not fully extend past the FDA approval and maybe they don't really want to drag that new product out until they have immunity, because potentially millions of cases are lined up currently, with potentially billions more soon.


So its trickery. Illusion. Pretend the current is FDA approved, and only bring out the new product if you know 100% you're not going to be sued out of your house, home, mansions, and rich lifestyles.

Thread: Robert Barnes Took A Look At The Strange Wording In The Fda Approval and Dr. Robert Malone's Take On It