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

a reply to: Xtrozero

What isn't true?

Israel having a high percentage of vaccinated people

Israel having an outbreak of covid

Which one was I wrong on?

a reply to: carewemust

Heh, heh, heh. Yeah. I was giving it more credit than it deserves. Youre right

a reply to: Vector99

The vaccine is fully approved for ages 16 and up, however there are some EUA allowed. For example...

Page two, paragraph two.

... to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.

Page four, second paragraph. Continued on page five, first paragraph.

Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

So there it is, right there. Cited with pages and paragraphs for you. It's approved for ages 16 and up, but also has a EUA for ages 12-15, a third dose for those aged 12 and up, available to those who have received an organ transplant, or those who are immunocompromised (have HIV or other illnesses, take immunosuppressant drugs, undergoing chemotherapy, etc...).

Also worth noting is this. Page two, footnote eight.

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.

I get it. I don't want the jab approved, can't understand how it was, don't trust any of it, and still have no intention of taking it myself.

But no amount of goal post moving, selective reading, or obfuscation of the legalese will change the fact that, yes, it is approved.

ETA:

Also, here is the statement of approval, since you said you couldn't find that.

Page two, paragraph one.

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.

originally posted by: Vector99

What isn't true?

Israel having a high percentage of vaccinated people

Israel having an outbreak of covid

Which one was I wrong on?

Maybe I was reading into your post with your other posts in mind too. People do not understand what 95% efficacy really means. It means the vaccine showed 95% less infections than the placebo, so if the placebo had 100 infections and the vaccine had 5 that is 95% efficacy and that is what their data showed. With Delta they are saying the efficacy dropped off to 70% or even lower...maybe 50%, but the over all recovery is greatly better than with the unvacced.

Israel right now has about 75k active cases, if no one was vacced we could see a much higher number of 2 or 3 times that or more, but I find it interesting that the infection rate is what everyone seems to focus on when we really should be looking at the serious illness rate of who is in hospitals. Should we really care if someone gets it and a few days later they are fine?

When we look at their data of who is in the hospitals from my chart the vaccine is working well in that area of prepping the body first for when the virus may come. I see the same thing in OR and WA where I'm from with 2% of those in hospitals are vacced.

In the end we want to protect the high risk from serious illness or dying right?

a reply to: cmdrkeenkid
I missed the news where all the other EUA vaccines lost their EUA status, because now that there's an approved vaccine, there is approved treatment available rendering all EUA's null.

Can you link me to that story? Because when a treatment gets full FDA approval, all the other emergency use treatments are no longer allowed due to there being an approved treatment.

They only get EUA if there is no other treatment available, now there is, so Moderna and J&J are now out millions of vaccines and billions of dollars.

If this is actually fully approved that is.

originally posted by: Vector99
Can you link me to that story? Because when a treatment gets full FDA approval, all the other emergency use treatments are no longer allowed due to there being an approved treatment.

You're the only one I've ever seen say that. Burden of proof is on you. I've done my due diligence.

a reply to: cmdrkeenkid

Am confused, and not sure that these are the same products :
Pfizer™-BioNTech™ COVID‑19™ Vaccine™, and ;
COMIRNATY (COVID-19 Vaccine, mRNA).


[www.bitchute.com...]Dr. Robert Malone suspects shenanigans. [/url]

Finally read and understood it...

It's the same product. I guess they had to change some little part in the product, for them to make to distinct legal products.

Pfizer vaccines labelled as Pfizer/ Biontech = Trial vaccines that fall under the EUA, and therefore are immune to lawsuits.

Comirnaty = The same product, now licensed and branded as "Comirnaty". For now, if you get this, you have better options at making claims for VI issues.

But really, it's the same. And they have to keep the EUA for the "Pfizer" version, because they recognise that there are so many in stock out there. And they would rather have you use those, because... welll any problems, no lawsuit from you.

Even if you have 1 Pfizer and then get a Comirnaty (again... same product), you wouldn't be able to sue for damages, because hey, you probably got those problems from the Pfizer labelled product and not the Comirnaty labelled product.

What a #hole business.

a reply to: Nothin

They are. It's in there. I think I even quoted that from the application in one of my previous posts.

Edit to add:

I did.

originally posted by: Vasa Croe

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.

January 30, 2022

The supposed fully FDA-approved Covid-19 vaccine named COMIRNATY, is still not being administered to citizens of the United States;

According to: twitter.com...

Since Comirnaty does NOT cause long-term medical problems for the recipients, it's not something the Medical and Pharmaceutical profession wants most people injected with.

It would be interesting to learn WHO IS being injected with this real vaccine.

a reply to: carewemust

nder section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. 

Get it?

Seriously, does everyone get whats going here??

www.fda.gov...