Comirnaty Package Insert Reveals All

FDA ^ | 08/02/21

[Enlightened1]

Direct from the Comirnaty package insert...

 

https://www.fda.gov/media/151707/download

 

5.2 Myocarditis and Pericarditis

 

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential longterm sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

 

5.5 Limitation of Effectiveness

COMIRNATY may not protect all vaccine recipients

 

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)].

 

Obviously they are well aware of myocarditis, pericarditis, otherwise they wouldn't have included it in the insert. They also admit that vaccine "may" not work. It is quite obvious that there have not been sufficient studies to rule out carcinogenicity, genotoxicity etc. They admit that they have no idea what it does to fertility in males. They admit that female fertility has only been briefly and incompletely studied in rats (no long term).

And all this is for the one that has actually been "approved". Of course there is much more in the insert that reveals the absolute lack of proper safety evaluation. But you can research the Pfizer EUA insert as well...

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

 

Bottom line. There is absolutely no justification for this being mandated. There really isn't any justification for administration at all, as there is nothing here that demonstrates that the risks outweigh the benefit, especially for a supposed illness, with an IFR of .15 or less for the majority of individuals. Never has the groundwork been better laid for a health disaster of unimaginable proportions. Every day this continues only demonstrates that there is truly no rule of law. But I guess most of you already knew that.

[devane617]

what?

[grobdriver]

Thanks!

[DugwayDuke]

So what? We’ve been told multiple times, IIRC including yourself, that Comirnaty isn’t even available within the US. BTW, if comirnaty isn’t available, where did they get the insert?

[4Liberty]

Bump for later!!

[Safrguns]

Thanks! printed this off after downloading

I dare anyone to read all the way through it before taking this crap!

[ThunderSleeps]

...Information is not yet available about potential longterm sequelae.

In other words, we don't know what may happen to people 5 or 10 years from now, what long-term chronic conditions we may be causing.

COMIRNATY may not protect all vaccine recipients...

That much is obvious. Better questions might be, does it protect any recipients? How well, for how long, and at what cost or risk? Oh, that's right... These are questions that could be answered after successful completion of drug testing. But everyone seems to be rushing headlong to short-circuit the well established process in favor of releasing experimental drugs after a few weeks and only phase 2 testing.

COMIRNATY has not been evaluated for the potential to cause carcinogenicity...

So it may cause or exacerbate cancers. Great, just great...

---

In late 2020 the FDA approved 3 vaccines under Emergency Use Authorization (EUA). They only had a few weeks of phase 1 and phase 2 testing data. Testing normally encompasses 4 phases and takes several years, sometimes as long as ten years, to complete. The FDA's actions were more-or-less justifiable given that there were no other vaccines available to help stem the alleged pandemic.

Pfizer then changed up the formulation for their mRNA vaccine, altering 4 components. Reasons unknown, well, unstated to the public. They branded it Comirnaty and rapidly put it through phase 1 and phase 2 trials. Pfizer presented this data to the FDA and got full-use approval.

This is insane. Even granting EUA to Comirnaty would have been a bit sketchy - there are already 3 other vaccines available, there is no "emergency" justifying a 4th. The FDA should have green-lighted phase 3 testing for Comirnaty. Full-use authorization based on mere phase 2 data violates best practices and procedures developed over decades from lessons learned the hard way. As in a price in pain, suffering, and death. The FDA's action is reckless and negligent in their duty.

[Enlightened1]

The links are from the FDA and CDC.

You can ask them.

[SaxxonWoods]

My doctor said she thinks getting vaxxed is a good idea but it’s my decision and that I’m in very good health.

My. Decision.

The govt hasn’t told me I have to do anything regarding vaccination.

[I want the USA back]

Mandating this is an act of contempt against the American people.

The name, which I don’t choose to even try to remember, was chosen so it would be hard to remember. Drug marketers know how to choose a name for a drug: easy to remember, nice sounding, pleasant. Lunesta, Lipitor, Ambien, Humira, Abilify.

They want this new “covid” vax to be obscure and confusing, and indeed it is.

[nurees]

Manufacturers need to include the PI and proposed marketing materials as a part of the drug review process

[DugwayDuke]

Enlightened1 wrote: “The links are from the FDA and CDC.
You can ask them.”

I’d like for you to answer this question: ‘If Comirnaty isn’t available in the US, why does this matter.?’

[SunTzuWu]

‘If Comirnaty isn't available in the US, why does this matter.?’

Why does information matter????
Attack the messenger much?

[DugwayDuke]

SunTzuWu wrote: “Why does information matter????
Attack the messenger much?”

It matters if the messenger is inconsistent. For weeks, the messenger has been telling us the vaccines are not approved because comarinty isn’t available in the US. Why is this information about a drug that isn’t ‘available’ important?

[TianaHighrider]

Bookmark.

[Ahithophel]

if comirnaty isn’t available, where did they get the insert?

Availability of comirnaty and existence of insert are not mutually exclusive. Insert can (and obviously does) exist independent of whether comirnaty is available.

[Enlightened1]

In post # 4 you asked, "where did they get the insert?"

 

Key word being "they". 

 

I provided you the FDA and CDC links that said this, and that is who you need to ask.

[DugwayDuke]

Ahithophel wrote: “Availability of comirnaty and existence of insert are not mutually exclusive. Insert can (and obviously does) exist independent of whether comirnaty is available.”

Why is the insert even important if the comirnaty vaccine isn’t available in the US?

Then there is the question of why some think this is ‘breaking news’? No one has ever claimed the vaccines are 100% effective in preventing illness. No one has ever claimed the vaccines are without side effects?

[DugwayDuke]

Enlightened1 wrote: “I provided you the FDA and CDC links that said this, and that is who you need to ask.”

And, you’re still dodging the question of why this information on a vaccine that ‘isn’t available’ is so important.

You might also want to answer why this information is reported as so important? No one has ever claimed the vaccines are 100% effective. No one has ever claimed the vaccines do not have side effects. Yet you act as if this has been kept a deep dark secret.