WHO Adverse Reaction Reporting site seems to challenge narrative.

originally posted by: Flyingclaydisk

They are NOT the same! You are simply incorrect with that statement! Period!

What part of "vaccine series" do you not understand?? See my ETA2 above, where I already explained this (anticipating this would be your retort).

And when you have something to promote, you need a brand name. That’s where “Comirnaty” (pronounced koe-mir’-na-tee) comes in. The shot has been called the “Pfizer vaccine” because that’s the name of one of the companies that developed it.

However, the name change led some people to believe the Food and Drug Administration-approved Comirnaty is a different version of the Pfizer vaccine — it’s not.

duh

I've heard that the U.S. Food and Drug Administration (FDA) said Pfizer's Comirnaty and BioNTech formulas are distinctly different in their vaccine approval letter. Is that true?

Answer from infectious diseases pharmacist Bryan Alexander, PharmD:
No. In terms of what is contained inside the vial of each they are identical. Pfizer and BioNTech simply formally "branded" or named their vaccine Comirnaty.

BioNTech is the German biotechnology company that partnered with Pfizer in bringing this COVID-19 vaccine to market.

"Pfizer Comirnaty" and "Pfizer BioNTech COVID-19 vaccine" are biologically and chemically the same thing.

The confusion stems from this section of the FDA's Comirnaty Vaccine Information for Recipients and Caregivers sheet:

"[1] 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. The products are legally distinct with certain differences that do not impact safety or effectiveness."

The FDA desires to have a single, combined Vaccine Information Sheet. A single sheet keeps things simple for the people administering and receiving the vaccines. Since the branded and unbranded vials of vaccines are chemically identical, despite being legally distinct, this information must be included.

The FDA's approval letter outlines rules Pfizer and BioNTech must follow to maintain full approval for people ages 16 and older. It also explains how the companies can earn full FDA approval for people 16 and under.

These rules include completing a series of studies focusing on people under age 16 to obtain full approval in this population. These studies are already underway. The companies must also maintain post-approval studies for those over 16 to monitor the vaccine's safety and efficacy.

These studies are a standard part of the post-approval process that most drugs must go through to maintain full FDA approval. This list of required studies does not mean the vaccine is not fully approved.

Why is the name just showing up now?

Medications often have a scientific name or number throughout the research and development process and are given a brand name upon FDA approval.

In a joint media statement released by Pfizer and BioNTech on Dec. 21, 2020, the companies explained, "The vaccine will be marketed in the EU under the brand name COMIRNATY, which represents a combination of the terms COVID-19, mRNA, community and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine…"

Pfizer and BioNTech received permission to market the vaccine as Comirnaty in the United States within the FDA's recent approval. The FDA's approval letter states, "You may label your product with the proprietary name, Comirnaty, and market it in 2.0 mL glass vials, in packages of 25 and 195 vials."

Comirnaty, also commonly referred to as the Pfizer COVID-19 vaccine, received final FDA approval for people age 16 and older on Aug. 23.

duh 2

Would you like 20 more? You are digging for something not there.

originally posted by: Vasa Croe

I can call back and ask about my 8 year old if you'd like. This is getting old when the goalposts keep moving.

I think my last post explained it well in you can most likely lie your way through it all. They do ask for the age etc. but you are correct in you can game the system if you try. I'm sure at some point a level or reasonableness creeps in if you are trying to vaxx a very young kid. Also you will need to pay direct for it too as your insurance will not approve it for your kid being under age, that could be a red flag too. Finally it will follow you and your kid and at some point it will come out since vaxx history follows all of us.

a reply to: Xtrozero

Meh....just gets old arguing about things that are actually occurring versus people who believe many are dumb enough to inject bleach or eat sunshine pills or call Ivermectin Horse Dewormer.

I would hazard a guess that at this point there have been millions of children under 12 that have been vaccinated worldwide.

Here is a 3 year old getting it at Stanford....story mentions it is one of 5 sites in the country running these trials.

originally posted by: Xtrozero

originally posted by: Type1338
unapproved experimental vaccine.

Might need to change this to "approved vaccine" now...

"approved" only 1 and that is a joke.

The FDA is owned by big pharma. They receive more than 45% of their funding from big pharma and more than 93% of FDA employees are former big pharma employees.

And for that matter the CDC is a massive revolving door of Washington establishment politicians and they, too, receive the majority of their funding from big pharma. When will you people wake up to what is going on? Are you really that obtuse?

You do the math.

Multiple Sources Cited in this excellent break down by Russell Brand:

originally posted by: Type1338

"approved" only 1 and that is a joke.

The FDA is owned by big pharma. They receive more than 45% of their funding from big pharma and more than 93% of FDA employees are former big pharma employees.

And for that matter the CDC is a massive revolving door of Washington establishment politicians and they, too, receive the majority of their funding from big pharma. When will you people wake up to what is going on? Are you really that obtuse?

You do the math.

1 + 1 = 2 Yep it works...

I'm not the one driving the whole "its an experimental drug under a EUA, and so I will not get it until approved!" crap. So they approved it now and the new narrative is "its all a joke" crap?

I really care less if it is approved or not, but people seemed to ride on that as if it really matter, and it really didn't.

originally posted by: Xtrozero

originally posted by: Type1338

"approved" only 1 and that is a joke.

The FDA is owned by big pharma. They receive more than 45% of their funding from big pharma and more than 93% of FDA employees are former big pharma employees.

And for that matter the CDC is a massive revolving door of Washington establishment politicians and they, too, receive the majority of their funding from big pharma. When will you people wake up to what is going on? Are you really that obtuse?

You do the math.

I'm not the one driving the whole "its an experimental drug under a EUA, and so I will not get it until approved!" crap. So they approved it now and the new narrative is "its all a joke" crap?

I really care less if it is approved or not, but people seemed to ride on that as if it really matter, and it really didn't.

Wrong again. People like me who argue against a STILL EXPERIMENTAL vaccine will never take one. Until you can point me to (at a minimum) 10 years of data that prove any of these experimental vaccines have no long term side effects I will always argue against them. Only an idiot ruled by their irrational fear and COMPLETE lack of understanding that the FDA and CDC are 100% OWNED by bid pharma lines up for this BS.

You can keep up with your irrational temper tantrum and it will never change the fact you are one who allows their decisions to be ruled by complete and absolute irrational fear and ignorance.

Please by all means continue to line up for your experimental vaccine and please by all means continue to keep yourself in forced ignorance of what's really going on.

originally posted by: Type1338

Wrong again. People like me who argue against a STILL EXPERIMENTAL vaccine will never take one. Until you can point me to (at a minimum) 10 years of data that prove any of these experimental vaccines have no long term side effects I will always argue against them. Only an idiot ruled by their irrational fear and COMPLETE lack of understanding that the FDA and CDC are 100% OWNED by bid pharma lines up for this BS.

First human testing was 8+ years ago, does that count? BTW I really don't care if you get it or not, your choice. That has never been my argument in any of this. So you want 10 years of data, OK fine...

You can keep up with your irrational temper tantrum and it will never change the fact you are one who allows their decisions to be ruled by complete and absolute irrational fear and ignorance.

Have you read any emotion in my posts, unlike yours here...lol I'm not sure what temper tantrum you suggest I'm having. Its kind of funny your words above is really what I think of the anti-vaxxers here. BTW what ignorance am I displaying?

Please by all means continue to line up for your experimental vaccine and please by all means continue to keep yourself in forced ignorance of what's really going on.

You do know I can on one hand see the vaccine as good, and on the other hand see that our Goverment is a total sh!t show... I'm multi dimensional here in what I see as true, so not one sided in anyway.

originally posted by: Xtrozero

originally posted by: Type1338

First human testing was 8+ years ago, does that count? BTW I really don't care if you get it or not, your choice. That has never been my argument in any of this. So you want 10 years of data, OK fine...

Show me the studies that have been conducted and the trials that have been conducted on a vaccine that never existed until recently on a virus that supposedly didn't exist until recently.

It doesn't exist. There is no data. Full stop.

Try harder next time.

And if vaccines are "so good" then explain to me why pneumonia, TB, and the flu have remained in the top 10 death causes for more than 50 years while there are vaccines for all of them? Vaccines for these type infections are total BS.

The best thing to happen to mankind (health wise) was centralized sanitation. That's what improved our general health when we stopped living in our own sh***T. Not vaccines.

Tell yourself whatever you need to continue to justify your irrational fear. I really could care less.

edit on 20-9-2021 by Type1338 because: (no reason given)

originally posted by: AugustusMasonicus

originally posted by: infolurker
Test subjects and idiots vax'ing their kids anyway.

How are they going to 'vax their kids anyway'? It has to be administered by a healthcare professional.

www.cnbc.com...
www.reuters.com... 8/
"The United States administered COVID-19 vaccinations to around 600,000 children ages 12 to 15 last week after regulators cleared Pfizer Inc’s (PFE.N) and BioNTech’s shots for use in that age group"

a reply to: panoz77

We were discussing under 12, try again.

originally posted by: Xtrozero

originally posted by: Type1338

"approved" only 1 and that is a joke.

The FDA is owned by big pharma. They receive more than 45% of their funding from big pharma and more than 93% of FDA employees are former big pharma employees.

And for that matter the CDC is a massive revolving door of Washington establishment politicians and they, too, receive the majority of their funding from big pharma. When will you people wake up to what is going on? Are you really that obtuse?

You do the math.

1 + 1 = 2 Yep it works...

I'm not the one driving the whole "its an experimental drug under a EUA, and so I will not get it until approved!" crap. So they approved it now and the new narrative is "its all a joke" crap?

I really care less if it is approved or not, but people seemed to ride on that as if it really matter, and it really didn't.

Technically and legally nobody has gotten the approved vaccine yet because the EUA is still in effect. If the EUA was dropped, then the only vaccine allowed would be the approved one.

It is a legal issue that is going to result in a lot of suits coming.

Unless J&J, Moderna and AstraZeneca get FDA approval before the EUA is up, they will be taken off market.

This is also the reason you still haven't seen any advertisements for the Pfizer vaccine from Pfizer at all.

Until the EUA is over, there is nobody legally getting an approved vaxx.

originally posted by: AugustusMasonicus
a reply to: panoz77

We were discussing under 12, try again.

www.cnbc.com...
"There’s a vaccine workaround for children under 12"
"but it could have major implications for children in the 5-to-11 age bracket.

Legally, full approval opens the door for doctors to administer the Pfizer vaccine for “off-label” use, where approved drugs or vaccines are prescribed for unapproved uses. Generally speaking, the tactic is common ⁠— medications are often prescribed for off-label uses, particularly for children ⁠— and could theoretically be used now to vaccinate young kids against Covid-19."

whyy.org...
www.npr.org... fectiv
"The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results. "

originally posted by: Type1338

Show me the studies that have been conducted and the trials that have been conducted on a vaccine that never existed until recently on a virus that supposedly didn't exist until recently.

It doesn't exist. There is no data. Full stop.

Try harder next time.

mRNA human trials stared in 2012-2013 for 3+ years 100+ people 300+ shots. I'm not sure what you are wanting here. mRNA has been around a long time, the process to make mRNA for any virus is the same and very quick, so are you concern with the COVID mRNA or just mRNA in general? The other mRNA was Ebola and Rabies, so they were more focused on the heavy hitters until COVID came along.

And if vaccines are "so good" then explain to me why pneumonia, TB, and the flu have remained in the top 10 death causes for more than 50 years while there are vaccines for all of them? Vaccines for these type infections are total BS.

The true purpose of the mRNA vaccine is to take it from a new virus to one your body has a signature for. The key is to greatly reduce the chances of serious reactions, and since 95% of the people in hospitals are unvaxxed then I think we can say it is doing its job. I don't think anyone should call it some magic pill cure all, just something to build a immune response before you actually get COVID.

Tell yourself whatever you need to continue to justify your irrational fear. I really could care less.

You have a lot of emotion in your posts and I really do not care one way or the other what you do. I'm providing some information and that is it. If you feel you need 10 years of study before you take anything that is fine with me, not something I really care to debate. In the end I do not fear either the virus or the vaccine and carry on with my life in a very normal way. Its like I don't fear getting a cut either, but then I still put a little ointment on it and a Band-Aid to help it heal. I got 50 vaccines in me, this one is no different than another, so I'm not sure how you see irrational fear in any of my posts as you are the one not trusting anything, not me...lol

originally posted by: Vasa Croe

Technically and legally nobody has gotten the approved vaccine yet because the EUA is still in effect. If the EUA was dropped, then the only vaccine allowed would be the approved one.

It is a legal issue that is going to result in a lot of suits coming.

Unless J&J, Moderna and AstraZeneca get FDA approval before the EUA is up, they will be taken off market.

This is also the reason you still haven't seen any advertisements for the Pfizer vaccine from Pfizer at all.

Until the EUA is over, there is nobody legally getting an approved vaxx.

I'm not sure you can sue either way as approved vaccines are also protected from litigation. The bottom line is the vaccine has received approval and the machine that made the unnamed EUA vaccine is the same that makes the named approved one with no changes in the process, so basically a different label is the only difference.

If a person was saying that they will wait for the FDA to approve then we are there now unless their reason to wait is based on the chance to sue if they get the approved one which I don't think they can no matter what.

This is why we are starting to see companies mandate vaccines more. I would bet they are keeping the EUA in place to use up the billions of vaccines out there that would need to be scrapped if they stopped the EUA now just because it is not the new named vaccine. They will use them up and then remove the EUA and move on with the one with the new label.

Trial. Not trail. Fyi.
a reply to: Xtrozero

originally posted by: 20Eyes1974
Trial. Not trail. Fyi.
a reply to: Xtrozero

Auto spell check sucks...lol

What's the evidence that doesn't contain VAERS similar data or reports are submitted by health professionals only?

My reading of the disclaimer and how to submit reports it seems it's made up of VAERS, Yellow Card and EU reports - it states patients are allowed to submit their own reports to the relevant national body and the criteria are identical to the European version and catagories like suicide and mental health/illness don't make sense for a vaccine.

a reply to: panoz77

Your links aren't about people backdooring the process and shows in fact that there is a process.

a reply to: Xtrozero

lol...you have no data. Get back to me 10 years from now after you have something.

Pretty soon you will need ID to enter a restaurant for lunch, but won’t need to provide one to vote.

You can’t make this # up.