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

a reply to: Vasa Croe

Yep a global phase 3 trial with a willing populace they loves to follow authority.

a reply to: Zitterbewegung

Because you an MSM that uses catchy words for fear mongering.

a reply to: HawkEyi

What? catchy words? MSM?

I know plenty that took it because they wanted to go to vacation, or thought they get rid of the mask, not because they were willing to try and see what happens with the vaccine.

They were told it's safe and everyone who has concerns is a conspiracy theorist.

originally posted by: HawkEyi
a reply to: rickymouse

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

Not at all, technically they are saying things in a way that misleads people into thinking something they said means something else. There are specialists at that PR that get paid megabucks. Graphs and figures are used more often to deceive people into believing something that is not real than in informing people of the truth.

Here is one article about that.....faculty.atu.edu...

another article about that......www.forbes.com...

Another Wikipedia article about this, google this and find lots of articles about how we are being deceived by people who want us to believe or invest in their products. en.wikipedia.org...

originally posted by: carewemust
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.

Yep. I was citing these things on 4ch this morning. The way they say this vaccine is approved in the same way cnn claims my ar15 is "fully semi-automatic."

This is one of the funniest parts from the approval release presser....

FDA’s analysis of the available efficacy data from 36,523
participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days
after dose 2 confirmed the vaccine was 95% effective (95% credible interval 90.3, 97.6) in
preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in
the vaccine group compared to 162 COVID-19 cases in the placebo group).

So it was 95% effective in preventing Covid for 7 days? What happened on the 8th day?

They also stated:

FDA’s review of the available safety data
from 37,586 of the participants 16 years of age and older, who were followed for a median of
two months after receiving the second dose, did not identify specific safety concerns that would
preclude issuance of an EUA

So they followed 37k patients for 2 months after the 2nd dose, yet only include 7 days of data for efficacy?

Huh?

Well, it still says it on page 1 that is EMERGENCY USE ONLY. lol

On the basis of such
determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist
justifying the authorization of emergency use of drugs and biological products during the
COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms
of any authorization issued under that section.2

EDITED: It says EXPERIMENTAL thruout the entire document.

a reply to: Vasa Croe

Some people who push or support these mRNA vaxs dont read the fine prints at the back and this is what i have an issue with you see.

I dont think Pfizer has being very open about what they told or shown to FDA. What is happening in Israel should be an example as a red flag.
Pfizer lied about their 95% effectiveness.

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 43998 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023

a reply to: HawkEyi

What dont you understand? Its 95% effective chief. *






* in 64% of all cases.

originally posted by: cmdrkeenkid
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.

The wording is clear alright, it's still an EUA approved vaccine

They specifically say approved for EUA several times, but I can't seem to find the page that authorizes it for full use outside of the EUA status.

It's only 13 pages, maybe you could actually read it and help, thanks in advance.

Oh, just a heads up on your search, if one vaccine becomes fully approved, all others lose their EUA status.

a reply to: HawkEyi

It was actually page 11 that did it for me, they openly declare it to be an EUA

All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine shall be consistent with the authorized labeling,as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.

originally posted by: Chalcedony
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?

Nothing is to be trusted without seeing the data that enabled the FDA to approve the drug.

originally posted by: drewlander
a reply to: HawkEyi

What dont you understand? Its 95% effective chief. *
* in 64% of all cases.

For the first week. It's all downhill from there.

originally posted by: carewemust

originally posted by: Chalcedony
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?

Nothing is to be trusted without seeing the data that enabled the FDA to approve the drug.

I still don't see it being approved. I see an EUA application being approved, but not full FDA approval. Do you have something to show it's fully approved?

originally posted by: Zitterbewegung

In conclusion. Who the hell would take this willingly? This was no real trial.

Do you take any meds at all including aspirin? You ever read the 100 possible side effects it seems every drug has... I also like the last one..."can include death" I bet flintstone vitamins has that one too...

For some reason now we care...

originally posted by: HawkEyi
What is happening in Israel should be an example as a red flag.

What is happening there?

originally posted by: Xtrozero

originally posted by: HawkEyi
What is happening in Israel should be an example as a red flag.

What is happening there?

an outbreak of covid amongst a highly vaccinated population?

originally posted by: Vector99

an outbreak of covid amongst a highly vaccinated population?

That is actually not true... Current numbers for them for the serious ill...