What age is your kid?
Hrrmmm, maybe this vaccine does need an audit
Did you actually read the document
@Splinty ?read pages 12-13 if you don't have much time
Doesn't seem like Full Approval at all.
YOU READ THE DOCUMENT ALSO HOT STUFF
M
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I’m illiterate
View: https://youtu.be/ob3ER7fKeDs?t=115
Biden urges employers to require Covid vaccination
The president’s call for schools and business to require vaccination comes amid stiff resistance by some Republican governors and lawmakers.
www.politico.com
View: https://twitter.com/RNCResearch/status/1387455978187247617
We know what he will recommend next
A slow creep on your Liberties is in play
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"sir" is far too authoritative for someone as warm and familial as I...feel free to call me "Daddy".
I agree that we should be far enough along in researching effective antibody levels to make some general "safe enough" judgments. But Tony Fauci isn't going to fund that research through NIH. Purdue Pharma isn't going to pay for that research either.
Because the FDA exists only to set unreasonably high hurdles for their benefactors' competition, and then remove those hurdles when it suits their benefactors.
Roger that Daddy"sir" is far too authoritative for someone as warm and familial as I...feel free to call me "Daddy".
I agree that we should be far enough along in researching effective antibody levels to make some general "safe enough" judgments. But Tony Fauci isn't going to fund that research through NIH. Purdue Pharma isn't going to pay for that research either.
Because the FDA exists only to set unreasonably high hurdles for their benefactors' competition, and then remove those hurdles when it suits their benefactors.
M
member 3289
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How are you this stupid?Did you actually read the document
read pages 12-13 if you don't have much time
Doesn't seem like Full Approval at all.
I guess you didn't read the document
Oh well...may as well just call names
Yep
Fuck those Mofos
Sell outs who are completely compromised
Blackmail folders are thicc as fuk
M
member 3289
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The EUA applies only to people 12-15 years old. The vaccine has been fully approved for those aged 16 and older.
Answer my question about your stupidity.
You tryna start the week pinked?
M
member 1013
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The peepee tape is real?!
“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. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide
updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to myocarditis and pericarditis.”
Not full approval
Safety Trials end in 2023 at the earliest
View: https://giphy.com/gifs/deal-with-it-sunglasses-jack-nicholson-Nx2Lx1RmLadtC
M
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@Splinty is this true?!
M
member 3289
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I think he was laundering yuge money waaaay back...surely documented.
No idea about PP tapes.
Biden's position in politics has gotten his family some really sweet deals...Hunter's being the least damning of the deals.
You don't get that job without a thicc blackmail folder IMO.
I ain't even got to get sexual about it...but surely a lot of that is also documented or on videos in vaults.
M
member 3289
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This is correct. Read the PR:
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Here's the part about ongoing safety monitoring with results coming in in '22 and '23:
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
It is a fast tracked push to get it available for kids, and to allow businesses and governments to enforce mandates.
It isn't about science, and it isn't about safety. Lets be honest about that at least.
FDA is full of shit, this "full approval" is basically a press release.
Vaccinating the young for something they have a 99.99% chance of surviving is a horrible plan, in the process you are robbing them of real long lasting immunity.
Knock yourselves out folks, enjoy your subscription plan to whatever Big Pharma wants to inject you with...I, for one, will not be party to such fuckery.
It isn't about science, and it isn't about safety. Lets be honest about that at least.
FDA is full of shit, this "full approval" is basically a press release.
Vaccinating the young for something they have a 99.99% chance of surviving is a horrible plan, in the process you are robbing them of real long lasting immunity.
Knock yourselves out folks, enjoy your subscription plan to whatever Big Pharma wants to inject you with...I, for one, will not be party to such fuckery.