Posted on 08/23/2021 1:03:46 PM PDT by rktman
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.
(Excerpt) Read more at fda.gov ...
Covid-1984 Placemarker
I highly recommend you share the link below with everyone. It is updated continuously and has medical personnel posting. Holocaust II?
Amy Lee
8 hours ago
29 athletic female. Now 2 months post first Pfizer jab. It’s been a roller coaster. Hair loss in first week. Swollen lymph nodes under arms hour after the shot and continued to increase in pain for 3-4 weeks. Triggered multi system inflammation for 1.5 months. Pain in lower back/kidney area. Heart palpitations within first week and continued to increase in intensity until the 2 week mark where I had severe heart palpitations, sweats and shortness of breath for 12 hours. Went to ER. Elevated D-dimer 900+. Scans looked fine. Referred to Cardiologist, pulmonologist and allergist. Ultrasound of heart looked fine. Cardiologist said he’s seeing many young females with similar symptoms. He couldn’t explain the serge of cases but likely linked to vaccine. Was very concerned. Told of possible heart issues in the future and to stay away from the second dose. Pulmonologist confirmed same. Myocarditis a possibility but hard to diagnose for certain. Family physician and allergist dismissed these specialists opinions and encouraged me to take the second dose. They said myocarditis is not a serious health issue (!!)
Muscles still feel tight - especially legs and calves in the morning. Twitching deltoid at injection site. Left leg muscle spasms although infrequent. Severe headache that has not gone away since the jab. Reduced efficacy, i.e. I used to workout 2 hours a day/ 5 days a week. Now it’s twice a week and just to move my legs and loosen the stiffness. Run out of breath easy and heart feels like it’s about to pump itself out of my chest.
Not sure what to make out of all of this. The specialists are concerned but the general practitioners seem to be dismissing all of this and playing it down. Shame on them for encouraging their patients to take the second dose when there is clear evidence that specialists are seeing increased complaints linked to heart issues and blood clots.
2-It has NOT been tested to be SAFE for pregnant mothers AND THEIR BABIES.
3-It has NOT been tested to be SAFE for previously infected Covid patients.
This is NOT "science", this IS propaganda!!!
Approval of BLA(biologics license application) for 16 and older
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.
Reauth of EUA for "certain uses that are not included in the approves BLA" eg 12-15 year old
Does that letter contain all the fine print?
Just feels like we’re missing something to me...
All that boilerplate about revisions and certain uses...
So, how much is Fauci worth, now?
Does the Constitution approve of the FDA?
Both announcements keep using that word; ‘prevent’. I do not think that word means what they think it means. Kinda like side effects; ‘rare’.
Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 12 through 15 years of age.
Benefits outweigh the risks. Same thing Fauxi said about the gain of function research that gave us covid in the first place.
Fkin bastard mad scientists.
Booster use not approved. Emergency use only.
They named the drug Comorbidity? That is an IN YOUR FACE move I think.
COMIRNATY
My first thought was Community+Conformity
I like John Wayne’s quote, “we’re gonna give ya a fair trial and a fine hangin”.
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health
For Immediate Release:
August 23, 2021
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.”
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
Correct-o-mondo!
As well as this first sentence in FDA press release:
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.
Oh, sort of like the link to this post says? LOL!
Thank God they followed all of their normal procedures...
8 months to full approval.
Excellent point!
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