CORONA FDA NON-approval of Pfizer jab

TerryK

TB Fanatic
Here's an article saying that mRNA might actually translate its instructions into host DNA. That would apply to Pfizer / Comirnaty and to Moderna. This seems to be a new line of research and it may not have been known during vaccine development, but it should still be resolved before providing or continuing to provide these shots to the public. SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome - PubMed

and here is a blog talking about how it could happen: MIT & Harvard Study Suggests mRNA Vaccine Might Permanently Alter DNA After All

J&J contains live adenovirus containing DNA. I'm not sure of the argument by which we are supposed to know that information will not be transcribed to host DNA. Are we sure?
In regards to your statement about J&J. Yes it is the only 1 of the 3 US vaccines that actually contains DNA and the only one that enters the cell nucleus where our DNA actually is. If any vaccine has the chance to react with our DNA, J&J would be the one.

The article you quote was a result of testing in a lab with human cells in a medium.
Since then it has been debunked.
Only certain types of virus, called retro viruses contain a special enzyme called reverse trascriptase. The aids virus is one such virus, but there are others. A retro virus carries it;s own special enzyme with it and that is what enables it to alter DNA.
It also penetrates the nucleus to do this.
mRNA vaccines cannot affect DNA. They do not carry the special enzyme and the coding to do this.
The only coding they have is to create a covid protein spike to prompt your body's immune system to create antibodies to Covid and your immune memory cells to remember the covid virus.
There is a study that came out after the one you are citing that disproved the hypothesis. Since then the study findings have been withdrawn.
Bottom line - mRNA vaccines do not enter the cell nucleus where our DNA is located. AND they do not contain the reverse transcriptase enzyme that allows RNA to insert itself into our DNA as in AIDS. 2 very good reasons why the mRNA vaccines do not affect our DNA.

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Messenger RNA (mRNA) is found in all living cells. These strands of genetic code act as chemical intermediaries between the DNA in our chromosomes and the cellular machinery that produces the proteins we need to function: mRNA provides the instructions this machinery needs to assemble these proteins.

mRNA isn’t the same as DNA, and it can’t combine with our DNA to change our genetic code.
However, mRNA isn’t the same as DNA, and it can’t combine with our DNA to change our genetic code. It is also relatively fragile, and will only hang around inside a cell for about 72 hours, before being degraded.

VIRAL MESSAGES
The manufacturing ability of our cells extends beyond human proteins. When we are infected with a virus - including relatively harmless viruses like those that cause the common cold - these invaders inject their genetic material into our cells, resulting in pieces of mRNA encoding viral proteins being sent to our protein-making machinery. Doing so enables the virus to assemble new viral particles out of these proteins, and spread. Although mRNA vaccines are a relatively new technology, they are based on the same ancient premise: delivering mRNA into our cells, which they will use to manufacture a viral protein.

Some viruses like HIV can integrate their genetic material into the DNA of their hosts, but this isn’t true of all viruses, and HIV can only do so with the help of specialised enzymes that it carries with it. MRNA vaccines don’t carry these enzymes, so there is no risk of the genetic material they contain altering our DNA.

Have you read?
VACCINE TECHNOLOGY
The RNA vaccines being developed for COVID-19 all provide instructions for making the same viral protein: the coronavirus ‘spike’ protein used by the virus to gain entry to our cells. Preclinical studies indicated that it was highly immunogenic, meaning that if our immune cells encounter this protein, they will mount a strong response, which should protect recipients against future COVID-19 disease. Once our cells have manufactured the viral protein, it is displayed on their surfaces, where passing immune cells can spot it and respond.

To produce an mRNA vaccine, scientists create a synthetic version of mRNA encoding the spike protein. This is packaged inside fatty parcels, to make it easier for the mRNA to cross the outer membranes of cells, which are also made of fatty material.

Once inside the cell, the mRNA comes into contact with protein making-machinery, which is located in the jelly-like cytoplasm filling the cell. It doesn’t enter the nucleus, which is where our chromosomes are stored.

EXISTING METHOD
The Pfizer/BioNTech vaccine is the first mRNA vaccine to be approved for use in humans, but the technology underpinning it has been in development for the past two decades. And although people are understandably concerned about the rollout of any new medical technology, a very similar principle underpins 'viral vector vaccines’, such as the rVSV-ZEBOV vaccine used to protect people against Ebola. It was extensively used during the recent Kivu Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda, with more than 300,000 people receiving the vaccine. The vaccine was also deployed during an earlier outbreak of Ebola.

Here, a weakened version of a cattle virus called vesicular stomatitis virus is modified to carry a gene for an Ebola protein. Once inside the cell, messenger RNA for that Ebola protein is generated and fed into the cell’s protein-making machinery.

So, although mRNA vaccines are a new technology, there is no reason to think that they will have a lasting effect on our biology – besides training our immune systems to prevent COVID-19 disease, that is.

Finally in regards to your article:
Fact Check-Controversial MIT study does not show that mRNA vaccines alter DNA
By Reuters Fact Check
5 MIN READ

A controversial study is being misrepresented on social media as evidence that mRNA COVID-19 vaccines modify your DNA.
The claims relate to a non-peer-reviewed paper published as a pre-print in December 2020 (here). The co-authors, which included two biologists from the respected Massachusetts Institute of Technology (MIT) here , here), claimed that the novel coronavirus could modify human DNA.
The study was heavily criticised by some experts, one of whom called the conclusions “strong, dangerous and largely unsupported” (here).
Despite this, a blog post appeared in March (here) that was reposted with the headline: “MIT & Harvard Study Suggests mRNA Vaccine Might Permanently Alter DNA After All” (here).
The blog author speculated on the paper’s implications for COVID-19 vaccines, although he acknowledged that “this study didn’t show that the RNA from the current vaccines is being integrated into our DNA”.


Rather confusingly, the penultimate paragraph reads: “I am not making the claim that an mRNA vaccine will permanently alter your genomic DNA…[but] I believe this current research validates that this is at least plausible, and most likely probable.”
The blog continues to be shared on social media, with one account writing: “Harvard and MIT have just scientifically demonstrated that mRNA messenger vaccine permanently alters DNA” (here , here). This is not what the pre-print paper said.
The completed, peer-reviewed study was published in May (here) and claimed to reveal why some patients tested positive for COVID-19 long after recovery (here).
But it still proved controversial. The findings were challenged in a study published the following month (here), while the Meedan health desk (here) reported conclusions from two experts stating there was no evidence that mRNA from COVID-19 vaccines would integrate with human DNA (here).
The clinical news outlet MedPage Today also reported concerns that the anti-vaccine community would misconstrue the results to apply to COVID-19 vaccines, even though the authors had stressed the work had no implications for the vaccines or human health (here).

The MIT biologist and study co-author Rudolf Jaenisch told Genetic Engineering and Biotechnology News: “We welcome scientific discussions, not politically motivated distortions.” (here)
Ultimately, while the study’s methodology and conclusions are controversial, it never claimed that COVID-19 vaccines would alter human DNA. This is a theory that has been peddled online without evidence since the pandemic began (here , here , here).
VERDICT
Missing context. A controversial study co-authored by MIT biologists did not conclude that COVID-19 vaccines would change the recipient’s DNA.
 
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TammyinWI

Talk is cheap
Pfizer CEO got the vaccine in Mar.

HEALTH AND SCIENCE
Pfizer will require U.S. employees to get Covid vaccine or undergo weekly testing
PUBLISHED WED, AUG 4 20213:18 PM EDT

This was before the vaccine received approval. Most places that had the above requirements had them because the vaccine was still classified for emergency use. After the approval most companies are already removing the option for weekly testing.

Gee, that's funny, I just got this today in my email:

Pfizer does not mandate COVID jab for its employees, internal documents revealed
by: Sara Middleton, staff writer | August 23, 2021

(NaturalHealth365) Mainstream media may be reluctant to show just how much opposition there is to the worldwide push for injection mandates, but massive protests are happening in places like France, Australia, and California. Do not believe the propaganda: mandate-opposition is NOT coming from just one side of the political aisle.

But unlike millions of healthcare workers, students, and other hard-working Americans who risk being dismissed for not getting the jab, employees of Pfizer – one of two makers of the new mRNA COVID shot – remain free to choose whether to put this medical product in their bodies.

Is your local government or employer trying to mandate the COVID jab? You won’t believe who isn’t – the makers of the jab themselves

Continued here:

 

glennb6

Inactive
The worldwide game plan is proof of vaccination. Call it what you will, it's SHOW YOUR PAPERS or 'no soup for you!'

Whether it's also eugenics or just profit motivated, or both or neither - that's up to speculation and opinion. Opinion does not really apply to a law. You either show your papers or you don't get to go into the supermarket to buy food, etc.

Whether such a law is actually "legal" or "just" is not going to stop the game plan. See the BS the FDA and big pharma are playing as shown in this thread. They keep SAYING it's approved, many people believe it, the TV will keep promoting jabs.

A "pass" is being openly floated in the press by the Thai govt as proof of being double jabbed. If that comes to be, is approved, then I will no longer live in this corner of the world. But it's an example of the worldwide game plan being implemented. It has nothing to do with health and welfare of the public.

The evidence thus far of fatalities and injuries from the jabs is scary enough reason not to ever get jabbed, well it's enough for me. Your life your choice, as long as that choice is not imposed with an or else (no soup).
The govt/globocorp/medical complex push is so hard it makes pushy used car salesmen sound pleasant and trustworthy. Never buy or accept anything from anyone who is trying too hard to get you to do so.

IF this comes to be in the ussa, the necessary push back will have to be against the businesses that support and follow a "show your papers" fascist edicts. Be that boycott, or blown out front glass windows, or any other not so nice methods of saying Hell No. Necessary, as in your Right and Duty.
 

naegling62

Veteran Member
Pfizer CEO got the vaccine in Mar.

HEALTH AND SCIENCE
Pfizer will require U.S. employees to get Covid vaccine or undergo weekly testing
PUBLISHED WED, AUG 4 20213:18 PM EDT

This was before the vaccine received approval. Most places that had the above requirements had them because the vaccine was still classified for emergency use. After the approval most companies are already removing the option for weekly testing.
That's interesting, you know, you would think Pfizer wouldn't have to mandate it in the company who designed it. You would think the staff would be fully vaccidented already. Hmmmm.
 

Marie

Veteran Member
"Per fda guidelines once a BLA is approved. There can no longer be a product used under EUA."

Marie, please provide a link to the FDA Guidelines that documents this claim.

Thanks!
"Per fda guidelines once a BLA is approved. There can no longer be a product used under EUA."

Marie, please provide a link to the FDA Guidelines that documents this claim.

Thanks!
It's funny. I read the guid6on the fda website and now that part has vanished. Funny how that mysteriously become unavailable.
However I did find something else in the bowels today that was updated for Aug 23 and it is stating the vaccine is approved in the first paragraph. But then through the rest of the paper it states both vaccines are still under EUA. Please see next post for information
 

Marie

Veteran Member
It's funny. I read the guid6on the fda website and now that part has vanished. Funny how that mysteriously become unavailable.
However I did find something else in the bowels today that was updated for Aug 23 and it is stating the vaccine is approved in the first paragraph. But then through the rest of the paper it states both vaccines are still under EUA. Please see next post for information
VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS
ABOUT COMIRNATY (COVID-19 VACCINE, mRNA)
AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)


You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and also includes information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the
FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
• It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.
• It is also authorized under EUA to be administered to:
o prevent COVID-19 in individuals 12 through 15 years, and o provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:
• prevent COVID-19 in individuals 12 years of age and older, and
• provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.



This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19. Talk to your vaccination provider if you have questions.

COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine are administered as a 2-dose series, 3 weeks apart, into the muscle.

[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.

Under EUA for individuals who are determined to have certain kinds of immunocompromise, a third dose may be administered at least 4 weeks after the second dose.

COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get
COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS COMIRNATY (COVID-19 VACCINE, mRNA) AND HOW IS IT RELATED TO THE PFIZER-BIONTECH COVID-19 VACCINE?

COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.


WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:
• have any allergies
• have had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection

WHO SHOULD GET THE VACCINE?
FDA has approved COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older and has authorized it for emergency use in individuals 12 through 15 years.

FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 12 years of age and older.

WHO SHOULD NOT GET THE VACCINE?
You should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine.

WHAT ARE THE INGREDIENTS IN COMIRNATY (COVID-19 VACCINE, mRNA) AND THE PFIZER-BIONTECH COVID-19 VACCINE?
COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine include the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-
6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,Nditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

HOW IS THE VACCINE GIVEN?
COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle.

The vaccination series is 2 doses given 3 weeks apart.

If you receive one dose of the vaccine, you should receive a second dose of the vaccine 3 weeks later to complete the vaccination series.

HAVE COMIRNATY (COVID-19 VACCINE, mRNA) AND THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine. Data from these clinical trials supported the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine and the approval of COMIRNATY (COVID-19 Vaccine, mRNA). Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020.

WHAT ARE THE BENEFITS OF COMIRNATY (COVID-19 VACCINE, mRNA) AND THE PFIZER-BIONTECH COVID-19 VACCINE?
The vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF COMIRNATY (COVID-19 VACCINE, mRNA) AND THE PFIZER-BIONTECH COVID-19 VACCINE?
There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received
COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:
• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported with COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine include:
• severe allergic reactions
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• myocarditis (inflammation of the heart muscle)
• pericarditis (inflammation of the lining outside the heart)
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• diarrhea
• vomiting
• arm pain

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to VAERS - Report an Adverse Event. Please include either “COMIRNATY (COVID-19 Vaccine, mRNA)” or “Pfizer-BioNTech COVID-19 Vaccine EUA”, as appropriate, in the first line of box #18 of the report form.

In addition, you can report side effects to Pfizer Inc. at the contact information provided below.

Website Fax number Telephone number
www.pfizersafetyreporting.com
1-866-635-8337 1-800-438-1985

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?
Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA) OR PFIZER-BIONTECH COVID-19 VACCINE?
Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.

CAN I RECEIVE THE COMIRNATY (COVID-19 VACCINE, mRNA) OR PFIZERBIONTECH COVID-19 VACCINE AT THE SAME TIME AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of COMIRNATY (COVID19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine at the same time with other vaccines. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.

WHAT IF I AM IMMUNOCOMPROMISED?
If you are immunocompromised, you may receive a third dose of the vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate.

WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?
No. The vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

KEEP YOUR VACCINATION CARD
When you get your first dose, you will get a vaccination card to show you when to return for your second dose or if you have certain kinds of immunocompromise, your third dose of COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. Remember to bring your card when you return.

ADDITIONAL INFORMATION
If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Global website Telephone number
www.cvdvaccine.co m
1-877-829-2619
(1-877-VAX-CO19)


HOW CAN I LEARN MORE?
• Ask the vaccination provider.
• Visit CDC at Coronavirus Disease 2019 (COVID-19).
• Visit FDA at https://www.fda.gov/emergency-prepa...-policy-framework/emergency-use-authorization.
• Contact your local or state public health department.

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs visit: About Immunization Information System (IIS) | CDC.

CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19 VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for noninsured recipients).

WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?
Individuals becoming aware of any potential violations of the CDC COVID-19
Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or Submit a Hotline Complaint.

WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.

This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.




Manufactured by
Pfizer Inc., New York, NY 10017


Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

LAB-1451-7.2

Revised: 23 August 2021
 

Marie

Veteran Member
The source
 

Attachments

  • Final_EUA Fact sheet for Recipients - Pfizer-BioNTECH COVID-19 Vaccine.pdf
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Kris Gandillon

The Other Curmudgeon
_______________
It's funny. I read the guid6on the fda website and now that part has vanished. Funny how that mysteriously become unavailable.
However I did find something else in the bowels today that was updated for Aug 23 and it is stating the vaccine is approved in the first paragraph. But then through the rest of the paper it states both vaccines are still under EUA. Please see next post for information
Yes, Marie, both ARE still under EUA for a vey specific subset of young people: authorized under EUA to be administered to prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The original BioNTech vax with the original EUA has millions of doses still in the pipeline that can still be used under the original EUA until they are gone and the branded, licensed, approved version COMIRNATY production of the same formula is ramped up.

Like the original, BioNTech, the approved, licensed COMIRNATY is NOT approved for those young people or the immunocompromised noted above, but they can both still be used for those young people under their respective EUAs. COMIRNATY is licensed and approved only for those 16 years and older. Over time it will likely be licensed and approved for those younger people, at which time that last paragraph of your article will kick in:

"This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed."
 
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Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine Approval

Sen. Ron Johnson (R-Wis.) on Thursday sent a letter to Dr. Janet Woodruff, acting commissioner of the U.S. Food and Drug Administration, demanding answers to five questions pertaining to the FDA’s approval of the Pfizer Comirnaty COVID vaccine.

By Children's Health Defense Team

August 27, 2021

Sen. Ron Johnson (R-Wis.) on Thursday sent a letter to Dr. Janet Woodruff, acting commissioner of the U.S. Food and Drug Administration (FDA), demanding answers to five questions pertaining to the FDA’s approval of the Pfizer Comirnaty COVID vaccine.

The FDA on Aug. 23 granted full approval to Pfizer’s vaccine, over the objections of some scientists who pointed out that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.

In his Aug. 26 letter, Johnson asked questions similar to those raised earlier this week by Children’s Health Defense Chairman Robert F. Kennedy, Jr. and Dr. Meryl Nass about the legal distinction between the Pfizer-BioNTech vaccine being administered under Emergency Use Authorization, and Pfizer’s Comirnaty vaccine, which was granted full licensure.

In his letter, Johnson asks these five questions:

1. Why didn’t the FDA grant full licensure for the Pfizer-BioNTech vaccine that is in use and available in the U.S.?

2. How are the Comirnaty and Pfizer-BioNTech COVID-19 vaccines “legally distinct” and what are the “certain differences”?

3. There is no doubt that the FDA’s action will lead to more vaccine mandates and increased pressure on those currently choosing not to get vaccinated. Your letter to Pfizer suggests that “there is not sufficient approved vaccine available for distribution.” Is there sufficient supply in the U.S. of the Comirnaty vaccine to ensure that those being vaccinated under mandates will be receiving the FDA-approved version? Or is it more likely (or certain) that they will be vaccinated using the vaccine administered under the reissued EUA?

4. If there is insufficient supply of Comirnaty vaccines for those succumbing to the coercion of mandates, isn’t the FDA de facto endorsing vaccine mandates utilizing EUA vaccines?

5. Will individuals who receive either vaccine be afforded the same legal protections if they are injured by the vaccine? If not, why not?

This isn’t the first time Johnson has written the FDA about COVID vaccines. On Aug. 22, he sent a letter to Woodcock; Dr. Francis Collins, director of the National Institutes of Health (NIH); and Dr. Rochelle P. Walensky, director of Centers for Disease Control and Prevention, criticizing the FDA’s decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its vaccine.

In July, Johnson held a news conference with families injured by the vaccines, during which he said the medical community was “repeatedly ignoring” the vaccine-injured.
 

Binkerthebear

Veteran Member
Once AGAIN!! Another bald face lie!! Right there in the text on page 12!! NOT APPROVED, but just extended. "THEY" are really pushing this agenda. Hmmmm......why? Why not FULLY approve AND LICENSE it? What are "THEY" hiding? You have to ask the question, you simply have to.



Funny, but that's not what's being said in the Drive By Media and the white House. Hmmmmmmm
Hmmmmm is right !
 

db cooper

Resident Secret Squirrel
I just read Martin Armstongs article;
The Fake News that FDA Approved the Vaccines is Made Clear in the Letter

I did read through the FDA letter (PDF link in article) and it appears as best as I can interpret that the FDA ONLY extended the Emergency Use Authorization (EUA) and did NOT fully approve the Pfizer jab.

FDA Letter Final_Pfizer LOA to issue with BLA approval 08.23.21_v2


The FDA did not approve the vaccines but extended the Emergency Use of the vaccines. They are also trying very hard to have agencies force employers to compel everyone to vaccinate but at the same time leaving themselves as an escape clause who they can return to claiming they never approved the vaccines beyond emergency use.


This is getting really questionable as to why they are forcing vaccines that clearly do not work and CANNOT work for as long as COVID exists in animals, it will constantly evolve and mutate just like the seasonal flu that sometimes comes from Birds or even Swine. The real question is WHY are we being lied to for what is the real purpose of the vaccines? They obviously do not care about the Great Unwashed, they prefer to thin the herd.

----------------
I saw this on page 12;
Page 12 – Pfizer Inc.


• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
----------------
Would be grateful if anyone can tolerate and read through the legal mush and confirm or not.
glennb6
This article is wrong, flat out lies. All covid fake-cines are fully approved and safe. I know this because my doctor told me so when I told him they were experimental. To add weight to his claims, he got angry with me when I stood my ground by refusing any covid shots. If a medical profession says they are safe, then they are safe. (seriously, this guy pissed me off as he is either totally propagandized, paid off, coerced into saying this shit, or all of the above)

I should also add that today is my deadline to get a $50 bonus from BC&BS for getting the shot. (I refuse to use the cool govt buz word "jab")
 
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