According to this link, no vials with the Comirnaty label are currently available in the US. If they aren't labeled Comirnaty, then they are still the old Emergency Use Authorized version. The reason this is important is liability. An approved product could put liability on the manufacturer. Products that are Authorized for Emergency Use offer liability protection to the manufacturer and to those responsible for injecting it.
It appears that manufacturers want to get these authorized for all age groups of children. Once they get them authorized for all children, the next step will be to get them on the children's vaccine schedule.
Due to the 1986 Vaccine Injury Compensation Act, manufacturers bear no liability for any injuries suffered from their products. Instead, injuries are compensated from a federal fund which is collected as a tax when injectable products are administered. This program has become notoriously difficult to succeed in receiving compensation. There is a statute of limitations and an adversarial system where you must prove that your child has been injured. They have a schedule of injuries so if you are claiming something other than what is on the schedule you are out of luck. Despite the challenges to receiving compensation, there have been over $4 billion in damages awarded from this program.
11.3 Pediatric Use
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders for use in individuals 5 through 11 years of age is based on safety and effectiveness data in this age group and in adolescents and adults.
For adolescents 12 through 17 years of age, a different formulation and a different presentation of this formulation of the Pfizer-BioNTech COVID-19 Vaccine are authorized.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals younger than 5 years of age.
11.4 Use in Immunocompromised
Safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in children with immunocompromise has been extrapolated from adult data. An independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med) described the safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine in adult persons that received solid organ transplants. In this report describing 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status.
13 DESCRIPTION
The Pfizer-BioNTech COVID-19 Vaccine in multiple dose vials with orange caps and labels with orange borders is supplied as a frozen suspension; each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders contains 10 mcg of modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders also includes the following ingredients: lipids (0.14 mg (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose.
The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex.
Revised: 03 January 2022
Pfizer-BioNTech (COMIRNATY) Name Change
Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals ages 16 years and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 vaccine. After FDA approval, the FDA-authorized Pfizer-BioNTech COVID-19 vaccine for individuals ages 16 years and older was marketed as COMIRNATY. No change was made to the vaccine’s formula with the name change.
The Pfizer-BioNTech vaccine label remains for individuals ages 5–15 years since the vaccine is authorized but not yet approved for this age group.
False. in the FDA issued letter, they stated that COMIRNATY has changes in two CODONS. it is designed with different amino acids to produce a more rigid spike and to evade immune system detection for longer.
January 3, 2022: FDA expands eligibility for the Pfizer-BioNTech COVID-19 Vaccine to include the use of a single booster dose in individuals 12 and older at least 5 months after primary vaccination with Pfizer-BioNTech COVID-19 Vaccine. Read the press release or view booster eligibility.
Comirnaty Information
Pfizer-BioNTech Fact Sheets
Pfizer-BioNTech Fact Sheet Translations
Información sobre las vacunas para el COVID-19
On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.
On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines.
Ingredients that are NOT used in COVID-19 vaccines
The above table lists ALL ingredients in the Pfizer-BioNTech COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in the table. The Pfizer-BioNTech COVID-19 vaccine has:
No preservatives like thimerosal or mercury or any other preservatives.
No antibiotics like sulfonamide or any other antibiotics.
No medicines or therapeutics like ivermectin or any other medications.
No tissues like aborted fetal cells, gelatin, or any materials from any animal.
No food proteins like eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts (COVID-19 vaccines are not manufactured in facilities that produce food products).
No metals like iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors.
No latex. The vial stoppers used to hold the vaccine also do not contain latex.
How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Is Comirnaty interchangeable with other COVID-19 vaccines?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
Did you catch that Moderna played the same game this week with "Spikevax?" Same application...
Damn!
According to this link, no vials with the Comirnaty label are currently available in the US. If they aren't labeled Comirnaty, then they are still the old Emergency Use Authorized version. The reason this is important is liability. An approved product could put liability on the manufacturer. Products that are Authorized for Emergency Use offer liability protection to the manufacturer and to those responsible for injecting it.
https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html#codes
It appears that manufacturers want to get these authorized for all age groups of children. Once they get them authorized for all children, the next step will be to get them on the children's vaccine schedule.
Due to the 1986 Vaccine Injury Compensation Act, manufacturers bear no liability for any injuries suffered from their products. Instead, injuries are compensated from a federal fund which is collected as a tax when injectable products are administered. This program has become notoriously difficult to succeed in receiving compensation. There is a statute of limitations and an adversarial system where you must prove that your child has been injured. They have a schedule of injuries so if you are claiming something other than what is on the schedule you are out of luck. Despite the challenges to receiving compensation, there have been over $4 billion in damages awarded from this program.
Then they contradict themselves here:
https://www.fda.gov/media/153714/download
11.3 Pediatric Use Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders for use in individuals 5 through 11 years of age is based on safety and effectiveness data in this age group and in adolescents and adults. For adolescents 12 through 17 years of age, a different formulation and a different presentation of this formulation of the Pfizer-BioNTech COVID-19 Vaccine are authorized. Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals younger than 5 years of age. 11.4 Use in Immunocompromised Safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in children with immunocompromise has been extrapolated from adult data. An independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med) described the safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine in adult persons that received solid organ transplants. In this report describing 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. 13 DESCRIPTION The Pfizer-BioNTech COVID-19 Vaccine in multiple dose vials with orange caps and labels with orange borders is supplied as a frozen suspension; each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders contains 10 mcg of modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each 0.2 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders also includes the following ingredients: lipids (0.14 mg (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose. The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex. Revised: 03 January 2022
Pfizer-BioNTech (COMIRNATY) Name Change Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals ages 16 years and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 vaccine. After FDA approval, the FDA-authorized Pfizer-BioNTech COVID-19 vaccine for individuals ages 16 years and older was marketed as COMIRNATY. No change was made to the vaccine’s formula with the name change.
The Pfizer-BioNTech vaccine label remains for individuals ages 5–15 years since the vaccine is authorized but not yet approved for this age group.
False. in the FDA issued letter, they stated that COMIRNATY has changes in two CODONS. it is designed with different amino acids to produce a more rigid spike and to evade immune system detection for longer.
Such liars!
ComiRNAty
Commie-RNA-ThankYou
FDA lies too!
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
January 3, 2022: FDA expands eligibility for the Pfizer-BioNTech COVID-19 Vaccine to include the use of a single booster dose in individuals 12 and older at least 5 months after primary vaccination with Pfizer-BioNTech COVID-19 Vaccine. Read the press release or view booster eligibility. Comirnaty Information Pfizer-BioNTech Fact Sheets Pfizer-BioNTech Fact Sheet Translations Información sobre las vacunas para el COVID-19
On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.
On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines.
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#comirnaty
Ingredients that are NOT used in COVID-19 vaccines The above table lists ALL ingredients in the Pfizer-BioNTech COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in the table. The Pfizer-BioNTech COVID-19 vaccine has:
No preservatives like thimerosal or mercury or any other preservatives. No antibiotics like sulfonamide or any other antibiotics. No medicines or therapeutics like ivermectin or any other medications. No tissues like aborted fetal cells, gelatin, or any materials from any animal. No food proteins like eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts (COVID-19 vaccines are not manufactured in facilities that produce food products). No metals like iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors. No latex. The vial stoppers used to hold the vaccine also do not contain latex.
How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Is Comirnaty interchangeable with other COVID-19 vaccines?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
Content current as of: 12/07/2021
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
https://www.fda.gov/media/153717/download
It is NOT approved for 5 year olds.
NEVERRRRRRR gonna get my kids unless they murder me and their father.
What’s been updated in this Jan 6th 2022 update? And why are they even including a Whats Not In It section. Nanotechnology?
Archived NIH docs on Covid treatment
https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/guidelines-archive/