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
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