Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 21 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 21 pages
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- INDICATIONS AND USAGE ---------------------------- COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 21 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: YYYY --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 20 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMI RNATY safely and effectively. See full prescribing information for COMIRNATY . COMIRNATY®(COVID -19 Vaccine , mRNA )suspension for injection , for intramuscular use Initial U.S. Approval: YYYY --------------------------- INDICATIONS AND USAGE ---------------------------- COMI RNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVI D-19) caused…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 21 pages
3 THAWING PRIOR TO DILUTION • Thaw vial(s) of COMIRNATY before dilution either by: o Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. o Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours. …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
MUST BE DILUTED BEFORE USE with sterile 0.9% Sodium Chloride Injection,USP. After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F). Discard after 6 hours.25 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Injection, for Intramuscular Use Rx onlyNDC 0069-1000-03 STORAGE: Prior to dilution, store at -90°C to -60°C (-130°F to -76°F).Store in this carton to protect from light. DOSAGE AND ADMINISTRATION: Diluent (sterile 0.9% Sodium Chloride…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Pfizer FDA submission document — 1 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
Follow -up Time After Dose 2 – Phase 2/3 Subjects ≥16 Years of Age and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n Vaccine Group (as Randomized) BNT162b2 (30 μg) (Na=21047) nb (%) Placebo (Na=21210) nb (%) Total (Na=42257) nb (%) Subjects (%) with length of follow -up of: Original blinded placebo -controlled follow -up period <2 Months 840 (4.0) 910 (4.3) 1750 (4.1) ≥2…