Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 23 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: YYYY --------------------------- 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: YYYY --------------------------- 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
· 23 pages
7 At the time of the analysis of the ongoing Study 2 with a data cut-off of March 13, 2021, there were 25,651 (58.2%) participants (13,031 COMIRNATY and 12,620 placebo) 16 years of age and older followed for ≥4 months after the second dose. Participants 16 years and older in the reactogenicity subset were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Participants are being monitored for unsolicited…
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
GS1 DataBar Code Scans as: (01)10300691000011 FPO GS1 Data BarFor ntramuscular use Contains no preservat ve DILUTE BEFORE USE D scard 6 hours after d lution when stored at 2 to 25º C (35 to 77º F) Di ut on date and time: US L cense No 2229 B oNTech Manufacturing GmbH & Pfizer Inc NDC 0069-1000-01Rx only After dilution, vial contains 6 doses of 0.3 mL® NOTE - expiry format: EXP: MM/YYYYLOT/EXP:COMVLABPComirnaty Label COMVLABP - Puurs 18P August 11, 2021 am Black PMS 7671 Body…
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
· 9 pages
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup – Blinded Placebo -Controlled Follow- up Period – 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) Placebo (Na=21210) Efficacy Endpoint Subgroup n1b Surveillance Timec (n2d) n1b Surveillance Timec (n2d) VE (%) (95% CIe) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 31 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: YYYY --------------------------- 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
· 22 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: YYYY --------------------------- 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
· 31 pages
3 • Before dilution invert vaccine vial gently 10 times. • Do not shake. • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles . • Do not use if liquid is discolored or if other particles are observed. DILUTION • ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. • Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21 -gauge or…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 9 pages
Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Subgroup – Blinded Placebo -Controlled Follow- up Period – 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) Placebo (Na=21210) Efficacy Endpoint Subgroup n1b Surveillance Timec (n2d) n1b Surveillance Timec (n2d) VE (%) (95% CIe) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 32 pages
Table.B Study Disposition of Phase 2/3 Randomized Participants 16 Years of Age and Older, Through Data Cutoff March 13, 2021 Vaccine Group (as Randomized) BNT162b2 (30 μg) (Na=22085) nb (%) Placebo (Na=22080) nb (%) Total (Na=44165) nb (%) Randomized 22085 (100.0) 22080 (100.0) 44165 (100.0) Not vaccinated 55 (0.2) 50 (0.2) 105 (0.2) Original blinded placebo -controlled follow -up period Vaccinated 22030 (99.8) 22030 (99.8) 44060 (99.8) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 29 pages
Table.A.1 Vaccine Efficacy – First COVID -19 Occurrence From 7 Days After Dose 2, by Test Status – Subjects With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population, Participants 16 Years of Age and Older (Data Cutoff March 13, 2021) RT-PCR NP Swab Results and Serostatus at Different Time Points BNT162b2 (Na=21047) Cases n1b Surveillance Timec (n2d) Placebo (Na=21210) Cases n1b Surveillance Timec (n2d) Vaccine Efficacy…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 29 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: YYYY --------------------------- I NDICATIONS 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
· 29 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: YYYY --------------------------- 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
· 30 pages
4 • Gently invert the vial containing the COMIRNATY 10 times to mix. • Do not shake. • Inspect the vaccine in the vial. • The vaccine will be an off -white suspension. Do not use if vaccine is discolored or contains particulate matter. • Record the date and time of dilution on the COMIRNATY vial label. • Store between 2°C to 25°C (35°F to 77°F). • Discard any unused vaccine 6 hours after dilution. PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY • Using aseptic…
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.