Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 2 of 7)


1
Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
2
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.
3
Notwithstanding the age limitations for use of the different formulations and presentations described above, individuals who will turn from 11 years to 12 years of age between doses in the primary regimen may receive, for any dose in the primary regimen, either: (1) the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA) (supplied in multidose vials with orange caps); or (2) COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA) (supplied in multidose vials with gray caps and multidose vials with purple caps).
4
Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.
FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION
PFIZER-BIONTECH COVID-19 VACCINE
FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*
1
AUTHORIZED USE
2
DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration Information
2.3 Vaccination Schedule
3
DOSAGE FORMS AND STRENGTHS
4
CONTRAINDICATIONS
5
WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Myocarditis and Pericarditis
5.3 Syncope
5.4 Altered Immunocompetence
5.5 Limitation of Effectiveness
6
OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Post Authorization Experience
8
REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
10
DRUG INTERACTIONS
11
USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Lactation
11.3 Pediatric Use
11.4 Geriatric Use
11.5 Use in Immunocompromised
13
DESCRIPTION
14
CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
18
CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
18.1 Efficacy of Primary Series in Participants 16 Years of Age and Older
18.2 Efficacy of Primary Series in Adolescents 12 Through 15 Years of Age
18.3 Immunogenicity of Primary Series in Adolescents 12 Through 15 Years of Age
18.4 Immunogenicity of a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise
19
HOW SUPPLIED/STORAGE AND HANDLING
20
PATIENT COUNSELING INFORMATION
21
CONTACT INFORMATION

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a gray cap and label with a gray border and MUST NOT be diluted prior to use.

Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Gray Cap and a Label with a Gray Border
Age Range Dilution Information Doses Per Vial Dose Volume
12 years and older Do not dilute prior to use 6 0.3 mL

2.1 Preparation for Administration

DO NOT DILUTE

  • The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap and a label with a gray border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
  • Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] [see How Supplied/Storage and Handling (19)].
  • Refer to thawing instructions in the panels below.
  • One vial contains 6 doses of 0.3 mL.
Preparation Instructions
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border – VIAL VERIFICATION
Figure
(click image for full-size original)
Gray plastic cap and label with gray border.
  • Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a gray plastic cap and a label with a gray border.
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border – THAWING PRIOR TO USE
FigureStore in the refrigerator for up to 10 weeks prior to use.
  • Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine (Do Not Dilute, for 12 years of age and older) before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks.
    • Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes.
  • Vials may be stored at room temperature [up to 25ºC (77ºF)] for up to 12 hours prior to use.
Figure
(click image for full-size original)
Gently × 10
  • Before use, mix by inverting vaccine vial gently 10 times.
  • Do not shake.
  • Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.
  • After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.
  • Do not use if liquid is discolored or if particles are observed after mixing.
Pfizer-BioNTech COVID-19 Vaccine Vial with Gray Cap and Label with Gray Border –PREPARATION OF INDIVIDUAL 0.3 mL DOSES
FigureWithdraw 0.3 mL dose of vaccine.
  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle.
  • Each dose must contain 0.3 mL of vaccine.
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
  • Administer immediately.
Figure
(click image for full-size original)
Record the date and time of first puncture. Use within 12 hours after first puncture.
  • Record the date and time of first vial puncture on the vial label.
  • Store between 2°C to 25°C (35°F to 77°F).
  • Discard any unused vaccine 12 hours after first puncture.

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