Pull back plunger to 1.8 mL to remove air from vial. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). 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 when prepared according to their respective instructions for use can be used interchangeably. J. Novavax monovalent vaccine may be used as a first booster in an adult patient N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. Visually inspect each dose in the dosing syringe prior to administration. Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap, Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage, Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent, Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap . In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. A doctor, nurse or pharmacist will prepare the injection for you before you are given it. Do not refreeze. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. 2022 . There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. This authorization is based on safety and effectiveness data in this age group and adults. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. Michael Patmas, MD. Symptoms may appear 2 to 14 days after exposure to the virus. Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. View Comirnaty information, press release and frequently asked questions. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. Package Inserts : Additional Immunization Resources : Photos: Adult Vaccination: Screening Checklists: Ask the Experts: Shop IAC: CDC Schedules . Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany, Manufactured by Pfizer Inc., New York, NY 10017, Long Version (Full EUA Prescribing Information) Begins On Next Page, FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION, FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*. The Countermeasures Injury Compensation Program. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). COMIRNATY [package insert]. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Storage of the vaccine COMIRNATY is stored at -90 C to -60C. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. FDA Approval - 6/3/22. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. Only NDCs for the subsequently BLA approved tri sucrose formulation will be produced." The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. Solicited Local and Systemic Adverse Reactions. The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. The storage, preparation, and administration information in this Fact Sheet 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 purple cap and MUST BE DILUTED before use. The vaccine will be an off-white suspension. The full list of ingredients are included in the vaccine package inserts: View the Pfizer package insert for ages 12+ View the Pfizer package insert for ages 5 to 11; View the Moderna package insert; View the Johnson & Johnson package insert In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. This product information is intended only for residents of the United States. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. This is the only active ingredient in the vaccine. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C (-130F to -76F) until the expiry date printed on the label. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. The vaccine is administered as a 2-dose series, 3 weeks apart. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. A third primary series dose may be administered at least 4 weeks after the second dose to individuals with certain kinds of immunocompromise. 2. and MMWR published EUA fact sheets revised with warning added, June 25 FDA approval of Pfizer BioNTech COVID -19 vaccine on August 23, 2021 If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. It is also authorized under EUA to provide: The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which you may receive because there is currently a pandemic of COVID-19. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. can be found in the package insert. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Symptoms may appear 2 to 14 days after exposure to the virus. . This is the Product Information that was approved with the submission described in this AusPAR. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. for a COVID-19 vaccine without a COVID- 19 vaccination documented. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Add 1.8 mL of sterile 0.9% sodium chloride injection, USP.
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