The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty . Route: Intramuscular. You will be subject to the destination website's privacy policy when you follow the link. Important: If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1.CDC and FDA do not provide individual medical treatment, advice, or diagnosis. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) . CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: September 27, 2022. Additional code details and fields values are included in the vaccine code sets. 5 through 11 years formulation (orange cap) o formulation does not have expiration printed on vial o instead, each vial has the lot number and date of manufacture printed on the label o. Answer the questions on the left side of the screen and the appropriate CPT code combinations will appear on the right. Follow good vaccine storage and practices by outlined by the. Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA). Please note, Internet Explorer is no longer up-to-date and can cause problems in how this website functionsThis site functions best using the latest versions of any of the following browsers: Edge, Firefox, Chrome, Opera, or Safari. The following vaccine NDCs and associated tradenames have been either submitted for FDA authorization (Pre-Authorization) or have been authorized or approved by the FDA under EUA or BLA License and may be included in FDA NDC files and Structured Product Labels (SPL). visit the COVID-19 vaccine development section. At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with . If the mRNA vaccine product given for the first two doses is not Administration codes track which dose in the regimen is being administered. The lot number you entered (AB0000) does not exist. Count out 18 months, using the month printed on the vial as month 1. All rights reserved. Note: Codes will become effective only upon EUA issuance or BLA licensure of COVID-19 vaccine(s) by the Food and Drug Administration (FDA). The following downloadable VIS code files will include the new EUA Fact Sheet for Recipients records: *Edition Date represents the date of update printed on the actual fact sheet document published by the FDA. 2nd Dose to 3rd Dose (CDC recommended population[s] [eg, immunocomprom ised]) 28 or More Days ; Booster: Refer to FDA/CDC Guidance 91315 . The information available covers all COVID-19 vaccines including the Australian manufactured AstraZeneca COVID-19 vaccine. After dilution, the vial should be held between 2C to 25C (35F to 77F). CDC has added two-dimensional (2D) data matrix barcodes to Vaccine Information Statements (VIS). Moderna received FDA BLA license on January 31, 2022, for its COVID-19 vaccine SPIKEVAX (COVID-19 Vaccine, mRNA) for use in individuals 18 and older. Each vial must be thawed before dilution. Cards also provide a space for the name of the vaccine manufacturer (Pfizer-BioNTech, Moderna, Johnson & Johnson), lot number, date of the shot, name of the healthcare provider or clinic that provided the vaccine and . The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. 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 . CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. As the expiration date approaches, contact the manufacturer to determine if it has been extended. 100% effective for those 12 to 15 years old. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, for intramuscular use, 100 mcg/0.5 mL for adult 18+ (Same formulation and concentration as EUA product). 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first dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation; second dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation; third dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; booster dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.5 mL dosage, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, monovalent, preservative free, 5 mcg/0.5 mL dosage, adjuvant AS03 emulsion, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, monovalent, preservative free, 5 mcg/0.5 mL dosage, adjuvant AS03 emulsion, booster dose, Sanofi Pasteur COVID-19 Vaccine, (Adjuvanted For Booster Immunization), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 25 mcg/0.25 mL dosage; 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