It's been approved for anyone over the age of 16 and will retain emergency use authorization for minors 12. Web(COVID-19 Vaccine, mRNA) COPPER (cupric chloride) CORLOPAM (fenoldopam mesylate) CORTEF (hydrocortisone tablets) CORTISPORIN (neomycin and polymyxin B sulfates, and hydrocortisone acetate) CORVERT (ibutilide fumarate injection) CORZIDE (nadolol and bendroflumethiazide) COVERA-HS (verapamil hydrochloride extended Used to record Pfizer vaccines administered in the US and in non-US locations (includes tradename Comirnaty), Pfizer-BioNTech COVID-19 Vaccine (US-EUA), COMIRNATY (US-BLA), COMIRNATY (Non-US), SARS-COV-2 (COVID-19) vaccine, vector non-replicating, recombinant spike protein-ChAdOx1, preservative free, 0.5 mL, COVID-19 vaccine, vector-nr, rS-ChAdOx1, PF, 0.5 mL, WHO authorized pandemic vaccine. Please follow these steps to begin submitting LDD Reports electronically: Step 1 Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label 91303 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike The lot number is a string of numbers and letters that tracks this specific batch of vaccine from production into your arm. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Vaccine information statements (VISs), used only for licensed vaccines, will not be available for COVID-19 vaccines while they are under Emergency Use Authorization (EUA). for Healthcare professionals: PREVNAR 13 U.S. Pfizer-BioNTech COVID-19 Vaccine supplied in vials with a maroon cap and labels with a maroon border is authorized for use to provide Dose 1 and Dose 2 of a 3-dose primary series in individuals 6months through 4 years of age. Pfizer-BioNTech COVID-19 Vaccine supplied in vials with an orange cap and labels with an orange border is authorized for use to provide: a 2-dose primary series to individuals 5 through 11years of age; and a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise. The CPT vaccine product codes are included in the Preview COVID-19 table and the CDC vaccine code sets. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. WebLot number: All cards contain the lot number of the vaccine administered. CDC twenty four seven. H\j0~ Download the Seasonal Influenza Crosswalk table. The webinar series is designed to communicate scientific information, including recent study results to support US healthcare providers knowledge regarding COVID-19 and Pfizer-BioNTech COVID-19 vaccines, including Pfizer-BioNTechs COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 30 mcg/0.3 mL for adult 16+ (original formula), Pfizer Statement: Pfizer received inital FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). msal token renewal . Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. abbvie ceo richard gonzalez wife; how far is haddonfield, illinois from chicago; Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for emergency use in individuals 6months through 4 years of age to provide Dose 3 of a 3-dose primary series. 59267-1055-01 ; 1st Dose to 2nd Dose: 21 Days . These NDCs will not be manufactured. These cookies may also be used for advertising purposes by these third parties. An overview of the IT systems and how they integrate to track distribution and administration, A free web-based tool to manage vaccine administration and registration, IIS consolidate immunization information into one reliable source, CDCs vaccine order management system and platform for all COVID-19 vaccine ordering, A cloud-based message routing service intended to enable data exchange, Information for jurisdictions and healthcare providers, Instructions on submitting COVID-19 vaccine administration data to CDC. WebEach Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. The second field is the edition date of the VIS. The Pfizer-BioNTech vaccine for children younger than 5 is a three-shot regimen tested in nearly Authorized by WHO 5/19/2022 Counted toward immunity in US, CONVIDECIA (CanSino Biologics) COVID-19 Vaccine, SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences), COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences, SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Jiangsu Province Centers for Disease Control and Prevention), COVID-19 PS Non-US Vaccine (Jiangsu Province Centers for Disease Control and Prevention), SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (EpiVacCorona), COVID-19 PS Non-US Vaccine (EpiVacCorona), SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (BIBP, Sinopharm), COVID-19 IV Non-US Vaccine (BIBP, Sinopharm), Pandemic Non-US Vaccine. 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. WebThe Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Providing senior living solutions in the Triangle and Triad areas of North Carolina, including Raleigh, Durham, Chapel Hill, Wake Forest, Burlington, Greensboro, High Point, Winston-Salem and surrounding areas CVX code 500 should be used to record Non-US vaccine where product is not known. All codes will be retired, Sanofi Pasteur COVID-19 Vaccine, booster dose, adult, 5mcg/0.5mL dose, including added AS03 adjuvant, booster dose only, SARS-COV-2 (COVID-19) vaccine, D614, prefusion spike recombinant protein subunit (CoV2 preS dTM), AS03 adjuvant added, preservative free, 5mcg/0.5mL dose, COVID-19, D614, recomb, preS dTM, AS03 adjuvant add, PF, 5mcg/0.5mL, 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, SARS-COV-2 (COVID-19) vaccine, UNSPECIFIED. Submit a medical question for Pfizer prescription products. First time users should review FDA's Electronic Submission Gateway (ESG) User Guide that provides industry participants with information and guidance on how to use the FDA ESG. SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3 mL dose, COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose, 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, diluent reconstituted, for intramuscular use. The AMA promotes the art and science of medicine and the betterment of public health. Questions regarding this table should be directed to the IIS Technical Assistance Team (or use IIS mailing address). The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the EUAauthorized 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 without presenting any safety or effectiveness concerns. EMR and IIS vendors may need to add fields to the EMR to record the VIS document type and edition date. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). Find more information about barcodes on VIS statements. After 8/31/2022, only bivalent boosters should be administered to ages 12+ years. Showing 1 to 4 of 4 entries Pfizer-BioNTech Regulatory Information Showing 1 to 35 of 35 entries Media Materials and Webcasts Showing 1 to 28 of 28 entries The products discussed herein may have different product labeling in different countries. Manufacturers can now begin electronic submission of post marketing lot distribution data for all regulated vaccine and other biological products marketed with biologic license applications (BLAs). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use0004A, 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, diluent reconstituted; booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, 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, 30 mcg/0.3mL dosage, diluent reconstituted; 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/0.3mL dosage, diluent reconstituted; 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/0.3mL dosage, diluent reconstituted; third dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL 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, 100 mcg/0.5mL dosage; 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, 100 mcg/0.5mL dosage; 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, 100 mcg/0.5 mL dosage; third dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x10 viral particles/0.5mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x10 viral particles/0.5mL dosage; first dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative free, 5x10 viral particles/0.5mL dosage; second dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x10 viral particles/0.5mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x10 viral particles/0.5 mL dosage; booster dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 5x10 viral particles/0.5mL dosage, single dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage, for intramuscular use, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage; booster, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage; first dose, Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant spike protein nanoparticle, saponin-based adjuvant, preservative free, 5 mcg/0.5mL dosage; second dose, 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, 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, 30 mcg/0.3 mL dosage, 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, 30 mcg/0.3 mL dosage, 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, 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; 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, 25 mcg/0.25 mL dosage; second dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, 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, bivalent spike protein, preservative free, 30 mcg/0.3 mL dosage, tris-sucrose formulation, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, 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, bivalent, preservative free, 50 mcg/0.5 mL dosage, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, 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, mRN-LNP, spike protein, bivalent, preservative free, 25 mcg/0.25 mL dosage, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent 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, bivalent spike protein, preservative free, 10 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 10 mcg/0.2 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, bivalent, preservative free, 10 mcg/0.2 mL dosage, booster dose, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, bivalent 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, bivalent spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, third dose. 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