91303 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. Used to record Janssen/J&J vaccines administered in the US and in non-US locations, SARS-COV-2 COVID-19 Non-US Vaccine, Specific Product Unknown, Pandemic Non-US Covid Administration specific CVX or product unknown, SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (QAZCOVID-IN), Pandemic Non-US Vaccine not Authorized by WHO not counted toward immunity in US, SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (COVAXIN), Pandemic Non-US Vaccine Authorized by WHO 11-3-2021, recognized toward immunity in US, https://extranet.who.int/pqweb/vaccines/who-recommendation-bharat-biotech-international-ltd-covid-19-vaccine-whole-virion, SARS-COV-2 COVID-19 Live Attenuated Virus Non-US Vaccine Product (COVIVAC), SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik Light), COVID-19 VVnr Non-US Vaccine (Sputnik Light), SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik V), SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (CONVIDECIA), CanSino Biological Inc./Beijing Institute of Biotechnology, COVID-19 VVnr Non-US Vaccine (CanSino Biological Inc./Beijing Institute of Biotechnology, Pandemic Non-US Vaccine. 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 H\j0~ 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. Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Tozinameran (mRNA vaccine, BNT162b2) suspension for injection: Vaccines, for human use: 251730: 2021-05-05: Pediatric indication (ages 12-15 years) Interim Order Authorized with terms and conditions: BioNTech Manufacturing GmbH: Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) There are multiple COVID-19 vaccines authorized for use across several brands (Moderna, Pfizer-BioNTech, Janssen, Novavax) . See more information below. Cookies used to make website functionality more relevant to you. The FDA issued its initial Emergency Use Authorization for the Novavax COVID-19 vaccine on Wednesday July 13, 2022. Inside this facility in Chesterfield, Missouri, trillions of bacteria are . This report includes COVID-19 vaccine lot numbers . SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3 mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose, tris-sucrose, 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, 30 mcg/0.3 mL for adult 12+ (Same as EUA tris sucrose formula), EUA-authorized for ages 5 yrs to < 12 yrs, 10 mcg/0.2 mL for primary series, IC 3rd dose, booster, SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 10 mcg/0.2 mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, PF, 10 mcg/0.2 mL dose, tris-sucrose, 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, SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 3 mcg/0.2 mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, PF, 3 mcg/0.2 mL dose, tris-sucrose, 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, Pfizer-BioNTech COVID-19 Vaccine Bivalent Booster, SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 30 mcg/0.3mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, bivalent booster, PF, 30 mcg/0.3 mL 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, SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 10 mcg/0.2 mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, bivalent booster, PF, 10 mcg/0.2 mL 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, Pfizer-BioNTech COVID-19 Vaccine Bivalent 6 months through 4 years (Tris-sucrose formulation), SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent, preservative free, 3 mcg/0.2 mL dose, tris-sucrose formulation, COVID-19, mRNA, LNP-S, bivalent, PF, 3 mcg/0.2 mL 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, 5 mcg/0.5 mL, primary series ages 12 years and older, booster ages 18 years and older, SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein-nanoparticle+Matrix-M1 Adjuvant, preservative free, 0.5mL dose, COVID-19, subunit, rS-nanoparticle+Matrix-M1 Adjuvant, PF, 0.5 mL, 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/0.5 mL dosage, for intramuscular use, EUA Submission withdrawn. 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 . Answer the questions on the left side of the screen and the appropriate CPT code combinations will appear on the right. 59267-1055-01 ; 1st Dose to 2nd Dose: 21 Days . Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 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. In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . visit the COVID-19 vaccine development section. reference number. EUA continues for 6 years to <12 year primary and IC doses. Unpunctured vials may be stored between8C to 25C (46F to 77F) for a maximum of 24 hours. 2C to 8C (36F to 46F) for up to 30 days Cannot be re-frozen, Do NOT refreeze thawed vaccine.Do NOT dilute.Do NOT shake but swirl the vial gently after thawing and between each withdrawal. Batch release assessment is a critical part of the regulatory oversight of vaccine quality. After the first dose has been withdrawn, the vial should be held between 2C to 25C (36F to 77F). Ensure the ID on the card matches a driver's license, then check for appropriate dose intervals. B~o[_o$Pz{%y .=8X Click here to view this information in a table. See full prescribing information for further detail. The information available covers all COVID-19 vaccines including the Australian manufactured AstraZeneca COVID-19 vaccine. Schedule: 3rd dose of Primary Series. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Saving Lives, Protecting People, COVID-19 Emergency Use Authorization Recipient and Caregiver Fact Sheets, https://www.cdc.gov/vaccines/covid-19/eua/modernatx.html, https://www.cdc.gov/vaccines/covid-19/eua/modernatx.pdf, https://www.cdc.gov/vaccines/covid-19/eua/moderna-children-6-months-under-6-years.html, https://www.cdc.gov/vaccines/covid-19/eua/moderna-children-6-months-under-6-years.pdf, https://www.cdc.gov/vaccines/covid-19/eua/pfizer.html, https://www.cdc.gov/vaccines/covid-19/eua/pfizer.pdf, https://www.cdc.gov/vaccines/covid-19/eua/pfizer-children.html, https://www.cdc.gov/vaccines/covid-19/eua/pfizer-children.pdf, https://www.cdc.gov/vaccines/covid-19/eua/pfizer-children-under-5-years.html, https://www.cdc.gov/vaccines/covid-19/eua/pfizer-children-under-5-years.pdf, https://www.cdc.gov/vaccines/covid-19/eua/janssen.html, https://www.cdc.gov/vaccines/covid-19/eua/janssen.pdf, https://www.cdc.gov/vaccines/covid-19/eua/novavax.html, https://www.cdc.gov/vaccines/covid-19/eua/novavax.pdf, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, 510^10 viral particles/0.5 mL for adult 18+, SARS-COV-2 (COVID-19) vaccine, vector non-replicating, recombinant spike protein-Ad26, preservative free, 0.5 mL, COVID-19 vaccine, vector-nr, rS-Ad26, PF, 0.5 mL, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, adenovirus type 26 (Ad26) vector, preservative free, 51010 viral particles/0.5 mL dosage, for intramuscular use, 100 mcg/0.5 mL for adult primary series and IC dose 12+ (existing product), SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 100 mcg/0.5mL dose or 50 mcg/0.25mL dose, COVID-19, mRNA, LNP-S, PF, 100 mcg/0.5mL dose or 50 mcg/0.25mL dose, 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, for intramuscular use. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. Information regarding the Moderna vaccines as well as both the EUA Provider Fact Sheet and the EUA Recipient and Caregiver Fact Sheets is now available on the following FDA web site link: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/spikevax-and-moderna-covid-19-vaccine#additional. 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. endstream endobj 159 0 obj <>stream Authorized by WHO 10/19/2022 Counted toward immunity in US, Pfizer COVID-19 Bivalent, Original + BA.1 (Non-US Tradename COMIRNATY Bivalent), COVID-19 Moderna Vaccine EUA Recipient-Caregiver Fact Sheet 6 yrs and older, COVID-19 Moderna EUA Recipient-Caregiver Fact Sheet Pediatric 6mo to <6yrs, COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet 12 years and older, COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs, COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric <5 yrs, COVID-19 Janssen Vaccine EUA Recipient-Caregiver Fact Sheet, COVID-19 Novavax EUA Recipient-Caregiver Fact Sheet, Centers for Disease Control and Prevention. 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