The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). Note: The VIS Fully-Encoded Text String is used for electronic reporting purposes. Authorized as a primary series: two doses (0.2 mL), three to eight weeks apart. Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event. As fake vaccine cards become a nationwide problem, it's crucial to know how to verify one. 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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, 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, booster, 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. The vials can be stored in the refrigerator for 10 weeks. Saving Lives, Protecting People, (Click on a column heading to sort table accordingly), Public Health Information Network (PHIN) Vocabulary Access and Distribution System (VADS), 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, Centers for Disease Control and Prevention. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. For further information/assistance contact SPL@fda.hhs.gov. Forgot your password? Open 24/7. Sign up for notifications from Insider! That process takes place in the Provider Enrollment Portal, at which time the individual provider will select which Vaccine Reporting System they would like to use, either the North Carolina Immunization Registry (NCIR) or the COVID-19 Vaccine Management System (CVMS). The data determined that the immune response to the vaccine for both age groups was comparable to the immune response of the older participants. In accordance with current automation initiatives, the FDA is moving toward electronic submission of all regulatory data in computer-readable formats in compliance with Health Level Seven (HL7) Structured Product Labeling (SPL) requirements http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Resend email confirmation. The Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine is approved as a booster for people who are 5 years of age and older. Administering COVID-19 vaccines in North Carolina requires first that a provider enrolls with the State. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices, and the FDA. Page 9 of the Controlant Onsite Temperature Monitoring Playbook for Sites provides step-by-step instructions for performing this task. FDA staff members then manually compiled the data into the Lot Distribution Database (LDD) system for use in post marketing safety surveillance. Per the Pfizer emergency use authorization fact sheet for people ages 12 years and older, one vial contains six doses of 0.3 mL after dilution. The dose for individuals 12 years of age and older (30 micrograms) is 3 times the dose used for children 5 to 11 years of age (10 micrograms) and 10 times the dose used for children 6 months to less than 5 years of age (3 micrograms). COVID-19 Pfizer BioNTech EUA Recipient-Caregiver Fact Sheet- Pediatric 5yrs to <12 yrs: 12/08/2022: 253088698300042411211001: 0886983000424 . 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. The VIS barcode does not contain any data that is not currently on the VIS, and there is no requirement that immunizers supply VIS data to IIS. The National Drug Code (NDC) uniquely identifies human drugs in the United States; it can be found on the vial containing the vaccine. DDL and temperature data issues should be directed to Pfizer. Moderna COVID-19 Vaccine Packaging . Manually upload the temperature monitoring data onto the computer. Comirnaty (COVID-19 Vaccine, mRNA) is licensed for individuals 12 years of age and older. Please follow these steps to begin submitting LDD Reports electronically: Step 1 visit the COVID-19 vaccine development section. d. In VAMS you will use the UoU lot number for both the UoS and UoU fields even if your vaccine has differing lot numbers for UoS and UoU. Its safety and effectiveness in people younger than 6 months of age have not yet been established. Pay . Once the data is received at the Control Tower, a quality disposition report is created which documents quality considerations and identifies any suspected nonconforming items. Copyright 1995 - 2023 American Medical Association. The change in buffer is not considered clinically significant. Search Search . If you are experiencing network disruptions or did not receive your quality disposition report within one to three hours of pressing the stop button, this may be related to connectivity issues. @k%T(9{W1d XLsd"[AD*xIg35F3hzz%"0O_zTO}M};u&S$J#HM*w2^/]4D E9joc8?ULH/pd?t(Vd'ax-h-?FiMr?\1v XR;#6\H^1axnDZpTZn hsx{qR \NAMu9I. Beginning the following Thursday, states can begin ordering doses from that week's new allocation of 1st doses. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to: Learn about theside effects we're currently monitoring. The mRNA sequence from the Pfizer-BioNTech Comirnaty COVID-19 vaccine is also included in the Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine. The lot number you entered (AB0000) does not exist. You may also visit the CDC's Vaccine Lot Number and Expiration Date webpage and complete the registration form to request access to COVID-19 vaccine expiration dates. Due to limited quantities, the Pfizer SDVs are available for direct ship order only. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine. All rights reserved. For assistance, please reach out to support@controlant.com. You must keep all logs for threeyears per the COVID-19 Vaccination Program Provider Agreement. Access your favorite topics in a personalized feed while you're on the go. In addition, the Agency has issued a Draft Guidance for Industry on Electronic Submission of Lot Distribution Reports, which provides information on how to submit the reports (e.g., method of transmission, media, file formats, preparation and organization of files). The following resources are also available on the above webpages: Contact McKesson MedSurg to reportEmail: snssupport@mckesson.com, Health care personnel or health departments in the U.S. can request a consultation fromThe Clinical Immunization Safety Assessment COVIDvax project websitePhone: 800-CDC-INFO (800-232-4636), COVID-19: Vaccinator Guidance for Pfizer Vaccine, Protecting and promoting the health and safety of the people of Wisconsin, American Rescue Plan Act Funding for Wisconsin, Governor Evers' Proposed 2023-2025 Budget, Statutory Boards, Committees and Councils, PRAMS (Pregnancy Risk Assessment Monitoring System), WISH (Wisconsin Interactive Statistics on Health) Query System, Find a Health Care Facility or Care Provider, Health Insurance Portability and Accountability Act (HIPAA), Long-Term Care Insurance Partnership (LTCIP), Psychosis, First Episode and Coordinated Specialty Care, Services for Children with Delays or Disabilities, Supplemental Security Income-Related Medicaid, Aging and Disability Resource Centers (ADRCs), Services for People with Developmental/Intellectual Disabilities, Services for People with Physical Disabilities, Nutrition, Physical Activity and Obesity Program, Real Talks: How WI changes the conversation on substance use, Small Talks: How WI prevents underage drinking, Health Emergency Preparedness and Response, Home and Community-Based Services Waivers, Medicaid Promoting Interoperability Program, Preadmission Screening and Resident Review, Alcohol and Other Drug Abuse (AODA) Treatment Programs, Environmental Certification, Licenses, and Permits, Health and Medical Care Licensing and Certification, Residential and Community-Based Care Licensing and Certification, stored in either a refrigerator or ultra-cold freezer, ingredient of the Pfizer-BioNTech COVID-19 vaccine, Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine, Emergency Use Authorization Fact Sheet for Recipients and Caregivers, Pfizer Vaccine Formulation/Presentation Guide, Pfizer-BioNTech COVID-19 Vaccine Expiry Tool, CDC's Vaccine Lot Number and Expiration Date webpage, Administration Overview for Pfizer-BioNTech COVID-19 Vaccine, Pfizer emergency use authorization fact sheet for people ages 12 years and older, COVID-19: General Guidance for Vaccinators page, https://www.pfizermedicalinformation.com/en-us/medical-updates, Food and Drug Administration (FDA) approved, CDC's webpage Pfizer-BioNTech COVID-19 Vaccine Overview and Safety, Comirnaty and Pfizer-BioNTech COVID-19 vaccine webpage, Advisory Committee on Immunization Practices, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, August 23, 2021 Approval Letter Comirnaty, receiving your single-use Controlant shipment, Controlant Onsite Temperature Monitoring Playbook for Sites, Pfizer's Vaccine Formulation/Presentation Guide, CDC's Pfizer-BioNTech COVID-19 Vaccine Products At-A-Glance, FDA's Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart, Pediatric COVID-19 Vaccine Dosing Quick Reference Guide, Children who Transition from a Younger to Older Age Group, Transporting vaccine for vaccination clinics held at satellite, temporary or off-site locations, recipients ages 6 months to 4 years and their caregivers, Beyond use-date (BUD) guidance and labels, recipients ages 5 to 11 years and their caregivers, recipients ages 12 years and older and their caregivers, Clinical Immunization Safety Assessment COVIDvax, Temperature excursions within the clinic or site, A complex COVID-19 vaccine safety question about an individual patient residing in the U.S. not readily addressed by CDC guidance. An official website of the State of North Carolina, Vaccination Information for Health Care Providers, See how you can enroll as a COVID-19 Vaccine Provider, Training materials, upcoming training events, and more, COVID-19 Vaccination Site Accessibility Checklist. This product information is intended only for residents of the United States. 00069-2025-1 . The FDA authorized a second bivalent booster for certain individuals most vulnerable to severe outcomes from Covid-19. Pfizer has received shelf-life extensions of all mRNA COVID-19 vaccines, including both monovalent and bivalent vaccines. Number of doses: 2 doses for a primary series in ages 5 years and older or 3 doses for a primary series in ages 6 months to under 5 years. One dose (0.2 mL) contains 10 micrograms of COVID-19 Bivalent mRNA vaccine booster. This is known as a mixed vaccine series. All Pfizer COVID-19 vaccine shipments will continue to have supporting Controlant DDL in-transit temperature monitoring. The currently available vaccine products with purple caps and a purple label border or grey caps with a grey label border are used to prepare the dose for individuals 12 years of age and older. The VIS Lookup table contains codes for these fields that EMRs and IISs may need to add to their applications to accommodate this information and associates each code with its human readable equivalent. A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. At ImmunaBand, we always check the following: Not all sites use the standard CDC card. The second field is the edition date of the VIS. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 It is important to read the label carefully to differentiate between the vaccine products to ensure people 12 years of age or older receive the appropriate vaccine. Such vaccines have a dynamic expiration date, which can change over time as additional stability data become available. Pfizer- BioNTech COVID-19 Lot Expiry \(cvdvaccine.com\) \(https://lotexpiry.cvdvaccine.com\) CDC twenty four seven. Name: Pfizer-BioNTech Comirnaty COVID-19 vaccine, Manufacturer: BioNTech Manufacturing GmbH, Approved for: Primary series in individuals age 6 months and older or as a booster dose in individuals age 5 to 11 years as well as 16 years and older (Pfizer-BioNTech Comirnaty COVID-19 vaccine), As a bivalent booster dose (Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5 in individuals age 5 years and older, As a bivalent booster dose (Pfizer-BioNTech Comirnaty Original and Omicron BA.1 in individuals age 12 years and older, How it's given: Injection in muscle (usually the upper arm). Once vials are thawed, they should not be refrozen. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: The Wisconsin Department of Health Services (DHS) supports the CDC's (Centers for Disease Control and Prevention) recommendation that children 6 months through 4 years of age are now eligible to receive the bivalent Pfizer COVID-19 vaccine as the third dose as part of their primary series. This is the same process that is used to order all COVID-19 vaccines. A single booster dose of the Pfizer-BioNTech ComirnatyCOVID-19 vaccine may be administered in individuals 5 years of age and older at least 6 months after completing their primary vaccine series (30 micrograms each for ages 12 and older or 10 micrograms each for ages 5 to 11). These cookies may also be used for advertising purposes by these third parties. You can check vaccine lot numbers through the Centers for Disease Control and Prevention's COVID-19 vaccine lot number and expiration date file. Once COVID-19 vaccines are made available in the United States, CDC will rely on existing systems and a new system, v-safe, to monitor vaccine safety. CDC INFORMATION. Saving Lives, Protecting People, COVID-19 Vaccine Breakthrough Case Investigation and Reporting, Clinical Decision Support for Immunization (CDSi), COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services.

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