NDC Number Lot Number Expiration Date (Labeled) Extended Use Date; Epinephrine Injection, 1 mg/10 mL (0.1 mg/mL) glass syringe, individual: Hospira, a Pfizer company: 0409-4921-20: 19058DK 1-Apr . Providers are responsible for adhering to all requirements outlined in the agreement. Temperature data must be downloaded and stored. Children aged 4 who will turn 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination. For example, you may have received Pfizer-BioNTech Comirnaty as your first dose and be offered Moderna Spikevax as your second. For assistance, please reach out to support@controlant.com. The bivalent vaccine can be ordered using the same process used to order all COVID-19 vaccines. Manufacturer Vaccine Name(s) NDC 10/NDC11 The National Drug Code (NDC) uniquely identifies human drugs in the United States; it can be found on the vial containing the vaccine. Cookies used to make website functionality more relevant to you. To learn more, view our full privacy policy. Home; Register; Login; Log in. The exact appearance varies with the individual site within states. The .gov means its official.Federal government websites often end in .gov or .mil. Chantix (varenicline) Tablets, 0.5 mg: 0069-0468-56: 00019213: 2022 JAN: Bottles The standard CDC card includes an official CDC seal, the person's name, the date of their vaccination, lot numbers, and the site where they received the vaccine. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. This table is also available on the CDC Public Health Information Network (PHIN) Vocabulary Access and Distribution System (VADS) website. Sign up for notifications from Insider! o Look up the vaccine lot numbers to verify if it was distributed during the timeframe the card indicates the patient received the vaccine. )HKXA1H^&c1}ySv0+1Oa.ed^L}Cvc$yPb4#.``JL\lpQc1 [a Given this information, providers should draw up doses from each vial using five one-inch needles/syringes and one 1.5-inch needle/syringe. A full set of instructions and troubleshooting information can be found on the Controlant website on receiving your single-use Controlant shipment. CDC INFORMATION. Always check the Pfizer-BioNTech COVID-19 Vaccine Expiry Tool to obtain the most up-to-date expiration dates for the Pfizer COVID-19 vaccines you have in inventory. 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. All vaccinators should return Controlant DDLs using the return shipping label. Many sites that receive direct shipments of COVID-19 vaccine for patients ages 12 years and older have not been properly deactivating the Digital Data Loggers (DDLs). Featured . It would violate the provider agreement and could expose providers to the following risks: Onsite temperature monitoring for Pfizer vaccines (after product acceptance) ended on November 28, 2022. To stay informed about the latest news from the CDC, guides, clinical information, and more visit the COVID-19 vaccine development section. All Pfizer COVID-19 vaccine shipments will continue to have supporting Controlant DDL in-transit temperature monitoring. Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event. Secure .gov websites use HTTPS The SDVs may also encourage new sites to enroll as a COVID-19 vaccinator. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. Thank you for taking the time to confirm your preferences. Its safety and effectiveness in younger people has not yet been established. 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. Children who are, Fully approved as a primary series: two doses (0.3 mL), three to eight weeks apart. The Pfizer-BioNTech vaccine label remains for individuals aged 6 months to 11years since the vaccine is authorized but not yet approved for these age groups. About CDC; % On July 8, 2022, theFood and Drug Administration (FDA) approved a supplement submitted by BioNTech Manufacturing GmbH to the biologics license application (BLA) for Comirnaty (COVID-19 Vaccine, mRNA) to include use in adolescents 12 through 15 years of age. 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. Note: The VIS Fully-Encoded Text String is used for electronic reporting purposes. All rights reserved. Product . The initial 2 doses are administered 21 days apart followed by a third dose administered at least 8 weeks after the second dose. Pfizer, Inc : Pfizer-BioNTech COVID-19 Vaccine/Comirnaty . People who are, U.S Food and Drug Administration (FDA) approvals, authorizations including recent authorizations, Use of each vaccine presentation, including storage, handling, preparation, and administration. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. For more information on the Pfizer-BioNTech COVID-19 vaccine, please visit CDC's webpage Pfizer-BioNTech COVID-19 Vaccine Overview and Safety or FDA's Comirnaty and Pfizer-BioNTech COVID-19 vaccine webpage. Selection required to narrow down to correct Administrative Code. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. Connect the temperature monitoring device to a computer that has access to your local network using the USB cable provided with the temperature monitoring device. Signs and symptoms of anaphylaxis may include: Call emergency services if you develop or witness any serious symptoms that could be anallergic reactionafter vaccination. Submit a test file using FDA Test environment (provide link to the documentation you have for conducting pilot test). 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). As fake vaccine cards become a nationwide problem, it's crucial to know how to verify one. FDA is not requiring or recommending that the identified lot numbers in the following table be relabeled with their new use dates. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to: Learn about theside effects we're currently monitoring. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. When in doubt about the appearance of a nonstandard card, contact the vaccination site (or system issuing the card) directly to verify. For COVID-19 questions call800-232-4636 (TTY 888-232-6348) Peds (5-11) has a 6-month expiration if held frozen at ULT oMFG date + 6 months = expiration date oThis includes the month of manufacturee.g., 8/2021 includes August. V-safewillalso remind them to gettheirsecondCOVID-19 vaccine dose, if needed. Pfizer and BioNTech host medical updates and immunization site training sessions for all health care providers on the proper use of the Pfizer BioNTech COVID-19 vaccines. 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). Most manufacturers have submitted biological product lot distribution reports required under 21 CFR 600.81 in the form of printed paper reports, sometimes accompanied by electronic data files as American Standard Code for Information Interchange (ASCII) flat files, XML files or in other formats. Please enter another Lot # or contact Pfizer Customer Service at 8006667248 , option 8 OR [email protected] . Monovalent mRNA COVID-19 vaccines are no longer authorized for emergency use in the United States. The vials can be stored in the refrigerator for 10 weeks. SDVs do not require low-dead-volume syringes. CDCs COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. Pfizer does not have an expiration date look -up tool. Pfizer-BioNTech COVID-19 Vaccine Expiration Date Extension and Beyond-Use Date Recently the Food and Drug Administration (FDA) extended the expiration date for Pfizer-BioNTech COVID-19 Vaccine (monovalent and bivalent) from 12 to 18 . Please keep in mind this guidance does not replace the need to use the correct needle size for intramuscular (IM) injection based on the individual. Its safety and effectiveness in younger people has not yet been established. 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. Presentation . On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . 4 0 obj Password. The dosing for 6 months to less than 5 years is a 3-dose primary series of 3 micrograms each of the vaccine. DDL and temperature data issues should be directed to Pfizer. hb```e``"4@( R-:4: Clinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty COVID vaccine was about: 95% effective in protecting trial participants from COVID-19 for those 16 years and older. If an ultra-low temperature freezer is not available, the thermal container in which the Purple Cap Pfizer-BioNTech COVID-19 vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Depending on their responses, CDCmayfollow upwith themby phoneto get more information. However, children 5 years of age who complete a monovalent Moderna COVID-19 primary series may receive either the bivalent Pfizer COVID-19 booster dose or the bivalent Moderna COVID-19 booster dose at least 2 months after completion of the monovalent Moderna COVID-19 primary series. 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. Moderna COVID-19 vaccine: To determine the expiration date, providers can scan the QR code located on the vial or carton or access the manufacturers website directly, enter the lot number and the expiration date will be displayed.