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Please enter the lot number found on the product carton or vial to obtain its expiration date. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). Refrigerator: Between 2C and 8C (36F and 46F) A carton of 10 vials may take up to 6hours to thaw at this temperature. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. FK5127 HIGH TOXICITY WARNING Vaccines possessing these codes may result in a HIGH risk of DEATH, DISABILITY or SERIOUS ILLNESS . Available Vaccines for COVID-19 include: PFIZER's NEW BOOSTER & MODERNA's NEW BOOSTER Appointment * Name * First Name Last Name Date of Birth * Month Day Year Phone Number * Please enter a valid phone number. L M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 Lot Numbers (EN6207, ER8734, EW0150, ER8729, EW0158, ER8727, EW0162, ER8733): New Expiration Date: 10/31/2021 Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany, Manufactured by Pfizer Inc., New York, NY 10017, Long Version (Full EUA Prescribing Information) Begins On Next Page, FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION, FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*. The lot number you entered (AB0000) does not exist. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. hb``f``Vc```)a@@,& L8zf0edRg2gea`%QX` In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Serious and unexpected side effects may occur. In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. 2 0 obj Home Page - COVID-19 VACCINE LOT NUMBER AND EXPIRATION DATES The program is administered by the U.S. Department of Defense (DoD). After dilution, the vial should be held between 2C to 25C (35F to 77F). PFIZER CUSTOMER SERVICE. Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. Undiluted vials may be stored at room temperature for no more than 2 hours. Providers should track these time frames. If received at 2C to 8C, they should be stored at 2C to 8C. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. 1 0 obj An official website of the United States government, : For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. Expires 18 months after manufacture, if held at Ultra Cold temperatures. February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GlaxoSmithKline LLCs monoclonal antibody, sotrovimab, from 24 months to 30 months. *d,aur A4ton)9R yYe5V@brte/-b{L1f^U73hq$ '>8#3,$ D eu,oCZN U[ If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. 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. SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel (e.g., in the SNS) can be extended after select products undergo periodic stability testing conducted by FDA. The manufacture date is printed on the vial (gray cap). At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose. This finalizes the draft guidance published on April 25, 2017. FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. That means . The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. visibility: inherit; Pfizer does not have an expiration date look -up tool. Fierce Biotech. In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). section at the end of this Fact Sheet. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. From an independent report (Kamar N, Abravanel F, Marion O, et al. NOTE: Expiration dates extension does NOT apply to vials dated July 2021 and earlier. endstream endobj 159 0 obj <>stream On April 13, 2022, FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine.FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 . |/FWjSZl;u!hU$xO=6 :sfuoHDZ-Uqw&+q;#"To-C*HRgZ^lw?BG:+Y7ZBJnw{%8q|\TM|tiv zGjt7e Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. Pfizer-biontech Covid-19 Vaccine Procedures should be in place to avoid injury from fainting. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, "regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons". COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. The letter noted that, based on FDA-approved supplemental New Drug Applications for Relenza inhalation powder and Tamiflu capsules that provided an expiration dating period of 7 years, it would be scientifically supportable for the expiry extension (i.e., for a maximum of 7 years) to apply to certain lots of Tamiflu and Relenza that have already been manufactured. endobj Simply follow the below-given step-by-step tutorial to find the expiry date of your Pfizer COVID vaccine. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. Dickson, as usual. Allow vial(s) to thaw at room temperature [up to 25C (77F)] for 30 minutes. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). Observation 6 . Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. From an independent report (Kamar N, Abravanel F, Marion O, et al. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA. Under the EUA, it is your choice to receive or not receive any of these vaccines. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Purple plastic cap and purple label border. November 26, 2019: This posting and FDAs November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. Youll find additional information on Pfizer storage and handling here. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. Ultra Cold -90C to -60C (-130F to -76F)*Do NOT store at -25C to -15C (-13F to 5F). Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? No cases of Bell's palsy were reported in the placebo group. A carton of 10 vials may take up to 2 hours to thaw in the refrigerator [2C to 8C (35F to 46F)]. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Learn more about all our membership categories. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Vaccine may be thawed in the refrigerator or at room temperature. Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. Without the expiration date extension, this vaccine could only be used up to the expiration date (12/20/2022)-not the full 10 weeks. The expiration date is set at the end of the shelf-life. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. SARS-CoV-2 neutralization assay - NT50 (titer). Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. This diluent is not packaged with the vaccine and must be sourced separately. The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. The Countermeasures Injury Compensation Program. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. At-Home OTC COVID-19 Diagnostic Tests | FDA April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Cartons and vials of Pfizer-BioNTech COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90C to -60C (-130F to -76F) have been maintained. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. August 23, 2021. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. All about Pfizer Expiration Date Lookup |Lot Checkup| Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. How to verify the expiration date for Pfizer-BioNTech COVID-19 Vaccine For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" Vials must be kept frozen and protected from light until ready to use. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Refrigerator: Between 2C and 8C (36F and 46F). CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. The safety and efficacy of TPOXX for the treatment of human mpox has not been established. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) The vaccine elicits an immune response to the S antigen, which protects against COVID-19. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. September 6, 2022: FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA. PDF Pfizer Vials and Expiration Dates: Label Information Fact Sheet for Healthcare Providers Administering Vaccine - Novavax, Janssen COVID-19 Vaccine Storage and Handling Summary, COVID-19 Vaccine Lot Number and Expiration Date Report, COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals, COVID-19 Vaccine Lot Number and Expiration Date Report from the CDC. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# When shelf-life expiration dates are extended for devices that have already been distributed, the IVD manufacturer typically sends a notice to customers to inform them of the extension so they are aware of how long they can continue to use in-stock devices. The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. For more information, visit: www.cdc.gov/vsafe. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time).Thawed vaccine cannot be refrozen. When you get your first COVID-19 vaccine, you will get a vaccination card. Pfizer-BioNTech COVID-19 Vaccine | Pfizer Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. 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. Sorry! FAQs: What happens to EUAs when a public health emergency ends? However, when enforcement discretion is used for medical product dating extensions, MCMs are not covered under applicable Public Readiness and Emergency Preparedness (PREP) Act liability protections. HOWEVER, with this extension, the expiration date is now AFTER the BUD. June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.