September 2022 - March 31, 2023. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. To access the most recent Fact Sheets, please scan the QR code provided below. This information in the package insert supersedes the storage conditions printed on the vial cartons. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. *Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2C to 8C. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { Currently available information is insufficient to determine a causal relationship with the vaccine. The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Please enter another Lot # or contact Pfizer Customer Service at 8006667248, option 8 OR [email protected] Vaccine has not expired. Storage for longer than 10 weeks requires an Ultra Cold freezer. Room temperature: Up to 25C (77F). As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including: For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. No cases of Bell's palsy were reported in the placebo group. stream Thawed vials can be handled in room light conditions. https://www.cdc.gov/coronavirus/2019-ncov/index.html. 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. Procedures should be in place to avoid injury from fainting. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. Please refer to the table on this page for updates. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . body > div[data-webbuilder-block-is-swe] { For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. display: contents; Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Vaccine expires 18 months after the manufacture date. Relenza inhalation powder (reminder of previous extension) Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The vial stoppers are not made with natural rubber latex. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturers labeled expiration date so the replacement of stockpiled product could be deferred. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. TERMS OF USE. Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The vaccine expires on the last day of the 18th month. The manufacture date is printed on the vial (dark blue cap) and carton. December 2022 - June 30, 2023. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. 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 diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. The vaccine can be used for the full 10 . In Study 2, all participants 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Always use the earliest date. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. The beyond-use time (12 hours) replaces the manufacturer's expiration date but NEVER extends it. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). Ultra Cold -90C to -60C (-130F to -76F)*Do NOT store at -25C to -15C (-13F to 5F). *Cartons of Pfizer-BioNTech COVID-19 Vaccine vials may also arrive at refrigerator temperature 2C to 8C. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. Two vaccines can be given in one appointment. Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. 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. NOTE: Expiration dates extension does NOT apply to vials dated July 2021 and earlier. <> Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). Check Lot. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Should you decide not to receive any of these vaccines, it will not change your standard medical care. April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Solicited reactogenicity data in 16 and 17 year-old participants are limited. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. The updated 12-hour timeline from the Fact Sheet supersedes the number of hours printed on vial labels and cartons. 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. An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. 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. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below.. 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%). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. HOWEVER, with this extension, the expiration date is now AFTER the BUD. It is important that the information reported to FDA be as detailed and complete as possible. Some vials also may have a purple label border. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. helix-grid.hydrated, helix-mega-menu.hydrated, helix-layout-container.hydrated, helix-core-grid.hydrated, helix-core-header.hydrated, helix-core-page-break.hydrated, helix-core-card-group.hydrated, helix-core-footer.hydrated, helix-core-band.hydrated { The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. FK5127. Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap, Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage, Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent, Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap . <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 11 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart to individuals 12 years of age and older. Allow vials to thaw at room temperature for 30 minutes. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 75 mg capsules held in strategic stockpiles to be used for a maximum of 15 years beyond their date of manufacture[and] for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture CDC has clarified that states should contact their MCM Specialist or email preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. Please enter the lot number found on the product carton or vial to obtain its expiration date. N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older. To calculate the expiration date, add 18 months to the manufacture date including the month of manufacture. Exp Date: 01/2022 . After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). l0{TuE"95Z)`]`{$D0; ,L RHs r @@g`: 9 endstream endobj startxref 0 %%EOF 123 0 obj <>stream Each vial must be thawed before dilution. Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine. The vaccine expires on the last day of the 18th month. CPT Codes - Ages 12 & Up Covid-19 Vaccination (Pfizer) 91300 ____ Administration FIRST Dose 0001A____ Administration SECOND Dose 0002A____ Diagnosis Code Encounter for Immunization Z23____ Product Name: COVID 19 Vaccine Mcf: . PRODUCT INFORMATION. For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" The manufacture date is printed on the vial (gray cap). As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration date will be January 2023 (1/31/23). August 23, 2021. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. No more than 2 hours at room temperature (up to 25C/77F). 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. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. 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. No. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies. FAQs: What happens to EUAs when a public health emergency ends? For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. July 2, 2021:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. 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). If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. 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. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. Each vial MUST BE DILUTED before administering the vaccine. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. Please see the, Table 1:Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. (Primary series completed) If the recipient has received 2 or more doses of a monovalent COVID-19 vaccine (Pfizer-BioNTech or Moderna), administer 1 booster dose of bivalent Pfizer-BioNTech COVID-19 Vaccine at least 8 weeks (2 months) after the previous dose. The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. In September 2022, the National Institute of Allergy and Infectious Diseases opened a randomized, controlled clinical trial to assess the safety and efficacy of TPOXX for the treatment of mpox infection. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. 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. 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. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. 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. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Undiluted vials may be stored at room temperature for no more than 2 hours. NDC#: 59267-1055-4 . Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this products expiration dating extension. From an independent report (Kamar N, Abravanel F, Marion O, et al. 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. Manufacturing. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. SSL Certificate. Solicited Local and Systemic Adverse Reactions. 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. Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older who received the primary series and their data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: If you have a medical question/general inquiry on a Pfizer product, please visithttps://www.pfizer.com/products/information and choose your location. Printed Expiry Date a 2-dose primary series to individuals 12 years of age and older; and. Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). The extended expiration date is effective immediately for all currently available batches that have not yet expired. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp/, email cicp@hrsa.gov, or call: 1-855-266-2427. Each vial must be thawed before dilution. Under the EUA, it is your choice to receive or not receive any of these vaccines. Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. There are 2 formulations of Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older: This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older and MUST BE DILUTED PRIOR TO USE. When you get your first COVID-19 vaccine, you will get a vaccination card. An extended expiration date means the manufacturer provided data. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry . The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total .