https://www.pfizer.com/products/information. January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Click here to view this information in a table. 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: . WHERE WILL MY VACCINATION INFORMATION BE RECORDED? Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. See this Fact Sheet for instructions for preparation and administration. Observation 6 . Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Vials should be discarded 8 hours (dark pink cap product) or 12 hours (blue and red cap products) after the first puncture. 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). FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron) CDC US COVID-19 Vaccine Product InformationCDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines. Vaccine expires 18 months after the manufacture date. 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*. Adverse Reactions Identified in Post Authorization Experience. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. 2023 National Community Pharmacists Association, FDA extends Pfizer vaccine expiration dates, The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. Login with Single Sign On . 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. Do NOT store at -25C to -15C (-13F to 5F). Based on the date the vaccine was placed in the refrigerator, the . For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration . 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. Thawed vials can be handled in room light conditions. There may be clinical trials or availability under EUA of other COVID-19 vaccines. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. FDA will continue to evaluate the available data and provide updated information as soon as possible. The manufacture date is printed on the vial (dark blue cap) and carton. May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. This includes working to ensure that MCM-related policy supports programs like SLEP. A medical product is typically labeled by the manufacturer with an expiration date. Learn more about the American Academy of Pediatrics including our mission, leadership and commitment to the optimal health and well-being of all children. Pull back plunger to 1.8 mL to remove air from vial. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to 10 weeks. In some cases, the expiration date for a test may be extended. B~o[_o$Pz{%y .=8X 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 For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. Table 7 presents the specific demographic characteristics in the studied population. Cardiac Disorders: myocarditis, pericarditis, Gastrointestinal Disorders: diarrhea, vomiting, Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: syncope, dizziness. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. 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. JB@W51q/S The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. You can get COVID-19 through contact with another person who has the virus. The possible side effects of these vaccines are still being studied. Pfizer-BioNTech COVID -19 Vaccine Products . WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. Vials should be discarded 12 hours after dilution.). 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. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)]. Vaccine may be thawed in the refrigerator or at room temperature. 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 . However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. 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. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods: IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES. 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. Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). FDA granted this extension following a thorough review of data submitted by Eli Lilly. 2C to 8C (36F to 46F)Unpunctured vials until the expiration date Do not freeze. 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 and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Allow vial(s) to thaw at room temperature [up to 25C (77F)] for 30 minutes. Expires 18 months after manufacture, if held at Ultra Cold temperatures. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably.2, COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.3, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. of Insurance Complaint Resource, Creating Health: Lifestyle & Weight Management, Diabetes Self-Management Education (DSME), NCPA Innovation Center/ CPESN Community Pharmacy Fellowship. Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. Currently available information is insufficient to determine a causal relationship with the vaccine. In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? Do not refreeze. 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.6. 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). Vaccine expires 18 months after the manufacture date. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. If received at 2C to 8C, they should be stored at 2C to 8C. This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. b s3"/fB`i:be#!GEaGf*bKn!/Px Z(S?|dG-^ZzT_ebT{|K. y*L|oDp8)jw=(9o} BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: September 27, 2022 Vaccine is expired. The vaccine expires on the last day of the 18th month. 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. 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 . Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. This Fact Sheet may have been updated. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . 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. Tamiflu 30mg, 45mg, and 75mg capsules Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Printed Expiry Date Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Ultra Cold -90C to -60C (-130F to -76F)*Do NOT store at -25C to -15C (-13F to 5F). The safety and efficacy of TPOXX for the treatment of human mpox has not been established. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. 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). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability.