Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). 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. [-130F to -76F]). Vials must reach room temperature before dilution. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. During the visual inspection. This shelf-life extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer's storage conditions. The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. Vaccine expires 18 months after the manufacture date. Primary Series (Monovalent)6 months 5 years: Dark Blue Cap / Magenta Label6-11 years primary series: Dark Blue Cap / Purple Label 12 years and up: Red Cap / Light Blue Label, Updated (Bivalent) Booster 6 months 5 years: Dark Pink Cap/Label with Yellow Box6 years and up: Dark Blue Cap / Gray Border LabelNote: Both 0.25mL (6 11 years) and 0.5mL (12+ years older) doses may be withdrawn from the same multiple-dose vial. October 2022 - April 30, 2023. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. IuaPmrE&n-W.2Icy^&PM | ,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. Fierce Healthcare. 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. In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. The safety and efficacy of TPOXX for the treatment of human mpox has not been established. 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 9C to 25C (47F to 77F) for up to 12 hours, Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursRoom Temperature 9C to 25C (47F to 77F) for up to 2 hours. Read below to find the specifics on COVID-19 vaccine storage and expiry. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. [Note: this guidance was finalized on April 24, 2019.] 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. Medical Countermeasures Initiative (MCMi), Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, Guidance for Industry: Changes to an Approved NDA or ANDA, Office of Counterterrorism and Emerging Threats, Public Readiness and Emergency Preparedness, Previous COVID-19 vaccine shelf-life extensions, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100, Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld, Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104, announced the authorization of an additional extension, Table 1: Extended Expiry Dating for Bebtelovimab Authorized under EUA 111, Table 1: Extended Expiry Dating for Lagevrio Authorized under EUA 108, announced the authorization of an extension to the shelf-life, Letter of Authorization for Emergency Use Authorization (EUA) 091, Previous COVID-19 therapeutic shelf-life extensions, Table 1: Extended Expiry Dating for Paxlovid Authorized under EUA 105, Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid, Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105, Statement Regarding Shelf-Life Extension of Sotrovimab, Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab, announcedthe authorization of an extension to the shelf-life, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Influenza (Flu) Antiviral Drugs and Related Information, HHS Increases Access to Tamiflu through the Strategic National Stockpile, Improving Access to Influenza Countermeasures for U.S. Jurisdictions, Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, [email protected], Previous doxycyline shelf-life extensions, Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles, Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles, recording of this webinar, slides and Q&A, Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles, Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension, Search List of Extended Use Dates to Assist with Drug Shortages, On June 10, 2021, based on data and information received from the manufacturer, FDA, February 22, 2023: On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. 1-800-666-7248. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). Recently the Food and Drug Administration (FDA) extended the expiration date for Pfizer-BioNTech COVID-19 Vaccine (monovalent and bivalent) from 12 to 18 months from manufacturer date. No more than 2 hours at room temperature (up to 25C/77F). WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? Fierce Pharma. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. The program is administered by the U.S. Department of Defense (DoD). Overview Job aid on how to verify the expiration date for Pfizer-BioNTech COVID-19 Vaccine paediatric formulation using the QR code found on the secondary packaging label. Booster Dose: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after: WHO SHOULD NOT GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? It does not start in Should you decide not to receive any of these vaccines, it will not change your standard medical care. 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). Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. of Insurance Complaint Resource, Creating Health: Lifestyle & Weight Management, Diabetes Self-Management Education (DSME), NCPA Innovation Center/ CPESN Community Pharmacy Fellowship. (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. CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. Serious and unexpected side effects may occur. When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDAs website. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. 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. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. Symptoms may appear 2 to 14 days after exposure to the virus. To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. 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. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. It is also authorized under EUA to provide: The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which you may receive because there is currently a pandemic of COVID-19. Vaccine may be thawed in the refrigerator or at room temperature. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. 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. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. NCPA Solicited Local and Systemic Adverse Reactions. Learn how your gifts makes that possible. Frozen vials transported at -25C to -15C (-13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). This information in the package insert supersedes the storage conditions printed on the vial cartons. In some cases, the expiration date for a test may be extended. The 24-month expiry date is based on the earliest date of manufacture between nirmatrelvir and ritonavir. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. 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. September 20, 2017: CDC and FDA hosted a webinar to discuss FDAs April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. 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. Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). To access a Pfizer expiration date lookup tool, kindly click on the above-given button. SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . When you get your first COVID-19 vaccine, you will get a vaccination card. 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). If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. %PDF-1.7 Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. States may contact their MCM Specialist or email [email protected] or [email protected] to confirm the new extended dates for their antiviral drug inventories eligible for extension. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. 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. 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. )$p-M?4s6.1K@, i From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). 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). The vial stoppers are not made with natural rubber latex. Currently available information is insufficient to determine a causal relationship with the vaccine. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. September 2022 - March 31, 2023. FK5127. Pfizer does not have an expiration date look -up tool. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. To access the most recent Fact Sheets, please scan the QR code provided below. 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. Dates: Are the intervals between the doses of Moderna or Pfizer vaccinations within the appropriate intervals, approximately 21 days apart for the Pfizer vaccination and approximately (within. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage.