Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. To calculate the expiration date,add 18 months to the manufacture dateincludingthe month of manufacture. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C (-130F to -76F) until the expiry date printed on the label. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. If you are immunocompromised, you may receive a third primary series dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). 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 EUA. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. No further extensions are anticipated beyond 10 years.Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR:HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), andImproving Access to Influenza Countermeasures for U.S. Jurisdictions. The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. 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. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably. Please refer to the table on this page for the new updates. Do not add more than 1.8 mL of diluent. WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. Two vaccines can be given in one appointment. Providers should track these time frames. Please enter the lot number found on the product carton or vial to obtain its expiration date. There is a remote chance that these vaccines could cause a severe allergic reaction. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Vaccine expires 18 months after the manufacture date. Do not discard vaccine without ensuring the expiration date has passed. 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. 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. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. 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. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Count out 18 months, using the month printed on the vial as month 1. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). 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). Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. Thawed vials can be handled in room light conditions. This diluent is not packaged with the vaccine and must be sourced separately. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. Record the date and time of dilution.Use within 6 hours after dilution. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? A third primary series dose may be administered at least 4 weeks after the second dose to individuals with certain kinds of immunocompromise. To access a Pfizer expiration date lookup tool, kindly click on the above-given button. A carton of 10 vials may take up to 4 hours to thaw at refrigerator temperature (2C to 8C [35F to 46F]). Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. of Insurance Complaint Resource, Creating Health: Lifestyle & Weight Management, Diabetes Self-Management Education (DSME), NCPA Innovation Center/ CPESN Community Pharmacy Fellowship. When you get your first COVID-19 vaccine, you will get a vaccination card. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. 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. 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. Tell the vaccination provider about all of your medical conditions, including if you: The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. 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. Know your Vaccine Products and Storage Needs, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs, Practice Research in the Office Setting (PROS), Pediatrician Life and Career Experience Study (PLACES), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Fact Sheet for Health Care Providers Administering Vaccine (5 11 years), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary, Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over, Fact Sheet for Health Care Providers Administering Vaccine (12 years and up), FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron), CDC US COVID-19 Vaccine Product Information, CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Moderna COVID-19 Vaccine Storage and Handling Summary, Fact Sheet for Health Care Providers Administering Vaccine (6 months 5 years), Fact Sheet for Health Care Providers Administering Vaccine (6 11 years). 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. FDA will continue to evaluate the available data and provide updated information as soon as possible. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. 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. Do NOT store at -25C to -15C (-13F to 5F). ,W7@M"NV?lG=nVk`SJt*"75Nry"E"nP8%T&v:$'4B5 "WY2Vvf5,psc=l(Zb0|4;"on#t|uL;5p~hn;ZVAJ0yTL)L/d)K.>gb[>FpZ[LRJaRjm7v(HU{K\:{g_%N;plI|~j-;||O-RqISR0jJc[:E*\CB8 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). Vials should be discarded 8 hours (dark pink cap product) or 12 hours (blue and red cap products) after the first puncture. Created Date: 12/3/2021 11:57:01 AM . PFIZER CUSTOMER SERVICE. 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 [email protected] to confirm extended dates for antiviral drug inventories eligible for extension. Do NOT use vaccine if the expiration date or beyond-use time has passed. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. 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. Access to this report is strictly managed by registration only. 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). 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. Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines This Fact Sheet may have been updated. The safety evaluation in Study 2 is ongoing. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). The top 15 blockbuster patent expirations coming this decade If an ultra-low temperature freezer is not available, the thermal container in which the 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. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. 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. Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to 10 weeks. As soon as you land on the tool page, You will have to enter 2 things. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. 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. N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. Each vial must be thawed before dilution. l0{TuE"95Z)`]`{$D0; ,L RHs r @@g`: 9 endstream endobj startxref 0 %%EOF 123 0 obj <>stream FDA will continue to evaluate the available data and provide updated information as soon as possible. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020. The vaccine will be an off-white suspension. 1-800-666-7248. Recipients should contact their MCM specialists with any questions regarding confirmation. Any vaccine remaining in vials must be discarded after 6 hours. A medical product is typically labeled by the manufacturer with an expiration date. Information to include: The following steps are highlighted to provide the necessary information for safety tracking: There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. H310F@lpXBU / endstream endobj 72 0 obj <>/Metadata 3 0 R/OpenAction 73 0 R/Outlines 7 0 R/PageLayout/SinglePage/Pages 69 0 R/StructTreeRoot 12 0 R/Type/Catalog/ViewerPreferences<>>> endobj 73 0 obj <> endobj 74 0 obj <. 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 { Login with Single Sign On . Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. The vaccine is administered as a 2-dose series, 3 weeks apart. Vials must reach room temperature before dilution. The extended expiry date for each lot can be found in Table 1 below. September 2022 - March 31, 2023. In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. Copyright 2023 American Academy of Pediatrics. In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2. Fierce Life Sciences Events. 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. Below are a few case scenarios you might encounter. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB). Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. 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. We're 67,000 pediatricians committed to the optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. Vials must reach room temperature before dilution. Check Lot. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. 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. June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV.