Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. The expiration date is set at the end of the shelf-life. 2C to 8C (36F to 46F)Unpunctured vials until the expiration date Do not freeze. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. 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. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. 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)]. >l$GO}Un}};]3kvpM[Ogw},O/ge_ua?&mwvGn/WyI}&^ccV.v[:Y~,pb~?+ A carton of 10 vials may take up to 4 hours to thaw at refrigerator temperature (2C to 8C [35F to 46F]). Two vaccines can be given in one appointment. Pfizer-BioNTech COVID-19 Vaccines | CDC Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. 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. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. TPOXX supplied by the, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients: COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. https://www.pfizer.com/products/information. 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. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. The extended expiry date for each lot can be found in Table 1 below. PDF COVID-19 Vaccine Provider Update - Louisiana Department of Health October 2022 - April 30, 2023. Please refer to the table on this page for updates. 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. 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. Each vial must be thawed before dilution. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. The extended expiration date is effective immediately for all currently available batches that have not yet expired. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Do not add more than 1.8 mL of diluent. 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. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). 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. ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? 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 <. It is important that the information reported to FDA be as detailed and complete as possible. 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. Symptoms may appear 2 to 14 days after exposure to the virus. Please refer to the table on this page for updates. 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. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. 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. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. FK5127 HIGH TOXICITY WARNING Vaccines possessing these codes may result in a HIGH risk of DEATH, DISABILITY or SERIOUS ILLNESS . Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. If received at 2C to 8C, they should be stored at 2C to 8C. December 14, 2022: On April 28, 2022, HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. Vials must be kept frozen and protected from light until ready to use. Pfizer-BioNTech COVID-19 Vaccine(N=18,242)n (%), Native Hawaiian or other Pacific Islander, Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation). 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. The vaccine will be an off-white suspension. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4MB) and the Letter of Authorization (PDF, 375KB). 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. 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. PFIZER CUSTOMER SERVICE. Information is not yet available about potential long-term sequelae. Please refer to the table on this page for updates. The safety and efficacy of TPOXX for the treatment of human mpox has not been established. SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . To access the most recent Fact Sheets, please scan the QR code provided below. Undiluted vials may be stored at room temperature for no more than 2 hours. 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. Upon FDAs authorization of a shelf-life extension, the labeling is updated by the IVD manufacturer to reflect the updated expiration date, which is calculated from the original manufacturing date of the device. To find the expiry date on your product, please download the data tables (by date or by batch number). Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. 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. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. 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. Exp Date: 01/2022 . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Fierce Healthcare. section at the end of this Fact Sheet. 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. Dickson, as usual. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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 .gov means its official.Federal government websites often end in .gov or .mil. Access to this report is strictly managed by registration only. No cases of Bell's palsy were reported in the placebo group. 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. 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). Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. MCM Legal, Regulatory and Policy Framework, Recalls, Market Withdrawals and Safety Alerts, MCM Legal, Regulatory and Policy Framework, MCM-Related Legal and Policy Presentations, Publications and Q&As, State, Tribal, Local, and Territorial Public Health Preparedness, Guidance and Other Information of Special Interest to MCM Stakeholders, Availability of Regulatory Management Plans, Vaccine EUA Questions and Answers for Stakeholders. 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. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The lot number you entered (AB0000) does not exist. 9 6sOvKB/SA~P=f}pK\"8 8oM~[2]'K v.J v~_SCmGnbv`kKMw36:\H&L(hA9Z;5fH3*B>z^J=b|,L'~ gTr 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 The manufacture date is printed on the vial (dark blue cap) and carton. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines Click here to view this information in a table. SARS-CoV-2 neutralization assay - NT50 (titer). Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. It is predominantly a respiratory illness that can affect other organs. } However, the U.S. Government recommends retaining the product in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the U.S. January 18, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life from 18 months to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). 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. endobj A medical product is typically labeled by the manufacturer with an expiration date. vaccine's BUD is 2/12/2023. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. Click here to view and download this information in a table. After dilution, 1 vial contains 6 doses of 0.3 mL. It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. Find valuable resources to assist you in your pediatrics career from pre-med and training to finding a job and growing a thriving practice. } 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. CAN I RECEIVE COMIRNATY (COVID-19 VACCINE, mRNA), PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT AT THE SAME TIME AS OTHER VACCINES? 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. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. October 21, 2020: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. 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. The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. 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. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Your close contacts should be vaccinated 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. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. After the first dose has been withdrawn, the vial should be held between 2C to 25C (36F to 77F). b s3"/fB`i:be#!GEaGf*bKn!/Px Z(S?|dG-^ZzT_ebT{|K. y*L|oDp8)jw=(9o} The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. One way is through issuing an Emergency Use Authorization (EUA) under section 564 of the FD&C Act since use of a product beyond its labeled expiry date is considered unapproved. H\j0~ N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. No. 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. Use Pfizer expiration date tool at https://lotexpiry.cvdvaccine.com Check beyond-use date/times Unpunctured vials may be stored between 2C and 8C (36F- 46F) for up to 10 weeks Unpunctured vials may be stored between 8C and 25C (46F and 77F) for a total of 12 hours 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. Kindly take a deep look at the above given updated expiry of Pfizer vaccines. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), 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 0.3% of placebo recipients. PRIVACY POLICY. Symptoms may appear 2 to 14 days after exposure to the virus. Talk to your vaccination provider if you have questions. 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. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. 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 older9. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. Learn more about the American Academy of Pediatrics including our mission, leadership and commitment to the optimal health and well-being of all children. For additional information, consult the Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, page 3, or Guidance for Industry: Changes to an Approved NDA or ANDA. Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry . 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. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be a single booster dose to individuals 12 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved COVID-19 vaccine; or, a single booster dose to individuals 12 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html, https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Clinical Trial Results and Supporting Data for EUA (18.1), https://www.cdc.gov/vaccines/programs/iis/about.html. Checker webpage to confirm expiration dates. The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. 2 0 obj 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. June 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 4 additional DuoDote lots that are no longer useable and should be properly disposed of. Some vaccine storage conditions are associated with beyond-use dates and times. The QR code on the label is a link to the EUA factsheet. Youll find additional information on Pfizer storage and handling here.