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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 . 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. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. From an independent report (Kamar N, Abravanel F, Marion O, et al. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. PRODUCT INFORMATION. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of the SARS-CoV-2 Wuhan-Hu-1 strain. 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. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. To access a Pfizer expiration date lookup tool, kindly click on the above-given button. 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. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). The vaccine efficacy information is presented in Table 8. Relenza inhalation powder (reminder of previous extension) INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. Talk to your vaccination provider if you have questions. Any vaccine remaining in vials must be discarded after 6 hours. (Federal Register notice). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. B~o[_o$Pz{%y .=8X Currently available information is insufficient to determine a causal relationship with the vaccine. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. 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. Irrespective of the type of syringe and needle: 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 Full EUA Prescribing Information). V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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? Count out 18 months, using the month printed on the vial as month 1. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. 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. Dickson, as usual. 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. Please refer to the table on this page for updates. Fierce Biotech. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. Procedures should be in place to avoid injury from fainting. Following approval, the FDA revised its fact sheet for health care providers administering vaccines to note cartons and vials of the Pfizer vaccine with an expiration date of August 2021 through . Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. A third primary series dose may be administered at least 4 weeks after the second dose to individuals with certain kinds of immunocompromise. 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. An extended expiration date means the manufacturer provided data. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Vaccine may be thawed in the refrigerator or at room temperature. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. 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. The vaccine will be an off-white suspension. (Federal Register notice) Please contact DoxycyclineExpirationExtensionRequest@fda.hhs.gov with questions regarding thisguidance. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. *Cartons of Pfizer-BioNTech COVID-19 Vaccine vials may also arrive at refrigerator temperature 2C to 8C. 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. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. 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. Vials must be kept frozen and protected from light until ready to use. 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. 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. 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. 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. After the first dose has been withdrawn, the vial should be held between 2C to 25C (36F to 77F). Also see: Expiration date extensions of certain lots of doxycycline hyclate. )$p-M?4s6.1K@, i Expires 18 months after manufacture, if held at Ultra Cold temperatures. l0{TuE"95Z)`]`{$D0; ,L RHs r @@g`: 9 endstream endobj startxref 0 %%EOF 123 0 obj <>stream Table 7 presents the specific demographic characteristics in the studied population. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. 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). Remember: You dont need ultra-cold storage to carry Pfizer-BioNTech COVID-19 vaccine. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. PRIVACY POLICY. The duration of protection against COVID-19 is currently unknown. Sorry! An additional 1 DuoDote lot is no longer useable and should be properly disposed of. 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%). It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. FDA granted this extension following a thorough review of data submitted by AstraZeneca. 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. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. 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. 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. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. 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. 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. endobj 3 0 obj 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 { As soon as you land on the tool page, You will have to enter 2 things. 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. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. For the most recent Fact Sheet, please see www.cvdvaccine.com. Don't worry. 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. There is a remote chance that these vaccines could cause a severe allergic reaction. 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. 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). Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. Providers should track these time frames. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. 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. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. 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. 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. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. 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). May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time).Thawed vaccine cannot be refrozen. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. 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). Login with Single Sign On . For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, "regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons". 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. 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. Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. Please see the most recent updates above for the latest information. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. Learn how your gifts makes that possible. 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. endstream endobj 159 0 obj <>stream Vaccine expires 18 months after the manufacture date. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. 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. endstream endobj 158 0 obj <>stream The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total . 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. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. 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.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Adverse Reactions Identified in Post Authorization Experience. As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 below) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. All rights reserved. As the expiration date approaches, contact the manufacturer to determine if it has been extended. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. The program is administered by the U.S. Department of Defense (DoD). Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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. Some vaccine storage conditions are associated with beyond-use dates and times. % December 2022 - June 30, 2023. 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.
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