Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. For the most recent Fact Sheet, please see www.cvdvaccine.com. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. 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. 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. The vaccine expires on the last day of the 18th month. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. 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. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. 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. For more information, visit: www.cdc.gov/vsafe. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. See Overall Safety Summary (Section 6) for additional information. 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. June 3, 2020: On February 11, 2020, 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. After dilution, 1 vial contains 6 doses of 0.3 mL. Observation 6 . 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. 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. PDF Pfizer-BioNTech COVID-19 Vaccines - CDC The 24-month expiry date is based on the earliest date of manufacture between nirmatrelvir and ritonavir. 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). Sorry! 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. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. See this Fact Sheet for instructions for preparation and administration. 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. In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). FDA will continue to evaluate the available data and provide updated information as soon as possible. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. Dickson, as usual. When you get your first COVID-19 vaccine, you will get a vaccination card. Do not discard vaccine without ensuring the expiration date has passed. 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. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. 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 sotrovimab, emerge and become prevalent in the United States. 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. 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. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. body > div[data-webbuilder-block-is-swe] { 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 expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) . Don't worry. 1 0 obj
Thawed vials can be handled in room light conditions. Expiration Dating Extension | FDA Evaluation of a future extension of shelf-life for sotrovimab is ongoing. An official website of the United States government, : 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. Recipients should contact their MCM specialists with any questions regarding confirmation. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). Access the expiration date by scanning the QR code located on the vaccine carton. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). Some vials also may have a purple label border on the label. 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. Manufacturing. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. 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. 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. Pfizer does not have an expiration date look -up tool. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Always use the earliest date. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. What is an Emergency Use Authorization (EUA)? Some COVID-19 vaccines expiration dates have been extended - KUSA 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. 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. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is made in the same way as COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older. 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? Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. PDF EXPIRATION EXTENSION: PFIZER-BIONTECH COVID-19 VACCINE - Michigan After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. [-130F to -76F]). 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. SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . 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). Pfizer-BioNTech COVID-19 Lot ExpiryLa FDA autoriza vacuna contra el COVID-19 de Pfizer-BioNTech para uso There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. } August 23, 2021. Moderna Fact Sheet for Bivalent Booster Dose for 18 6 years and older. No cases of Bell's palsy were reported in the placebo group. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 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. Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. )$p-M?4s6.1K@,
i For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration . Kindly take a deep look at the above given updated expiry of Pfizer vaccines. Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Please refer to the table on this page for updates. Currently available information is insufficient to determine a causal relationship with the vaccine. The vaccine expires on the last day of the 18th month. Room temperature: Up to 25C (77F). 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. More information, April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness, Expiration date extensions of certain lots of doxycycline hyclate, February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals (West-Ward) held in strategic stockpiles for anthrax emergency preparedness and response purposes. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. NDC#: 59267-1055-4 . 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. It is important that the information reported to FDA be as detailed and complete as possible. PDF COVID-19 Vaccine Provider Update - Louisiana Department of Health