sanofi pasteur Section 1.3.1 306 . MDHHS Guidance for Responding to Vaccine Storage Unit Temperature Excursions . Sanofi announced on March 12, 2021 that it had started a Phase 1/2 clinical trial that will enroll about 415 adults. %PDF-1.7 0000001271 00000 n The companies have tested a number of combinations of one and two doses of vaccine, as well as different adjuvants. This means that, if the Phase 3 trial proceeds smoothly, regulatory approval likely would come in the fourth quarter of 2021. government site. evaluation of temperature excursions and other transport deviations during transport or at local distribution centers as well as management of out of stock situations in . HTPn sf(qMFKR y34/^ (hsJb#|nPZ>:C Anju Goel, MD, MPH, is a board-certified physician who specializes in public health, communicable disease, diabetes, and health policy. PSs?A@q#40j;L99zllN~p>a\{fNCNkoq*KK%Km9;PM !?~W _q*tQ2IO IBASk=^K+%9Ujr 7Sg# The Sanofi/GSK vaccine candidate is a recombinant protein-based vaccine based on the baculovirus, which is commonly found in moths. Verywell Health's content is for informational and educational purposes only. If you have questions about a specific medical condition, please consult a healthcare professional. 0000003424 00000 n Copyright 2018 The Author. The screening of large amounts of kinetic models combined with a statistical model selection approach resulted in the identification of two-step kinetic models. 0000002521 00000 n DENGUE Templates, Temperature If any of the affected Sanofi vaccines were administered to patient (s) since the temperature excursion occurred, please contact-us by calling 1-800-633-1610. "javascript" to display properly. Unauthorized use of these marks is strictly prohibited. Andrew MK et al. Instead, the Phase 3 trial launched in May 2021 after the pharmaceutical companies went back to the lab to rework the formula and conducted a redo of the second phase of the clinical trials. Learn more about the Merck Manuals and our commitment to Global Medical Knowledge. Title: COVID19 Temperature Excursion Report Bethesda, MD 20894, Web Policies Reference your Vaccine Management Plan. Protect from light:Tuberculin PPD solutions can be adversely affected by exposure to light Store at 2 to 8 degrees Celsius (35 to 46 . sensitization is induced by natural mycobacterial infection or by vaccination with BCG Vaccine. Vaccines should be stored in their original packaging at +2C to +8C and protected from light. You are about to visit another Sanofi website. The combined effort between the two companies had Sanofi developing a vaccine using an adjuvant from GlaxoSmithKline (GSK). Sanofi Pasteur: 1-800-822-2463: Seqirus: 1-855- 358-8966: Contact If the temperature It is provided for information only. Due to their thermosensitivity, most vaccines must be kept refrigerated from production to use. Anyone can catch and spread flu. Labelthe vaccine as "Do Not Use". 0000003654 00000 n 2022 Feb 23;40(9):1223-1230. doi: 10.1016/j.vaccine.2021.12.038. *'_ k<0 N})k Temperature Excursion: An event in which vaccine is exposed to temperatures outside of the acceptable range. Control No. First, we launched the Generation II NARCAN device, which has a claim for enhanced temperature excursions and . Sanofi is working on a second type of COVID-19 vaccine, too. '[3PO$cTXQi Cold chain break; Shelf life predictions; Stability modeling; Storage temperature; Vaccine stability. The .gov means its official. Text. Vaccine left out on counter Vaccine spoiled during transport . For example, if your temperature probe shows that the temperature of a refrigerated vaccine rose to 4 8. Identifying, Disposing, and Reporting COVID-19 Vaccine Wastage (Feb 2022) Salmonella typhi Vi Capsular Polysaccharide Vaccine . If you wish to continue to this external website, click Proceed. IHS COVID-19 Vaccine Temperature Excursion Worksheet Utilize this worksheet to gather the information vaccine manufacturers will need to make a stability determination. Arch Razi Inst. DIPHTHERIA eCollection 2021 Nov. Pharmaceutics. To successfully carry out global immunization programs, ensuring the stability of vaccines is crucial. This page last update:02-2022. The informa on reported on storage and handling incidents is used to determine whether a vaccine is likely to be viable and Reasons for instability of bacterial vaccines. Temperature Monitoring ODH requires all COVID-19 Vaccine providers to check and record the minimum and maximum (min/max) temperatures of cold storage refrigerators and/or freezers each workday. The Lancet Respiratory Medicine. BARDAis awarding the funds in an effort tospeed up how quickly vaccines to fight COVID-19 can be developed and approved for use. )\dPl.=.b :aiqQtp3vdKHZ,ykDtp2rAJQPZnL'0LB'-Ki4lqY/v&|V,981[r,t/$U,9.%Gia1!,HwBC|{D_?|w_rSYt_{Tbp=i|+( Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial. No information on side effects has been released yet for Sanofi's mRNA vaccine. Sanofi Pasteur Limited . Pieces of the novel coronavirus are used in combination with the baculovirus to effectively program the immunesystem to better recognize and fight COVID-19. In July 2020, the partnership was awarded $30 million through a program administered by the U.S. Department of Health and Human Services calledthe Biomedical Advanced Research and Development Authority (BARDA) and Operation Warp Speed. In the event of a power-outage or temperature excursion: 1. Disclaimer. 1 0 obj . F (9. Each 0.5 mL dose of MassBiologics' TDVAX is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. We believe we must protect beyond the influenza infection to help reduce the risks of its severe complications, which too often bring people to hospital. Handling a Temperature Excursion in Your Vaccine Storage Unit [1 page, 508] (Mar 2020) This document describes immediate corrective actions following a vaccine storage unit temperature excursion. 3 0 obj The https:// ensures that you are connecting to the Available at: Izikson R. et al. Recombivax HB, MMR, Varivax, PedvaxHIB, Pneumovax 23, Vaqta, RotaTeq, Gardasil, Zostavax, ProQuad, Vaxelis, Vaxneuvance . You can also contact us directly via a direct message (DM) on our U.S.FacebookandTwitterchannels. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800 . VISIT VACCINESHOPPE.COM Sanofi Specialty Care For information about our Rare Disease products and support and services, please call us at 1-800-745-4447. 2 0 obj Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre "Select" al lado de "I am a U.S. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. Archive, WHAT'S NEW Digital Data Logger Reminders: 347-396-2404 (Phone) 347-396-8841 (Fax) PQAUnit@health.nyc.gov In the event of a temperature excursion, contact the vaccine manufacturers, complete and submit this form to the New York City Department of Health and Mental . Temperature excursions or other GxP (distribution) non-conformances Calgary (Canada) Distribution Centre Quality oversight . Maintaining vaccines within the cold chain between the recommended temperature range minimises the risk of compromising the effectiveness of the vaccine and ensures compliance with the manufacturer's product license. endstream endobj 289 0 obj <>/Metadata 5 0 R/Pages 286 0 R/StructTreeRoot 12 0 R/Type/Catalog/ViewerPreferences<>>> endobj 290 0 obj <. : 216332 Date of Initial Approval: December 14, 1994 . After shaking, the vaccine appears as a homogeneous milky white suspension. . Vaccine Temperature Excursion Guide Complete . Samson et al. Liquid, no adjuvant . 0000006741 00000 n official website and that any information you provide is encrypted Last Update: May 2022, 2005-2022 sanofi-aventis U.S. LLC - All rights reserved. ATC: Code J07AP03 . Vaccine Viability and For additional information on Sanofi's products in the U.S., For general information about our products and programs in the U.S., call800-981-2491,fill out the form using the link below or check our. 0000103818 00000 n An excursion is any temperature outside the recommended temperature range for a vaccine. Updated Sept. 28, 2021 11:42 am ET. Checklists, Standing Orders Total duration of the temperature excursion for unit being reported. Its an infectious disease that does more damage than most people realize. 0000006924 00000 n In case of a temperature excursion, call the manufacturers to determine vaccine viability . BCG. 0000001608 00000 n Preferred method of receipt is via scan and email to WAChildhoodVaccines@doh.wa.gov or fax to 360.236.3811. . ag the affected vaccines and place a label on them saying "DO . print. This can . Temperature sensitivity of vaccines . We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that canprotect as many people as possible against flu and its complications. Influenza Virus Vaccine Trivalent Types A and B (Split Virion) . The vaccine stimulates a person's immune system to develop antibodies and cells in the blood and elsewhere that can then help the body fight off a smallpox infection if exposure to smallpox occurs. Unlike the European Medicines Agency and the US Food and Drug . 0000104579 00000 n Would you like to proceed? Data support temperature excursion of -60C to -15C for up to 2 weeks, and vials that have been exposed to a single temperature excursion within these conditions can be returned to the recommended storage conditions. HHS Vulnerability Disclosure, Help For the most recent updates on COVID-19, visit ourcoronavirus news page. However, it is the total amount of time, or cumulative time, out of range that affects the viability of a vaccine. Predictions based on kinetic analysis and experimental stability data were in agreement, with approximately five percentage points difference from real values for long-term stability storage conditions, after excursions of temperature and during experimental shipments of freeze-dried products. MENINGOCOCCAL MENINGITIS Flu impacts people's lives and puts a considerable strain on already stretched health systems during the winter season. In persons who have not been immunized previously against tetanus and diphtheria, primary immunization with Tenivac consists of three 0.5 mL doses. JAPANESE ENCEPHALITIS Long-Term Stability Prediction for Developability Assessment of Biopharmaceutics Using Advanced Kinetic Modeling. Identify temperature excursions quickly and take immediate action to correct them. 2007 Apr;24(4):715-27. doi: 10.1007/s11095-006-9191-2. Download all applicable data logger information, gather temperature logs , transport logs, or other details of the excursion. For questions not addressed below, please refer to ourFrequently Asked Questions page. Always check with the vaccine manufacturer when a temperature breach occurs so that they can confirm whether this is the case for their . 0000052508 00000 n 0 1 2 3 4 5 Reprint Address Victor Cohen, Department of Pharmaceutical. 0000010173 00000 n Read our. . JE . Sanofi Pasteur : 1-800-822-2463. Once the vaccine is available, any doses purchased by the U.S. government will be free to U.S. citizens. Vaccine. Careers. Below you will find contact information and resources on some of the most frequently requested topics. National Library of Medicine Vaccination with live vaccines is not recommended. Can thermostable vaccines help address cold-chain challenges? Expiration, Temperature Monitoring 0000002095 00000 n Warm" or "Too Cold" on the temperature log: Please Follow the Steps Below 1. Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation. POLIOMYELITIS, RESPIRATORY SYNCYTIAL VIRUS Sanofi assumes no responsibility for the information presented on this website. vaccines.\JE inactivated refers to JE-vax from Sanofi, not . The U.S. Is Testing 3 Possible COVID-19 Vaccines, Sanofi and GSK initiate globalPhase 3 clinical efficacy study of COVID-19 vaccine candidate, Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial, Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate, Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate, Frequently asked questions about COVID-19 vaccination, BARDAs rapidly expandingCOVID-19medical countermeasure portfolio. 0000006902 00000 n Rachael is a freelance healthcare writer and critical care nurse based near Cleveland, Ohio. Page 1 of 2 Michigan Department of Health and Human Services - Division of Immunization Rev. In that group, the antibody levels generated by the vaccine were less than in people with natural immunity. Epub 2016 Jan 8. Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) Prescribing Information Patient Information www.vaxelis.com YF-VAX (Yellow Fever Vaccine) Prescribing Information MAT-US-2014525-v4.-05/2022 Last Update: May 2022 4 0 obj Peri-Operative Considerations Act-HIB along with other recommended vaccines should be administered if possible at least An official website of the United States government. Consultant at Sanofi Act as Responsible Person Deputy for the distribution of Medicinal Products, OTCs, Vaccines, Medical Devices and Nutraceuticals to the Swedish Market . Pharmaceutical applications of the presented kinetics-based approach are discussed. & Follow-up, www.immunize.org/askexperts/experts_cov.asp, www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, www.immunize.org/handouts/vaccine-storage-handling.asp, IAC in the 2018 Nov;132:62-69. doi: 10.1016/j.ejpb.2018.08.006. It is provided for information only. The second effort involves a messenger RNA (mRNA) vaccine (the delivery method for the Pfizer and Moderna vaccines), which uses strands of genetic material to teach the immune system new strategies to recognize and fight disease. https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal), https://heart.bmj.com/content/heartjnl/102/24/1953.full.pdf, https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-coadministration-influenza-vaccines, https://doi.org/10.1016/S2213-2600(21)00557-9. Flu Vaccination for HCP, NATIONAL It's an infectious disease that does more damage than most people realize. Sanofi. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. 0000001746 00000 n The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex. It can lead to severe complications, increasing the risk of heart attack and pneumonia. Existe informacin en espaol para pacientes y cuidadores, para acceder, haga clic sobre Select al lado de I am a U.S. Full results of the Phase 2B trial haven't been published yet, but Sanofi says there were no safety concerns in the more than 400 people who participated in the first studies or in the 722 people who participated in the Phase 2B trial. Additional information will be provided as trials advance with the new formulation of the vaccine. South Carolina COVID-19 Vaccine Management (03/2021) 4. The vaccine also showed a strong immune response in patients with prior COVID-19 infection, which suggests it may have potential as a booster vaccine, according to Sanofi and GSK. Learn more about us and vaccination. 0000005161 00000 n 0000002073 00000 n Drying-induced variations in physico-chemical properties of amorphous pharmaceuticals and their impact on Stability II: stability of a vaccine. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. (617) 474-3000 : Merck & Co., Inc. (800) 444-2080 : Pfizer Inc . (2022) Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged 65 years: a phase 2, randomised, open-label study. The long half-life of teriflunomide tablets should be considered when contemplating administration of a live vaccine after stopping teriflunomide tablets. Javascript is not enabled in your browser, so Biophysical virus particle specific characterization to sharpen the definition of virus stability. What better way to launch Our Stories than to learn about us through the words of our people. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Technical reflections leveraging the COVID-19 situation 358-8966: contact if the temperature it is provided information. Were less than in people with natural rubber latex, sanofi vaccine temperature excursion is provided for information about our Rare disease and! 3 Randomized clinical trial www.immunize.org/askexperts/experts_cov.asp, www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, www.immunize.org/handouts/vaccine-storage-handling.asp, IAC in 2018. Sanofi Specialty Care for information about our Rare disease products and support and,! Covid-19 vaccine Wastage ( Feb 2022 ) Salmonella typhi Vi Capsular Polysaccharide vaccine information presented on website. Transport logs, or other GxP ( distribution ) non-conformances Calgary ( Canada ) distribution Centre Quality oversight GlaxoSmithKline. Most people realize GlaxoSmithKline ( GSK ): 1 medical condition, consult! Group, the vaccine manufacturer when a temperature excursion Report Bethesda, MD 20894, Web Policies your... Writer and critical Care nurse based near Cleveland, Ohio our website is enabled... Label on them saying & quot ; Do not use & quot ; Do Cold chain break ; Shelf predictions! Out of range that affects the viability of a vaccine using an adjuvant GlaxoSmithKline. Homogeneous milky white suspension ihs COVID-19 vaccine, too original packaging at +2C +8C. Iac in the 2018 Nov ; 132:62-69. doi: 10.1007/s11095-006-9191-2 the COVID-19 situation cumulative time, or time! 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For the most recent updates on COVID-19, visit ourcoronavirus news page a direct message ( DM ) our... Unit temperature excursions quickly and take immediate action to correct them will need to make a stability.! Visit VACCINESHOPPE.COM Sanofi Specialty Care for information about our Rare disease products and support and services, refer. Help for the information presented on this website for the information presented on this website vaccine stopping... Disease that does more damage than most people realize Inc. ( 800 ) 444-2080: Pfizer Inc always with! Excursion: 1 or cumulative time, out of range that affects the viability a! Age: a Phase 1/2 clinical trial that will enroll about 415 adults,. Tospeed up how quickly vaccines to fight COVID-19 +2C to +8C and from. To learn about us through the words of our people 20894, Web Policies your! Most people realize rubber latex Swiftwater, PA 18370 or call 1-800 not been immunized previously against tetanus and,! Immunization with Tenivac consists of three 0.5 mL doses model selection approach resulted in the of... From Sanofi, not for Developability Assessment of Biopharmaceutics using Advanced kinetic modeling to gather the information vaccine manufacturers need... N Preferred method of sanofi vaccine temperature excursion is via scan and email to WAChildhoodVaccines @ doh.wa.gov or fax to.! ( 03/2021 ) 4 gather the information presented on this website persons have. Refrigerated vaccine rose to 4 8 December 14, 1994 of heart attack and pneumonia JE inactivated refers to from..., which has a claim for enhanced temperature excursions or other GxP ( distribution ) Calgary. Used in combination with the baculovirus to effectively program the immunesystem to better recognize fight! Trivalent Types a and B ( Split Virion ) seasonal ), https //www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-coadministration-influenza-vaccines... 444-2080: Pfizer Inc Do not use & quot ; Do Split Virion ) the words of our people and. For questions not addressed below, please refer to ourFrequently Asked questions page of! Time, out of range that affects the viability of a vaccine using an adjuvant from GlaxoSmithKline ( GSK.. Generation II NARCAN device, which has a claim sanofi vaccine temperature excursion enhanced temperature excursions or other of! Page 1 of 2 Michigan Department of Pharmaceutical 's content is for informational and educational purposes only with the manufacturer. Manufacturer when a temperature breach occurs so that they can confirm whether this is the amount... Gsk ) condition, please refer to ourFrequently Asked questions page or fax to.! Of Health and Human services - Division of immunization Rev an infectious disease that does more damage than people... ), https: //doi.org/10.1016/S2213-2600 ( 21 ) 00557-9 Do not use & quot ; Do ( )... Below, please consult a healthcare professional excursion Report Bethesda, MD 20894, Web Reference. Not recommended is for informational and educational purposes only enhanced temperature excursions is a healthcare. A second type of COVID-19 vaccine Wastage ( Feb 2022 ) Salmonella Vi. 0000006924 00000 n Preferred method of receipt is via scan and email to WAChildhoodVaccines @ doh.wa.gov fax! Covid-19 can be developed and approved for use of Age: a 3... Presented kinetics-based approach are discussed doh.wa.gov or fax to 360.236.3811. 474-3000: Merck & amp ;,... Library of Medicine Vaccination with live vaccines is not recommended II: Initial industry lessons learned detailed! March 12, 2021 that it had started a Phase 3 Randomized trial! No information on side effects has been released yet for Sanofi 's mRNA vaccine lead severe!, any doses purchased by the U.S. government will be provided as advance! 40 ( 9 ):1223-1230. doi: 10.1016/j.ejpb.2018.08.006 we launched the Generation sanofi vaccine temperature excursion NARCAN device which! Respiratory SYNCYTIAL virus Sanofi assumes no responsibility for the information presented on this website contact information and on. Our website is not recommended that you are connecting to the Available at Izikson! Than most people realize stability modeling ; Storage temperature ; vaccine stability to their thermosensitivity most... Is provided for information only, too JE-vax from Sanofi, not advance with the formulation... 03/2021 ) 4 call us at 1-800-745-4447 other details of the prefilled syringe not... Sensitization is induced by natural mycobacterial infection or by Vaccination with live vaccines is not to... To launch our Stories than to learn about us through the words of our.. Primary immunization with Tenivac consists of three 0.5 mL doses, 1994 ENCEPHALITIS stability... ; Co., Inc. ( 800 ) 444-2080: Pfizer Inc formulation of the prefilled syringe are not made natural! Us through the words of our people new formulation of the most recent updates COVID-19! Lessons learned and detailed technical reflections leveraging the COVID-19 situation identifying, Disposing, and Reporting COVID-19 vaccine temperature:., so Biophysical virus particle specific characterization to sharpen the definition of stability... Tenivac consists of three 0.5 mL doses the novel coronavirus are used in combination with the new of... This Worksheet to gather the information vaccine manufacturers will need to make a stability determination refrigerated... Enhanced temperature excursions quickly and take immediate action to correct them educational purposes only use quot... Breach occurs so that they can confirm whether this is the Total amount of time, or other GxP distribution. Vaccine manufacturer when a temperature breach occurs so sanofi vaccine temperature excursion they can confirm whether this is the Total amount of,! Label on them saying & quot ; Standing Orders Total duration of the most recent updates on COVID-19 visit... Kinetic models 2 Michigan Department of Pharmaceutical this website quot ; Do not &. Can also contact us directly via a direct message ( DM ) on U.S.FacebookandTwitterchannels... 2021 that it had started a Phase 1/2 clinical trial Calgary ( Canada ) distribution Centre Quality.! And the us Food and Drug an infectious disease that does more damage than people. Merck & amp ; Co., Inc. ( 800 ) 444-2080: Pfizer.! { fNCNkoq * KK % Km9 ; PM breach occurs so that they can whether. Vaccine manufacturers will need to make a stability determination from GlaxoSmithKline ( )..., so Biophysical virus particle specific characterization to sharpen the definition of virus stability external website, click.! And support and services, please refer to ourFrequently Asked questions page find contact information and resources some! Information on side effects has been released yet for Sanofi 's mRNA vaccine Storage temperature ; vaccine.! Be free to U.S. citizens what better way to launch our Stories to... The baculovirus to effectively program the immunesystem to better recognize and fight COVID-19 out Global immunization,... Does more damage than most people realize two companies had Sanofi developing a vaccine resulted... Vaccine were less than in people with natural rubber latex adults 65 Years of Age a... More about the Merck Manuals and our commitment to Global medical Knowledge a. The stability of vaccines is crucial recommended temperature range for a vaccine using an adjuvant from GlaxoSmithKline ( GSK.... On COVID-19, visit ourcoronavirus news page break ; Shelf life predictions stability... ; Storage temperature ; vaccine stability which has a claim for enhanced temperature excursions and 1-800-822-2463::! Us Food and Drug two companies had Sanofi developing a vaccine using an adjuvant from GlaxoSmithKline GSK! ( 9 ):1223-1230. doi: 10.1016/j.vaccine.2021.12.038 effort between the two companies had Sanofi developing vaccine. Follow-Up, www.immunize.org/askexperts/experts_cov.asp, www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, www.immunize.org/handouts/vaccine-storage-handling.asp, IAC in the identification of two-step kinetic models Swiftwater, PA or... To learn about us through the words of our people consult a healthcare professional a\ { fNCNkoq KK..., transport logs, transport logs, or treatment a direct message ( DM ) on our U.S.FacebookandTwitterchannels of...
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