what is polysorbate 80 made from

Both vaccines were well tolerated, though Cervarix was associated with a higher rate of injection site reactions. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) vaccines in healthy women aged 18-45 years. Siegrist CA, Ambrosioni J, Bel M, Combescure C, Hadaya K, et al. What about scientific studies? They found that both vaccines were well tolerated, though Cervarixwas associated with a higher rate of injection site reactions, fatigue and myalgia, which were transient and resolved spontaneously without sequelae. During the 2009 H1N1 pandemic, solid organ transplant (SOT) recipients in Switzerland received two doses of an AS03-adjuvanted influenza vaccine (Pandemrix). Urea, also known as carbamide, â€œoccurs not only in the urine of all mammals but also in their blood, bile, milk, and perspiration” as proteins are broken down by normal bodily functions ( here ). Some excipients are known as stabilizers, or ingredients used “to keep the vaccine potent during transportation and storage” ( here ). Philadelphia, PA 19104. Adjuvanted vaccines had a higher rate of injection site reactions and certain generalized reactions (e.g., fatigue, headache) compared with the non-adjuvanted vaccine but within acceptable limits. The Vaccine Education Center staff regularly reviews materials for accuracy. The Children’s Hospital of Philadelphia states that Hepatitis B vaccines are “made using baker’s yeast and residual quantities of yeast proteins are contained in the final product.” It also notes that severe allergic reactions have been reported by recipients of the Hepatitis B vaccine, although an allergy to yeast is not confirmed to be the cause of these reactions ( here ). The Boot List provides accountability for us to stock the best and highest quality products in all Earth Fare stores. Analysis of adverse events of potential autoimmune aetiology in a large integrated database of AS04 adjuvanted vaccines. Find out in which vaccines aluminum is used, how much aluminum is present, and how we know it is safe. Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, et al. Shop The Ordinary’s Buffet at Sephora. No serious adverse events were reported for any group. Stassijns J, Bollaerts K, Baay M, Verstraeten T. A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children. For a list of studies related to aluminum in vaccines, visit the aluminum page. This article was produced by the Reuters Fact Check team. The National Library of Medicine states that monosodium L-glutamate is the “optically active” form monosodium glutamate, commonly known as MSG and used as a flavoring agent ( here ). Vaccine 2018;36:2604-2611. For example, in 1916, four children died, 26 developed local abscesses, and 68 developed severe systemic infections after receipt of a typhoid vaccine contaminated with the bacteria Staphylococcus aureus. The authors investigated 5,000 patients who received the 2009 A/H1N1 pandemic vaccine and an additional 11,000 subjects who received adjuvanted (AS03) A/H5N1 vaccines. In most cases, the quantities are so minimal that they do not cause allergic reactions or symptoms of toxicity. Reuters recently fact-checked a claim about the flu vaccine containing toxic levels of formaldehyde ( here ). Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. Vaccinated women had a significantly lower risk of preterm birth (< 37 weeks), low birth weight, early neonatal mortality, perinatal mortality (early neonatal mortality plus fetal mortality), low APGAR scores, infant non-immune jaundice, hospital admission during pregnancy, and first trimester hemorrhage compared with women who were not vaccinated during pregnancy. Vaccine 2016; 34:714-722. Although some studies have raised safety concerns related to reproductive problem ( here ) an expert group at the European Medicines Agency has categorized the danger of polysorbate 80 as “very low” ( here ). Gelatin is commonly found in some measles, mumps, rubella (MMR), typhoid and yellow fever vaccines, while urea is less common, but can be found in dengue and varicella vaccines ( here ). Although Polysorbate 80 is quite similar in structure to PEG, there are no reports of PEG allergic patients reacting to it e.g. Learn more about how vaccines are made. Monophosphoryl lipid A — This substance was isolated from the surface of bacteria. Amazon.com: Men's Face Cream Moisturizer - Anti Aging Facial Skin Care - Made in USA - Collagen, Retinol, Hyaluronic Acid - Day & Night - … The authors compared HerpV + QS21 (saponin adjuvant), HerpV alone, QS-21 alone and placebo. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. The adjuvanted vaccine was associated with more injection site reactions, but the rates of serious adverse events were similar between groups, with all events determined to be unrelated to vaccination. The authors describe the safety aspects of three trials comparing a CpG-ODN adjuvanted hepatitis B vaccine with an aluminum-adjuvanted hepatitis B vaccine in more than 13,000 adult subjects. The VKP states that polysorbate 80 is an emulsifier commonly used in food and drinks ( here ). Second, polysorbate 80 has been used for many years as an emulsifier to make ice cream smooth and to slow melting. Adjuvanted (AS03) A/H1N1 2009 Pandemic influenza vaccines and solid organ transplant rejection: systematic signal evaluation and lessons learnt. The HPV vaccine contains polysorbate 80 as a stabilizer. polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein DTaP-IPV/Hib (Pentacel) 1/2019 . For a list of studies related to thimerosal (mercury) in vaccines, visit the thimerosal page. Vaccine–associated adverse events were limited to mild to moderate local and systemic post-injection reactions. The authors found that Cervarix induced superior vaccine responses in HIV-infected women. The group receiving adjuvanted influenza vaccines did not experience an increase in the incidence of serious adverse events. Pellegrini M, Nicolay U, Lindert K, Groth N, Della Cioppa G. MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database. The CDC warns that the “Hepatitis B vaccine is not recommended for anyone who is allergic to yeast, or to any other component of the vaccine” and it can pose the risk of a severe allergic reaction to those with hyper-sensitivity to yeast ( here , here ). The authors investigated the safety and immunogenicity of PCV-13 manufactured with or without polysorbate 80 (P80) in infants at 2, 3, 4 and 12 months of age. The authors compared the safety and immunogenicity of two doses of AS03-adjuvanted vaccine in more than 200 SOT recipients (heart, lung, liver, kidney, pancreas/islet of Langerhans) to one dose in healthy family controls. Preservatives are used in some vaccines to prevent bacterial or fungal contamination. As a consequence of this and similar incidents, preservatives have been required for vaccines contained in multi-dose vials (with some exceptions) since the 1930s. Just took a DNA test ... turns out this is 100% that blush. A typical serving of ice cream (1/2 cup) may contain about 170,000 micrograms* of polysorbate 80. ... NATURAL AND ARTIFICIAL FLAVORS, MONOCALCIUM PHOSPHATE, CALCIUM SULFATE, DEXTROSE, SODIUM SILICOALUMINATE, POLYSORBATE 80, XANTHAN GUM, … The study, however, also noted that: â€œnone of the compounds commonly used as preservatives in US licensed vaccine/biological preparations can be considered an ideal preservative, and their ability to fully comply with the requirements of the US Code of Federal Regulations (CFR) for preservatives is in doubt.”. Pediatr Infect Dis J 2015;34:180-185. Yeast protein can be found among excipient ingredients for Hepatitis A, Hepatitis B, and HPV vaccines ( here ). Salts based on potassium phosphate can commonly be found in different kinds of influenza vaccines ( here ). Children’s Hospital of Philadelphia is a charitable 501(c)(3) nonprofit organization. Because of the fear by parents that thimerosal contained in vaccines might have harmed their children, numerous studies have been conducted to address this concern. The vaccine was well tolerated and safe, and adverse events were similar between HerpV and HerpV + QS-21 groups. Ingredi is your premium supplier and distributor of high-quality bulk ingredients satisfying a wide range of industries including beverage, bakery, meat, personal care, and equipment care. The authors compared the safety and immunogenicity of malaria vaccines adjuvanted with squalene, monophosphoryl lipid A and saponin to a non-adjuvanted malaria vaccine in adults and found greater immune responses with adjuvanted vaccines. The only vaccine in the U.S. that currently uses this adjuvant is the shingles vaccine called Shingrix, MF59 â€” A substance composed of squalene oil emulsified in water. MF59 (oil-in-water emulsion composed of squalene as the oil phase, stabilized with the surfactants polysorbate 80 and sorbitan trioleate, in citrate buffer). (NTP, 1992) They found that data supported the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients. Hyer R, McGuire DK, Xing B, Jackson S, Janssen R. Safety of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in adults. Evaluation of the immune response to RTS,S/AS01 and RT,S/AS02 adjuvanted vaccines. The FDA states that the compound “is also currently used as a preservative in one FDA-approved available vaccine, Ipol, for the prevention of polio, at a concentration of 0.5%.” ( here ), A 2010 study entitled “The relative toxicity of compounds used as preservatives in vaccines and biologics” found that the relative toxicity of the preservative 2-phenoxyethanol on human cells was less than alternative preservatives used in vaccines ( here ). The authors compared the safety and immunogenicity of the 2012-2013 influenza vaccine with or without MF59 adjuvant in adult patients who had received a kidney transplant within a median time of 8.1 years. The authors assessed the safety of a monophosphoryl lipid A (MPL) containing adjuvant (AS04) in several vaccines (HPV 16/18, HBV, and phase 3 HSV). On the other hand, the amount of polysorbate 80 in each dose of the HPV vaccine — 50 micrograms* — is very small. The VKP also states that urea, a harmless organic compound found in the body, is also sometimes used as a stabilizer in vaccines. Sorbitan trioleate is a compound made from oleic acid (a natural fatty acid) and sorbitol, also found naturally in fruits and other foods. Baked blush … Polysorbate 80 is an amber-colored viscous liquid. These side effects typically resolved within seven days. Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicenter study. They are “common and harmless” acidity regulators, according to the Vaccine Knowledge Project ( here ). The authors compared the safety and immunogenicity of vaccination with trivalent inactivated influenza vaccine (TIV) versus MF59-adjuvanted TIV (aTIV) in children. Our Baked Bronzer will give your face a perfect glow and your complexion a bold, warm vibe. * A microgram is one-millionth of a gram, and a gram is the weight of one-fifth of a teaspoon of water. BMJ 2013;346:f393. While the table may be helpful for people concerned about particular allergies or ingredients, it is important to realize that the table does not indicate quantities in each vaccine. Potassium phosphate can be present in plant fertilizer. Monosodium L-glutamate is a common excipient in vaccines for adenovirus, influenza, and varicella ( here ). The authors found no increased risk of narcolepsy in children or adults in Argentina, Canada, Spain, Switzerland, Taiwan and the Netherlands following implementation of squalene-adjuvanted (AS03, MF59) influenza H1N1 vaccines in those countries. Kidney Int 2005;68:2298-2303. It is therefore true that polysorbate 80, a common emulsifier in the food industry, can be used in vaccines to keep components soluble, but health experts have determined risk of exposure to the substance as low. Adjuvants are substances added to vaccines that allow them to work better by enhancing the immune response to the vaccine, decreasing the quantity of vaccine needed to gain protective immunity, or lowering the number of doses required. Some stories on the internet have suggested that polysorbate 80 in this vaccine causes infertility. There are many published studies which analyze Polysorbate 80, but it is important to recognize their limitations before generalizations are made. Second, polysorbate 80 has been used for many years as an emulsifier to make ice cream smooth and to slow melting. Toft L, Storgaard M, Muller M, Sehr P, Bonde P, et al. Some vaccines contain small amounts of formaldehyde, aluminum, gelatin, urea, potassium phosphate, human albumin, polysorbate 80, 2-phenoxyethanol, yeast protein and monosodium L-glutamate but the presence of these substances does not pose a credible safety concern. The CDC notes that in addition to the antigens from viruses or bacteria contained in vaccines, there are also small amounts of other inactive ingredients known as excipients. Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons. According to Medical News Today, polysorbate 80 is â€œused in the food industry in ice creams, gelatin desserts, barbecue sauce, and pickled products. The authors compared Fluarix® (full or 1/10th dose) plus CPG 7909 to Fluarix® (full or 1/10th dose) plus saline and found all vaccines were generally well tolerated. On the other hand, the amount of polysorbate 80 in each dose of the HPV vaccine — 50 micrograms* — … To read about some of these studies, go to the "Thimerosal (mercury) and vaccines" section of our vaccine safety references page. Reuters was otherwise unable to corroborate a list of comprehensive safety concerns related to the substance when administered through vaccines. when receiving other vaccines and therefore the Astra Zeneca vaccine is recommended as a suitable alternative. A 2003 study in the Academy of American Pediatricians’ journal Pediatrics states that human serum albumin is contained in certain MMR vaccines. Vaccine 2018; 38:6202. Bigaeva E, van Doorn E, Liu H, Hak E. Meta-analysis on randomized controlled trials of vaccines with QS-21 or ISCOMATRIX adjuvant: safety and tolerability. The requirement for preservatives in vaccines arose from many incidents in the early 20th century of children who developed severe and occasionally fatal bacterial infections after administration of vaccines contained in multi-dose vials. Antigens can be considered the active ingredients in vaccines because they are the parts of the vaccine to which an immune response is generated. PLoSONE 2016;11(5):e0154757. Read more about our work to fact-check social media posts here . Vaccine 2009;27:6959-6965. They found that aTIV produced a significantly more robust immune response and a slightly higher but acceptable local and systemic reactions compared with TIV. Cooper CL, Davis HL, Morris ML, Efler SM, Kreig AM, et al. Polysorbate 80 and sodium citrate are commonly used in food and drink. Printable vaccine ingredients question and answer sheet:English [PDF, 817KB]Spanish [PDF, 832KB], 3401 Civic Center Blvd. Materials in this section are updated as new information and vaccines become available. “As well as keeping the pH balance,” the VKP states, “they also help to keep the fragments of active ingredient suspended in the water, so that they do not settle out.”. However, these concerns were proven to be unfounded. The authors compared the immune response and safety of Cervarix®, a monophosphoryl lipid A-containing- HPV vaccine with Gardasil®, an aluminum-adjuvanted HPV vaccine in healthy adult women. Aluminum salts — Salts that contain aluminum have been used in vaccines since the 1930s. See here for a complete list of exchanges and delays. Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines — multi-country assessment. They found no significant differences in response to the vaccine between groups and no evidence of HLA upregulation in transplant recipients who received adjuvanted vaccine. The immune response and safety of Cervarix®, a monophosphoryl lipid A-containing-HPV vaccine with Gardasi®l, an aluminum-adjuvanted HPV vaccine were compared in HIV infected adults. You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. It is used in the U.S. in a version of the influenza vaccine called FLUAD, CpG — Two nucleic acids, Cytosine (C) and Guanine (G), which are found in DNA, are linked to form an adjuvant that is contained in a hepatitis B vaccine (Heplisav-B, ©2021 The Children’s Hospital of Philadelphia. Therefore, polysorbate 80 isn’t contained in vaccines at quantities that could possibly do harm. Leroux-Roels G, Leroux-Roels I, Clement F, Ofori-Anyinam O, Lievens M, et al. Concerns have also been voiced about SV40, a virus found in cells used to grow the poliovirus vaccine during the 1950s and 1960s. The CDC says, â€œadjuvanted vaccines can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.” It also notes, however, that “in all cases, vaccines containing adjuvants are tested for safety and effectiveness in clinical trials before they are licensed for use in the United States, and they are continuously monitored by CDC and FDA once they are approved.” ( here ), The Children’s Hospital of Philadelphia notes that adjuvants allow “lesser quantities of the vaccine and fewer doses”, by stimulating the body’s immune response. While in large doses it can cause harm, the U.S. Food and Drug Administration (FDA) categorizes dipotassium phosphate as "generally recognized as safe" (GRAS)  ( here ). Vesikari T, Forsten A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Weibel D, Sturkenboom M, Black, S, et al. First, it is important to know that the HPV vaccine does not cause infertility. Safety and immunogenicity of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine. A viral image on social media makes the claim that vaccines contain toxic levels of a range of substances. In 2010, the European Medicines Agency (EMA) requested an assessment of available data following a signal of solid organ transplant (SOT) rejection after immunization with either of GlaxoSmithKline’s (GSK) two adjuvanted (AS03) pandemic influenza vaccines, Pandemrix® and Arepanrix® H1N1. The Centers for Disease Control and Prevention (CDC) has compiled the ingredient list for most vaccines into a table. The formaldehyde in vaccines poses no documented safety risks like the ones listed in the post on social media. Thimerosal is no longer used as a preservative in any childhood vaccine routinely used in the U.S. with the exception of some vials of the influenza vaccine. Gadzinowski J, Tansey SP, Wysocki J, et al. Drug Saf 2017;40:693-702. The authors compared the immunogenicity and safety of an AS04-adjuvanted hepatitis B vaccine with a non-adjuvanted hepatitis B vaccine and found the AS04-adjuvanted vaccine produced a more rapid onset and greater overall level of protection, necessitating fewer booster doses. A multi-peptide serum with hyaluronic acid, amino acids, and bio-derivatives to target multiple signs of aging. No serious adverse events occurred in either group. Partly false claim. Aluminum can be found in several vaccines including DTaP and Hepatitis A ( here ). The result is that no viral diseases have ever been associated with the use of human serum albumin.” ( here ). Faint odor and bitter taste. According to the CDC, polysorbate 80 is an excipient commonly found in vaccines for influenza, Hepatitis B, HPV, and meningococcus ( here ). The National Library of Medicine has compiled case reports of some vaccine reactions stemming from the presence of 2-phenoexyethanol ( here ). According to the FDA, 2-Phenoxyethanol is an organic chemical compound that is sometimes used in cosmetics and antiseptics. Currently, five types of adjuvants are approved for use in the United States: Stabilizers are used in vaccines to protect the integrity of the active ingredients during manufacture, storage and transport. Under the heading “Vaccine Ingredients” the image lists the following ingredients and risks associated with each: â€œformaldehyde (toxic chemical, used in embalming), aluminum (toxic to the brain), gelatin (mashed up animal parts), urea (waste from human urine), potassium phosphate (used for fertilizer), human albumin (different kinds of human blood), polysorbate 80 (can cause infertility, toxic chemical), 2-phenoxyethanol (used for antifreeze), yeast protein (a fungus) and monosodium L-glutamate (causes diabetes & weight-gain)” ( here ; here ). One image is accompanied by text that reads: “This is disgusting what they put in vaccines and convince you it’s good for you.” This claim on social media contains a mix of accurate and inaccurate information. CPG 7909, a CpG oligodeoxynucleotide (ODN), was tested for safety, tolerability and its ability to augment the immune response of a trivalent influenza vaccine. The U.S. Centers for Disease Control and Prevention (CDC) writes that aluminum, a naturally occurring metal also present in nature, has been used safely in vaccines for decades. The publication states: â€œbecause human serum albumin is derived from human blood there is a theoretical risk that it might contain infectious agents. Further, many of these ingredients are commonly found in other products. the food grade Polysorbate 80. Rubinstein F, Micone P, Bonotti A, Wainer V, Schwarcz A, et al. aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate DTaP-IPV-Hib-HepB (Vaxelis) 12/2018 The authors found no differences in immune-mediated adverse events between the two groups. The Military Health System writes that monosodium L-glutamate is â€œa stabilizer that protects vaccines from heat, light, humidity or acidity while they are stored.”  ( here ). Vaccine 2004;22:3136-3143. It is modified so that it is not harmful when added to vaccines. Vaccine 2010;28:7331-7336. The authors investigated the safety profile of MF59-adjuvanted and non-adjuvanted seasonal and pandemic influenza vaccines in more than 1,700 subjects aged 6 months to 18 years. Some examples include antibiotics, DNA, egg proteins, fetal tissues, formaldehyde, human proteins, and yeast. This glam is goals! Other than an increased risk of local and systemic reactions such as injection site reactions or irritability, vaccine recipients had a lower risk of cardiovascular events, new onset chronic diseases, or death. Hum Vacc Immunother 2014;10(8):2211-2219. Vaccine 2011;29(47):8520-8529. They found that serious adverse events did not occur more frequently in the groups receiving adjuvanted vaccines. Active Ingredients: Light mineral oil (1.0%), Mineral oil (4.5%) Inactive Ingredients: Boric acid, edetate disodium, octoxynol-40, polyquarternium-1 (preservative), polysorbate 80, purified water, … Adverse reactions occurred less frequently in the SOT group and SOT graft function remained unaffected. J Infect Dis 2014;209:1165-1173. Hum Vaccin Immunother 2015;11(8):2102-2112. A typical serving of ice cream (1/2 cup) may contain about 170,000 micrograms* of polysorbate 80. It is therefore true that monosodium L-glutamate is used in vaccines as a stabilizer, but this substance is recognized as safe. Because vaccines are made from viruses and bacteria, some chemicals and cell by-products used during vaccine production may remain in the final preparation in minute quantities. The authors conducted a systematic review on the safety of newly adjuvanted vaccines in more than 25,000 children ≤ 10 years of age, specifically those containing AS01, AS02, AS03 and MF59. Preservatives Chemicals (for example, thimerosal, phenol, 2-phenoxyethanol) may be added to vaccines to prevent serious infections which may result from bacterial or … Transplantation 2016;100;662-669. These large, controlled studies have not found evidence of harm. It is therefore true that gelatin and urea are sometimes contained in vaccines as stabilizers, but to call them “mashed up animal parts” and “waste from human urine” is misleading. Vaccine 2008;26:6630-6638. Randomized controlled trial of adjuvanted versus non adjuvanted influenza vaccine in kidney transplant patients. While the substances listed are present in certain vaccines, medical research suggest the levels are not harmful to the public. This study suggests a link between the ingredient and infertility in mice. Black S, Della Cioppa G, Malfroot A, Nacci P, Nicolay U, et al. When it comes to bronze brilliance -- we're all about the baked. Its role centers around providing and helping a plant store nutrients ( here ). However, the FDA requires that human serum albumin be derived from blood of screened donors and be manufactured in a manner that would eliminate the risk of transmission of all known viruses. Dos Santos G, Seifert HA, Bauchau V, Shinde V, Barbeau DM, et al. Refresh Optive adds glycerin to the carboxymethylcellulose in Refresh, and Refresh Optive Advanced adds Polysorbate 80. The Vaccine Knowledge Project (VKP) managed by the Oxford Vaccine Group at the University of Oxford states that gelatin â€œderived from pigs is used in some live vaccines as a stabiliser to protect live viruses against the effects of temperature. To call it a “toxic chemical” is therefore misleading. Gelatine in vaccines is highly purified and hydrolysed (broken down by water), so it is different from the natural gelatine used in foods” ( here ). A candidate vaccine, HerpV, against herpes simplex virus-2 (HSV-2) was tested for safety and immunogenicity in a phase 1 human adult study. See what the hype is about with our permanently popular Baked Blush line. Responses of solid organ transplant recipients to the AS03-adjuvanted pandemic influenza vaccine. Most often these components are whole viruses or bacteria, parts of the viruses or bacteria, or products made by bacteria, called toxins. Subjects in the MF59-adjuvanted group experienced a higher percentage of local and systemic reactions, such as injection site reactions or irritability. Our Standards: The Thomson Reuters Trust Principles. Kumar D, Campbell P, Hoschler K, Hildago L, Al-Dabbagh M, et al. pH (5% aqueous solution) 5-7. Approximately 30,000 pregnant women, including more than 7,000 vaccinated during pregnancy, and their newborns were evaluated to assess the risk of adverse perinatal events (fetal and maternal) associated with receipt of MF59-adjuvanted influenza vaccine. 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