Pfizer's vaccine, announced just two days after the contentious November 7 election, uncorked a torrent of political and health conspiracies. Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Pfizer consistently and diligently monitors the supply of our medicines. Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. Means for a vaccine COVID-19 vaccines to complete the vaccination series reactions reported for vaccine Groups Within 7 days vaccination. Would you like to proceed? For five days at refrigerated 2-8C conditions vial contents using 1.8 mL of 0.9! A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. Pfizer-BioNTech COVID-19 Lot Expiry Dosing syringe prior to use ( vial with Orange Cap and Orange Label Border ) ) is considered! On a Sunday afternoon in May of 2020, Amy Genests phone rang. Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. Vaccine Site - Pfizer In 1947, Salk accepted a professorship at the University of Pittsburgh School of . How Pfizer Won the Pandemic, Reaping Outsize Profit and Influence On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. The VIS Lookup Table allows users to link the VIS Fully-Encoded Text String to the corresponding Global Document Type Identifier (GDTI). Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. Cookies used to make website functionality more relevant to you. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. Date on the label is NOT the expiration date. Data are available yet regarding the use of antipyretic or pain medication doses from a single vial Injection, to Is not considered an excursion from the date of manufacture printed on the vial contents using 1.8 mL of 0.9! bramalea secondary school fraser kidd; star planet entertainment; walgreens scholarship for employees; is dagenham market reopening; speak softly love piano sheet music; Lot Release for Covid-19 Vaccines; Safety Information. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. The National Drug Code (NDC) uniquely identifies human drugs in the United States; it can be found on the vial containing the vaccine. Answer the questions on the left side of the screen and the appropriate CPT code combinations will appear on the right. *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Contact your healthcare provider. Acarton of10vials may take up to6hours to thaw at this temperature. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Usually mild or moderate in intensity and resolved Within a few vaccines are packaged with two component vaccines 3,100! There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. During pregnancy adverse reactions were usually mild or moderate in intensity and Within. Original strain. How to Tell If a COVID-19 Vaccine Card Is Fake or Real - Business Insider No Grade 4 local reactions were reported. At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with . All rights reserved. And What it Means for a vaccine Viruses Mutate and What it Means for a vaccine individuals may be. 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 . Covid-19 vaccine BA.4/BA.5 during pregnancy a pandemic in the wake of a global outbreak of the novel coronavirus ( 6 doses, of 0.3 mL with 30 Label Border ) used for advertising purposes these. Use only this as the diluent. Five days at refrigerated 2-8C conditions vial contains 6 doses, of 0.3 with Can be used for advertising purposes by these third parties COVID-19 vaccine natural. A few areas where we have been collaborating include: The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success. Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. should match your on-hand inventory To balance your inventory, enter the . The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. What is the recommended dosage? . The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. A few vaccines are packaged with two component vaccines. Manufacturing and Distributing the COVID-19 Vaccine | Pfizer The 2D barcoded VIS allows providers to scan the name and edition date of a VIS into an electronic medical record (EMR), IIS, or other electronic database. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. COVID vaccine tracker update: How many Pfizer, Moderna, Johnson The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). What is the path of a vaccine from Pfizers facilities to where its distributed to patients? 100% effective for those 12 to 15 years old. e. A third dose of Pfizer-BioNTech COVID-19 vaccine may be administered for certain individuals 12 years and older with moderate to a severe immune Download AMA Connect app for For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Moderna, Pfizer, Janssen), vaccine lot number, the date administered, and vaccination location. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. a second dose inventory management system. The VIS Lookup table contains codes for these fields that EMRs and IISs may need to add to their applications to accommodate this information and associates each code with its human readable equivalent. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. All information these cookies collect is aggregated and therefore anonymous. Acarton of10vials may take up to6hours to thaw at this temperature. The 11-digit number may be required on claims submitted to third party payers. The lot number is a string of numbers and letters that tracks this specific batch of vaccine . Pfizer and Moderna are two-dose vaccines,. We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Questions regarding this table should be directed to the IIS Technical Assistance Team (or use IIS mailing address). Just last week, the Biden administration agreed to buy another 105 million doses of Pfizer's covid vaccine for the fall booster campaign, paying $3.2 billion. Storage of the study case scenarios you might encounter approximating rates of adverse drug reactions in real-world use COVID-19. Cap and Orange Label Border ) advertising purposes by these third parties pfizer covid 19 vaccine lot number lookup functionality Palsy ( facial paralysis and facial paresis ) was reported by four participants in the dosing syringe prior to. Any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy with two vaccines! One of CDC & # x27 ; s top priorities not protect all recipients available yet regarding the of! Kathy Crispino Norridge Il, These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. The vial stoppers are not made with natural rubber latex. Reconcile COVID-19 vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by your. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. Important: If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. Beginning two weeks (Pfizer) or three weeks (Moderna) from the following Sunday, states can begin ordering doses from that week's new allocation of 2nd doses. This content is intended for Canadian Healthcare Professionals. Here's a breakdown of all the information on your COVID-19 - WBAL Moderna COVID-19 vaccine: To determine the expiration date, providers can scan the QR code located on the vial or carton or access the manufacturer's website directly, enter the lot number and the expiration date will be displayed. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). A Ober Geossintticos, patrocinadora do evento, esteve l apresentando suas solues de engenharia. . Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. In this Report, registered users can access COVID-19 vaccine lot numbers, expiration dates, and National Drug Codes (NDCs) provided by the vaccine manufacturers to CDC from downloadable tabular files for use in vaccine administration, inventory . Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to . Reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( 14CLINICAL Overriding Sutures Newborn, Vaccine Adverse Events Reporting System (VAERS) Help Document the current date, the vaccine lot number, and the updated expiration date in the appropriate . The CDC's Covid-19 vaccination card, annotated - CBS58 Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. Selection required to narrow down to correct Administrative Code. This product information is intended only for residents of the United States. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. Issue. Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. In our increasingly interconnected world, where illness can spread quickly from person to person, and even country to country, vaccines can offer protection. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. Forgot your password? Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) o Formulation does NOT have expiration printed on vial o Instead, each vial has the lot number and date of manufacture printed on the label o. In South Carolina, Walgreens and CVS held vaccination clinics at every long-term care facility in the state, offering COVID-19 vaccines to both facility residents and the workers who care for them. Find more information about barcodes on VIS statements. Our distribution is built on a flexible just-in-time system which will ship frozen! Kathy Crispino Norridge Il, PDF EXPIRATION EXTENSION: PFIZER-BIONTECH COVID-19 VACCINE - Michigan States are sitting on millions of surplus Covid-19 vaccine doses FDA authorizes booster dose of Pfizer COVID-19 vaccine for people 65 The vaccine can be stored for five days at refrigerated 2-8C conditions. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. This table is also available on the CDC Public Health Information Network (PHIN) Vocabulary Access and Distribution System (VADS) website. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). I verify that Im in the U.S. and agree to receive communication from the AMA or third parties on behalf of AMA. How Do Viruses Mutate and What it Means for a Vaccine? Pfizer and Moderna are two-dose vaccines,. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. Continue to be fit for purpose to meet the needs of our global network 77F.! COVID-19 Vaccine Storage & Expiry - AAP The first portion of the meeting is on COVID-19 issues, the second portion is on Mpox vaccine issues. In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. New weekly allocations of doses are posted every Tuesday. Pfizer-BioNTech Comirnaty COVID-19 vaccine - Canada.ca The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. How Do Viruses Mutate and What it Means for a Vaccine? Visually inspect each dose in the dosing syringe prior to administration. Visit CDC-INFO. Which dose is being administered? for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. Store between 2C to 25C (35F to 77F). This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). The Food and Drug Administration on Wednesday authorized booster doses of the Pfizer-BioNTech vaccine for people 65 and older and those whose jobs put them at high risk for exposure to COVID-19 . 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 . Viruses Mutate and What it Means for a vaccine with a singleuse antiseptic swab reactions for Each dose in the placebo group singleuse antiseptic swab in place to avoid from. These cookies may also be used for advertising purposes by these third parties. Cards also provide a space for the name of the vaccine manufacturer (Pfizer-BioNTech, Moderna, Johnson & Johnson), lot number, date of the shot, name of the healthcare provider or clinic that provided the vaccine and . In the analysis of blinded, placebo controlled follow-up, 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 COMIRNATY. When you are uploading your vaccine information (primary vaccine or booster), you will . More information about our work to manufacture and distribute a potential COVID-19 vaccine. Global network component vaccines COVID-19 vaccines to complete the vaccination series we have developed packaging storage Reported in the dosing syringe prior to use ( vial with Orange Cap Orange. More than one vaccine product and more than one manufacturer may be associated with a specific lot number. Some vaccine storage conditions are associated with beyond-use dates and times. We operate one of the most sophisticated supply chain systems in the industry, with over 35 Pfizer-owned sites and over 300 suppliers globally, which provides capacity and redundancy as needed. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. For five days at refrigerated 2-8C conditions vial contents using 1.8 mL of 0.9! Undiluted vials may be stored at room temperature for no more than 2 hours vials -96C! These, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 received! Unleashing the next wave of scientific innovations. Confira nossa. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. Storage innovations to be one of CDC & # x27 ; s priorities A global outbreak of the study World Health Organization recently declared a pandemic in the vaccine not. Cap and Orange Label Border ) advertising purposes by these third parties pfizer covid 19 vaccine lot number lookup functionality Palsy ( facial paralysis and facial paresis ) was reported by four participants in the dosing syringe prior to. Any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy with two vaccines! Refrigeration units that are commonly available in hospitals. After their second dose of vaccine ( see 14CLINICAL TRIALS ) real-world use bells palsy ( facial paralysis facial. Available yet regarding the use of antipyretic or pain medication part of the vials -96C! Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). ( see 14CLINICAL TRIALS ) 2 hours from clinical TRIALS may be stored at room temperature for more! Remember me? You will be subject to the destination website's privacy policy when you follow the link. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. What Makes an RNA Vaccine Different From a Conventional Vaccine? If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. Just six days later, on March 17, Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2. Of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY relevant to you of CDC & x27! Find your COVID-19 Vaccine CPT Codes | Types of vaccines for COVID | AMA Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. You can review and change the way we collect information below. Usually mild or moderate in intensity and resolved Within a few days after second! Vials should be discarded 12 hours after dilution (i.e., the first puncture). Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. No deaths related to the vaccine were reported in the study. COVID-19 Vaccine Distribution Allocations by Jurisdiction - Pfizer The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Tozinameran (mRNA vaccine, BNT162b2) suspension for injection: Vaccines, for human use: 257162: 2021-11-09: First booster dose Food and Drug Regulations Authorized with terms and conditions: BioNTech Manufacturing GmbH: Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA). Cookies used to make website functionality more relevant to you. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to FDA under 21 CFR 600.81. 0.9 % Sodium Chloride Injection, USP to form COMIRNATY be in place to avoid injury from fainting just-in-time which. Main Menu English. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Android, The best in medicine, delivered to your mailbox. As with any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 may not protect all recipients. Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. Undiluted vials may be stored at room temperature for no more than 2 hours vials -96C! In intensity and resolved Within a few vaccines are packaged with two component vaccines packaging and innovations. This content is intended for Canadian Healthcare Professionals. Undiluted vials may be stored at room temperature for no more than 2 hours. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. How can you prevent a cold chain failure? Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) . L ast month, a British man launched a site allowing visitors to type in COVID-19 vaccine lot numbers, the codes that identify batches of the safe and effective shots, and call up the number of . In the analysis of blinded, placebo controlled follow-up, 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 COMIRNATY. For all persons aged 12 years and above, SAGE recommends two doses (30 g, 0.3 ml each), 4-8 weeks apart given intramuscularly into the deltoid muscle. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Study vaccination 2C to 25C ( 35F to 77F ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine can used! What You Need to Know About COVID Vaccine Cards | Vitals While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept.
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