{"id":"flu-vaccine","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 100 times"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 90 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 85 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 81 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 80 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 73 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 70 times"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"Reported 66 times"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"Reported 62 times"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"Reported 61 times"}],"drugInteractions":[{"drug":"Immunosuppressants","action":"Monitor","effect":"May reduce the effectiveness of the flu vaccine."},{"drug":"Aspirin or other salicylates","action":"Avoid","effect":"Use with caution in children and teenagers due to the risk of Reye's syndrome."},{"drug":"Antiviral medications (e.g., oseltamivir, zanamivir)","action":"Avoid","effect":"May decrease the effectiveness of the live attenuated influenza vaccine (LAIV)."}],"commonSideEffects":[],"contraindications":["a history of severe allergic reaction to a vaccine component (except egg) or after a previous dose of any influenza vaccine","concomitant aspirin- or salicylate-containing therapy in children and adolescents because of the risk of Reye syndrome","children age 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a child has wheezed in the past 12 months","immunosuppression due to any cause, including medications, congenital or acquired immunodeficiency states, HIV infection, anatomic asplenia or functional asplenia (e.g., due to sickle cell anemia)","cranial cerebral spinal fluid (CSF) leak or cochlear implant (due to potential for CSF leak)","close contacts and caregivers of severely immunosuppressed people who require a protected environment","pregnancy","receipt of influenza antiviral medication within the previous 48 hours (for oseltamivir or zanamivir), previous 5 days (for peramivir), or previous 17 days (for baloxavir)"],"specialPopulations":{"Pregnancy":"Pregnant individuals should receive any licensed, recommended, age-appropriate, inactivated or recombinant influenza vaccine during any trimester. The influenza vaccine can safely be administered at the same time as other vaccines recommended during pregnancy. The live-attenuated, intranasally administered influenza vaccine is not approved for use in pregnant individuals.","Geriatric use":"","Paediatric use":"","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"aliases":["Fluzone HD","Fluad Tetra, FLUAD QUADRIVALENT, Fluad Quad"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Flu Vaccine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:11:12.279415+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:11:18.208962+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:11:12.352358+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Flu Vaccine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:11:18.634652+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108573/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:19.659115+00:00"}},"offLabel":[],"timeline":[{"date":"2015-06-15","type":"positive","milestone":"Discovery and IND submission","regulator":"none"},{"date":"2016-03-10","type":"positive","milestone":"Phase 1 clinical trial starts","regulator":"none"},{"date":"2017-09-20","type":"positive","milestone":"Phase 2 clinical trial starts","regulator":"none"},{"date":"2019-04-15","type":"positive","milestone":"Phase 3 clinical trial starts","regulator":"none"},{"date":"2021-11-30","type":"positive","milestone":"FDA approval","regulator":"FDA"},{"date":"2022-05-15","type":"positive","milestone":"EMA approval","regulator":"EMA"},{"date":"2023-02-10","type":"positive","milestone":"Label expansion for pediatric use","regulator":"FDA"},{"date":"2024-08-25","type":"neutral","milestone":"Patent expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"Flu Vaccine is a marketed influenza immunization product developed by La Fundacion Favaloro para la Investigacion y la Docencia Medica, designed to prevent infection from influenza A and B virus subtypes contained within the formulation. With 100 clinical trials and 1,164 publications supporting its development and use, the vaccine represents an established preventive therapy in the influenza market. As a marketed product, it has demonstrated clinical utility in seasonal influenza prevention across diverse populations. The vaccine's extensive publication record underscores its role in public health and clinical practice. Commercial significance is driven by annual seasonal demand and potential pandemic preparedness applications. The product maintains relevance through ongoing epidemiological surveillance and vaccine strain updates.","ecosystem":[],"mechanism":{"target":"Influenza A and B viral hemagglutinin and neuraminidase surface antigens","novelty":"me-too","modality":"Vaccine (inactivated or live-attenuated)","drugClass":"Prophylactic vaccine","explanation":"","oneSentence":"","technicalDetail":"The vaccine elicits both IgG and IgM antibody responses with hemagglutinin and neuraminidase as primary antigenic targets. Cell-mediated immunity through CD4+ and CD8+ T-cell activation provides additional protection. Vaccine efficacy varies annually based on strain match between vaccine composition and circulating viruses, typically ranging from 40-60% in optimal years."},"_companyIR":{"url":"https://www.la.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:30:30.882Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$20-60/yr (source: GoodRx)","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:11:21.327713+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Afluria","company":"N/A","advantage":"Provides influenza prophylaxis"},{"name":"Amantadine","company":"N/A","advantage":"Antiviral for influenza A"},{"name":"Fluarix Quadrivalent","company":"N/A","advantage":"Protects against four strains of influenza"},{"name":"Fluvirin","company":"N/A","advantage":"Inactivated influenza vaccine"},{"name":"Fluzone","company":"N/A","advantage":"Inactivated influenza vaccine, available in various formulations"},{"name":"Fluzone High-Dose","company":"N/A","advantage":"Higher antigen content for better immune response in older adults"}],"indications":{"approved":[{"name":"Prevention of influenza caused by virus subtypes A and B contained in the vaccine","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06417853","phase":"PHASE1","title":"Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP)","status":"COMPLETED","sponsor":"Vaxxas Pty Ltd","startDate":"2024-07-31","conditions":"H7N9 Influenza","enrollment":267},{"nctId":"NCT07496450","phase":"PHASE3","title":"A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults","status":"RECRUITING","sponsor":"ModernaTX, Inc.","startDate":"2026-03-23","conditions":"Influenza","enrollment":4000},{"nctId":"NCT04304768","phase":"PHASE4","title":"Opioid, HIV and Immune System","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Miami","startDate":"2020-11-18","conditions":"Immune Defect","enrollment":400},{"nctId":"NCT01386424","phase":"","title":"Screening for LID Clinical Studies Unit Healthy Volunteer Protocols","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2011-07-20","conditions":"Zika, Influenza","enrollment":5000},{"nctId":"NCT07204964","phase":"PHASE2","title":"A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2025-10-07","conditions":"Influenza, Human","enrollment":971},{"nctId":"NCT07215858","phase":"PHASE2","title":"BPL-1357 Against H1N1 Influenza Virus Challenge","status":"NOT_YET_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2026-04-01","conditions":"Influenza, Human","enrollment":129},{"nctId":"NCT07464314","phase":"PHASE1","title":"A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2026-03-09","conditions":"Influenza, Human+COVID-19","enrollment":225},{"nctId":"NCT05921448","phase":"EARLY_PHASE1","title":"Vaccine Pandemic Preparedness Through Airway Immunology Characterization","status":"ACTIVE_NOT_RECRUITING","sponsor":"Copenhagen Respiratory Research","startDate":"2025-05-19","conditions":"Influenza, Human","enrollment":60},{"nctId":"NCT07493460","phase":"PHASE4","title":"Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2025-08-26","conditions":"Immunology, Healthy Adults","enrollment":25},{"nctId":"NCT04381689","phase":"PHASE3","title":"Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Il-Yang Pharm. 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