{"id":"tozinameran-5-to-11-years-of-age","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live, intranasal influenza vaccines","action":"Avoid","effect":"Decreased response to vaccine"},{"drug":"Chimeric antigen receptor (CAR) T-cell immunotherapy","action":"Avoid","effect":"Decreased efficacy of CAR T-cell therapy"},{"drug":"Interleukin-2 (IL-2) therapy","action":"Avoid","effect":"Decreased efficacy of IL-2 therapy"},{"drug":"Other vaccines","action":"Avoid","effect":"Decreased response to vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"Decreased response to vaccine"},{"drug":"Interferon","action":"Avoid","effect":"Decreased efficacy of interferon"},{"drug":"Immunosuppressive therapies","action":"Avoid","effect":"Decreased efficacy of immunosuppressive therapies"},{"drug":"Corticosteroids","action":"Avoid","effect":"Decreased efficacy of corticosteroids"},{"drug":"Immunoglobulins","action":"Avoid","effect":"Decreased efficacy of immunoglobulins"},{"drug":"Other immunosuppressive agents","action":"Avoid","effect":"Decreased efficacy of other immunosuppressive agents"}],"commonSideEffects":[],"contraindications":["Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine"],"specialPopulations":{"Pregnancy":"text","Geriatric use":"text","Paediatric use":"This vaccine resource provides key vaccine-specific information for the paediatric formulation of the Pfizer-BioNTech COVID-19 vaccine COMIRNATY®, a messenger RNA (mRNA) based vaccine against coronavirus disease 2019 (COVID-19), recommended for use in children from 5 years to 11 years of age.","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=tozinameran-5-to-11-years-of-age","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:31:15.312671+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:31:21.645509+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:31:15.384139+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tozinameran-5-to-11-years-of-age","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:31:21.994777+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Spike glycoprotein vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:31:23.583167+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4650429/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:31:23.246639+00:00"}},"allNames":"tozinameran 5 to 11 years of age","offLabel":[],"timeline":[],"aiSummary":"Tozinameran is a COVID-19 vaccine developed by Pfizer Inc. It works by stimulating the body's immune system to produce antibodies against the SARS-CoV-2 virus. The vaccine is indicated for the prevention of COVID-19 in individuals 5 years of age and older. It has shown significant commercial success, generating $21.2B in revenue. Tozinameran is a novel vaccine, providing a crucial tool in the fight against COVID-19. Its mechanism of action and clinical differentiation set it apart from other vaccines. Its commercial significance and pipeline developments make it a key player in the pharma industry.","brandName":"Tozinameran 5 to 11 Years of age","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 virus","novelty":"best-in-class","modality":"mRNA","drugClass":"vaccine","explanation":"","oneSentence":"","technicalDetail":"Tozinameran is a mRNA-based vaccine that uses a piece of genetic material called messenger RNA (mRNA) to instruct cells in the body to produce a protein from the SARS-CoV-2 virus. This protein is then recognized by the immune system, triggering an immune response and the production of antibodies. The vaccine is designed to stimulate both humoral and cellular immunity, providing broad protection against COVID-19."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=tozinameran-5-to-11-years-of-age","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tozinameran-5-to-11-years-of-age","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:36:59.402784+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Pfizer-BioNTech COVID-19 Vaccine (10mcg)","company":"Pfizer","advantage":"Has a similar mRNA-based technology and has been approved for emergency use in the same age group.","genericName":"mRNA-1273"},{"name":"Moderna COVID-19 Vaccine (100mcg)","company":"Moderna Therapeutics","advantage":"Also uses mRNA-based technology and has been approved for emergency use in the same age group.","genericName":"mRNA-1273"},{"name":"Novavax COVID-19 Vaccine (5mcg)","company":"Novavax","advantage":"Uses a different technology, but has been approved for emergency use in the same age group.","genericName":"NVX-CoV2373"}],"genericName":"tozinameran-5-to-11-years-of-age","indications":{"approved":[{"name":"Prevention of COVID-19 in individuals 5 years of age and older","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05032976","phase":"","title":"Korea Comirnaty Post-marketing Surveillance","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2022-03-18","conditions":"COVID-19, Vaccines, Adverse Effects","enrollment":12000}],"_emaApprovals":[{"date":"","name":"Tozinameran 5 to 11 Years of age","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL4650429","moleculeType":"Vaccine component","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL4650429"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-04-01 10:46:06.083601+00","biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_revenueClearedDupe":"famtozinameran-12-years-of-age-and-older","_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"mRNA","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":2,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:36:59.402784+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}