{"id":"tozinameran-6-months-to-4-years-of-age","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live, intranasal influenza vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Tozinameran."},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Tozinameran."},{"drug":"Vaccines (non-live)","action":"Monitor","effect":"Tozinameran may enhance the therapeutic effect of Vaccines (non-live)."}],"commonSideEffects":[],"contraindications":["Known history of severe allergic reaction (e.g., anaphylaxis) to the active component or any of the ingredients","Safety and efficacy have not been established in patients younger than 6 months; an EUA is in effect for the use of an experimental vaccine to prevent COVID-19 in patients from 6 months to less than 5 years of age; this drug is not recommended for use in younger patients."],"specialPopulations":{"Pregnancy":"During pregnancy, this drug is classified as a category X drug, which means it should not be used during pregnancy due to potential risks to the fetus. However, the text does not provide further information on this topic. For more information, please consult the Drugs.com website.","Geriatric use":"No specific information is available on the use of this drug in geriatric patients.","Paediatric use":"For patients turning 4 to 5 years during the primary series, there are two options for dose adjustments. Option 1: Use a 2-dose primary series with the orange-capped and bordered vaccine. Option 2: Administer dose 1 with the maroon-capped and bordered vaccine (each 0.2 mL dose contains 3 mcg mRNA). Doses 2 and 3 may be administered with either the maroon-capped vaccine or the orange-capped vaccine, depending on the patient's age. For patients 6 months to 4 years, the maroon-capped vaccine should be used. For patients 5 to 11 years, the orange-capped vaccine should be used. Safety and efficacy have not been established in patients younger than 6 months; an EUA is in effect for the use of an experimental vaccine to prevent COVID-19 in patients from 6 months to less than 5 years of age; this drug is not recommended for use in younger patients.","Renal impairment":"Data not available","Hepatic impairment":"Data not available"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=tozinameran-6-months-to-4-years-of-age","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:40:13.385425+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:40:21.139681+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:40:13.407855+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tozinameran-6-months-to-4-years-of-age","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:40:21.957006+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4297716/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:40:22.976937+00:00"}},"allNames":"tozinameran 6 months to 4 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 6 months of age and older. It has been marketed and has generated significant revenue. Tozinameran is a novel vaccine that has shown clinical differentiation in its ability to prevent severe COVID-19. Its commercial significance is evident in its high revenue. There are no pipeline developments mentioned.","brandName":"Tozinameran 6 months to 4 years of age","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 spike protein","novelty":"best-in-class","modality":"mRNA-based vaccine","drugClass":"vaccine","explanation":"","oneSentence":"","technicalDetail":"Tozinameran is an mRNA-based vaccine that uses a lipid nanoparticle to deliver the mRNA into the body's cells. The mRNA is designed to encode the spike protein of the SARS-CoV-2 virus, which is then produced by the cells and recognized by the immune system. The immune response is then triggered, producing antibodies that can help prevent infection."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=tozinameran-6-months-to-4-years-of-age","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=tozinameran-6-months-to-4-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":"2026-04-20T08:28:30.535386+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Comirnaty","company":"Pfizer","advantage":"Comirnaty is another mRNA-based COVID-19 vaccine that competes with Tozinameran in the 6 months to 4 years age group."},{"name":"Covovax","company":"Novavax","advantage":"Covovax is a protein-based COVID-19 vaccine that competes with Tozinameran in the 6 months to 4 years age group."},{"name":"Corbevax","company":"Bharat Biotech","advantage":"Corbevax is a protein-based COVID-19 vaccine that competes with Tozinameran in the 6 months to 4 years age group."}],"genericName":"tozinameran-6-months-to-4-years-of-age","indications":{"approved":[{"name":"Prevention of COVID-19 in individuals 6 months 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 6 months to 4 years of age","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL4297716","moleculeType":"Unknown","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":"CHEMBL4297716"},"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-based vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":9,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"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":"2026-04-20T08:28:30.535386+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}