{"id":"famtozinameran-5-to-11-years-of-age","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"Decreased vaccine efficacy"},{"drug":"Interferons","action":"Monitor","effect":"Increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine-related adverse reactions"},{"drug":"Immunosuppressive therapies","action":"Monitor","effect":"Decreased immune response to the vaccine"},{"drug":"Antiviral medications","action":"Monitor","effect":"Decreased antiviral efficacy"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased immune response to the vaccine"},{"drug":"Other vaccines","action":"Avoid","effect":"Decreased vaccine efficacy"},{"drug":"Blood thinners","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Medications that affect blood clotting","action":"Monitor","effect":"Increased risk of bleeding"}],"commonSideEffects":[],"contraindications":["Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY. Do not administer COMIRNATY to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY[seeDescription (11)]or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine."],"specialPopulations":{"Lactation":"The benefits of breastfeeding should be considered along with the mother’s clinical need for VOXZOGO and any potential adverse effects on the breastfed child from VOXZOGO or from the underlying maternal condition.","Pregnancy":"Risk Summary There are no available data on vosoritide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at doses equivalent to 14-times and 200-times, the human exposure at the recommended dose. The available data on vosoritide use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. There are risks to the fetus associated with achondroplasia. The benefits of breastfeeding should be considered along with the mother’s clinical need for VOXZOGO and any potential adverse effects on the breastfed child from VOXZOGO or from the underlying maternal condition.","Geriatric use":"There is no information available on the use of VOXZOGO in patients 65 years of age and older.","Pediatric use":"The safety and effectiveness of VOXZOGO have been established in pediatric patients for the improvement in linear growth in patients with achondroplasia with open epiphyses. Use of VOXZOGO for this indication is supported by a study in 121 pediatric patients aged 5 to 15 years with achondroplasia, pharmacokinetic data in pediatric patients aged 0.4 to 15 years, and pharmacokinetic data in pediatric patients <5 years [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].","Renal impairment":"VOXZOGO is not recommended for patients with eGFR < 60 mL/min/1.73 m2. No dosage adjustment is needed for patients with eGFR ≥ 60 mL/min/1.73 m2."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=famtozinameran-5-to-11-years-of-age","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:39:45.465114+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:39:51.348558+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:39:45.537909+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=famtozinameran-5-to-11-years-of-age","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:39:51.636355+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5315094/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:39:52.906451+00:00"}},"allNames":"famtozinameran 5 to 11 years of age","offLabel":[],"timeline":[],"aiSummary":"Famtozinameran is a COVID-19 prevention medication developed by Pfizer Inc. It works by targeting the SARS-CoV-2 virus. The key indication is for individuals 5 years of age and older. Famtozinameran is a marketed drug with significant commercial success, generating $21.2B in revenue. It has a novel mechanism of action, making it a valuable addition to the COVID-19 prevention landscape. The drug's clinical differentiation lies in its ability to prevent COVID-19 in a younger age group. Its commercial significance is evident in its high revenue generation.","brandName":"Famtozinameran 5 to 11 Years of age","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 spike protein","novelty":"Best-in-class","modality":"Monoclonal antibody","drugClass":"Monoclonal antibody","explanation":"","oneSentence":"","technicalDetail":"Famtozinameran is a monoclonal antibody that binds to the SARS-CoV-2 spike protein, preventing the virus from entering host cells. This mechanism of action is specific to the SARS-CoV-2 virus, making famtozinameran a valuable tool in the fight against COVID-19. The drug's ability to target the virus at the molecular level makes it an effective prevention medication."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=famtozinameran-5-to-11-years-of-age","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=famtozinameran-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":0,"lastValidatedAt":"2026-04-20T08:28:29.243113+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Tozinameran+riltozinameran","company":"Pfizer","advantage":"Provides some protection against BA.4-5 as well as BA.1"},{"name":"Tozinameran+famtozinameran","company":"Pfizer","advantage":"Provides some protection against BA.1 as well as BA.4-5"}],"genericName":"famtozinameran-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":"Famtozinameran 5 to 11 Years of age","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL5315094","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":"CHEMBL5315094"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Infectious Disease"],"_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":"Vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"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":"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":0,"lastValidatedAt":"2026-04-20T08:28:29.243113+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}