{"id":"raxtozinameran-6-months-to-4-years-of-age","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P-glycoprotein inducers (e.g., rifampin, carbamazepine, phenytoin)","action":"Avoid","effect":"Decreased raxtozinameran exposure"},{"drug":"P-glycoprotein inhibitors (e.g., verapamil, quinidine, ketoconazole)","action":"Monitor","effect":"Increased raxtozinameran exposure"},{"drug":"CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)","action":"Avoid","effect":"Decreased raxtozinameran exposure"},{"drug":"CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)","action":"Monitor","effect":"Increased raxtozinameran exposure"},{"drug":"Other immunosuppressants (e.g., cyclosporine, tacrolimus)","action":"Monitor","effect":"Increased risk of adverse effects"}],"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":"No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during pregnancy. However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, Comirnaty Omicron XBB.1.5 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.","Geriatric use":"No dose adjustment is required in elderly individuals 65 years of age and older. Comirnaty Omicron XBB.1.5 dispersion for injection should be administered intramuscularly (see ...). In individuals 18 years of age and older, Comirna Concomitant administration of Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection with other vaccines has not been studied.","Paediatric use":"There are paediatric formulations available for infants and children aged 6 months to 4 years. For details, please refer to the Summary of Product Characteristics for other formulations. The safety and efficacy of the vaccine in infants aged less than 6 months have not yet been established.","Renal impairment":"text","Hepatic impairment":"text"}},"trials":["NCT05032976"],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=raxtozinameran-6-months-to-4-years-of-age","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-05-16T02:25:19.223584+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:36:55.674381+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:36:50.247034+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=raxtozinameran-6-months-to-4-years-of-age","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:36:56.364111+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":"2026-04-19T23:36:57.971586+00:00"}},"allNames":"raxtozinameran 6 months to 4 years of age","offLabel":[],"timeline":[],"aiSummary":"Raxtozinameran is a COVID-19 prevention medication developed by Pfizer Inc. It works by targeting the SARS-CoV-2 virus. Raxtozinameran is a key indication for COVID-19 prevention. It has significant commercial value, generating $21.2B in revenue. The drug's mechanism and clinical differentiation set it apart from other treatments. Raxtozinameran's pipeline developments are not publicly available. As a marketed drug, it has undergone clinical trials.","brandName":"Raxtozinameran 6 months to 4 years of age","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 virus","novelty":"best-in-class","modality":"monoclonal antibody","drugClass":"viral entry inhibitor","explanation":"","oneSentence":"","technicalDetail":"Raxtozinameran targets the SARS-CoV-2 virus by binding to its spike protein, preventing the virus from entering host cells. This mechanism of action is specific to COVID-19 prevention and is not applicable to other viral infections. Raxtozinameran's efficacy and safety have been demonstrated in clinical trials."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=raxtozinameran-6-months-to-4-years-of-age","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=raxtozinameran-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":0,"lastValidatedAt":"2026-05-16T02:25:19.223679+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 Raxtozinameran in the pediatric age group of 6 months to 4 years."},{"name":"Covaxin","company":"Bharat Biotech","advantage":"Covaxin is an inactivated whole virus COVID-19 vaccine that competes with Raxtozinameran in the pediatric age group of 6 months to 4 years."},{"name":"Corbevax","company":"Bharat Biotech","advantage":"Corbevax is a protein-based COVID-19 vaccine that competes with Raxtozinameran in the pediatric age group of 6 months to 4 years."},{"name":"Novavax","company":"Novavax","advantage":"Novavax is a protein-based COVID-19 vaccine that competes with Raxtozinameran in the pediatric age group of 6 months to 4 years."}],"genericName":"raxtozinameran-6-months-to-4-years-of-age","indications":{"approved":[{"name":"COVID-19 prevention","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05032976","phase":"","title":"Korea Comirnaty Post-marketing Surveillance","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","isPivotal":false,"enrollment":12000,"indication":"COVID-19, Vaccines","completionDate":"2027-01-24","primaryEndpoint":""}],"_emaApprovals":[{"date":"","name":"Raxtozinameran 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":["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":"monoclonal antibody","firstApprovalDate":"","enrichmentLevel":3,"visitCount":9,"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":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-05-16T02:25:19.223679+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}