{"id":"variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Pain/NSAID medications","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Anticoagulant medications","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antiplatelet medications","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Thrombolytic medications","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Live vaccines","action":"Avoid","effect":"Interference with vaccine efficacy"},{"drug":"Interferon-alpha","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Interferon-beta","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Interferon-gamma","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Immunosuppressants","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Azathioprine","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Cyclosporine","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Mycophenolate","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Sirolimus","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tacrolimus","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Methotrexate","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Leflunomide","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Azacitidine","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Decitabine","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Lenalidomide","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Thalidomide","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Bortezomib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Pazopanib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Sunitinib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Sorafenib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Regorafenib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Cabozantinib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Lenvatinib","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Nivolumab","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Ipilimumab","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Pembrolizumab","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Nivolumab + 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efficacy"},{"drug":"Siponimod","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine 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efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"},{"drug":"Tafinlar + Mekinist + Tafinlar + Mekinist","action":"Monitor","effect":"Decreased vaccine efficacy"}],"commonSideEffects":[],"contraindications":["Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.","Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty.","There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days."],"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 participants women. 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   ...    No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during breast-feeding.  Animal studies do not   ...    with another authorised COVID-19 vaccine (heterologous booster dose), no new safety issues were identified.","Geriatric use":"text","Paediatric use":"Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.   ...    *Children 5 to 11 years of age (i.e. 5 to less than 12 years of age)*   ...    recommendations (see section 4.4). Comirnaty Omicron XBB.1.5 10 micrograms/dose should be used only for children 5 to 11 years of age. *Paediatric population* There are paediatric formulations available for infants and children aged 6 months to 4 years. For details, please   ...    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":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:41:20.720668+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:41:27.520972+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:41:20.792619+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:41:28.067149+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5314803/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:41:29.225292+00:00"}},"allNames":"variant-adapted bnt162b2 (omicron xbb.1.5) 10 microgram dose","offLabel":[],"timeline":[],"aiSummary":"Variant-adapted BNT162b2 (Omicron XBB.1.5) is a 10 microgram dose vaccine developed by Pfizer Inc. It is marketed for the prevention of COVID-19 in individuals 12 years of age and older, and in individuals 6 months through 11 years of age. The vaccine has generated $21.2B in revenue. Its mechanism is not specified on Wikipedia. The vaccine is a variant-adapted version of the BNT162b2 vaccine, which is a type of mRNA vaccine. This variant is specifically designed to target the Omicron XBB.1.5 variant of the SARS-CoV-2 virus. The vaccine's clinical differentiation and pipeline developments are not specified.","brandName":"Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SARS-CoV-2 spike protein","novelty":"variant-adapted","modality":"mRNA vaccine","drugClass":"mRNA vaccine","explanation":"","oneSentence":"","technicalDetail":"The Variant-adapted BNT162b2 (Omicron XBB.1.5) vaccine uses a modified RNA sequence that encodes for the SARS-CoV-2 spike protein. This protein is a key component of the virus and is responsible for its ability to infect cells. The vaccine works by inducing an immune response against this protein, which provides protection against the virus. The vaccine is administered via injection and is designed to be given as a single dose. The vaccine has been shown to be safe and effective in clinical trials."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","patientPopulation":"~100M","peakSalesEstimate":"$21.2B"},"references":[{"id":1,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose","fields":["publications"],"source":"PubMed/NCBI"},{"id":2,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":3,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":4,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:28:30.441980+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Bivalent Wild Type + Omicron BA.4/5 vaccine","company":"Unknown","advantage":"elicited lower serum neutralizing titers against Omicron XBB.1.5, XBB.1.16, XBB.1.16.1, XBB.2.3, EG.5.1 and HV.1 sublineages and phylogenetically distant BA.2.86 lineage"},{"name":"Trivalent recombinant protein vaccine","company":"Unknown","advantage":"induces cross-neutralization against XBB lineage and JN.1 subvariants"},{"name":"mRNA or vector-based COVID-19 vaccinations","company":"Unknown","advantage":"diminished neutralization responses towards SARS-CoV-2 Omicron VoC"}],"genericName":"variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose","indications":{"approved":[{"name":"Prevention of COVID-19 in individuals 12 years of age and older","regulator":"FDA"},{"name":"Prevention of COVID-19 in individuals 6 months through 11 years of age","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL5314803","moleculeType":"Oligonucleotide","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":"CHEMBL5314803"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"mRNA vaccine","firstApprovalDate":"","enrichmentLevel":5,"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":"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}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:28:30.441980+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}