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vaccine."]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=bnt162b2-omi-kp-2","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:40:32.795062+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:40:39.407596+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:40:32.813410+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bnt162b2-omi-kp-2","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:40:40.177791+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA 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It prevents COVID-19 in individuals 5 years of age and older, and in those with certain health conditions. The vaccine has generated $36.8B in revenue. Its mechanism is not explicitly stated. BNT162b2 has undergone 1 clinical trial and has 0 publications. It is a key player in the COVID-19 vaccine market.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Spike protein of SARS-CoV-2","novelty":"first-in-class","modality":"mRNA vaccine","drugClass":"mRNA vaccine","explanation":"","oneSentence":"","technicalDetail":"BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes for the SARS-CoV-2 spike protein. It is designed to induce both humoral and cellular immune responses against SARS-CoV-2."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$36.8B","patientPopulation":"~3 billion","peakSalesEstimate":"$36.8B"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=bnt162b2-omi-kp-2","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=bnt162b2-omi-kp-2","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":"2026-04-19T23:40:43.440285+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"XBB.1.5-adapted vaccines","company":"Unknown","advantage":"Reduced neutralizing activity and effectiveness"},{"name":"Omicron XBB.1.5-adapted BNT162b2 COVID-19 vaccine","company":"Unknown","advantage":"Enhances interferon-JAK-STAT-regulated antiviral programs"},{"name":"BA.2.86 and JN.1 lineages","company":"Unknown","advantage":"Diminished immune response and effectiveness against XBB lineages"},{"name":"XBB lineages","company":"Unknown","advantage":"Diminished immune response and effectiveness against BA.2.86 and JN.1 lineages"},{"name":"BNT162b2 XBB.1.5-adapted vaccines","company":"Unknown","advantage":"Improved neutralizing responses over BNT162b2 XBB.1.5-adapted vaccines"},{"name":"JN.1-adapted vaccines","company":"Unknown","advantage":"Improved neutralizing responses over BNT162b2 XBB.1.5-adapted vaccines"},{"name":"KP.2-adapted vaccines","company":"Unknown","advantage":"Improved neutralizing responses over BNT162b2 XBB.1.5-adapted vaccines"},{"name":"Omicron JN.1 or KP.2-updated BNT162b2 vaccine","company":"Unknown","advantage":"Neutralizing responses to JN.1 sublineages in a vaccine-experienced mouse model"},{"name":"BNT162b2 JN.1- and KP.2-adapted vaccines","company":"Unknown","advantage":"Comparable S-specific CD4+ and CD8+ T cell responses"},{"name":"JN.1 sublineages","company":"Unknown","advantage":"Diminished immune response and effectiveness against XBB lineages"},{"name":"KP.3 sublineage","company":"Unknown","advantage":"Contains the F456L, but not the R346T substitution"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina 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conditions","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05997290","phase":"PHASE2, PHASE3","title":"A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals","status":"COMPLETED","sponsor":"BioNTech SE","startDate":"2023-08-10","conditions":"SARS-CoV-2 Infection, COVID-19","enrollment":1051}],"_emaApprovals":[{"date":"","name":"BNT162b2 (Omi KP.2)","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://investors.biontech.de/news-releases/news-release-details/biontech-announces-second-quarter-2025-financial-results-and/","date":"2026-04-07","type":"news","title":"BioNTech Announces Second Quarter 2025 Financial Results and ...","source":"investors.biontech.de"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Announce Topline Data Demonstrating Robust ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Granted FDA Fast Track Designation for Two ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/announcements/pfizer-and-biontech-announce-us-fda-approval-their-covid-19-vaccine-comirnatyr","date":"2026-04-07","type":"news","title":"Pfizer and BioNTech Announce U.S. FDA Approval of their COVID ...","source":"www.pfizer.com"}],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL4297297","moleculeType":"Small molecule","molecularWeight":"372.42"},"_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":"CHEMBL4297297"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"commercialAnalysis":{"text":"BNT162b2 (Omi KP.2), developed by Pfizer Inc. and BioNTech, is a COVID-19 vaccine with a strong market position, particularly in the prevention of COVID-19 in individuals 5 years of age and older [1]. According to BioNTech's second-quarter 2025 financial results, the company reported €0.3 billion in revenues, with a net loss of €0.4 billion [2]. Despite this, the company maintains a strong financial position with €16.0 billion in cash, cash equivalents, and security investments as of June 30, 2025 [2].\n\nThe competitive landscape for COVID-19 vaccines is intense, with multiple players vying for market share. However, Pfizer's BNT162b2 has received U.S. FDA approval and authorization for the Omicron KP.2-adapted COVID-19 vaccine, which is a significant advantage in the market [3]. Additionally, the vaccine's adaptability to new variants, such as the JN.1 lineage, provides a competitive edge [3].\n\nKey upcoming catalysts for BNT162b2 include the potential for label expansions and pipeline competitors. The vaccine's approval for individuals 6 months through 11 years of age is a significant milestone, and further expansions to this age group could drive revenue growth [3]. However, pipeline competitors, such as mRNA-based cancer immunotherapy candidates, may pose a threat to the vaccine's market share [2].\n\nThe market outlook for BNT162b2 is positive, driven by the vaccine's strong market position and adaptability to new variants. However, the competitive landscape remains intense, and the company will need to continue to innovate and expand its product portfolio to maintain its market share [1].","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://investors.biontech.de/news-releases/news-release-details/biontech-announces-second-quarter-2025-financial-results-and/","date":"","title":"BioNTech Announces Second Quarter 2025 Financial Results and ...","source":"investors.biontech.de"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-topline-data-demonstrating","date":"","title":"Pfizer and BioNTech Announce Topline Data Demonstrating Robust ...","source":"www.pfizer.com"},{"url":"https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization","date":"","title":"Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for ...","source":"www.pfizer.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"BNT162b2 (Omi KP.2)","genericName":"bnt162b2-omi-kp-2","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"mRNA vaccine","firstApprovalDate":"","enrichmentLevel":3,"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":"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":"2026-04-19T23:40:43.440285+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}