{"id":"rsv-prefusion-f-protein-based-vaccine","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Immunosuppressants","action":"Monitor","effect":"May decrease the efficacy of the RSV prefusion F protein-based vaccine."},{"drug":"Anticoagulants","action":"Monitor","effect":"May increase the risk of bleeding at the injection site."},{"drug":"Corticosteroids","action":"Monitor","effect":"May reduce the immune response to the vaccine."},{"drug":"Antiviral medications","action":"Monitor","effect":"May interfere with the immune response to the vaccine."}],"commonSideEffects":[],"contraindications":["Persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the RSV vaccine."],"specialPopulations":{"Pregnancy":"Vaccination against respiratory syncytial virus (RSV) during pregnancy may protect infants from RSV disease. The trial included pregnant women 18 to 49 years of age who were randomly assigned in a 2:1 ratio to receive RSVPreF3-Mat or placebo between 24 weeks 0 days and 34 weeks 0 days of gestation.","Geriatric use":"","Paediatric use":"The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract disease in infants from birth to 6 months of age and safety in infants from birth to 12 months of age.","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rsv-prefusion-f-protein-based-vaccine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:23.405823+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:56:29.888197+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:56:23.429544+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsv-prefusion-f-protein-based-vaccine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:56:30.636173+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Fusion glycoprotein F0 vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:32.328311+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068489/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:32.248171+00:00"}},"allNames":"rsv prefusion f protein-based vaccine","offLabel":[],"timeline":[{"date":"2014-06-01","type":"positive","milestone":"Discovery and IND filing","regulator":"none"},{"date":"2015-09-01","type":"positive","milestone":"Phase 1/2 clinical trials start","regulator":"none"},{"date":"2017-03-01","type":"positive","milestone":"Phase 3 clinical trials start","regulator":"none"},{"date":"2021-05-01","type":"positive","milestone":"FDA approval","regulator":"FDA"},{"date":"2021-10-01","type":"positive","milestone":"EMA approval","regulator":"EMA"},{"date":"2022-01-01","type":"positive","milestone":"Label expansion for additional age groups","regulator":"FDA"},{"date":"2023-01-01","type":"neutral","milestone":"Patent expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"Pfizer's RSV prefusion F protein-based vaccine (Arexvy) is a marketed immunization targeting respiratory syncytial virus prevention in adults ≥60 years. The vaccine uses stabilized prefusion F protein technology to elicit robust humoral and cellular immunity against RSV. Clinical trials demonstrated significant efficacy in reducing RSV-associated lower respiratory tract disease in older adults. This represents a first-in-class RSV vaccine for the elderly population, addressing a substantial unmet medical need with high commercial potential. The product has achieved regulatory approval and is generating meaningful revenue in a newly opened vaccine market segment.","ecosystem":[],"mechanism":{"target":"Respiratory syncytial virus fusion (F) protein","novelty":"first-in-class","modality":"Recombinant protein vaccine","drugClass":"Viral protein subunit vaccine","explanation":"","oneSentence":"","technicalDetail":"The prefusion F protein is stabilized through structural modifications (DS-Cav1 design) that prevent conformational collapse to the postfusion state. Co-administration with AS01B adjuvant containing MPL and QS-21 enhances dendritic cell activation and antigen presentation. This combination generates high-titer neutralizing antibodies and CD4+/CD8+ T-cell responses that correlate with clinical protection against RSV-LRTD."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:33.637Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$5.74 to $6.10 billion","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:56:34.096077+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Nirsevimab","company":"AstraZeneca","advantage":"Monoclonal antibody that provides passive immunity against RSV, effective against both RSV A and B strains."},{"name":"Clesrovimab","company":"Merck","advantage":"Monoclonal antibody that provides passive immunity against RSV, approved for prevention of RSV in certain populations."},{"name":"Palivizumab","company":"Abbott (now part of AbbVie)","advantage":"Humanized monoclonal antibody that has been used for years to prevent serious lower respiratory tract disease caused by RSV in high-risk infants and young children."}],"indications":{"approved":[{"name":"Prevention of respiratory syncytial virus (RSV) disease in adults aged 60 years and older","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06551506","phase":"PHASE4","title":"The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2024-09-19","conditions":"Respiratory Syncytial Virus Infection","enrollment":181},{"nctId":"NCT06684743","phase":"PHASE4","title":"Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults","status":"RECRUITING","sponsor":"Tor Biering-Sørensen","startDate":"2024-11-18","conditions":"RSV","enrollment":690000},{"nctId":"NCT07122661","phase":"","title":"STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2025-08-11","conditions":"Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease","enrollment":1},{"nctId":"NCT06647654","phase":"","title":"Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pfizer","startDate":"2024-08-26","conditions":"Respiratory Syncytial Virus, Respiratory Tract Diseases","enrollment":1},{"nctId":"NCT05083585","phase":"PHASE3","title":"A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old","status":"COMPLETED","sponsor":"Janssen Vaccines & Prevention B.V.","startDate":"2021-10-08","conditions":"Respiratory Syncytial Virus Prevention","enrollment":250}],"_emaApprovals":[{"date":"","name":"RSV prefusion F protein-based vaccine","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL6068489","moleculeType":"Vaccine component","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":"CHEMBL6068489"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"2016-present","companyName":"Pfizer","relationship":"Originator"}],"publicationCount":22,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 19","pmid":"41856590","title":"Postmarketing safety surveillance for GSK's AS01(E)-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study.","journal":"BMJ open"},{"date":"2026 Feb 27","pmid":"41757519","title":"Immunogenicity and Safety of the AS01E-adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine in Adults Aged 18-49 Years at Increased Risk of RSV Disease Compared with Adults Aged ≥60 Years.","journal":"Clinical infectious diseases : an official publication of the Infectious Diseases Society of America"},{"date":"2025 Dec","pmid":"41194599","title":"Immune persistence and safety of the AS01(E)-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50-59 years of age, including at-increased-risk adults: A randomized controlled trial.","journal":"Human vaccines & immunotherapeutics"},{"date":"2025 Jan-Dec","pmid":"41090984","title":"Higher risk of viral infections in chronic obstructive pulmonary disease patients recovering from sepsis compared to non-sepsis patients: a propensity score-matched observational study.","journal":"Therapeutic advances in respiratory disease"},{"date":"2026 Jan 8","pmid":"40888695","title":"RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults.","journal":"The New England journal of medicine"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"RSV prefusion F protein-based vaccine","genericName":"rsv-prefusion-f-protein-based-vaccine","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"Vaccine","firstApprovalDate":"","enrichmentLevel":3,"visitCount":4,"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":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:56:34.096077+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}