{"id":"rsvpref","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"CYP3A4 inhibitors","action":"Monitor","effect":"Increased RSVpreF levels"},{"drug":"CYP3A4 inducers","action":"Monitor","effect":"Decreased RSVpreF levels"},{"drug":"Live attenuated influenza vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Live attenuated MMR vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Live attenuated varicella vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Live attenuated zoster vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Live or inactivated vaccines","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Pneumococcal conjugate vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Pneumococcal polysaccharide vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Rabies vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"},{"drug":"Typhoid vaccine","action":"Avoid","effect":"Reduced vaccine efficacy"}],"commonSideEffects":[],"contraindications":["Nirsevimab (Beyfortus, Sanofi) and clesrovimab (Enflonsia, Merck) are contraindicated in persons with a history of severe allergic reactions (e.g., anaphylaxis) after a previous dose of the same product or to a product component.","As with any injection, when administering nirsevimab or clesrovimab to children with increased risk for bleeding, providers should follow ACIP’s general best practice guidelines for immunization of children with bleeding disorders: www.cdc.gov/vaccines/hcp/imz-best-practices/special-situations.html#cdc_report_pub_study_section_8-vaccinating-persons -with-increased-bleeding-risk.","RSV vaccines are contraindicated for and should not be administered to persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine.","People experiencing moderate or severe acute illness with or without fever should delay RSV vaccination until they are improved, as a precaution."],"specialPopulations":{"Pregnancy":"This study aimed to evaluate maternal safety outcomes following RSVpreF vaccination during pregnancy compared with an unvaccinated cohort using large-scale real-world data. The lack of increased risk of preterm birth (OR 0.90 (95%CI 0.80–1.00)) 13. Our study provides further evidence that nonadjuvanted maternal RSVpreF vaccination did not increase the risk of selected maternal outcome events. However, further research is needed to strengthen the evidence regarding maternal safety outcomes following RSVpreF vaccination. This study compared the maternal safety outcomes following RSVpreF using real-world data. The higher prevalence of the following pre-existing underlying conditions was observed in the vaccinated group: obesity, multiparity, gestational diabetes (GDM), pregestational hypertension, edema, proteinuria or HDP, hemorrhage in early pregnancy, multiparity, infertility, kidney disease, migraine, cystitis, sexually transmitted infection, inflammation","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rsvpref","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:35:45.189708+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:35:50.833131+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:35:45.263117+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:35:51.178330+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"RSVpreF, developed by Pfizer Inc., is a marketed drug used to prevent RSV lower respiratory tract disease in high-risk neonates, infants, and children. It is a monoclonal antibody that targets the RSV virus. The drug has shown significant clinical differentiation in its ability to prevent severe RSV disease. Its commercial significance is evident in its high revenue of $63.6 billion. With 164 publications and 26 trials, RSVpreF has a strong clinical foundation. The drug's mechanism of action involves binding to the RSV F protein, preventing the virus from entering host cells. As a marketed product, RSVpreF has established itself as a key player in the prevention of RSV disease.","brandName":"RSVpreF","ecosystem":[],"isGeneric":true,"mechanism":{"target":"RSV F protein","novelty":"Best-in-class","modality":"Monoclonal antibody","drugClass":"Monoclonal antibody","explanation":"","oneSentence":"","technicalDetail":"RSVpreF is a recombinant human monoclonal antibody that targets the RSV F protein. It is administered via intramuscular injection and has a half-life of approximately 26-30 days. RSVpreF has been shown to be highly effective in preventing severe RSV disease, with a reduction in hospitalization rates of up to 70%."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Biologic — patent protected","currentRevenue":"","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=rsvpref","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref","fields":["publications"],"source":"PubMed/NCBI"},{"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":"2026-04-19T23:35:53.665888+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Nirsevimab","company":"Merck","advantage":"Provides up to 300,000-fold resistance over the parental strain"},{"name":"Clesrovimab","company":"Merck","advantage":"Provides up to 300,000-fold resistance over the parental strain"},{"name":"Palivizumab","company":"Abbott","advantage":"Reduces hospitalization resulting in neutralization escape from antibody MEDI8897"},{"name":"MEDI8897","company":"Not specified","advantage":"Escape from neutralization by Palivizumab"}],"genericName":"rsvpref","indications":{"approved":[{"name":"Prevention of RSV lower respiratory tract disease in neonates at high risk of RSV disease","regulator":"FDA"},{"name":"Prevention of RSV lower respiratory tract disease in infants and children at high risk of RSV 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Multidose Vials in Healthy Female Adults.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-06-24","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":453},{"nctId":"NCT05842967","phase":"PHASE3","title":"A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-05-11","conditions":"RESPIRATORY SYNCYTIAL VIRUS (RSV)","enrollment":885},{"nctId":"NCT06325657","phase":"PHASE3","title":"A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-03-12","conditions":"Respiratory Syncytial Virus","enrollment":648},{"nctId":"NCT06955728","phase":"PHASE4","title":"A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.","status":"NOT_YET_RECRUITING","sponsor":"University of Witwatersrand, South Africa","startDate":"2025-05-01","conditions":"RSV Infections, RSV Immunisation, Preterm Labour","enrollment":13000},{"nctId":"NCT05900154","phase":"PHASE1","title":"A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-06-22","conditions":"RESPIRATORY SYNCYTIAL VIRUS (RSV)","enrollment":128},{"nctId":"NCT04424316","phase":"PHASE3","title":"A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-06-17","conditions":"Respiratory Tract Infection","enrollment":14727},{"nctId":"NCT05886777","phase":"PHASE2","title":"A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus 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monitoring of health outcomes following RSVPreF3 + AS01 and RSVPreF vaccination among Medicare beneficiaries aged 65 years and older in the United States, 2023-2024.","journal":"Vaccine"},{"date":"2026 Mar 14","pmid":"41832196","title":"Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains.","journal":"NPJ vaccines"}],"_drugWebsiteChecked":true,"_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 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