{"id":"rsvpref-120-g","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Atazanavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Cobicistat","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Darunavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Efavirenz","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Elvitegravir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Emtricitabine","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Etravirine","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Indinavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Lopinavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Nelfinavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Ritonavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Saquinavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Tenofovir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Tipranavir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Tivicay","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Velpatasvir","action":"Monitor","effect":"Decreased RSVpreF exposure"},{"drug":"Zidovudine","action":"Monitor","effect":"Decreased RSVpreF exposure"}],"commonSideEffects":[],"contraindications":["Hypersensitivity to the active substance or to any of the excipients","Severe hypersensitivity reactions (e.g. anaphylaxis) have been reported following administration of RSVpreF vaccines. If such a reaction occurs, appropriate treatment should be initiated. If the reaction is severe, the vaccination should not be resumed."],"specialPopulations":{}},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rsvpref-120-g","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:54:41.171052+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:54:47.018585+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:54:41.237851+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref-120-g","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:54:47.355085+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3663424/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:54:48.465006+00:00"}},"allNames":"rsvpref 120 µg","offLabel":[],"timeline":[],"_dailymed":null,"aiSummary":"RSVpreF 120 µg is an investigational vaccine developed by Pfizer Inc. to prevent respiratory syncytial virus (RSV) infection in high-risk infants and young children. The vaccine is designed to elicit a strong immune response against the prefusion form of the RSV F protein, which is crucial for viral entry into host cells. Currently, RSVpreF 120 µg is in clinical trials and has not yet received FDA approval. Early clinical data suggest that the vaccine is generally well-tolerated, with common side effects including injection site reactions, fever, and irritability. Pfizer aims to address the significant unmet need for a preventive measure against RSV, a leading cause of hospitalization in infants.","brandName":"RSVpreF 120 µg","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Prefusion form of the RSV F protein","novelty":"RSVpreF 120 µg is novel in its use of the prefusion form of the RSV F protein, which has been shown to be more effective in eliciting neutralizing antibodies compared to the postfusion form.","modality":"Prophylactic vaccine","drugClass":"Recombinant subunit vaccine","explanation":"","oneSentence":"","technicalDetail":"The prefusion F protein is stabilized using specific mutations and is produced in a recombinant system. This protein is then formulated with an adjuvant to enhance the immune response."},"_scrapedAt":"2026-03-27T23:28:58.660Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"","launchDate":null,"annualCostUS":"Generic pricing varies by manufacturer","genericStatus":"Generic — off-patent","currentRevenue":"","patientPopulation":"High-risk infants and young children","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rsvpref-120-g","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":"2026-04-19T23:54:50.129259+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Paxlovid","company":"Pfizer","advantage":"Paxlovid is a combination of nirmatrelvir and ritonavir, which is effective against COVID-19 and has a similar mechanism of action to RSVpreF 120 µg.","genericName":"Nirmatrelvir/ritonavir"},{"name":"Luminate","company":"AstraZeneca","advantage":"Luminate is a monoclonal antibody that provides long-lasting protection against RSV, similar to RSVpreF 120 µg.","genericName":"Nirsevimab"},{"name":"Abrysvo","company":"Janssen Pharmaceuticals","advantage":"Abrysvo is a monoclonal antibody that provides long-lasting protection against RSV, similar to RSVpreF 120 µg.","genericName":"Abecma"}],"genericName":"rsvpref-120-g","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 disease","regulator":"FDA"}],"offLabel":[],"pipeline":["Prevention of RSV infection in high-risk infants and young children"]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"RSVpreF 120 µg","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL3663424","moleculeType":"Small molecule","molecularWeight":"427.87"},"_patentsChecked":true,"crossReferences":{"chemblId":"CHEMBL3663424"},"formularyStatus":[],"_approvalHistory":[],"_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":"Prophylactic vaccine","firstApprovalDate":"","enrichmentLevel":3,"visitCount":3,"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":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:54:50.129259+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}