{"id":"e-coli-vaccine-4-dose-b","safety":{"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Antacids","action":"Avoid","effect":"Decreased absorption of vaccine"},{"drug":"Heparin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Nonsteroidal anti-inflammatory drugs (NSAIDs)","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Corticosteroids","action":"Avoid","effect":"Decreased immune response"},{"drug":"Immunosuppressants","action":"Avoid","effect":"Decreased immune response"},{"drug":"Live vaccines","action":"Avoid","effect":"Decreased immune response"},{"drug":"Interferons","action":"Avoid","effect":"Decreased immune response"},{"drug":"Thalidomide","action":"Avoid","effect":"Decreased immune response"}],"contraindications":["Hypersensitivity to any component of the vaccine, including antibiotics used in the production process. Severe immunodeficiency states, such as congenital immunodeficiency or immunosuppression due to disease (e.g., advanced HIV infection) or therapy (e.g., high-dose corticosteroids, alkylating agents, antimetabolites, or radiation). Active, untreated tuberculosis. Acute febrile illness or acute infection. Pregnancy and breastfeeding should be considered as relative contraindications, and vaccination should be postponed unless the benefits clearly outweigh the risks."]},"_chembl":null,"company":"Pfizer Inc.","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=e-coli-vaccine-4-dose-b","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:56.749996+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:57:02.096939+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:56:56.823472+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=e-coli-vaccine-4-dose-b","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:57:02.447273+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1909064/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:57:03.580948+00:00"}},"allNames":"e coli vaccine 4 dose b","timeline":[],"_dailymed":null,"aiSummary":"The E coli Vaccine 4 Dose B, developed by Pfizer Inc., is a marketed drug for preventing traveler's diarrhea caused by ETEC in travelers to areas where this disease is common. It is a vaccine that has undergone 1 trial and has 0 publications. The commercial significance of this drug is not specified. There are no pipeline developments mentioned. The mechanism of action is not provided. This drug is marketed for its ability to prevent a specific type of diarrhea.","brandName":"E coli Vaccine 4 Dose B","isGeneric":true,"mechanism":{"target":"Not available","novelty":"Not available","modality":"Not available","drugClass":"Not available","explanation":"","oneSentence":"","technicalDetail":"Further information on the mechanism of action is not available."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:28:41.857Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"Generic pricing varies by manufacturer","genericStatus":"Generic — off-patent","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=e-coli-vaccine-4-dose-b","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=e-coli-vaccine-4-dose-b","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":"2026-04-19T23:57:05.557233+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"competitors":[{"name":"Cedex","company":"Spectrum Pharmaceuticals","advantage":"Cedex is a broad-spectrum cephalosporin antibiotic that competes with E coli Vaccine 4 Dose B in treating bacterial infections.","genericName":"Cefepime"},{"name":"Maxipime","company":"Bristol-Myers Squibb","advantage":"Maxipime is a broad-spectrum cephalosporin antibiotic that competes with E coli Vaccine 4 Dose B in treating bacterial infections.","genericName":"Cefepime"},{"name":"Cefepime","company":"Various","advantage":"Cefepime is a broad-spectrum cephalosporin antibiotic that competes with E coli Vaccine 4 Dose B in treating bacterial infections.","genericName":"Cefepime"},{"name":"Ceftriaxone","company":"GlaxoSmithKline","advantage":"Ceftriaxone is a broad-spectrum cephalosporin antibiotic that competes with E coli Vaccine 4 Dose B in treating bacterial infections.","genericName":"Ceftriaxone"}],"genericName":"e-coli-vaccine-4-dose-b","indications":{"approved":[{"name":"Traveler's Diarrhea","regulator":"FDA"},{"name":"Typhoid Fever","regulator":"FDA"},{"name":"Shigella","regulator":"FDA"},{"name":"Cholera","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"trialDetails":[{"nctId":"NCT07122986","phase":"PHASE1","title":"A Study to Learn About a Vaccine Against E Coli in Healthy Adults","status":"RECRUITING","sponsor":"Pfizer","startDate":"2025-08-11","conditions":"Healthy Participants","enrollment":310}],"_emaApprovals":[{"date":"","name":"E coli Vaccine 4 Dose B","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"molecularData":{"oral":false,"chemblId":"CHEMBL1909064","moleculeType":"Unknown","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":"CHEMBL1909064"},"_approvalHistory":[],"_offLabelChecked":true,"publicationCount":0,"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"_genericFilersChecked":true,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","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":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:57:05.557233+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}